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Guideline Summary
Guideline Title
(1) American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non–small-cell lung cancer. (2) 2011 focused update of 2009 American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non–small-cell lung cancer.
Bibliographic Source(s)
Azzoli CG, Baker S Jr, Temin S, Pao W, Aliff T, Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, Nordquist L, Pfister DG, Piantadosi S, Schiller JH, Smith R, Smith TJ, Strawn JR, Trent D, Giaccone G, American Society of Clinical Oncology. American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol. 2009 Dec 20;27(36):6251-66. [157 references] PubMed External Web Site Policy

Azzoli CG, Temin S, Aliff T, Baker S Jr, Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, Nordquist L, Pao W, Pfister DG, Piantadosi S, Schiller JH, Smith R, Smith TJ, Strawn JR, Trent D, Giaccone G. 2011 focused update of 2009 American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol. 2011 Oct 1;29(28):3825-31. [18 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 2004 Jan 15;22(2):330-53.

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory information has been released.

  • June 20, 2014 – Docetaxel External Web Site Policy: The U.S. Food and Drug Administration (FDA) is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk.

Scope

Disease/Condition(s)

Stage IV (advanced) non–small-cell lung cancer (NSCLC)

Guideline Category
Evaluation
Management
Treatment
Clinical Specialty
Internal Medicine
Medical Genetics
Oncology
Pulmonary Medicine
Intended Users
Physicians
Guideline Objective(s)

2009 Guideline

To provide updated recommendations for the treatment of patients with stage IV non–small-cell lung cancer with a narrowed scope of chemotherapy and biologic therapy

2011 Focused Update

To update one recommendation of the American Society of Clinical Oncology (ASCO) Guideline Update on Chemotherapy for Stage IV Non–Small-Cell Lung Cancer (NSCLC) regarding switch maintenance chemotherapy

Target Population

Patients (including the elderly) with stage IV (advanced) non–small-cell lung cancer

Interventions and Practices Considered
  1. First-line chemotherapy
    • Platinum-based two-drug combination of cytotoxic drugs
    • Nonplatinum therapy combinations
    • Cisplatin or carboplatin, considering individual patient factors
    • Drugs that may be combined with platinum: third-generation cytotoxic drugs (docetaxel, gemcitabine, irinotecan, paclitaxel, pemetrexed, and vinorelbine)
    • Single-agent chemotherapy for performance status (PS) 2 patients
    • Alternative, single-agent chemotherapy such as pemetrexed in patients with nonsquamous histology, docetaxel in unselected patients, or erlotinib in unselected patients (for patients with stable disease or response after four cycles)
    • Gefitinib therapy in patients with activating EGFR mutations
    • Bevacizumab added to carboplatin-paclitaxel
    • Cetuximab added to cisplatin-vinorelbine
  2. Second-line chemotherapy
    • Docetaxel, erlotinib, gefitinib, or pemetrexed
  3. Third-line chemotherapy
    • Erlotinib
  4. Molecular analysis of tissue for purpose of selecting chemotherapy (insufficient evidence to recommend routine use)
Major Outcomes Considered
  • Survival rates (disease-free, progression-free, overall)
  • Health-related quality of life
  • Symptom relief
  • Objective response
  • Toxicity

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

2009 Guideline

Literature Search Strategy

This systematic review was initially developed by Cancer Care Ontario's Program in Evidence-Based Care. For the 2009 update, MEDLINE and EMBASE databases were searched from January 2002 through July 2008. Results were supplemented by a search of the American Society of Clinical Oncology (ASCO) Annual Meeting Abstracts from 2007 and 2008 and of the International Association for the Study of Lung Cancer (IASLC) Annual Meeting from 2007 and additional suggestions from Update Committee members. Search terms included the following: "non–small-cell lung cancer," "advanced non–small-cell lung cancer," "bronchioloalveolar carcinoma," "antineoplastic protocols," "drug therapy combinations," "drug therapy," "receptor protein-tyrosine kinase," "receptor, epidermal growth factor," "mutation or genes, ras," "serum tumor markers," other specific molecular markers, and "performance status." Additional terms included generic and brand names of chemotherapeutic and biologic agents. Searches were limited to randomized controlled trials (RCTs), practice guidelines, systematic reviews, and meta-analyses. For chemotherapy, searches were limited to phase III RCTs; for biologic agents, searches included phase II and III randomized trials. In this guideline, however, the term chemotherapy refers to any anticancer drug, regardless of its mechanism of action (i.e., cytotoxic and biologic agents included) unless otherwise specified. For molecular analysis, the search protocol permitted retrospective and subgroup analyses from clinical trials, as well as cohort studies. For chemotherapy and biologic agent trials, cohort studies were excluded. Other study designs excluded for all topics were phase I or case-control trials. Publications that were fully published English-language reports involving human subjects in peer-reviewed journals were eligible.

Inclusion and Exclusion Criteria

Articles were selected for inclusion if they met the following criteria: participants were not candidates for surgery or definitive radiotherapy with curative intent, and participants were randomly assigned to a treatment arm or a control arm (control arm could consist of placebo, best supportive care, the same treatment at an alternate dose or a different schedule of administration or for a different duration, a different treatment, or the same treatment combined with a different treatment). Outcome measures reported included at least one of the following for chemotherapy and biologic therapies: overall survival (OS), progression-free survival (PFS), objective response rate (ORR), toxicity, and quality of life (QOL)/symptom relief. For molecular analysis studies, outcome measures included one of the following: objective response, OS, or PFS. The primary outcome of interest was OS, and recommendations were primarily based on statistically significant improvements in OS documented in prospective RCTs. The Update Committee acknowledges the trend of phase III clinical trials for stage IV non-small-cell lung cancer (NSCLC) where the primary end point is PFS. Treatments that improve only PFS prompted greater scrutiny for toxicity, adverse effects, and QOL.

An a priori decision was made to exclude papers on individual molecular markers (molecular analysis after completion of the systematic review if there were less than five retrospective studies and no prospective studies of the particular marker. To allow the Update Committee to consider more recent phase III data not yet published in the literature, a separate search was conducted of all phase III abstracts presented at the 2007 and 2008 annual meetings of ASCO and the 2007 meeting of the IASLC. Whenever data from an abstract had any impact on a guideline recommendation, the Update Committee recognized these data as inferior to data published in the literature and were careful to specify the source of the data in the language of the recommendation and in the discussion section for each recommendation.

Relevant articles were selected and reviewed by two reviewers sequentially, and the reference lists from those sources were searched for additional trials.

2011 Addendum

For the 2011 focused update, the NSCLC update committee reviewed and analyzed data from new peer-reviewed publications of phase III RCTs on maintenance chemotherapy published since the search date cutoff for the November 2009 guideline update. The update committee addressed the maintenance aspect of the clinical question, "What is the optimal duration of first-line chemotherapy for stage IV NSCLC?" from the previous guideline. To be included in this 2011 focused update, a trial had to compare outcomes for patients receiving new maintenance/consolidation/sequential chemotherapy before disease progression versus those receiving a regular course of chemotherapy/placebo/observation/best supportive care after first-line therapy. This type of maintenance therapy is also known as switch maintenance or consolidation therapy.

A computerized literature search of Medline was performed for English-language literature published between January 2008 and June 2010 to address recommendation A6 in the 2009 update. Searches of ASCO 2009 and 2010 Annual Meeting abstracts and International Association for the Study of Lung Cancer meeting abstracts from 2008, 2009, and 2010 were also performed. Searches were limited to phase III RCTs, meta-analyses, or systematic reviews. Search terms and inclusion and exclusion criteria were the same as those used for the 2009 guideline. Search terms included "lung neoplasms," "non–small-cell lung cancer," "antineoplastic protocols," and specific names of chemotherapeutic agents. Publications that were fully published English-language reports involving humans in peer-reviewed journals were eligible.

Abstracts were considered but given less weight because of their interim nature. Four hundred twenty-seven abstracts of published articles were retrieved from Medline and reviewed by one reviewer. Seven articles were selected for full-text review and data extraction. Titles of 545 abstracts from ASCO 2009 and 2010 Annual Meetings were reviewed. In addition, titles and abstracts from International Association of the Study of Lung Cancer 2008, 2009, and 2010 meetings were searched for the word "maintenance" and reviewed. One abstract from the ASCO 2009 Annual Meeting and two abstracts from the ASCO 2010 Annual Meeting (one provided additional data from study in 2009 abstract) met the inclusion criteria. Ultimately, eight reports of seven RCTs were included. Details of the search strategy and a quality of reporting of meta-analyses document with numbers of articles included and excluded are provided in the Data Supplement (see the "Availability of Companion Documents" field).

Number of Source Documents

2009 Guideline

A total of 162 publications met the inclusion criteria. The recommendations were based on 52 randomized control trials (RCTs) and 29 meta-analyses, plus retrospective tissue analyses that were included only for molecular analysis.

2011 Addendum

The evidence base for this 2011 focused update comprises peer-reviewed publications of five RCTs and two RCTs presented in abstract form. Because of the literature search parameters, some studies discussed in the 2009 update were considered for the 2011 focused update.

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
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

Data Extraction

Relevant articles were selected and reviewed by two reviewers sequentially, and the reference lists from those sources were searched for additional trials. Evidence was selected and reviewed by one member of the Program in Evidence-Based Care, and this systematic review was updated and completed by one American Society of Clinical Oncology (ASCO) staff member. Each article meeting the inclusion criteria underwent data extraction for patient characteristics, study design and quality, intervention, and outcomes, including adverse events. Evidence summary tables were developed based on data extracted from studies meeting the criteria for inclusion.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

2009 Guideline

The American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines Committee convened an Update Committee consisting of experts in medical oncology, in both academic and community practice, and in statistics; and two patient representatives.

Consensus Development Based on Evidence

The entire Update Committee met once; additional work on the guideline was completed through a steering group. The purposes of the Update Committee meeting were to draft guideline recommendations and distribute writing assignments. During review of the results of the literature search, members of the Update Committee were allowed to nominate studies recently published but not identified in the literature search or presented as an abstract(s) but not identified in the search of abstracts from ASCO 2007, ASCO 2008, or International Association for the Study of Lung Cancer (IASLC) 2007 meetings for consideration by the rest of the Update Committee. Members of the Update Committee participated in the preparation of the draft guideline document, which was then disseminated for review by the entire Update Committee.

2011 Addendum

Consensus Development Based on Evidence

The 2009 update committee co-chairs and ASCO staff drafted this 2011 focused update and circulated it to the entire update committee for approval.

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
Comparison with Guidelines from Other Groups
Internal Peer Review
Description of Method of Guideline Validation

2009 Guideline

The guideline was submitted to the Journal of Clinical Oncology for peer review.

The content of the guidelines were reviewed and approved by the Clinical Practice Guidelines Committee and by the American Society of Clinical Oncology (ASCO) Board of Directors.

Previous Guidelines and Consensus Statements

The American College of Chest Physicians, the National Comprehensive Cancer Network, and Cancer Care Ontario have produced guidelines, and the European Society for Medical Oncology and Gridelli et al have produced consensus statements that make recommendations regarding stage IV non–small cell lung cancer (NSCLC). The Update Committee has evaluated the guidelines and consensus statements and found them to be consistent with the ASCO guidelines.

2011 Addendum

The ASCO Clinical Practice Guideline Committee leadership reviewed and approved the final document. The focused update was submitted to the Journal of Clinical Oncology for peer review. The content of the 2011 focused update was also reviewed and approved by the ASCO Board of Directors Executive Committee before publication.

Recommendations

Major Recommendations

Note from the American Society of Clinical Oncology (ASCO) and the National Guideline Clearinghouse (NGC): In 2011, ASCO produced a focused update in response to new peer-reviewed publications of phase III randomized clinical trials (RCTs) on maintenance chemotherapy published since the literature search date cutoff for the November 2009 update. The 2011 focused update addresses switch maintenance therapy only, and the affected recommendation is labeled "2011 focused update recommendation."

Recommendations on first-line chemotherapy begin with A, those on second-line chemotherapy begin with B, those on third-line chemotherapy begin with C, and those on molecular analysis begin with D.

First-Line Chemotherapy

  1. Which patients with stage IV non–small-cell carcinoma (NSCLC) should be treated with chemotherapy?

    2009 recommendation A1. Evidence supports the use of chemotherapy in patients with stage IV NSCLC with Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status (PS) of 0, 1, and possibly 2.

  2. What is the most effective first-line chemotherapy for the treatment of patients with stage IV NSCLC?

    2009 recommendation A2. In patients with a PS of 0 or 1, evidence supports using a combination of two cytotoxic drugs for first-line therapy. Platinum combinations are preferred over nonplatinum combinations because they are superior in response rate, and marginally superior in overall survival (OS). Nonplatinum combinations are reasonable in patients who have contraindications to platinum therapy. Recommendations A8 and A9 address whether to add bevacizumab or cetuximab to first-line cytotoxic therapy.

  3. What is the best chemotherapy for treatment of patients with PS 2 with stage IV NSCLC?

    2009 recommendation A3. Available data support the use of single-agent chemotherapy in patients with a PS of 2. Data are insufficient to make a recommendation for or against using a combination of two cytotoxic drugs for patients with a PS of 2.

  4. What is the best chemotherapy for treatment of the elderly with stage IV NSCLC?

    2009 recommendation A4. The evidence does not support the selection of a specific first-line chemotherapy drug or combination based on age alone.

  5. Is cisplatin more effective than carboplatin in the first-line treatment of stage IV NSCLC?

    2009 recommendation A5. The choice of either cisplatin or carboplatin is acceptable. Drugs that may be combined with platinum include the third-generation cytotoxic drugs docetaxel, gemcitabine, irinotecan, paclitaxel, pemetrexed, and vinorelbine. The evidence suggests that cisplatin combinations have a higher response rate than carboplatin and may improve survival when combined with third-generation agents. Carboplatin is less likely to cause nausea, nephrotoxicity, and neurotoxicity than cisplatin but is more likely to cause thrombocytopenia.

  6. What is the optimal duration of first-line treatment for stage IV NSCLC?

    2011 focused update recommendation A6. In patients with stage IV NSCLC, first-line cytotoxic chemotherapy should be stopped at disease progression or after four cycles in patients whose disease is stable but not responding to treatment. Two-drug cytotoxic combinations should be administered for no more than six cycles. For patients with stable disease or response after four cycles, immediate treatment with an alternative, single-agent chemotherapy such as pemetrexed in patients with nonsquamous histology, docetaxel in unselected patients, or erlotinib in unselected patients may be considered. Limitations of this data are such that a break from cytotoxic chemotherapy after a fixed course is also acceptable, with initiation of second-line chemotherapy at disease progression.

  7. What are the benefits, with respect to overall survival (OS), performance-free survival (PFS), toxicity, and quality of life/symptom relief, in the treatment of stage IV NSCLC with targeted therapies?

    2009 recommendation A7. In unselected patients with stage IV NSCLC, erlotinib or gefitinib should not be used in combination with cytotoxic chemotherapy as first-line therapy. In unselected patients, evidence is insufficient to recommend single-agent erlotinib or gefitinib as first-line therapy. The first-line use of gefitinib may be recommended for patients with activating epidermal growth factor receptor (EGFR) mutations. If EGFR mutation status is negative or unknown, then cytotoxic chemotherapy is preferred (see recommendation A2).

    2009 recommendation A8. On the basis of the results of one large phase III randomized controlled trial (RCT), the Update Committee recommends the addition of bevacizumab, 15 mg/kg every 3 weeks, to carboplatin/paclitaxel, except for patients with squamous cell carcinoma histologic type, brain metastases, clinically significant hemoptysis, inadequate organ function, ECOG PS of more than 1, therapeutic anticoagulation, clinically significant cardiovascular disease, or medically uncontrolled hypertension. Bevacizumab may be continued, as tolerated, until disease progression.

    2009 recommendation A9. Based on the results of one large phase III RCT, clinicians may consider the addition of cetuximab to cisplatin/vinorelbine in first-line therapy in patients with an EGFR-positive tumor as measured by immunohistochemistry (IHC). Cetuximab may be continued, as tolerated, until disease progression.

Second-Line Chemotherapy

  1. Is there an optimal second-line treatment for stage IV NSCLC? Is there evidence to support the use of combination biologic therapy as second-line therapy? Is there an optimal schedule of administration in second-line treatment for stage IV NSCLC?

    2009 recommendation B1. Docetaxel, erlotinib, gefitinib, or pemetrexed is acceptable as second-line therapy for patients with advanced NSCLC with adequate PS when the disease has progressed during or after first-line, platinum-based therapy.

  2. What is the optimal second-line treatment for elderly patients with stage IV NSCLC?

    2009 recommendation B2. The evidence does not support the selection of a specific second-line chemotherapy drug or combination based on age alone.

Third-Line Chemotherapy

  1. Is there a role for third-line therapy in the treatment of stage IV NSCLC?

    2009 recommendation C1. When disease progresses on or after second-line chemotherapy, treatment with erlotinib may be recommended as third-line therapy for patients with PS 0 to 3 who have not received prior erlotinib or gefitinib.

    2009 recommendation C2. The data are not sufficient to make a recommendation for or against using a cytotoxic drug as third-line therapy. These patients should consider clinical trials, experimental treatment, or best supportive care (BSC).

Molecular Analysis

  1. For the purposes of prescribing chemotherapy, what is the relevance of molecular analysis of tissue?

    2009 recommendation D1. Evidence is insufficient to recommend the routine use of molecular markers to select systemic treatment in patients with metastatic NSCLC.

    2009 recommendation D2. In order to obtain tissue for more accurate histologic classification or for investigational purposes, the Update Committee supports reasonable efforts to obtain more tissue than what is contained in a routine cytology specimen.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

2009 Guideline

The recommendations are based on 53 randomized controlled trials (RCTs) and 29 meta-analyses, plus retrospective tissue analyses that were included only for molecular analysis. Refer to the "Literature Update" sections of the original guideline document for specific evidence for each recommendation.

2011 Addendum

The evidence base for this 2011 focused update comprises peer-reviewed publications of five RCTs and two RCTs presented in abstract form.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate treatment of chemotherapy and biologic therapy in patients with stage IV non–small-cell lung cancer

Potential Harms

Treatment-related toxicity

Contraindications

Contraindications
  • Contraindications to platinum-based therapy include allergy to cisplatin or carboplatin, baseline hearing loss, renal insufficiency, intolerable nausea despite optimal emesis prophylaxis, intolerance to corticosteroids needed for emesis prophylaxis, and patient refusal to take a platinum drug. For these patients, nonplatinum combinations are acceptable alternatives.
  • Contraindications to cisplatin include baseline hearing loss, renal insufficiency, comorbid illnesses such as congestive heart failure or urinary problems that limit intravenous saline hydration, and diabetes, which limits use of corticosteroids for emesis prophylaxis.
  • Relative contraindications to carboplatin include baseline thrombocytopenia and bleeding risk.

Qualifying Statements

Qualifying Statements

2009 Guideline

American Society of Clinical Oncology (ASCO) practice guidelines reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and settings for further research. Because of the rapid flow of scientific information in oncology, new evidence may have emerged since the time a guideline was submitted for publication. Guidelines are not continually updated and may not reflect the most recent evidence. Guidelines cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. ASCO guidelines describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's guidelines or for any errors or omissions.

Limitations of the Literature

There were limited numbers of trials enrolling patients with poor performance status (PS) (PS ≥2 based on the Eastern Cooperative Oncology Group [ECOG]/Zubrod scale or <70% on the Karnofsky PS scale) or elderly patients. In addition, there is currently a lack of phase III data on patients who have been treated with third-line therapy and beyond. The recommendations in this guideline were based on statistically significant improvements in outcomes documented in prospective randomized controlled trials (RCTs), primarily in overall survival (OS). As a result, potentially important issues in the selection of treatment, including toxicity, quality of life, and cost effectiveness, were discounted by the Update Committee during the review process. For some clinical questions, only improvement in progression-free survival (PFS) was observed. Treatments that improved only PFS prompted greater scrutiny for toxicity, adverse events (AEs), and quality of life.

2011 Addendum

This focused update of an ASCO clinical practice guideline is intended for physicians. The practice guideline and this focused update are not intended to substitute for the independent professional judgment of the treating physician. Practice guidelines do not account for individual variation among patients and may not reflect the most recent evidence. This focused update does not recommend any particular product or course of medical treatment. Use of the practice guideline and this focused update is voluntary.

Implementation of the Guideline

Description of Implementation Strategy

For information on the American Society for Clinical Oncology (ASCO) implementation strategy, please see the ASCO Web site External Web Site Policy.

Implementation Tools
Chart Documentation/Checklists/Forms
Patient Resources
Quick Reference Guides/Physician Guides
Slide Presentation
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Azzoli CG, Baker S Jr, Temin S, Pao W, Aliff T, Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, Nordquist L, Pfister DG, Piantadosi S, Schiller JH, Smith R, Smith TJ, Strawn JR, Trent D, Giaccone G, American Society of Clinical Oncology. American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol. 2009 Dec 20;27(36):6251-66. [157 references] PubMed External Web Site Policy

Azzoli CG, Temin S, Aliff T, Baker S Jr, Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, Nordquist L, Pao W, Pfister DG, Piantadosi S, Schiller JH, Smith R, Smith TJ, Strawn JR, Trent D, Giaccone G. 2011 focused update of 2009 American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol. 2011 Oct 1;29(28):3825-31. [18 references] PubMed External Web Site Policy
Adaptation

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

Date Released
1997 May (updated 2009 Nov 16; addendum released 2011 Oct 1)
Guideline Developer(s)
American Society of Clinical Oncology - Medical Specialty Society
Source(s) of Funding

American Society of Clinical Oncology (ASCO)

Guideline Committee

American Society of Clinical Oncology (ASCO) Practice Guidelines Update Committee

Composition of Group That Authored the Guideline

2009 Guideline

The ASCO Clinical Practice Guidelines Committee convened an Update Committee consisting of experts in medical oncology, in both academic and community practice, and in statistics; and two patient representatives.

Panel Members: Christopher G. Azzoli, MD (Co-Chair), Memorial Sloan-Kettering Cancer Center, New York, NY; Giuseppe Giaccone, MD (Co-Chair), National Cancer Institute, Bethesda, Maryland; John R. Strawn, MD, Patient Representative, Houston, TX; Reily Smith, Patient Representative, Bakersfield, CA; Timothy Aliff, MD, Northwest Oncology & Hematology Associates; Sherman Baker Jr, MD, Virginia Commonwealth University, Massey Cancer Center; Julie Brahmer, MD, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; David H. Johnson, MD (Co-Chair, 2003 Update and current panelist), Vanderbilt-Ingram Cancer Center; Janessa L. Laskin, MD, British Columbia Cancer Agency; Gregory Masters, MD Helen F. Graham Cancer Center; Daniel Milton, MD, Hematology/Oncology of Indiana, PC; Luke Nordquist, MD, Nebraska Cancer Specialists, PC; William Pao, MD, PhD, Vanderbilt-Ingram Cancer Center; David G. Pfister, MD (Co-Chair, 2003 Update and current panelist), Memorial Sloan-Kettering Cancer Center, New York, NY; Steven Piantadosi, MD, PhD, Samuel Oschin Comprehensive Cancer Institute; Joan H. Schiller, MD, University of Texas, Southwestern Medical Center; Thomas J. Smith, MD, Virginia Commonwealth University, Massey Cancer Center; David Trent, MD, PhD, Virginia Cancer Center

2011 Addendum

Christopher G. Azzoli and David G. Pfister, Memorial Sloan-Kettering Cancer Center, New York, NY; Sarah Temin, American Society of Clinical Oncology, Alexandria; Sherman Baker Jr and Thomas J. Smith, Virginia Commonwealth University, Massey Cancer Center; David Trent, Virginia Cancer Center, Richmond, VA; Timothy Aliff, Northwest Oncology and Hematology Associates, Coral Springs, FL; Julie Brahmer, Sidney Kimmel Cancer Comprehensive Center, Johns Hopkins University, Baltimore; Giuseppe Giaccone, National Cancer Institute, Bethesda, MD; David H. Johnson and Joan H. Schiller, University of Texas, Southwestern Medical Center, Dallas; John R. Strawn, patient representative, Houston, TX; Janessa L. Laskin, British Columbia Cancer Agency, Vancouver, British Columbia, Canada; Gregory Masters, Helen F. Graham Cancer Center, Newark, DE; Daniel Milton, Hematology/Oncology of Indiana, Indianapolis, IN; Luke Nordquist, Nebraska Cancer Specialists, Omaha, NE; William Pao, Vanderbilt-Ingram Cancer Center, Nashville, TN; Steven Piantadosi, Samuel Oschin Comprehensive Cancer Center Institute, Los Angeles; and Reily Smith, patient representative, Bakersfield, CA

Financial Disclosures/Conflicts of Interest

The Update Committee was assembled in accordance with the American Society of Clinical Oncology's (ASCO's) Conflict of Interest Management Procedures for Clinical Practice Guidelines. Members of the panel completed ASCO's disclosure form, which requires disclosure of financial and other interests that are relevant to the subject matter of the guideline, including relationships with commercial entities that are reasonably likely to experience direct regulatory or commercial impact as the result of promulgation of the guideline. Categories for disclosure include employment relationships, consulting arrangements, stock ownership, honoraria, research funding, and expert testimony. In accordance with the Procedures, the majority of the members of the Committee did not disclose any of these relationships. Disclosure information for each member of the Committee is published adjunct to this guideline.

Authors' Disclosures of Potential Conflicts of Interest -- 2009 Guideline

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 of the journal of publication.

Employment or Leadership Position: None Consultant or Advisory Role: Julie Brahmer, Eli Lilly (C), ImClone Systems (C); Joan H. Schiller, Genentech (C), AstraZeneca (C), Pfizer (C), Eli Lilly (C) Stock Ownership: None Honoraria: Sherman Baker Jr, Lilly Oncology; Janessa L. Laskin, Hoffman-La Roche, Eli Lilly, AstraZeneca Research Funding: Christopher G. Azzoli, Allos Therapeutics, sanofi-aventis, Genentech BioOncology; David H. Johnson, Merck; Janessa L. Laskin, Hoffman-La Roche; David G. Pfister, sanofi-aventis, Eli Lilly, AstraZeneca, Genentech; Joan H. Schiller, ArQuele, Pfizer, Merck Expert Testimony: None Other Remuneration: William Pao, Molecular MD

Authors' Disclosures of Potential Conflicts of Interest -- 2011 Addendum

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 of the journal of publication.

Employment or Leadership Position: None Consultant or Advisory Role: Julie Brahmer, AstraZeneca (C), Genentech (C), Eli Lilly (C); William Pao, Bristol-Myers Squibb (C), AstraZeneca (C); Steven Piantadosi, Eli Lilly (C); Joan H. Schiller, AstraZeneca (C), Bristol-Myers Squibb (C), Genentech (C), Eli Lilly (C) Stock Ownership: None Honoraria: Sherman Baker Jr, Eli Lilly; Janessa L. Laskin, Eli Lilly Research Funding: Christopher G. Azzoli, Genentech, sanofi-aventis, Eli Lilly; Daniel Milton, Genentech; William Pao, AstraZeneca; David G. Pfister, AstraZeneca, Genentech, Eli Lilly, sanofi-aventis; Joan H. Schiller, Genentech Expert Testimony: None Other Remuneration: None

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 2004 Jan 15;22(2):330-53.

Guideline Availability

Electronic copies of the guideline and the addendum: Available from the American Society of Clinical Oncology (ASCO) Web site External Web Site Policy.

Print copies: Available from American Society of Clinical Oncology, Cancer Policy and Clinical Affairs, 2318 Mill Rd, Suite 800, Alexandria, VA 22314; E-mail: guidelines@asco.org.

Availability of Companion Documents

The following are available:

  • Decision aid set: stage IV non–small cell lung cancer (NSCLC). 2009. Available in Portable Document Format (PDF) from the American Society of Clinical Oncology (ASCO) Web site External Web Site Policy.
  • Clinical practice guideline update on chemotherapy for stage IV non–small cell lung cancer. 2011. Slide set. Available in PDF External Web Site Policy and Power Point External Web Site Policy from the ASCO Web site.
  • American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non–small-cell lung cancer. Guideline summary. 2010 Jan. 5 p. Electronic copies: Available in PDF from the ASCO Web site External Web Site Policy.
  • 2011 focused update of 2009 American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. Data supplement. 2011. 11 p. Electronic copies: Available in PDF from the ASCO Web site External Web Site Policy.
Patient Resources

The following is available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This summary was completed by ECRI on September 1, 1998. It was verified by the guideline developer on December 1, 1998. This summary was updated by ECRI on February 16, 2004. The updated information was verified by the guideline developer on February 26, 2004. This summary was updated by ECRI Institute on March 25, 2010. The updated information was verified by the guideline developer on April 9, 2010. This summary was updated by ECRI Institute on October 25, 2011. This summary was updated by ECRI Institute on July 18, 2014 following the U.S. Food and Drug Administration advisory on Docetaxel.

Copyright Statement

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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