Guideline:
Cancer Care Ontario and American Society of Clinical Oncology adjuvant chemotherapy and adjuvant radiation therapy for stages I-IIIA resectable non-small-cell lung cancer guideline
Bibliographic Source(s)
- Pisters KM Evans WK Azzoli CG Kris MG Smith CA Desch CE Somerfield MR Brouwers MC Darling G Ellis PM Gaspar LE Pass HI Spigel DR Strawn JR Ung YC Shepherd FA. Cancer Care Ontario and American Society of Clinical Oncology adjuvant chemotherapy and adjuvant radiation therapy for stages I-IIIA resectable non-small-cell lung cancer guideline. J Clin Oncol 2007 Dec 1;25(34):5506-18. [76 references] PubMed
Guideline Status
This is the current release of the guideline.
Guideline Category
Assessment of Therapeutic Effectiveness
Management
Treatment
Intended Users
Physicians
Guideline Objective(s)
To determine the role of adjuvant chemotherapy and radiation therapy in patients with completely resected stage IA-IIIA non–small-cell lung cancer (NSCLC)
Specifically to address the following questions:
- What is the benefit in terms of overall survival and role of adjuvant chemotherapy in patients with completely resected stage I-IIIA NSCLC?
- What is the benefit in terms of overall survival and role of adjuvant radiation therapy in patients with completely resected stage I-IIIA NSCLC?
Target Population
Post-operative non-small cell lung cancer (NSCLC) patients
This guideline does not address postoperative NSCLC patients with positive margins (i.e. microscopic residual disease R1 resection) or macroscopic residual disease (R2 resection).
Interventions and Practices Considered
- Adjuvant cisplatin-based chemotherapy
- Adjuvant radiation therapy
Major Outcomes Considered
- Overall survival (primary outcome of interest)
- Disease-free survival
- Recurrence rates
- Adverse effects toxicity and complications related to treatment
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Searches of Unpublished Data
Description of Methods used to Collect/Select the Evidence
Literature Review and Analysis
The Cancer Care Ontario (CCO) systematic reviews on adjuvant chemotherapy and adjuvant radiation. The CCO Lung Disease Site Group (DSG) first published a systematic review on the role of adjuvant radiation therapy and chemotherapy in patients with stage II or IIIA resected non-small-cell lung cancer (NSCLC) in 1997. More recently two separate systematic reviews were undertaken by CCO to update the original systematic review: one on adjuvant chemotherapy for patients with stage I-IIIA completely resected NSCLC and one on adjuvant radiation in patients with stage II or IIIA completely resected NSCLC. These systematic reviews have been published elsewhere and serve as the primary source of evidence for this practice guideline.
The Cancer Care Ontario-American Society of Clinical Oncology (CCO-ASCO) Panel literature review and analysis. The Cancer Care Ontario-Program in Evidence Based Care (CCO-PEBC) staff updated the literature searches in August 2006 before the joint CCO-ASCO Panel meeting. Articles were included in the CCO-PEBC systematic reviews of chemotherapy (or radiation therapy) for NSCLC if they were in the following categories:
- Evidence-based practice guidelines addressing the role of postoperative chemotherapy (or radiation therapy) following complete resection of NSCLC and published since 2000 (to identify trials published since the prior systematic review) or
- Randomized clinical trials (RCTs) or meta-analyses that
- Compared postoperative chemotherapy (or radiation therapy) versus surgery without chemotherapy (or radiation therapy) in patients with completely resected NSCLC
- Reported overall survival or disease-free survival as a main outcome; or
- Were published in peer-reviewed journals or reported in a conference abstract
Articles published in a language other than English were excluded. Articles lacking information on the stage distribution of the study population were also not considered. Studies involving alkylating chemotherapy agents alone or in combination with nonplatinum agents or involving immunotherapy were not included.
Number of Source Documents
Adjuvant Chemotherapy
The systematic review identified eight meta-analyses and 16 randomized clinical trials (RCTs) relevant to this guideline.
Adjuvant Radiation Therapy
Evidence from a meta-analysis of nine RCTs evaluating postoperative radiation therapy and data obtained from three additional RCTs published after this meta-analysis were reviewed.
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
The Cancer Care Ontario Program in Evidence-Based Care (CCO-PEBC) and the American Society of Clinical Oncology (ASCO) convened a Joint Expert Panel in August 2006 to review the evidence and draft recommendations for these therapies.
Panel Composition
CCO and ASCO convened a Joint Expert Panel consisting of experts in clinical medicine clinical research health services research and related disciplines (biostatistics medical decision-making patient-physician communication) with a focus on expertise in lung cancer. Patient representatives were also included on the Panel. The clinical experts represented medical oncology radiation oncology and surgical oncology. A steering committee under the auspices of the Health Services Committee (HSC) and the CCO Program in Evidence-Based Care (PEBC) Lung Cancer Disease Site Group (DSG) chose Panel participants for the clinical practice guideline development process.
Consensus Development Based on Evidence
The CCO systematic reviews on adjuvant chemotherapy and radiation therapy were circulated to the CCO-ASCO Joint Panel members in August 2006 for review. The Panel also reviewed the new evidence that had emerged since the completion of the CCO systematic reviews refined the questions to be addressed by the guideline and developed recommendations at a meeting at the ASCO Headquarters Office (Alexandria VA) in August 2006. A draft version of the guideline was circulated to the four co-chairs of the Joint Panel in February 2007 for review and approval. Additional work on the guideline was completed via teleconferences with Panel members. A revised version was circulated to all Panel members in April 2007 for final review and approval. The draft guideline was disseminated to practitioners in Ontario Canada and in the United States for external review.
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
Both the Cancer Care Ontario Program in Evidence-Based Care (CCO-PEBC) and the American Society of Clinical Oncology (ASCO) conducted an external review of the recommendations in this guideline. The initial systematic review and practice guideline developed by CCO were distributed to practitioners in Ontario Canada for review in October 2004. Feedback was obtained through a mailed survey accompanying the guideline in which practitioners could rate a number of items including the quality of the review whether or not they agreed with the recommendations and whether they would follow the recommendations in their own practice. Written feedback was also encouraged. Feedback from external reviewers was also solicited by ASCO. ASCO distributed the guideline draft to six oncologists and two patient advocates and asked them to complete a similar form to that employed in the CCO practitioner feedback process. The content of the guideline and manuscript were reviewed and approved by the ASCO HSC the ASCO Board of Directors and by the CCO Report Approval Panel before dissemination.
Major Recommendations
| Summary of Recommendations for Adjuvant Cisplatin-Based Chemotherapy for Stages I-IIIA Resectable Non-Small-Cell Lung Cancer |
|
|---|---|
| Stage IA | Adjuvant chemotherapy is not recommended. |
| Stage IB | Adjuvant cisplatin-based chemotherapy is not recommended for routine use. |
| Stage IIA | Adjuvant cisplatin-based chemotherapy is recommended. |
| Stage IIB | Adjuvant cisplatin-based chemotherapy is recommended. |
| Stage IIIA | Adjuvant cisplatin-based chemotherapy is recommended. |
| General | The use of adjuvant chemotherapy regimens that include alkylating agents is not recommended as these agents have been found to be detrimental to survival. |
| Summary of Recommendations for Adjuvant Radiotherapy for Stages I-IIIA Resectable Non-Small-Cell Lung Cancer |
|
| IA/B and IIA/B | Adjuvant radiation is not recommended. |
| IIIA | Adjuvant radiation therapy is not recommended for routine use because of the lack of prospective randomized clinical trial data evaluating its efficacy. A clinical trial is underway to determine the advisability of its routine use. |
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
In general the literature review supporting these recommendations centered on randomized clinical trials and meta-analyses of data from randomized clinical trials.
Potential Benefits
- Appropriate use of adjuvant chemotherapy and adjuvant radiation therapy in resectable non-small-cell lung cancer
- Improved patient outcomes
Potential Harms
Adverse effects of treatment
Qualifying Statements
It is important to emphasize that practice guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations and cannot be considered inclusive of all proper methods of care or exclusive of other treatments reasonably directed at obtaining the same result. Accordingly the American Society of Clinical Oncology (ASCO) and Cancer Care Ontario (CCO) consider adherence to these guidelines to be voluntary with the ultimate determination regarding their application to be made by the physician in light of each patient's individual circumstances. In addition these guidelines describe administration of therapies in clinical practice; they cannot be assumed to apply to interventions performed in the context of clinical trials given that clinical studies are designed to test innovative therapies in a disease for which better therapy is needed. In that guideline development involves a review and synthesis of the latest literature a practice guideline also serves to identify important questions for further research and those settings in which investigational therapy should be considered.
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
Patient Resources
Personal Digital Assistant (PDA) Downloads
Quick Reference Guides/Physician Guides
Slide Presentation
For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.
IOM Care Need
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness
Bibliographic Source(s)
- Pisters KM Evans WK Azzoli CG Kris MG Smith CA Desch CE Somerfield MR Brouwers MC Darling G Ellis PM Gaspar LE Pass HI Spigel DR Strawn JR Ung YC Shepherd FA. Cancer Care Ontario and American Society of Clinical Oncology adjuvant chemotherapy and adjuvant radiation therapy for stages I-IIIA resectable non-small-cell lung cancer guideline. J Clin Oncol 2007 Dec 1;25(34):5506-18. [76 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American Society of Clinical Oncology
Guideline Committee
Joint Cancer Care Ontario- American Society of Clinical Oncology (CCO-ASCO) Expert Panel
Composition of Group that Authored the Guideline
Authors: Katherine M.W. Pisters; William K. Evans; Christopher G. Azzoli; Mark G. Kris; Christopher A. Smith; Christopher E. Desch; Mark R. Somerfield; Melissa C. Brouwers; Gail Darling; Peter M. Ellis; Laurie E. Gaspar; Harvey I. Pass; David R. Spigel; John R. Strawn; Yee C. Ung; Frances A. Shepherd
Panel Members: Christopher E. Desch MD Co-Chair National Comprehensive Cancer Network; William K. Evans MD (Co-Chair) Juravinski Cancer Centre at Hamilton Health Sciences; Mark G. Kris MD (Co-Chair) Memorial Sloan-Kettering Cancer Center; Katherine M.W. Pisters MD (Co-Chair) M.D. Anderson Cancer Center; Frances A Shepherd MD (Co-Chair) University Health Network Princess Margaret Hospital; Christopher G. Azzoli MD Memorial Sloan-Kettering Cancer Center; Gail Darling MD University Health Network Princess Margaret Hospital; Peter M. Ellis MD Juravinski Cancer Centre at Hamilton Health Sciences; Laurie E. Gaspar MD University of Colorado at Denver Health Sciences Centre; Harvey I. Pass MD NYU School of Medicine and NCI Cancer Centre; David R. Spigel MD The Sarah Cannon Cancer Center; John R. Strawn MD Patient Advocate; Yee C. Ung MD Toronto-Sunnybrook Regional Cancer Centre
Financial Disclosures/Conflicts of Interest
All members of the Expert Panel complied with the American Society of Clinical Oncology (ASCO) policy on conflicts of interest which requires disclosure of any financial or other interest that might be construed as constituting an actual potential or apparent conflict. Members of the expert Panel completed ASCO's disclosure form and were asked to reveal ties to companies with products that might be affected by promulgation of the guidelines. Information was requested regarding employment consultancies stock ownership honoraria research funding expert testimony and membership on company advisory committees. The Panel made decisions on a case-by-case basis as to whether an individual's role should be limited as a result of a conflict. No limiting conflicts were identified.
Note: Although all authors completed the disclosure declaration the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories or for more information about ASCO's conflict of interest policy please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors in the original journal of publication.
Employment or Leadership Position: None Consultant or Advisory Role: David R. Spigel Genentech (C); Frances A. Shepherd Pierre Fabre (C) GlaxoSmithKline (C)
Stock Ownership: None Honoraria: Peter M. Ellis Bristol-Myers Squibb; Frances A. Shepherd Pierre Fabre GlaxoSmithKline Research Funding: Christopher G. Azzoli Genentech Biooncology Sanofi-aventis Allos Therapeutics; David R. Spigel Genentech Sanofi-aventis Expert Testimony: None Other Remuneration: None
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from the American Society of Clinical Oncology (ASCO) Web site.
Print copies: Available from American Society of Clinical Oncology Cancer Policy and Clinical Affairs 1900 Duke Street Suite 200 Alexandria VA 22314; E-mail: guidelines@asco.org.
Availability of Companion Documents
The following are available:
- Cancer Care Ontario and American Society of Clinical Oncology adjuvant chemotherapy and adjuvant radiation therapy for stages I-IIIA resectable non-small cell lung cancer guideline. Slide set. 2007. 17 p. Electronic copies: Available in Portable Document Format (PDF) and PowerPoint from the American Society of Clinical Oncology (ASCO) Web site.
- CCO-ASCO adjuvant chemotherapy and adjuvant radiation therapy for resectable non-small cell lung cancer. Guideline summary. 2007. 4 p. Electronic copies: Available from the ASCO Web site.
Guidelines are available for Personal Digital Assistant (PDA) download from the ASCO Web site.
Patient Resources
The following are available:
- ASCO patient guide: adjuvant treatment for lung cancer. 2007 Oct. 4 p. Available from the Cancer.Net Web site.
- Decision aid tool. Stage IB non-small cell lung cancer (NSCLC) cisplatin plus vinorelbine chemotherapy after surgery. 2007. 4 p. Available in Portable Document Format (PDF) from the American Society of Clinical Oncology (ASCO) Web site.
- Decision aid tool. Stage II non-small cell lung cancer (NSCLC) cisplatin plus vinorelbine chemotherapy after surgery. 2007. 4 p. Available in Portable Document Format (PDF) from the American Society of Clinical Oncology (ASCO) Web site.
- Decision aid tool. Stage III non-small cell lung cancer (NSCLC) cisplatin plus vinorelbine chemotherapy after surgery. 2007. 4 p. Available in Portable Document Format (PDF) from the American Society of Clinical Oncology (ASCO) Web site.
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NGC STATUS
This NGC summary was completed by ECRI Institute on February 19 2008. The information was verified by the guideline developer on February 20 2008.
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This summary is based on the original guideline which is subject to the American Society of Clinical Oncology's copyright restrictions.
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