Download Biological agents for metastatic colorectal cancer: clinical

Biological agents for
metastatic colorectal cancer
Clinical audit tool
Implementing NICE guidance
2012
Clinical audit tool: Biological agents for metastatic colorectal cancer (2012)
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NICE clinical guideline 131 and technology
242, 212, 176 and 118
This clinical audit tool accompanies the NICE guidance:
‘Colorectal cancer: the diagnosis and management of colorectal cancer’
‘Bevacizumab and cetuximab for the treatment of metastatic colorectal cancer’
‘Cetuximab for the first-line treatment of metastatic colorectal cancer‘
‘Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or
capecitabine for the treatment of metastatic colorectal cancer‘
‘Cetuximab (monotherapy or combination chemotherapy), bevacizumab (in combination
with non-oxaliplatin chemotherapy) and panitumumab (monotherapy) for the treatment
of metastatic colorectal cancer after first-line chemotherapy’
Issue date: 2012
This clinical audit tool replaces the colorectal cancer: chemotherapy clinical audit tool
published in November 2011 to differentiate between chemotherapy and biological
agents in accordance with the colorectal cancer pathway.
This document is a support tool for clinical audit based on the NICE guidance. It is not
NICE guidance.
Acknowledgements
NICE would like to thank the following people who have contributed to the development
of this clinical audit tool and have agreed to be acknowledged:
Dave Asplin, Pathology Quality Manager, Royal Berkshire NHS Foundation Trust
Christine Holman, National Collaborating Centre for cancer
Stephanie Loveridge, Clinical Governance Manager, Bradford Teaching Hospitals NHS
Foundation Trust
Dr Sundar Santhanam, Consultant Oncologist, Nottingham University Hospitals NHS
Trust
Clinical audit tool: Biological agents for metastatic colorectal cancer (2012)
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NICE has adapted the action plan template produced by the Healthcare Quality
Improvement Partnership (HQIP) in their template clinical audit report.
National Institute for Health and Clinical Excellence
Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BT; www.nice.org.uk
© National Institute for Health and Clinical Excellence, 2012. All rights reserved. This material
may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for
commercial organisations, or for commercial purposes, is allowed without the express written
permission of NICE.
Clinical audit tool: Biological agents for metastatic colorectal cancer (2012)
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Biological agents for metastatic colorectal cancer clinical audit tool
This document can be used as a starting point for a local clinical audit project that aims
to improve biological agent prescribing practices for patients with advanced and
metastatic colorectal cancer. It contains:
 clinical audit standards
 a data collection form
 an action plan template.
There is also an electronic audit tool available, which can be used with this document
or on its own to collect and analyse the data.
The audit standards and data collection form can be adapted to focus on a smaller part
of the tool or expanded to include other local priorities.
The audit could be carried out in the following services: secondary or tertiary care,
including specialist cancer services.
The audit should involve clinical and non-clinical stakeholders, which may include
medical staff, nursing staff, clinical audit staff and patients.
The audit sample should include adults (aged 18 years and older) with metastatic
colorectal cancer (suggested ICD-10 code C18 Malignant neoplasm of colon). Advice
on how to decide on sample size is available on HQIP’s website.
The audit standards are based on the NICE guidance:
 ‘Colorectal cancer: the diagnosis and management of colorectal cancer’
 ‘Bevacizumab and cetuximab for the treatment of metastatic colorectal cancer’
 ‘Cetuximab for the first-line treatment of metastatic colorectal cancer’
 ‘Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid
or capecitabine for the treatment of metastatic colorectal cancer’
 ‘Cetuximab (monotherapy or combination chemotherapy), bevacizumab (in
combination with non-oxaliplatin chemotherapy) and panitumumab (monotherapy)
for the treatment of metastatic colorectal cancer after first-line chemotherapy’.
Clinical audit tool: Biological agents for metastatic colorectal cancer (2012)
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A baseline assessment tool is available. This can help to compare practice with the
guideline’s recommendations and prioritise implementation activity, including clinical
audit.
The audit based on this guideline should be considered in conjunction with other
clinical audit priorities such as those listed in appendix A.
The audit standards in this document include a reference to the guidance
recommendation numbers, and any associated NICE quality standard statements
and exceptions. Exceptions not explicitly referred to in the guideline can be added
locally, for example, patients declining treatment.
NICE recommends compliance of 100%. If this is not achievable an interim local target
could be set, although 100% should remain the ultimate aim.
A data collection form should be completed for each patient. There is a section for
demographic information that can be completed if this information is essential to the
project. Patient identifiable information should never be recorded.
Following the audit the action plan template can be used to develop and implement
an action plan to take forward any recommendations made.
Re-audit is a key part of the clinical audit cycle, required to demonstrate that
improvement has been achieved and sustained. Once a re-audit has been completed,
the shared learning database can be used to share the experience of putting NICE
guidance into practice.
For further information about clinical audit refer to a local clinical audit professional in
your own organisation or the HQIP website.
To ask a question about this clinical audit tool, or to provide feedback to help inform
the development of future tools, please email [email protected]
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Standards for biological agents for metastatic colorectal cancer clinical audit
Audit standards
Guidance reference
Exceptions
Definitions
BEVACIZUMAB IN COMBINATION WITH OXALIPLATIN AND EITHER 5-FLUOROURACIL OR CAPECITABINE FOR THE TREATMENT OF
METASTATIC COLORECTAL CANCER
1. People with metastatic colorectal cancer should not be
prescribed bevacizumab in combination with oxaliplatin and either
fluorouracil plus folinic acid or capecitabine
TA212 1.1 and 1.2
Data collection form, question 1

A – people receiving the
drug(s) before publication of
NICE technology appraisal
guidance 212 (December
2010)
None
None
None
CETUXIMAB FOR THE FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER
2. People with metastatic colorectal cancer should be offered

cetuximab in combination with 5-fluorouracil (5-FU), folinic acid and
oxaliplatin (FOLFOX), as a first-line treatment for metastatic
colorectal cancer, only when all of the following criteria are met:
TA 176 1.1
• the primary colorectal tumour had been resected or was potentially
operable
• the metastatic disease was confined to the liver and was
unresectable
• the patient was fit enough to undergo surgery to resect the primary
colorectal tumour and to undergo liver surgery if the metastases
became resectable after treatment with cetuximab
Data collection form, questions 2 to 6
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
Audit standards
Guidance reference
3. People with metastatic colorectal cancer should be offered

cetuximab in combination with 5-FU, folinic acid and irinotecan
(FOLFIRI), as a first-line treatment for metastatic colorectal cancer
only when all of the following criteria are met:
TA176 1.2
TA176 1.3
Exceptions
Definitions

None
None

None
None
• the primary colorectal tumour had been resected or was potentially
operable
• the metastatic disease was confined to the liver and was
unresectable
• the patient was fit enough to undergo surgery to resect the primary
colorectal tumour and to undergo liver surgery if the metastases
became resectable after treatment with cetuximab
• the patient was unable to tolerate or had contraindications to
oxaliplatin
Data collection form, questions 7 to 12
4. People who meet criteria above (from guidance references

TA176 1.1 and 1.2) should receive treatment with cetuximab for no
more than 16 weeks.
5. At 16 weeks, treatment with cetuximab should stop and the
patient should be assessed for resection of liver metastases
Data collection form, questions 13 to 15
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BEVACIZUMAB AND CETUXIMAB FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER
6. People with colorectal cancer should not be prescribed
bevacizumab in combination with 5-FU plus folinic acid, with or
without irinotecan for the first-line treatment of metastatic colorectal
cancer
TA118 1.1 and 1.3
B – people receiving the
drug(s) before publication of
NICE technology appraisal
118 (January 2007)
None
Data collection form, questions 16 and 17
CETUXIMAB (MONOTHERAPY OR COMBINATION THERAPY), BEVACIZUMAB (IN COMBINATION WITH NON-OXALIPLATIN
CHEMOTHERAPY) AND PANITUMUMAB (MONOTHERAPY) FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER AFTER
FIRST-LINE CHEMOTHERAPY
7. Cetuximab monotherapy or combination chemotherapy should
not be prescribed for the treatment of metastatic colorectal cancer
that has progressed after first-line chemotherapy
TA242 1.1
C – people receiving the
drug(s) before publication of
NICE technology appraisal
guidance 242 (January
2012)
None
TA242 1.2
C – people receiving the
drug(s) before publication of
NICE technology appraisal
guidance 242 (January
2012)
None
TA242 1.3
C – people receiving the
drug(s) before publication of
NICE technology appraisal
guidance 242 (January
2012)
None
Data collection form, questions 18 and 19
8. Bevacizumab in combination with non-oxaliplatin
(fluoropyrimidine-based) chemotherapy should not be prescribed for
the treatment of metastatic colorectal cancer that has progressed
after first-line chemotherapy
Data collection form, questions 18 and 20
9. Panitumumab should not be prescribed for the treatment of
metastatic colorectal cancer that has progressed after first-line
chemotherapy
Data collection form, questions 18 and 21
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Data collection form for biological agents for metastatic colorectal cancer
clinical audit
Audit ID:
Sex:
Age:
The audit ID should be an anonymous code. Patient identifiable information should never be recorded.
White
British
Irish
Any other white
background
No
Mixed
White and black
Caribbean
White and black
African
White and Asian
Asian or Asian British
Indian
Black or black British
Caribbean
Other
Chinese
Pakistani
African
Bangladeshi
Any other black
background
Any other
ethnic group
Not stated
Any other mixed
background
Any other Asian
background
Question
Yes
No
Exception*
/NA/Notes
BEVACIZUMAB IN COMBINATION WITH OXALIPLATIN AND EITHER 5-FLUOROURACIL OR
CAPECITABINE FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER
1
Was the person prescribed bevacizumab in combination
with oxaliplatin and either fluorouracil plus folinic acid or
capecitabine?
A
CETUXIMAB FOR THE FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER

2
Was the person with metastatic colorectal cancer offered
cetuximab in combination with 5-fluorouracil (5-FU), folinic
acid and oxaliplatin (FOLFOX)?

If no, go to question 7

3
Was this as a first-line treatment for metastatic colorectal
cancer?
Were the following criteria met:
4
• the primary colorectal tumour had been resected or was
potentially operable

5
• the metastatic disease was confined to the liver and was
unresectable
6
• the patient was fit enough to undergo surgery to resect the
primary colorectal tumour and to undergo liver surgery if the
metastases became resectable after treatment with
cetuximab
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
7
Was the person with metastatic colorectal cancer offered
cetuximab in combination with 5-FU, folinic acid and
irinotecan (FOLFIRI)?

If no, go to question 16

8
Was this as a first-line treatment for metastatic colorectal
cancer?
Were the following criteria met:
9
• the primary colorectal tumour had been resected or was
potentially operable

10
• the metastatic disease was confined to the liver and was
unresectable

11
• the patient was fit enough to undergo surgery to resect the
primary colorectal tumour and to undergo liver surgery if the
metastases became resectable after treatment with
cetuximab

12
• the patient was unable to tolerate or had contraindications
to oxaliplatin
13- Did the person receive cetuximab for more than 16 weeks?
14- At 16 weeks did treatment with cetuximab stop?
15- Was the patient assessed for resection of liver metastases?
BEVACIZUMAB AND CETUXIMAB FOR THE TREATMENT OF METASTATIC COLORECTAL
CANCER
16
Was the person with colorectal cancer prescribed
bevacizumab in combination with 5-fluorouracil plus folinic
acid, with or without irinotecan?
17
Was this for the first-line treatment of metastatic colorectal
cancer?
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B
CETUXIMAB (MONOTHERAPY OR COMBINATION THERAPY), BEVACIZUMAB (IN
COMBINATION WITH NON-OXALIPLATIN CHEMOTHERAPY) AND PANITUMUMAB
(MONOTHERAPY) FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER AFTER
FIRST-LINE CHEMOTHERAPY
18
Did the person have metastatic colorectal cancer which has
progressed after first-line chemotherapy?
19
Was the person prescribed:
• cetuximab monotherapy or combination chemotherapy?
20
• bevacizumab in combination with non-oxaliplatin
(fluoropyrimidine-based) chemotherapy?
21
• panitumumab
C
*Circle exception codes as appropriate.
Exception codes
A – people receiving the drug(s) before publication of NICE technology appraisal guidance 212
(December 2010).
B – people receiving the drug(s) before publication of NICE technology appraisal 118 (January 2007)
C – people receiving the drug(s) before publication of NICE technology appraisal guidance 242
(January 2012)
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Action plan for biological agents for metastatic colorectal cancer clinical audit
KEY (Change status)
1 Recommendation agreed but not yet actioned
2 Action in progress
3 Recommendation fully implemented
4 Recommendation never actioned (please state reasons)
5 Other (please provide supporting information)
Action plan
lead
Name:
Title:
Contact:
The ‘Actions required’ should specifically state what needs to be done to achieve the recommendation. All updates to the action plan should be
included in the ‘Comments’ section.
Recommendation
Actions required
(specify ‘None’, if
none required)
Action by
date
Person
responsible
Comments/action status
(Provide examples of action in progress,
changes in practices, problems
encountered in facilitating change, reasons
why recommendation has not been
actioned etc)
Change
stage
(see Key)
When making improvements to practice, organisations may like to use the tools developed by NICE to help implement the guidance on:
Colorectal cancer: the diagnosis and management of colorectal cancer, Bevacizumab and cetuximab for the treatment of metastatic colorectal
cancer, Cetuximab for the first-line treatment of metastatic colorectal cancer, Bevacizumab in combination with oxaliplatin and either fluorouracil
plus folinic acid or capecitabine for the treatment of metastatic colorectal cancer, Cetuximab (monotherapy or combination chemotherapy),
bevacizumab (in combination with non-oxaliplatin chemotherapy) and panitumumab (monotherapy) for the treatment of metastatic colorectal
cancer after first-line chemotherapy
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Appendix A
Other clinical audits that should be considered when planning an audit based on this tool.
 The National Bowel Cancer Audit Project
NICE has also produced a number of other clinical audit tools based on clinical
guidelines and technology appraisals for colorectal cancer, including:
 Colorectal cancer: diagnosis
 Colorectal cancer: staging of colorectal cancer
 Colorectal cancer management of local disease – colonic stents in acute bowel
obstruction
 Colorectal cancer: management of local disease – preoperative management of the
primary tumour
 Colorectal cancer: management of local disease – stage I colorectal cancer
 Colorectal cancer: management of metastatic disease
 Colorectal cancer: chemotherapy for advanced and metastatic colorectal cancer
 Colorectal cancer: ongoing care and support
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