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Guideline Summary
Guideline Title
Non-small cell lung cancer stage IV.
Bibliographic Source(s)
Alberta Provincial Thoracic Tumour Team. Non-small cell lung cancer stage IV. Edmonton (Alberta): Alberta Health Services, Cancer Care; 2011 Jun. 16 p. (Clinical practice guideline; no. LU-004).  [80 references]
Guideline Status

Note: This guideline has been updated. The National Guideline Clearinghouse (NGC) is working to update this summary.

Scope

Disease/Condition(s)

Stage IV non-small cell lung cancer (NSCLC)

Guideline Category
Management
Treatment
Clinical Specialty
Oncology
Pulmonary Medicine
Radiation Oncology
Thoracic Surgery
Intended Users
Physician Assistants
Physicians
Guideline Objective(s)

To outline management decisions for patients with stage IV non-small cell lung cancer

Target Population

Adult patients over the age of 18 years

Interventions and Practices Considered
  1. Consideration for eligibility in ongoing clinical trials
  2. Surgical intervention
  3. Stereotactic radiotherapy
  4. Combination chemotherapy (platinum-based doublet; triple agent chemotherapy is not routinely recommended)
  5. Alternatives to combination platinum-based chemotherapy (non-platinum doublets or single agents, e.g., vinorelbine, gemcitabine, paclitaxel, or docetaxel)
  6. Testing for epidermal growth factor receptor (EGFR) mutations
  7. EGFR tyrosine kinase inhibitor (gefitinib) for patients with EGFR mutation-positive non-small cell lung cancer
  8. Second-line chemotherapy (single-agent docetaxel or erlotinib, or pemetrexed for adenocarcinomas)
  9. Palliative radiotherapy
  10. Best supportive care
Major Outcomes Considered
  • Tumour response rate
  • 1-year survival
  • Time to progression
  • Overall survival
  • Adverse effects of therapy
  • Quality of life

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

Research Questions

Specific research questions to be addressed by the guideline document were formulated by the guideline lead(s) and Knowledge Management (KM) Specialist using the PICO question format (patient or population, intervention, comparisons, outcomes).

Guideline Questions

  1. What is the recommended first-line therapy for patients with stage IV non-small cell lung cancer (NSCLC)?
  2. What is the role for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in first-line treatment of patients with stage IV NSCLC?
  3. What is the optimal second-line therapy for patients with stage IV NSCLC?
  4. What is the role of palliative radiotherapy in the management of patients with stage IV NSCLC?

Search Strategy

For this guideline update, the working group conducted a search for new or updated practice guidelines published since August 2009 by accessing the websites of the following organizations: Cancer Care Ontario, the British Columbia Cancer Agency, Cancer Care Nova Scotia, the National Comprehensive Cancer Network, the American Society of Clinical Oncology, the Scottish Intercollegiate Guidelines Network, the National Institute for Health and Clinical Excellence, the American College of Chest Physicians, the British Thoracic Society, the Australian Cancer Network, the Italian Association of Thoracic Oncology, and the European Society for Medical Oncology.

Medical journal articles were searched using the Medline (1950 to February Week 2, 2011), EMBASE (1980 to February Week 2, 2011), Cochrane Database of Systematic Reviews (1st Quarter, 2011), and PubMed electronic databases; the references and bibliographies of articles identified through these searches were scanned for additional sources. The Medline search terms were: "Lung Neoplasms" [MeSH heading], "Carcinoma, Non-Small Cell Lung" [MeSH heading], "NSCLC" [keyword], and "non-small cell lung cancer" [keyword]. The search was limited to the following publication types: practice guidelines, systematic reviews, meta-analyses, randomized controlled trials, and clinical trials. This search strategy was modified as necessary and repeated in each of the other electronic databases. The working group excluded articles from the final review if they had a non-English abstract, were not available through the library system, or were published prior to August 2009.

The working group reviewed the currency and acceptability of all relevant literature and updated published guidelines for the treatment for stage IV NSCLC.

Number of Source Documents

Not stated

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

Updated evidence was selected and reviewed by a working group comprised of members from the Alberta Provincial Thoracic Tumour Team and a Knowledge Management (KM) Specialist from the Guideline Utilization Resource Unit (GURU). A detailed description of the methodology followed during the guideline development process can be found in the Guideline Utilization Resource Unit Handbook External Web Site Policy (see the "Availability of Companion Documents" field).

Evidence Tables

Evidence tables containing the first author, year of publication, patient group/stage of disease, methodology, and main outcomes of interest are assembled using the studies identified in the literature search. Existing guidelines on the topic are assessed by the KM Specialist using portions of the AGREE II instrument (http://www.agreetrust.org External Web Site Policy) and those meeting the minimum requirements are included in the evidence document. Due to limited resources, GURU does not regularly employ the use of multiple reviewers to rank the level of evidence; rather, the methodology portion of the evidence table contains the pertinent information required for the reader to judge for himself the quality of the studies.

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

Formulating Recommendations

The working group members formulated the guideline recommendations based on the evidence synthesized by the Knowledge Management (KM) Specialist during the planning process, blended with expert clinical interpretation of the evidence. As detailed in the Guideline Utilization Resource Unit Handbook External Web Site Policy (see the "Availability of Companion Documents" field), the working group members may decide to adopt the recommendations of another institution without any revisions, adapt the recommendations of another institution or institutions to better reflect local practices, or develop their own set of recommendations by adapting some, but not all, recommendations from different guidelines.

The degree to which a recommendation is based on expert opinion of the working group and/or the Provincial Tumour Team members is explicitly stated in the guideline recommendations. Similar to the American Society of Clinical Oncology (ASCO) methodology for formulating guideline recommendations, the Guideline Utilization Resource Unit (GURU) does not use formal rating schemes for describing the strength of the recommendations, but rather describes, in conventional and explicit language, the type and quality of the research and existing guidelines that were taken into consideration when formulating the recommendations.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

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

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

This updated guideline was reviewed and endorsed by the Alberta Provincial Thoracic Tumour Team.

When the draft guideline document is completed, revised, and reviewed by the Knowledge Management Specialist and the working group members, it will be sent to all members of the Provincial Tumour Team for review and comment. The working group members will then make final revisions to the document based on the received feedback, as appropriate. Once the guideline is finalized, it will be officially endorsed by the Provincial Tumour Team Lead and the Director of Provincial Clinical Teams.

Recommendations

Major Recommendations

Note: This guideline has been updated. The National Guideline Clearinghouse (NGC) is working to update this summary. The recommendations that follow are based on the previous version of the guideline.

  1. Whenever possible, patients with advanced non-small cell lung cancer (NSCLC) should be considered for eligibility in ongoing clinical trials.
  2. Patients with a solitary metastasis as the basis for stage IV disease with good performance status and otherwise resectable and limited thoracic disease may benefit from more aggressive management, including surgical intervention and/or stereotactic radiotherapy.
  3. Combination chemotherapy consisting of a platinum-based doublet is the standard of care for first-line treatment of advanced NSCLC. The combination of three chemotherapeutic agents for the first-line treatment of advanced NSCLC is not routinely recommended based on current evidence.
  4. Therapy should be continued for four cycles in most patients, and not more than six cycles in responding patients.
  5. Acceptable alternatives to combination chemotherapy include non-platinum doublets or monotherapy
    • For patients with a borderline performance status (PS=2), single-agent chemotherapy with vinorelbine, gemcitabine, paclitaxel, or docetaxel is recommended over best supportive care alone.
    • For elderly patients who cannot tolerate a platinum-based combination, single-agent chemotherapy with vinorelbine, gemcitabine, or docetaxel is associated with improved survival and quality of life when compared to best supportive care alone. However, elderly patients with a good performance status (PS=0-1) should receive combination chemotherapy with a platinum-based doublet.
  6. First-line monotherapy with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor gefitinib is recommended for patients with EGFR mutation-positive NSCLC.
  7. Testing for EGFR mutations should take place for all eligible patients with advanced NSCLC and adenocarcinoma histology who are being considered for first-line therapy with gefitinib, irrespective of their gender, ethnicity, and smoking status.
  8. Second-line or subsequent chemotherapy options for advanced NSCLC include single-agent docetaxel or erlotinib for patients with any histology, irrespective of EGFR mutational status, or pemetrexed for patients with adenocarcinoma histology.
  9. Palliative radiotherapy is recommended for relief of specific symptoms and prophylactic prevention of symptom development.
Clinical Algorithm(s)

A treatment algorithm for patients with stage IV non-small cell lung cancer is provided in the original guideline document.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The recommendations are supported in part by systematic reviews, meta-analyses, randomized controlled trials, and new or updated practice guidelines.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate management of patients with stage IV non-small cell lung cancer

Potential Harms

Adverse events and toxicity associated with therapy

Qualifying Statements

Qualifying Statements

The recommendations contained in this guideline are a consensus of the Alberta Provincial Thoracic Tumour Team synthesis of currently accepted approaches to management, derived from a review of relevant scientific literature. Clinicians applying these guidelines should, in consultation with the patient, use independent medical judgment in the context of individual clinical circumstances to direct care.

Implementation of the Guideline

Description of Implementation Strategy
  • Present the guideline at the local and provincial tumour team meetings and weekly rounds.
  • Post the guideline on the Alberta Health Services website.
  • Send an electronic notification of the new guideline to all members of Alberta Health Services, Cancer Care.
Implementation Tools
Clinical Algorithm
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
End of Life Care
Getting Better
Living with Illness
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Alberta Provincial Thoracic Tumour Team. Non-small cell lung cancer stage IV. Edmonton (Alberta): Alberta Health Services, Cancer Care; 2011 Jun. 16 p. (Clinical practice guideline; no. LU-004).  [80 references]
Adaptation

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

Date Released
2011 Jun
Guideline Developer(s)
Alberta Health Services, Cancer Care - State/Local Government Agency [Non-U.S.]
Source(s) of Funding

Alberta Health Services, Cancer Care

Guideline Committee

Non-Small Cell Lung Cancer Stage IV Working Group

Composition of Group That Authored the Guideline

Not stated

Financial Disclosures/Conflicts of Interest

Participation of members of the Alberta Provincial Thoracic Tumour Team in the development of this guideline has been voluntary and the authors have not been remunerated for their contributions. There was no direct industry involvement in the development or dissemination of this guideline. Alberta Health Services – Cancer Care recognizes that although industry support of research, education and other areas is necessary in order to advance patient care, such support may lead to potential conflicts of interest. Some members of the Alberta Provincial Thoracic Tumour Team are involved in research funded by industry or have other such potential conflicts of interest. However the developers of this guideline are satisfied it was developed in an unbiased manner.

Guideline Status

Note: This guideline has been updated. The National Guideline Clearinghouse (NGC) is working to update this summary.

Guideline Availability

Electronic copies of the updated guideline: Available in Portable Document Format (PDF) from the Alberta Health Services Web site External Web Site Policy.

Availability of Companion Documents

The following is available:

  • Guideline utilization resource unit handbook. Edmonton (Alberta): Alberta Health Services, Cancer Care; 2011 Dec. 5 p. Electronic copies: Available in Portable Document Format (PDF) from the Alberta Health Services Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on February 10, 2012. The information was verified by the guideline developer on March 30, 2012.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouseâ„¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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