This is the current release of the guideline.

Stages I-IIIA resectable non–small-cell lung cancer (NSCLC)

Assessment of Therapeutic Effectiveness
Management
Treatment

Oncology
Radiation Oncology
Surgery

Physicians

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?

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).

1. Adjuvant cisplatin-based chemotherapy
2. Adjuvant radiation therapy

• Overall survival (primary outcome of interest)
• Disease-free survival
• Recurrence rates
• Adverse effects, toxicity, and complications related to treatment

Searches of Electronic Databases
Searches of Unpublished Data

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:

1. 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
2. Randomized clinical trials (RCTs) or meta-analyses that
   1. Compared postoperative chemotherapy (or radiation therapy) versus surgery without chemotherapy (or radiation therapy) in patients with completely resected NSCLC
   2. Reported overall survival or disease-free survival as a main outcome; or
   3. 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.

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.

Expert Consensus

Not applicable

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Not stated

Expert Consensus

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.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

External Peer Review
Internal Peer Review

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.

None provided

In general, the literature review supporting these recommendations centered on randomized clinical trials and meta-analyses of data from randomized clinical trials.

• Appropriate use of adjuvant chemotherapy and adjuvant radiation therapy in resectable non-small-cell lung cancer
• Improved patient outcomes

Adverse effects of treatment

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.

An implementation strategy was not provided.

Living with Illness

Effectiveness
Patient-centeredness

Not applicable: The guideline was not adapted from another source.

2007 Dec

American Society of Clinical Oncology - Medical Specialty Society
Cancer Care Ontario - State/Local Government Agency [Non-U.S.]

American Society of Clinical Oncology

Joint Cancer Care Ontario- American Society of Clinical Oncology (CCO-ASCO) Expert Panel

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

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

This is the current release of the guideline.

This NGC summary was completed by ECRI Institute on February 19, 2008. The information was verified by the guideline developer on February 20, 2008.

This summary is based on the original guideline, which is subject to the American Society of Clinical Oncology's copyright restrictions.