Internet Download Accelerator v2.0.1.532 serial key or number
Internet Download Accelerator v2.0.1.532 serial key or number
NXS Form 63-2600, Users Manual, Technical Data - CONTROL ...
NX Series
Constant and Variable Torque Variable
Speed Drives for Induction Motors
63-2600—1
REFER TO THE START-UP QUICK GUIDE BELOW DURING INSTALLATION AND COMMISSIONING.
IF ANY PROBLEMS OCCUR, PLEASE CONTACT YOUR LOCAL DISTRIBUTOR.
Start-up Quick Guide
1. Check that the delivery corresponds to your order, see Chapter 3.
2. Before taking any commissioning actions read carefully the safety instructions in Chapter
1.
3. Before the mechanical installation, check the minimum clearances around the unit and
check the ambient conditions in Chapter 5.
4. Check the size of the motor cable, mains cable, mains fuses and check the cable
connections, read Chapters 6.1.1.1 to 6.1.1.5..
5. Follow the installation instructions, see Chapter 6.1.5.
6. Control connections are explained in Chapter 6.2.1.
7. If the Start-Up wizard is active, select the language of the keypad and the application
you want to use and confirm by pressing the Enter button. If the Start-Up wizard is not
active, follow the instructions 7a and 7b.
7a. Select the language of the keypad from the Menu M6, page 6.1. Instructions on using
the keypad are given in Chapter 7.
7b. Select the application you want to use from the Menu M6, page 6.2. Instructions on
using the keypad are given in Chapter 7.
8. All parameters have factory default values. In order to ensure proper operation, check
the rating plate data for the values below and the corresponding parameters of
parameter group G2.1.
• nominal voltage of the motor
• nominal frequency of the motor
• nominal speed of the motor
• nominal current of the motor
• motor cosϕ
All parameters are explained in the All in One Application Manual.
9. Follow the commissioning instructions, see Chapter 8.
10. NX_ Frequency Drive is now ready for use.
The Manufacturer is not responsible for the use of the frequency drives
outside the instructions provided.
CONTENTS
NX USER’S MANUAL
INDEX
1 SAFETY
2 EU DIRECTIVE
3 RECEIPT OF DELIVERY
4 TECHNICAL DATA
5 INSTALLATION
6 CABLING AND CONNECTIONS
7 CONTROL KEYPAD
8 COMMISSIONING
9 FAULT TRACING
THE NX FREQUENCY DRIVE USER'S MANUAL
AND THE APPLICATION MANUAL
The User's Manual will provide the necessary information about the installation, commissioning
and operation of NX Frequency Drives. It is recommended that these instructions are studied,
before powering up the frequency drive for the first time.
The Application Manual provides information about the different applications included in the
standard frequency drive. Should these applications not meet the requirements of the process,
contact Honeywell for information on special applications.
This manual is available in both paper and electronic editions. It is recommended that the
electronic version be used where possible as it contains several links and cross-references to
other locations in the manual which makes it easier for the reader to move around in the manual,
to check and find things faster.
NX User's Manual
Index
1. SAFETY....................................................................................................................................6
1.1 WARNINGS..............................................................................................................................................6
1.2 SAFETY INSTRUCTIONS............................................................................................................................6
1.3 GROUNDING AND GROUND FAULT PROTECTION.........................................................................................7
1.4 RUNNING THE MOTOR..............................................................................................................................7
2. DIRECTIVES.............................................................................................................................8
2.1 CE MARKING...........................................................................................................................................8
2.2 EMC DIRECTIVE......................................................................................................................................8
2.2.1 General...............................................................................................................................................8
2.2.2 Technical criteria ................................................................................................................................8
2.2.3 NX frequency drive EMC classification...............................................................................................8
2.2.4 Manufacturer's declaration of conformity............................................................................................9
2.3 UL-LABEL................................................................................................................................................9
3. RECEIPT OF SHIPMENT .......................................................................................................13
3.1 TYPE DESIGNATION CODE ......................................................................................................................13
3.2 STORAGE..............................................................................................................................................13
3.3 MAINTENANCE.......................................................................................................................................14
3.4 WARRANTY ...........................................................................................................................................14
4. TECHNICAL DATA ................................................................................................................15
4.1 INTRODUCTION......................................................................................................................................15
4.2 POWER RATINGS ...................................................................................................................................17
4.2.1 NX_5 – Mains voltage 380—500 V ..................................................................................................17
4.2.2 NX_6 – Mains voltage 525—690 V ..................................................................................................18
4.2.3 NX_2 – Mains voltage 208—240 V ..................................................................................................19
4.3 BRAKE RESISTOR RATINGS ....................................................................................................................20
4.4 TECHNICAL DATA...................................................................................................................................22
5. INSTALLATION......................................................................................................................24
5.1 MOUNTING ............................................................................................................................................24
5.2 COOLING...............................................................................................................................................34
5.2.1 FR4 to FR9 .......................................................................................................................................34
5.2.2 Standalone units (FR10 to FR12).....................................................................................................35
5.3 POWER LOSS ........................................................................................................................................36
5.3.1 Power loss as function of switching frequency .................................................................................36
6. CABLING AND CONNECTIONS............................................................................................40
6.1 POWER UNIT .........................................................................................................................................40
6.1.1 Power connections ...........................................................................................................................40
6.1.1.1 Mains and motor cables ................................................................................................................40
6.1.1.2 DC supply and brake resistor cables.............................................................................................41
6.1.1.3 Control cable .................................................................................................................................41
6.1.1.4 Cable and fuse sizes, NXS B and NXS A......................................................................................41
6.1.1.5 Cable and fuse sizes, NXS C ........................................................................................................42
6.1.1.6 Cable and fuse sizes, NX_A, FR10 to FR12 .................................................................................42
6.1.1.7 Cable and fuse sizes, NX_C, FR10 to FR12 .................................................................................43
6.1.2 Understanding the power unit topology ............................................................................................43
6.1.3 Changing EMC protection class from H to T ....................................................................................44
6.1.4 Mounting of cable accessories .........................................................................................................46
6.1.5 Installation instructions .....................................................................................................................48
6.1.5.1 Stripping lengths of motor and mains cables.................................................................................50
6.1.5.2 NX frequency drive frames and installation of cables....................................................................51
6.1.6 Cable installation and the UL standards...........................................................................................58
6.1.7 Cable and motor insulation checks...................................................................................................59
6.2 CONTROL UNIT ......................................................................................................................................60
6.2.1 NXS and NXP single phase input applications 380-500 VAC ..........................................................61
6.2.2 Control connections..........................................................................................................................62
6.2.2.1 Control cables................................................................................................................................63
6.2.2.2 Galvanic isolation barriers .............................................................................................................63
6.2.3 Control terminal signals ....................................................................................................................65
6.2.3.1 Digital input signal inversions ........................................................................................................66
6.2.3.2 Jumper selections on the OPT-A1 basic board .............................................................................67
7. CONTROL KEYPAD ..............................................................................................................69
7.1 INDICATIONS ON THE KEYPAD DISPLAY ...................................................................................................69
7.1.1 Drive status indications.....................................................................................................................69
7.1.2 Control place indications ..................................................................................................................70
7.1.3 Status LEDs (green – green – red)...................................................................................................70
7.1.4 Text lines ..........................................................................................................................................71
7.2 KEYPAD PUSH-BUTTONS........................................................................................................................72
7.2.1 Button descriptions ...........................................................................................................................72
7.3 NAVIGATION ON THE CONTROL KEYPAD ..................................................................................................73
7.3.1 Monitoring menu (M1) ......................................................................................................................75
7.3.2 Parameter menu (M2) ......................................................................................................................76
7.3.3 Keypad control menu (M3) ...............................................................................................................78
7.3.3.1 Selection of control place ..............................................................................................................78
7.3.3.2 Keypad reference ..........................................................................................................................79
7.3.3.3 Keypad direction............................................................................................................................79
7.3.3.4 Stop button activated.....................................................................................................................79
7.3.4 Active faults menu (M4)....................................................................................................................80
7.3.4.1 Fault types .....................................................................................................................................81
7.3.4.2 Fault codes....................................................................................................................................82
7.3.4.3 Fault time data record....................................................................................................................84
7.3.5 Fault history menu (M5)....................................................................................................................85
7.3.6 System menu (M6) ...........................................................................................................................86
7.3.6.1 Language selection .......................................................................................................................89
7.3.6.2 Application selection......................................................................................................................89
7.3.6.3 Parameter copy .............................................................................................................................90
7.3.6.4 Parameter comparison ..................................................................................................................92
7.3.6.5 Security..........................................................................................................................................93
7.3.6.6 Keypad settings .............................................................................................................................95
7.3.6.7 Hardware settings..........................................................................................................................96
7.3.6.8 System info....................................................................................................................................99
7.3.7 Expander board menu (M7)............................................................................................................103
7.4 FURTHER KEYPAD FUNCTIONS .............................................................................................................104
8. COMMISSIONING ................................................................................................................105
8.1 SAFETY...............................................................................................................................................105
8.2 COMMISSIONING OF THE FREQUENCY DRIVE.........................................................................................105
9. FAULT TRACING .................................................................................................................108
1
6(110) Safety
1. SAFETY
ONLY A COMPETENT ELECTRICIAN SHOULD CARRY OUT
THE ELECTRICAL INSTALLATION
1.1 Warnings
WARNING
1
The NX frequency drive is meant for fixed installations only.
2
Do not perform any measurements when the frequency drive is
connected to the mains. The motor terminals U, V, W and the DClink/brake
resistor terminals –/+ are live when the NX is connected to
mains, even if the motor is not running.
3
Do not perform any voltage withstand tests on any part of the NX.
4
The frequency drive has a large capacitive leakage current.
5
If the frequency drive is used as a part of a machine, the machine
manufacturer is responsible for providing the machine with a main switch
(EN 60204-1).
6
Only spare parts delivered by Honeywell can be used.
7
The motor starts at power-up if the start command is 'ON'. Furthermore,
the I/O functionalities (including start inputs) may change if parameters,
applications or software are changed. Disconnect, therefore, the motor if
an unexpected start can cause danger.
8
Prior to measurements on the motor or the motor cable, disconnect the
motor cable from the frequency drive.
9
Do not touch the IC-circuits on the circuit boards. Static voltage discharge
may damage the components.
1.2 Safety instructions
1
The components of the power unit of the frequency drive are live when
the NX is connected to mains potential. ontact with this voltage is
extremely dangerous and may cause death or severe injury. The
control unit is isolated from the potential.
2
The motor terminals U, V, W and the DC-link/brake resistor terminals –/+
are live when the NX is connected to mains, even if the motor is not
running.
3
After disconnecting the frequency drive from the mains, wait until the fan
stops and the indicators on the keypad extinguish. (if no keypad is
attached see the indicators on the cover). Wait 5 more minutes before
doing any work on the NX connections. Do not even open the cover
before this time has expired.
4
The control I/O-terminals are isolated from the mains potential. However,
the relay outputs and other I/O-terminals may have a dangerous control
voltage present even when the NX is disconnected from mains.
5
Before connecting the frequency drive to mains, ensure that the
frequency drive front and cable covers are closed.
Safety 7(110)
1
1.3 Grounding and ground fault protection
The NX frequency drive must always be grounded via a conductor connected to the grounding
terminal .
The ground fault protection inside the frequency drive protects only the drive itself against ground
faults in the motor or the motor cable.
If fault current protective switches (e.g. RCD or Ground Leakage devices) are to be used in
conjunction with the frequency drive, they must be tested with ground fault currents that are
possible to arise in fault situations.
1.4 Running the motor
Warning symbols
For your own safety please pay special attention to the instructions marked with the following
symbols:
= Dangerous voltage
WARNING
= General warning
HOT SURFACE
= Hot surface – Risk of burn
MOTOR RUN CHECK LIST
1
Before starting the motor, check that the motor is mounted properly
and ensure that the machine connected to the motor allows the
motor to be started.
2
Set the maximum motor speed (frequency) according to the motor
and the machine connected to it.
3
Before reversing the motor shaft rotation direction make sure that
WARNING this can be done safely.
4
Ensure that no power correction capacitors are connected to the
motor cable.
5
Ensure that the motor terminals are not connected to mains
potential.
8(110) DIRECTIVES
2. DIRECTIVES
2.1 CE marking
The CE marking on the product guarantees the free movement of the product within the EEA
(European Economic Area). It also guarantees that the product meets the various requirements
defined by the directive.
The NX frequency drives carry the CE label as a proof of compliance with the Low Voltage
Directive (LVD) and the Electro Magnetic Compatibility (EMC). The company SGS FIMKO has
acted as the Competent Body.
2.2 EMC directive
2.2.1 General
The EMC Directive provides that the electrical apparatus must not excessively disturb the
environment it is used in, and also, it shall have an adequate level of immunity toward other
disturbances from the same environment.
The compliance of the NX frequency drives with the EMC directive is verified with Technical
Construction Files (TCF) checked and approved by SGS FIMKO, which is a Competent Body. The
Technical Construction Files are used to authenticate the comformity of the NX frequency drives
with the Directive due to the large product family & variety of installations possibilities.
2.2.2 Technical criteria
The NX frequency drives are marketed throughout the world, a fact which makes the EMC
requirements of customers different. As far as the immunity is concerned, all NX frequency drives
are designed to fulfil even the strictest requirements, while as regards the emission level, the
customer may want to upgrade the NX's already high ability to filter electro-magnetic
disturbances.
2.2.3 NX frequency drive EMC classification
The NX frequency drives are divided into three classes, according to the level of electromagnetic
disturbances emitted. There is no difference in the functions or the control electronics between
these classes but their EMC properties vary as follows:
Class H:
NX_5 frequency drives (FR4 to FR9) and NX_2 frequency drives (FR4 to FR6) have been
designed to fulfil the requirements of the product standard IEC 61800-3+A11 for the 1st
environment restricted distribution and the 2nd environment.
The emission levels correspond to the requirements of IEC 61000-6-4.
Class L (NX_5, FR10 only):
Provides filtering for the 2 nd environment, restricted distribution according to IEC 61800-3+A11.
2
DIRECTIVES 9(110)
Class T:
The T-class drives have a small ground current and can be used with IT supplies only. If they are
used with other supplies no EMC requirements are complied with.
Class N:
The drives of this class do not provide EMC emission protection. This kind of drives are mounted
in enclosures.
All NX frequency drives fulfil all EMC immunity requirements (standards IEC 61000-6-1,
61000-6-2 and IEC 61800-3+A11).
Warning: This is a product of the restricted sales distribution class according to IEC 61800-
3. In a domestic environment this product may cause radio interference in which case the
user may be required to take adequate measures.
Note: For changing the EMC protection class of your NX frequency drive from class H to class T,
please refer to the instructions given in Chapter 6.3.1.
2.2.4 Manufacturer's declaration of conformity
The following pages present the photocopies of the Manufacturer's Declarations of Conformity
assuring the compliance of the NX frequency drives with the EMC-directives.
2.3 UL-label
The NX frequency drives are UL-listed according to the standards, based on the needed voltage
and power range. For more information contact you local Honeywell distributor. More information
of cable selection and installation can be found from chapter 5 and 6.
2
10(110) DIRECTIVES
We
Manufacturer's name:
EU DECLARATION OF CONFORMITY
Vacon Oyj
Manufacturer's address: P.O.Box 25
Runsorintie 7
FIN-65381 Vaasa
Finland
hereby declare that the product
Product name:
Model designation:
NXS/P Frequency converter
NXS/P 0003 5…. to 0520 5….
has been designed and manufactured in accordance with the following
standards:
Safety: EN50178 (1997), EN60204-1 (1996)
EN 60950 (3rd edition 2000, as relevant)
EMC: EN61800-3 (1996)+A11(2000), EN 61000-6-2
(1999), EN 61000-6-4 (2001)
and conforms to the relevant safety provisions of the Low Voltage Directive
(73/23/EEC) as amended by the Directive (93/68/EEC) and EMC Directive
89/336/EEC.
It is ensured through internal measures and quality control that the product
conforms at all times to the requirements of the current Directive and the
relevant standards.
In Vaasa, 5th of May, 2003
Vesa Laisi
President
The year the CE marking was affixed: 2002
2
Receipt of shipment 11(110)
3
We
Manufacturer's name:
EU DECLARATION OF CONFORMITY
Vacon Oyj
Manufacturer's address: P.O.Box 25
Runsorintie 7
FIN-65381 Vaasa
Finland
hereby declare that the product
Product name:
NXS/P Frequency converter
Model designation:
NXS/P 0004 6…. to 0416 6….
has been designed and manufactured in accordance with the following
standards:
Safety: EN50178 (1997), EN60204-1 (1996)
EN 60950 (3rd edition 2000, as relevant)
EMC: EN61800-3 (1996)+A11(2000), EN 61000-6-2
(1999), EN 61000-6-4 (2001)
and conforms to the relevant safety provisions of the Low Voltage Directive
(73/23/EEC) as amended by the Directive (93/68/EEC) and EMC Directive
89/336/EEC.
It is ensured through internal measures and quality control that the product
conforms at all times to the requirements of the current Directive and the
relevant standards.
In Vaasa, 17th of November, 2003
Vesa Laisi
President
The year the CE marking was affixed: 2003
3
12(110) Receipt of shipment
We
Manufacturer's name:
EU DECLARATION OF CONFORMITY
Vacon Oyj
Manufacturer's address: P.O.Box 25
Runsorintie 7
FIN-65381 Vaasa
Finland
hereby declare that the product
Product name:
NXS/P Frequency converter
Model designation:
NXS/P 0003 2…. to 0114 2….
has been designed and manufactured in accordance with the following
standards:
Safety: EN50178 (1997), EN60204-1 (1996)
EN 60950 (3rd edition 2000, as relevant)
EMC: EN61800-3 (1996)+A11(2000), EN 61000-6-2
(1999), EN 61000-6-4 (2001)
and conforms to the relevant safety provisions of the Low Voltage Directive
(73/23/EEC) as amended by the Directive (93/68/EEC) and EMC Directive
89/336/EEC.
It is ensured through internal measures and quality control that the product
conforms at all times to the requirements of the current Directive and the
relevant standards.
In Vaasa, 10th of November, 2003
Vesa Laisi
President
The year the CE marking was affixed: 2003
Note: Ask factory for other possible installation combinations.
Receipt of shipment 13(110)
3
3. RECEIPT OF SHIPMENT
The NX frequency drives have undergone rigorous tests and quality checks at the factory before
delivery. However, after unpacking the product, check that no signs of transport damages are to
be found on the product and that the delivery is complete (compare the type designation of the
product to the code below, Figure 3-1.
Should the drive have been damaged during the shipping, contact the carrier and or distributor.
If the delivery does not correspond to your order, contact the supplier immediately.
In the small plastic bag included in the delivery you will find a silver Drive modified sticker. The
purpose of the sticker is to notify the service personnel about the modifications made in the
frequency drive. Attach the sticker on the side of the frequency drive to avoid losing it. Should the
frequency drive be later modified (option board added, IP or EMC protection level changed), mark
the change in the sticker.
3.1 Type designation code
N X S 0 0 5 0 B 1 2
E n c l osure 00 Open chassis
10 Nema 1
12 Nema 12
V o l t a ge range B 208-240 Vac 3 p h a s e
A 380-500 Vac 3 p h a s e
C 525-690 Vac 3 p h a s e
M o t or Power (HP) 0005 1/2 HP
L o w overloadability: 0050 5 HP
1 0 % overload at 0400 40 HP e t c
1 0 4 deg F
Figure 3-1. NX type designation code
P r o duct Series
NXS
NXL
3.2 Storage
If the frequency drive is to be kept in store ensure that the ambient conditions are acceptable:
Storing temperature -40…+158°F (-40…70° C)
Relative humidity
3
14(110) Receipt of shipment
3.3 Maintenance
In normal conditions, the NX frequency drives are maintenance-free. However, it is recommended
the heatsink be cleared periodically with compressed air. The cooling fan can easily be changed if
necessary.
It may also be necessary to check the tightening torques of terminals at regular intervals.
3.4 Warranty
Only manufacturing defects are covered by the warranty. The manufacturer assumes no
responsibility for damages caused during or resulting from transport, receipt of the delivery,
installation, commissioning or use.
The manufacturer shall in no event and under no circumstances be held responsible for damages
and failures resulting from misuse, incorrect installation, unacceptable ambient temperature, dust,
corrosive substances or operation outside the rated specifications.
Neither can the manufacturer be held responsible for consequential damages.
The Manufacturer's period of warranty is 18 months from the delivery or 12 months from the
commissioning whichever expires first.
The local distributor may grant a warranty time different from the above. This warranty period shall
be specified in the distributor's sales and warranty terms. The manufacturer assumes no
responsibility for warranties offered by others. With all warranty issues, please contact the
distributor first.
Technical data 15(110)
4. TECHNICAL DATA
4.1 Introduction
Figure 4-1 presents the block diagram of the NX frequency drive. The frequency drive consists of
two units, the Power Unit and the Control Unit.
The three-phase AC-choke (1) at the mains end together with the DC-link capacitor (2) form an
LC-filter, which, again, together with the diode bridge produce the DC-voltage supply to the IGBT
Inverter Bridge (3) block. The AC-choke also functions as a filter against High Frequency
disturbances from the mains as well as against those caused by the frequency drive to the mains.
It, in addition, enhances the waveform of the input current to the frequency drive. The entire power
drawn by the frequency drive from the mains is active power.
The IGBT Inverter Bridge produces a symmetrical, 3-phase PWM-modulated AC-voltage to the
motor.
The Motor and Application Control Block is based on microprocessor software. The
microprocessor controls the motor basing on the information it receives through measurements,
parameter settings, control I/O and control keypad. The motor and application control block
controls the motor control ASIC which, in turn, calculates the IGBT positions. Gate drivers amplify
these signals for driving the IGBT inverter bridge.
Power
module
Brake resistor*
Mains
L1
L2
L3
1)
Integrated input module
Rectifier
3~
=
Charg.res.
Brake
Chopper*
2)
3)
IGBT
Inverter Current
Sensors
=
3~
Motor
U Output
V EMCfilter
W
Fan
Power
Supply
Measurements
Gate
Drivers
Voltage
Sensors
NXP
Control
Keypad
Control
module
Motor and
Application
Control
Motor
Control
ASIC
Control
I/O
Control
I/O
Control
I/O
Control
I/O
Control
I/O
*The brake resistor can be installed internally in classes FR4 to FR6 (NX_2 and NX_5). In all other
frames of voltage classes NX_2 and NX_5, as well as in all frames of all other voltage classes, the
brake resistor is available as option and installed externally.
Brake chopper belongs to the standard equipment in classes FR4 to FR6, while in greater classes
(FR7 to FR9) it is optional.
Figure 4-1. NX block diagram
Automation and Control Solutions
Honeywell
Honeywell Limited-Honeywell Limitée
1985 Douglas Drive North 35 Dynamic Drive
Golden Valley, MIN 55422 Scarborough, Ontario 63-2600-1
MIV 4Z9
www.honeywell.com
4
16(110) Technical data
The control keypad provides a link between the user and the frequency drive. The control keypad
is used for parameter setting, reading status data and giving control commands. It is detachable
and can be operated externally and connected via a cable to the frequency drive. Also a PC can
be used instead of the control keypad, to control the frequency drive, if connected through a
similar cable.
Control I/O boards which are either isolated (OPT-A8) or not isolated (OPT-A1) from the ground
are available.
The default application (Basic Application) is preferred when speed control will be dictated by a
separate automation system. If a more versatile interface or parameters are required, a more
suitable application can be chosen from the Application Package. See the Application Manual for
more information on the different applications.
A brake resistor is available as internal option for frames FR4 to FR6 of voltage classes NX_2 and
NX_5. In all other frames of voltage classes NX_2 and NX_5, as well as in all frames of all other
voltage classes, the brake resistor is available as option and installed externally.
Optional I/O expander boards that increase the number of inputs and outputs to be used are also
available. For details please contact your nearest Honeywell office or your local distributor (see
back cover).
The input and output EMC filters have no influence on the basic functions of the frequency drives
and significantly enhance the protection of the drive from external interference as well as
protecting other sensitive equipment from harmonics generated by the frequency drive. They are
also necessary for the fulfillment of the EMC directives.
4
Automation and Control Solutions
Honeywell
Honeywell Limited-Honeywell Limitée
1985 Douglas Drive North 35 Dynamic Drive
Golden Valley, MIN 55422 Scarborough, Ontario 63-2600-1
MIV 4Z9
www.honeywell.com
Technical data 17(110)
4.2 Power ratings
4.2.1 NX_5 – Mains voltage 380—500 V
Low overload = 150% starting torque, 2 sec/20 sec, 110% overloadability, 1 min/10 min
Following continuous operation at rated output current, 110% rated output current (IL)
for 1 min, followed by a period of load current less than rated current, and of such
duration that the r.m.s output current, over the duty cycle, does not exceed rated output
current (IL)
High overload = 200% starting torque, 2 sec/20 sec, 150% overloadability, 1 min/10 min
Following continuous operation at rated output current, 150 % rated output current (IH)
for 1 min, followed by a period of load current less than rated current, and of such
duration that the r.m.s output current, over the duty cycle, does not exceed rated output
current (IH)
All sizes up to and including FR9 are wall mounted available with NEMA1 enclosure and
NEMA12 as option. All sizes above and including FR10 are standalone NEMA 1 NXP units.
For single phase input connections, ratings and wiring instructions can be found in 6.2.1
Mains voltage 380-500 V, NEMA 1/12, EMC-level H
Frequency Motor shaft power (500V) and current
drive type Low overload High overload
P [Hp]
(500V)
I(L)
P [Hp]
(500V)
I(H)
I(max)
Size / prot. FR/IP
Dimensions
WxHxD
(in)
Weight
(lb)
NX_ 0015 A 1.5 3.3 1 2.2 4.4 FR4/NEMA 1/12 5.0x11.5x7.5 11.02
NX_ 0020 A 2 4.3 1.5 3.3 6.2 FR4/NEMA 1/12 5.0x11.5x7.5 11.02
NX_ 0030 A 3 5.6 2 4.3 8.6 FR4/NEMA 1/12 5.0x11.5x7.5 11.02
NX_ 0040 A 4 7.6 3 5.6 10.8 FR4/NEMA 1/12 5.0x11.5x7.5 11.02
NX_ 0050 A 5 9 4 7.6 14 FR4/NEMA 1/12 5.0x11.5x7.5 11.02
NX_ 0075 A 7.5 12 5 9 18 FR4/NEMA 1/12 5.0x11.5x7.5 11.02
NX_ 0100 A 10 16 7.5 12 24 FR5/NEMA 1/12 5.7x15.4x8.4 17.86
NX_ 0150 A 15 23 10 16 32 FR5/NEMA 1/12 5.7x15.4x8.4 17.86
NX_ 0200 A 20 31 15 23 46 FR5/NEMA 1/12 5.7x15.4x8.4 17.86
NX_ 0250 A 25 38 20 31 62 FR6/NEMA 1/12 7.7x20.4x9.3 40.8
NX_ 0300 A 30 46 25 38 76 FR6/NEMA 1/12 7.7x20.4x9.3 40.8
NX_ 0400 A 40 61 30 46 92 FR6/NEMA 1/12 7.7x20.4x9.3 40.8
NX_ 0500 A 50 72 40 61 122 FR7/NEMA 1/12 9.3x23.3x10.1 77.2
NX_ 0600 A 60 87 50 72 144 FR7/NEMA 1/12 9.3x23.3x10.1 77.2
NX_ 0750 A 75 105 60 87 174 FR7/NEMA 1/12 9.3x23.3x10.1 77.2
NX_ 1000 A 100 140 75 105 210 FR8/NEMA 1/12 11.2x28.4x11.3 127.9
NX_ 1250 A 125 170 100 140 280 FR8/NEMA 1/12 11.2x28.4x11.3 127.9
NX_ 1500 A 150 205 125 170 336 FR8/NEMA 1/12 11.2x28.4x11.3 127.9
NX_ 2000 A 200 261 150 205 349 FR9/NEMA 1/12 18.9x45.3x14.3 321.9
NX_ 2500 A 250 300 200 245 444 FR9/NEMA 1/12 18.9x45.3x14.3 321.9
NXP 3000 A 300 385 250 300 540 FR10/NEMA1 23.6x89.6x23.6 661.1
NXP 3500 A 350 460 300 385 693 FR10/NEMA1 23.6x89.6x23.6 661.1
NXP 4500 A 450 520 350 460 828 FR10/NEMA1 23.6x89.6x23.6 661.1
NXP 5000 A 500 590 450 520 936 FR11/NEMA1 31.6x79.4x23.6 815.7
NXP 5500 A 550 650 500 590 1062 FR11/NEMA1 31.6x79.4x23.6 815.7
NXP 6000 A 600 730 550 650 1170 FR11/NEMA1 31.6x79.4x23.6 815.7
NXP 6500 A 650 820 600 730 1314 FR12/NEMA1 47.6x 79.4x 23.6 1322.8
NXP 7000 A 700 920 650 820 1476 FR12/NEMA1 47.6x 79.4x 23.6 1322.8
NXP 8000 A 800 1030 700 920 1654 FR12/NEMA1 47.6x 79.4x 23.6 1322.8
Table 4-1. Power ratings and dimensions of the NX, supply voltage 380—500V.
Note: The rated currents in given ambient temperatures are achieved only when the switching frequency is
equal to or less than the factory default.
Note: The rated currents for FR10 to FR12 are all valid at an ambient temperature of 104 °F.
Automation and Control Solutions
Honeywell
Honeywell Limited-Honeywell Limitée
1985 Douglas Drive North 35 Dynamic Drive
Golden Valley, MIN 55422 Scarborough, Ontario 63-2600-1
MIV 4Z9
www.honeywell.com
4
18(110) Technical data
4.2.2 NX_6 – Mains voltage 525—690 V
High overload = Max current IS, 2 sec/20 sec, 150% overloadability, 1 min/10 min
Following continuous operation at rated output current, 150 % rated output current (IH)
for 1 min, followed by a period of load current less than rated current, and of such
duration that the r.m.s output current, over the duty cycle, does not exceed rated output
current (IH)
Low overload = Max current IS, 2 sec/20 sec, 110% overloadability, 1 min/10 min
Following continuous operation at rated output current, 110% rated output current (IL)
for 1 min, followed by a period of load current less than rated current, and of such
duration that the r.m.s output current, over the duty cycle, does not exceed rated output
ORIGINAL RESEARCH Impact of pretreatment PET ... - Surgery News
ORIGINALRESEARCH
ImpactofpretreatmentPET on disease control
and treatment decisions in locoregionally
advanced esophageal cancer patients treated
with chemoradiotherapy
John M. Watkins et al p. 8
Variation by age in neutropenic
complications among patients with
cancer receiving chemotherapy
Henry J. Henk et al p. 16
COMMENTARY
Regorafenib monotherapy for previously
treated metastatic colorectal cancer
Stuart M. Lichtman, MD p. 3
COMMUNITY TRANSLATIONS
Regorafenib in previously treated
metastatic colorectal cancer
Edited by Jame Abraham, MD p. 5
FEATURES
Technology: LinkedIn Facebook
HIPPA friendly and secure Doximity
Neil Osterweil p. 33
Volume 10 ● Number 1 ● January 2013
There is an association between
pretreatmentPET and disease
control endpoints, including
locoregional control in esophageal
tumors treated with
chemoradiotherapy.
John M. Watkins p. 8
Oncologists should evaluate patient
comorbidities and chemotherapy
characteristics as well as age when
assessing the risks for neutropeniarelated
hospitalization.
Henry J. Henk p. 16
One of the caveats for regorafenib for
previously treated metastatic
colorectal is that none of the patients
in the trial were in their 70s, which
is the age range of most patients
with this disease.
Stuart M. Lichtman p. 3
Complete table of contents, page A7
COMMUNITY ONCOLOGY January 2013
Volume 10, Number 1 (pp 1–34)
For chronic lymphocytic leukemia (CLL)
refractory to fludarabine and alemtuzumab
EXPAND YOUR OPTIONS
A study population in need of additional treatment options 1,2
5 median
prior therapies
59%
93%
100%
The following serious adverse events (AEs) are discussed in greater detail below:
Infusion reactions, cytopenias, progressive multifocal leukoencephalopathy, hepatitis B
infection and reactivation, and intestinal obstruction.
To learn more, please visit www.ARZERRA.com.
Indication
ARZERRA (ofatumumab) is indicated for the treatment
of patients with chronic lymphocytic leukemia (CLL)
refractory to fludarabine and alemtuzumab.
The effectiveness of ARZERRA is based on the
demonstration of durable objective responses. No
data demonstrate an improvement in disease-related
symptoms or increased survival with ARZERRA.
Important Safety Information
Infusion Reactions
ARZERRA can cause serious infusion reactions manifesting
as bronchospasm, dyspnea, laryngeal edema, pulmonary
edema, flushing, hypertension, hypotension, syncope,
cardiac ischemia/infarction, back pain, abdominal pain,
pyrexia, rash, urticaria, and angioedema. Infusion reactions
occur more frequently with the first 2 infusions. Premedicate
with acetaminophen, an antihistamine, and a corticosteroid.
Interrupt infusion for infusion reactions of any severity.
Institute medical management for severe infusion reactions
including angina, or other signs and symptoms of myocardial
ischemia. In a study of patients with moderate to severe
chronic obstructive pulmonary disease, an indication for
which ARZERRA is not approved, 2 of 5 patients developed
Grade 3 bronchospasm during infusion. Infusion reactions
occurred in 44% of patients on the day of the first infusion
(300 mg), 29% on the day of the second infusion (2,000 mg),
and less frequently during subsequent infusions.
of patients received prior rituximab
of patients received prior alkylating agents
of patients received prior fludarabine and alemtuzumab
Cytopenias
Prolonged (≥1 week) severe neutropenia and
thrombocytopenia can occur with ARZERRA. Monitor
complete blood counts (CBC) and platelet counts at regular
intervals during therapy, and increase the frequency of
monitoring in patients who develop Grade 3 or 4 cytopenias.
Of 108 patients with normal neutrophil counts at baseline,
45 (42%) developed ≥Grade 3 neutropenia. Nineteen (18%)
developed Grade 4 neutropenia. Some patients experienced
new onset Grade 4 neutropenia >2 weeks in duration.
Progressive Multifocal Leukoencephalopathy
Progressive multifocal leukoencephalopathy (PML),
including fatal PML, can occur with ARZERRA. Consider
PML in any patient with new onset of or changes in
pre-existing neurological signs or symptoms. Discontinue
ARZERRA if PML is suspected and initiate evaluation for
PML including consultation with a neurologist, brain MRI,
and lumbar puncture.
Hepatitis B Infection and Reactivation
Fulminant and fatal hepatitis B virus (HBV) infection and
reactivation can occur in patients following treatment with
ARZERRA. Screen patients at high risk of HBV infection
before initiation of ARZERRA. Closely monitor carriers of
hepatitis B for clinical and laboratory signs of active HBV
infection during treatment with ARZERRA and for 6 to 12
months following the last infusion of ARZERRA. Discontinue
ARZERRA in patients who develop viral hepatitis or
When treated with ARZERRA monotherapy, 42% of patients with
CLL refractory to fludarabine and alemtuzumab achieved a partial response 1
Overall response rate with ARZERRA
60
50
40
30
20
10
42%
FLUDARABINE AND
ALEMTUZUMAB REFRACTORY
(n=59)
reactivation of viral hepatitis, and institute appropriate
treatment. Insuffi cient data exist regarding the safety of
administration of ARZERRA in patients with active hepatitis.
Intestinal Obstruction
Obstruction of the small intestine can occur in patients
receiving ARZERRA. Perform a diagnostic evaluation if
obstruction is suspected.
Immunizations
The safety of immunization with live viral vaccines during or
following administration of ARZERRA has not been studied.
Do not administer live viral vaccines to patients who have
recently received ARZERRA. The ability to generate an
immune response to any vaccine following administration
of ARZERRA has not been studied.
Most Common Adverse Reactions
In the pivotal study (total population, n=154) the most
common adverse reactions (≥10%, all grades) were
neutropenia, followed by pneumonia (23%), pyrexia (20%),
cough (19%), diarrhea (18%), anemia (16%), fatigue (15%),
dyspnea (14%), rash (14%), nausea (11%), bronchitis (11%),
and upper respiratory tract infections (11%).
Most Common Serious Adverse Reactions
In the pivotal study (total population, n=154), where
ARZERRA was administered at 2,000 mg beginning with the
second dose for 11 doses, the most common serious adverse
Patients had received a median of 5 prior therapies
The investigator-determined overall response rate
in patients with CLL refractory to fl udarabine and
alemtuzumab was 42% (99% CI: 26, 60)
There were no complete responses
The eff ectiveness of ARZERRA is based on the
demonstration of durable objective responses
No data demonstrate an improvement in disease-related
symptoms or increased survival with ARZERRA
6.5 months—median duration of response
(95% CI: 5.8, 8.3)
reactions were infections (including pneumonia and sepsis),
neutropenia, and pyrexia.
A total of 108 patients (70%) experienced bacterial, viral, or
fungal infections. A total of 45 patients (29%) experienced
≥Grade 3 infections, of which 19 (12%) were fatal. The
proportion of fatal infections in the fludarabine- and
alemtuzumab-refractory group was 17%.
Please see Brief Summary of Prescribing Information on
adjacent pages.
How Supplied: Available as 2 diff erent single-use glass vials
for dilution and intravenous administration. Each vial contains
either 100 mg ofatumumab in 5 mL of solution or 1,000 mg
ofatumumab in 50 mL of solution.
References: 1. ARZERRA (ofatumumab) [package insert]. Research Triangle Park,
NC: GlaxoSmithKline; 2011. 2. Tam CS, O’Brien S, Lerner S, et al. Leuk Lymph.
2007;48(10):1931-1939.
BRIEF SUMMARY
ARZERRA ® (ofatumumab) Injection, for intravenous infusion
The following is a brief summary only; see full prescribing information for
complete product information.
1 INDICATIONS AND USAGE
ARZERRA ® (ofatumumab) is indicated for the treatment of patients
with chronic lymphocytic leukemia (CLL) refractory to fludarabine and
alemtuzumab. The effectiveness of ARZERRA is based on the demonstration
of durable objective responses [see Clinical Studies (14) of full prescribing
information]. No data demonstrate an improvement in disease-related
symptoms or increased survival with ARZERRA.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Infusion Reactions ARZERRA can cause serious infusion reactions
manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema,
flushing, hypertension, hypotension, syncope, cardiac ischemia/infarction,
back pain, abdominal pain, pyrexia, rash, urticaria, and angioedema. Infusion
reactions occur more frequently with the first 2 infusions [see Adverse
Reactions (6.1)]. Premedicate with acetaminophen, an antihistamine, and a
corticosteroid [see Dosage and Administration (2.1, 2.4) of full prescribing
information]. Interrupt infusion for infusion reactions of any severity. Institute
medical management for severe infusion reactions including angina or other
signs and symptoms of myocardial ischemia [see Dosage and Administration
(2.3) of full prescribing information]. In a study of patients with moderate
to severe chronic obstructive pulmonary disease, an indication for which
ARZERRA is not approved, 2 of 5 patients developed Grade 3 bronchospasm
during infusion. 5.2 Cytopenias Prolonged (≥1 week) severe neutropenia and
thrombocytopenia can occur with ARZERRA. Monitor complete blood counts
(CBC) and platelet counts at regular intervals during therapy, and increase
the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias.
5.3 Progressive Multifocal Leukoencephalopathy Progressive multifocal
leukoencephalopathy (PML), including fatal PML, can occur with ARZERRA.
Consider PML in any patient with new onset of or changes in pre-existing
neurological signs or symptoms. Discontinue ARZERRA if PML is suspected,
and initiate evaluation for PML including consultation with a neurologist,
brain MRI, and lumbar puncture. 5.4 Hepatitis B Infection and Reactivation
Fulminant and fatal hepatitis B virus (HBV) infection and reactivation can
occur in patients following treatment with ARZERRA. Screen patients at high
risk of HBV infection before initiation of ARZERRA. Closely monitor carriers
of hepatitis B for clinical and laboratory signs of active HBV infection during
treatment with ARZERRA and for 6 to 12 months following the last infusion
of ARZERRA. Discontinue ARZERRA in patients who develop viral hepatitis or
reactivation of viral hepatitis, and institute appropriate treatment. Insufficient
data exist regarding the safety of administration of ARZERRA in patients with
active hepatitis. 5.5 Intestinal Obstruction Obstruction of the small intestine
can occur in patients receiving ARZERRA. Perform a diagnostic evaluation
if obstruction is suspected. 5.6 Immunizations The safety of immunization
with live viral vaccines during or following administration of ARZERRA has
not been studied. Do not administer live viral vaccines to patients who have
recently received ARZERRA. The ability to generate an immune response to
any vaccine following administration of ARZERRA has not been studied.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in
other sections of the labeling:
• Infusion Reactions [see Warnings and Precautions (5.1)]
• Cytopenias [see Warnings and Precautions (5.2)]
• Progressive Multifocal Leukoencephalopathy [see Warnings and
Precautions (5.3)]
• Hepatitis B Reactivation [see Warnings and Precautions (5.4)]
• Intestinal Obstruction [see Warnings and Precautions (5.5)]
The most common adverse reactions (≥10%) in Study 1 were neutropenia,
pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash,
nausea, bronchitis, and upper respiratory tract infections. The most common
serious adverse reactions in Study 1 were infections (including pneumonia
and sepsis), neutropenia, and pyrexia. Infections were the most common
adverse reactions leading to drug discontinuation in Study 1. 6.1 Clinical
Trials Experience Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and
may not reflect the rates observed in practice. The safety of monotherapy
with ARZERRA was evaluated in 181 patients with relapsed or refractory
CLL in 2 open-label, non-randomized, single-arm studies. In these studies,
ARZERRA was administered at 2,000 mg beginning with the second dose
for 11 doses (Study 1 [n = 154]) or 3 doses (Study 2 [n = 27]). The data
described in Table 1 and other sections below are derived from 154 patients
in Study 1. All patients received 2,000 mg weekly from the second dose
onward. Ninety percent of patients received at least 8 infusions of ARZERRA
and 55% received all 12 infusions. The median age was 63 years (range: 41
to 86 years), 72% were male, and 97% were White.
Table 1. Incidence of All Adverse Reactions Occurring in ≥5% of Patients
in Study 1 and in the Fludarabine- and Alemtuzumab-Refractory Subset
of Study 1 (MedDRA 9.0)
Total Population
(n = 154)
All
Grades
%
Grade
≥3
%
Fludarabine- and
Alemtuzumab-
Refractory
(n = 59)
All
Grades
%
Grade
≥3
%
Body System/
Adverse Event
Infections and infestations
Pneumoniaa 23 14 25 15
Upper respiratory tract
infection
11 0 3 0
Bronchitis 11
7 DRUG INTERACTIONS
No formal drug-drug interaction studies have been conducted with ARZERRA.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy Pregnancy Category C: There are no adequate or well-controlled
studies ofofatumumab in pregnant women. A reproductive study in pregnant
cynomolgus monkeys that received ofatumumab at doses up to 3.5 times the
recommended human dose ofofatumumab did not demonstrate maternal
toxicity or teratogenicity. Ofatumumab crossed the placental barrier, and fetuses
exhibited depletion of peripheral B cells and decreased spleen and placental
weights. ARZERRA should be used during pregnancy only if the potential benefit
to the mother justifies the potential risk to the fetus. There are no human or
animal data on the potential short- and long-term effects of perinatal B-cell
depletion in offspring following in utero exposure to ofatumumab. Ofatumumab
does not bind normal human tissues other than B lymphocytes. It is not known
if binding occurs to unique embryonic or fetal tissue targets. In addition, the
kinetics of B-lymphocyte recovery are unknown in offspring with B-cell depletion
[see Nonclinical Toxicology (13.3)]. 8.3 Nursing Mothers It is not known whether
ofatumumab is secreted in human milk; however, human IgG is secreted in
human milk. Published data suggest that neonatal and infant consumption of
breast milk does not result in substantial absorption of these maternal antibodies
into circulation. Because the effects of local gastrointestinal and limited systemic
exposure to ofatumumab are unknown, caution should be exercised when
ARZERRA is administered to a nursing woman. 8.4 Pediatric Use Safety and
effectiveness of ARZERRA have not been established in children. 8.5 Geriatric
Use Clinical studies of ARZERRA did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently from younger
subjects [see Clinical Pharmacology (12.3) of full prescribing information].
8.6 Renal Impairment No formal studies of ARZERRA in patients with renal
impairment have been conducted [see Clinical Pharmacology (12.3) of full
prescribing information]. 8.7 Hepatic Impairment No formal studies of ARZERRA
in patients with hepatic impairment have been conducted.
10 OVERDOSAGE
No data are available regarding overdosage with ARZERRA.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity
or mutagenicity studies ofofatumumab have been conducted. In a repeat-dose
toxicity study, no tumorigenic or unexpected mitogenic responses were noted in
cynomolgus monkeys treated for 7 months with up to 3.5 times the human dose
ofofatumumab. Effects on male and female fertility have not been evaluated
in animal studies. 13.3 Reproductive and Developmental Toxicology
Pregnant cynomolgus monkeys dosed with 0.7 or 3.5 times the human dose
ofofatumumab weekly during the period of organogenesis (gestation days
20 to 50) had no maternal toxicity or teratogenicity. Both dose levels of
ofatumumab depleted circulating B cells in the dams, with signs of initial
B cell recovery 50 days after the final dose. Following Caesarean section
at gestational day 100, fetuses from ofatumumab-treated dams exhibited
decreases in mean peripheral B-cell counts (decreased to approximately
10% of control values), splenic B-cell counts (decreased to approximately
15 to 20% of control values), and spleen weights (decreased by 15% for the
low-dose and by 30% for the high-dose group, compared to control values).
Fetuses from treated dams exhibiting anti-ofatumumab antibody responses
had higher B cell counts and higher spleen weights compared to the fetuses
from other treated dams, indicating partial recovery in those animals
developing anti-ofatumumab antibodies. When compared to control animals,
fetuses from treated dams in both dose groups had a 10% decrease in mean
placental weights. A 15% decrease in mean thymus weight compared to
the controls was also observed in fetuses from dams treated with 3.5 times
the human dose ofofatumumab. The biological significance of decreased
placental and thymic weights is unknown. The kinetics of B-lymphocyte
recovery and the potential long-term effects of perinatal B-cell depletion in
offspring from ofatumumab-treated dams have not been studied in animals.
17 PATIENT COUNSELING INFORMATION
Advise patients to contact a healthcare professional for any of the following:
• Signs and symptoms of infusion reactions including fever, chills, rash,
or breathing problems within 24 hours of infusion [see Warnings and
Precautions (5.1) and Adverse Reactions (6.1)]
• Bleeding, easy bruising, petechiae, pallor, worsening weakness, or fatigue
[see Warnings and Precautions (5.2)]
• Signs of infections including fever and cough [see Warnings and
Precautions (5.2) and Adverse Reactions (6.1)]
• New neurological symptoms such as confusion, dizziness or loss of
balance, difficulty talking or walking, or vision problems [see Warnings and
Precautions (5.3)]
• Symptoms of hepatitis including worsening fatigue or yellow discoloration
of skin or eyes [see Warnings and Precautions (5.4)]
• New or worsening abdominal pain or nausea [see Warnings and
Precautions (5.5)]
• Pregnancy or nursing [see Use in Specific Populations (8.1, 8.3)]
Advise patients of the need for:
• Periodic monitoring for blood counts [see Warnings and Precautions (5.2)]
• Avoiding vaccination with live viral vaccines [see Warnings and
Precautions (5.6)]
Manufactured by:
GLAXO GROUP LIMITED
Greenford, Middlesex, UB6 0NN, United Kingdom
U.S. Lic. 1809
Distributed by:
GlaxoSmithKline
Research Triangle Park, NC 27709
©2011, GlaxoSmithKline. All rights reserved.
September 2011
ARZ:6BRS
©2011 The GlaxoSmithKline Group of Companies
All rights reserved. Printed in USA. AZA293R0 September 2011
The Journal of Clinical Issues in Community Practice
Call for Papers
We are seeking papers in the following categories:
• Original Research • Reviews
• Letters • Case Letters
• Research Letters • Commentaries
To submit a paper, go to http://editorialmanager.com/co/
Editor-in-Chief
David H. Henry,
MD, FACP
Pennsylvania Hospital
Philadelphia
Editorial Board
Athanassios Argiris, MD
University of Texas Health Science Center, San Antonio
Ludovico Balducci, MD
Moffitt Cancer Center, Tampa, FL
Johanna Bendell, MD
Sarah Cannon Research Institute, Nashville, TN
Charles L. Bennett, MD, PhD, MPP
University of South Carolina, Columbia
Roy A. Beveridge, MD
US Oncology, Houston, TX
Ralph V. Boccia, MD
Georgetown University, Washington, DC
Matt Brow
US Oncology, Washington, DC
Leslie T. Busby, MD
Rocky Mountain Cancer Centers, Boulder, CO
Sant P. Chawla, MD, FRACP
Sarcoma Oncology Center Santa Monica, CA
Michael J. Fisch, MD, MPH
The University of Texas
MD Anderson Cancer Center, Houston
John A. Fracchia, MD
Lenox Hill Hospital, New York
James N. George, MD
University of Oklahoma Health Sciences Center
Oklahoma City
James Gilmore, PharmD
Georgia Cancer Specialists, Atlanta
Axel Grothey, MD
Mayo Clinic, Rochester, MN
Daniel G. Haller, MD
Professor Emeritus, University of Pennsylvania, Bryn Mawr
David M.J. Hoffman, MD
Tower Hematology Oncology Medical Group
Beverly Hills, CA
Jimmie Holland, MD
Memorial Sloan-Kettering Cancer Center, New York
Thomas Julian, MD
Allegheny General Hospital, Pittsburgh, PA
Vivek Kavadi, MD
Texas Oncology Cancer Center, Austin
Shaji Kumar, MD
Mayo Clinic, Rochester, MN
Kartik Konduri
Texas Oncology Cancer Center, Austin
Corey J Langer, MD, FACP
University of Pennsylvania, Philadelphia
Editors
Jame Abraham, MD
West Virginia University
Morgantown, WV
Linda D. Bosserman,
MD, FACP
Wilshire Oncology
Medical Group
La Verne, CA
January 2013
VOLUME 10, NUMBER 1
Debra A. Patt,
MD, MPH
Texas Oncology Cancer
Center, Austin
Stuart M. Lichtman, MD
Memorial Sloan-Kettering Cancer Center, Commack, NY
John L. Marshall, MD
Lombardi Comprehensive Cancer Center, Washington, DC
Cathy Maxwell, RN, OCN, CCRC
Advanced Medical Specialties, LLC, Miami, FL
Bradley J. Monk, MD, FACOG
Creighton University School of Medicine at St. Joseph’s Hospital and
Medical Center, Phoenix, AZ
Anne Moore, MD
Weill Medical College of Cornell University, New York
Eric Nadler, MD
Texas Oncology Cancer Center, Austin
Deborah A. Nagle, MD
Beth Israel Deaconess Medical Center, Boston, MA
Marcus Neubauer, MD
University of Kansas Cancer Center, Overland Park
Geoffrey R. Norman, PhD
McMaster University, Hamilton, Ontario, Canada
Steven O’Day, MD
The Angeles Clinic & Research Institute, Los Angeles, CA
Theodore A. Okon, MBA
Supportive Oncology Services, Memphis, TN
Philip A. Philip, MD, PhD
Barbara Ann Karmanos Cancer Institute, Detroit, MI
Jondavid Pollock, MD, PhD
Schiffler Cancer Center, Wheeling, WV
Nicholas J. Robert, MD
US Oncology, Fairfax, VA
Peter J. Rosen, MD
Roy & Patricia Disney Family
Cancer Research Center, Burbank, CA
Myrna R. Rosenfeld, MD, PhD
University of Pennsylvania School of Medicine, Philadelphia
Lee S. Schwartzberg, MD, FACP
The West Clinic, Memphis, TN
Mark A. Sitarik, MD
Rocky Mountain Cancer Centers, Boulder, CO
David Streiner, PhD, CPsych
University of Toronto, Toronto, Ontario, Canada
Debu Tripathy, MD
University of Southern California/ Norris Comprehensive Cancer Center,
Los Angeles
Steven Tucker, MD
Tucker Medical, Singapore, Malaysia
Volume 10/Number 1 January 2013 COMMUNITY ONCOLOGY A5
Information for Authors and Advertisers
Aims and Scope
COMMUNITY ONCOLOGY is an independent journal that publishes peerreviewed
research, review articles and commentary on all aspects of
clinical oncology practice. Article types include original clinical studies in
practice-based settings, state-of-the-art review papers, peer viewpoints,
commentaries, and letters to the editor.
For a full and complete guide for authors, go to ees.elsevier.com/co/
For further information, contact the Managing Editor, Renée Matthews,
at 240-221-2461 or e-mail, renee.matthews@elsevier.com.
Correspondence
For general, noneditorial enquiries, write to COMMUNITY ONCOLOGY, 7
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Letters to the Editor should be addressed to the Editor-in-Chief, David
H. Henry, MD, FACP, e-mail: c.oncology@elsevier.com.
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January 2013
VOLUME 10, NUMBER 1
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© Copyright 2013 by Frontline Medical Communications Inc. No part
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Discussions, views, opinions, and recommendations as to medical
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A6 COMMUNITY ONCOLOGY January 2013 www.CommunityOncology.net
Alan Imhoff, President and Publisher
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FROM THE EDITOR
1 From ASH, studies that advance the treatment of
hematologic malignancies
David H. Henry, MD, FACP
COMMENTARY
3 Regorafenib monotherapy for previously treated metastatic
colorectal cancer
Stuart M. Lichtman, MD
COMMUNITY TRANSLATIONS
5 Regorafenib in previously treated metastatic colorectal
cancer
Edited by Jame Abraham, MD; report prepared by Matt Stenger, MS
ORIGINALRESEARCH
January 2013
VOLUME 10, NUMBER 1
contents
8 ImpactofpretreatmentPET on disease control and
treatment decisions in locoregionally advanced esophageal
cancer patients treated with chemoradiotherapy
Patricia L. Watkins, MS, John M. Watkins, MD, A. Jason Zauls, MD,
Daniel T. Lackland, DrPH, M. Boyd Gillespie, MD, Thomas C. Hulsey, ScD,
and Joseph M. Jenrette III, MD
16 Variation by age in neutropenic complications among
patients with cancer receiving chemotherapy
Henry J. Henk, PhD, James A. Kaye, MD, DrPH, Kenneth J. Rothman, DrPH,
Laura K. Becker, MS, Jason C. Legg, PhD, Xiaoyan Li, PhD, and
Robert Deeter, PharmD
LETTERS
Case Letter
27 Plasmablastic lymphoma presenting as proptosis and
impending visual loss
Mihaela Vatca, MD, Katherine Robbins, MD, David D. Grier, MD,
James O. Cappellari IV, MD, and Seema Naik, MD
FEATURES
Technology
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Neil Osterweil
Volume 10/Number 1 January 2013 COMMUNITY ONCOLOGY A7
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Important Safety Information
Serious adverse reactions associated with SYNRIBO
are myelosuppression (including thrombocytopenia,
neutropenia, and anemia), bleeding, and
hyperglycemia. Some adverse reactions, such as
myelosuppression, gastrointestinal hemorrhages,
and cerebral hemorrhage, have been severe and/or
fatal. Patients with neutropenia are at an increased
risk of infection
Closely monitor patient complete blood counts,
symptoms of infection or fever. Monitor glucose levels,
especially in patients with diabetes or risk factors for
diabetes. Avoid SYNRIBO in patients with poorly
controlled diabetes mellitus until good glycemic
control has been established. Consider dose
modifications for toxicities
©2012 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.
All rights reserved. OMA-0027 November 2012. Printed in USA.
NOW APPROVED
SYNRIBO.com
SYNRIBO (omacetaxine mepesuccinate) for
Injection, for subcutaneous use, is indicated for
the treatment of adult patients with chronic or
accelerated phase chronic myeloid leukemia
(CML) with resistance and/or intolerance to
two or more tyrosine kinase inhibitors (TKIs).
This indication is based upon response rate.
There are no trials verifying an improvement in
disease-related symptoms or increased survival
with SYNRIBO.
SYNRIBO can cause fetal harm when administered
to a pregnant woman. Women should be advised to
avoid becoming pregnant while using SYNRIBO
Most common adverse reactions (frequency ≥20%)
in chronic and accelerated phase patients:
thrombocytopenia, anemia, neutropenia, diarrhea,
nausea, fatigue, asthenia, injection site reaction,
pyrexia, infection, and lymphopenia
Please see the following brief summary
of Prescribing Information.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
See package insert for full Prescribing Information.
SYNRIBO (omacetaxine mepesuccinate) for Injection, for subcutaneous use
1 INDICATIONS AND USAGE
SYNRIBO is indicated for the treatment of adult patients with chronic or accelerated phase chronic
myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).
This indication is based upon response rate. There are no trials verifying an improvement in disease-related
symptoms or increased survival with SYNRIBO.
2 DOSAGE AND ADMINISTRATION
2.1 Induction Schedule
The recommended starting schedule for induction is 1.25 mg/m2 administered subcutaneously twice daily
for 14 consecutive days every 28 days, over a 28-day cycle. Cycles should be repeated every 28 days until
patients achieve a hematologic response.
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