The electronic databases, MEDLINE (1996 through November Week 3 2005), EMBASE (1996 through 2005, week 53), and the Cochrane Library (2005, Issue 4), were searched using the search terms detailed in Appendix A of the original guideline document.
In addition, conference proceedings of the American Society of Clinical Oncology (ASCO), the European Cancer Conference (ECCO), the European Society for Medical Oncology (ESMO), and the International Association for the Study of Lung Cancer (IASLC) were searched for abstracts of relevant trials published between 2000 and 2005. The Canadian Medical Association Infobase (http://mdm.ca/cpgsnew/cpgs/index.asp), the National Guideline Clearinghouse (http://www.guideline.gov/), and the National Institute for Clinical Excellence (http://www.nice.org.uk/) were also searched for existing evidence-based practice guidelines.
The initial literature searches were reviewed by one member of the Disease Site Group (DSG), and articles that did not meet the broad inclusion criteria were excluded (i.e., general review articles, study type or design was not applicable, trials focusing on disease types other than non-small cell lung cancer [NSCLC], trials of first-line therapy, and trials not involving systemic therapy). Two reviewers selected relevant articles and abstracts from the remaining literature, resolving any disagreements on article selection by discussion. The reference lists from the selected articles were searched for additional trials, as were the reference lists from relevant review articles.
Study Selection Criteria
Articles published as full reports or as abstracts were selected for inclusion in this systematic review of the evidence if they focused on second-line or subsequent systemic therapy for recurrent or progressive non-small cell lung cancer, reported outcomes of interest, and were:
- Systematic reviews or practice guidelines of systemic therapy; or
- Meta-analyses comparing systemic therapy with best supportive care (BSC) or another systemic therapy; or
- Randomized trials comparing different systemic therapy agents or regimens, or systemic therapy with best supportive care; or
- Randomized trials comparing different doses and/or schedules of systemic therapy agents.
The following were excluded from the systematic review of the evidence:
- Systematic reviews or meta-analyses that pre-dated, or confined their analysis to, trials included in the 2001 practice guideline developed by the Lung Disease Site Group on the role of single-agent docetaxel as second-line treatment for advanced non-small cell lung cancer.
- Trials that included a mix of untreated and previously treated patients.
- Articles published in a language other than English.
- Trials that included less than 50 patients per trial arm. Trials with less than 100 patients were considered underpowered to detect any clinically meaningful difference in effect given the range of typical accrual times, follow up times, and times-to-event. Trials with less than 50 patients per trial arm are reported in Appendix B in the original guideline document and are included in any relevant meta-analyses conducted.