Hainsworth 2007.

Methods	Randomized multi‐center phase III trial Eligible patients Biospy‐proven stage IIIB (pleural effusion) or IV NSCLC > 65 years old or poor candidate for standard platinum chemotherapy because of co‐existent medical illness or poor performance status No prior chemotherapy PS :0 to 2 on ECOG scale Measurable or evaluable disease Adequate bone marrow and liver function Creatinine 2.0 mg/dL Exclusion criteria Parenchymal brain metastasis or leptomeningeal metastasis, except for solitary brain metastasis treated with definitive resection and/or radiation therapy with no residual metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) Major surgical procedure within 4 weeks Pre‐existing peripheral neuropathy > grade 1 Other invasive cancers treated within 5 years Pregnant or lactating female
Participants	D arm: 171 ITT population/115 elderly population DG arm: 174 ITT population/117 elderly population
Interventions	D arm: docetaxel 36 mg/m2 over 30‐minute i.v. infusion on days 1, 8 and 15, and every 4 weeks DG arm: gemcitabine 800 mg/m2, over 30‐minute i.v. infusion, followed by docetaxel 30 mg/m2, over 30‐minute i.v. infusion; both drugs administered on days 1, 8, and 15, every 4 weeks Standard hypersensitivity and antiemetic prophylaxis administered before each dose of chemotherapy
Outcomes	Primary outcome Overall survival ‐ determine superiority of DG arm over D arm Secondary outcomes Objective response rate Time‐to‐tumor progression
Notes	No information on subgroup analysis of elderly participants, despite multiple attempts to contact study authors.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Participant enrollment in this multi‐center, randomized, phase III study was initiated in August 2001. Random sequence generation was not mentioned
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not mentioned
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome	Unclear risk	Open‐label study assigned unclear impact on mortality outcomes
Blinding of outcome assessment (detection bias) Other outcomes	High risk	Open‐label study
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Study authors reported insufficient data to allow attrition bias analysis in the elderly subgroup
Selective reporting (reporting bias)	Low risk	No outcome data were provided for participants older than 70 years. Study authors presented a separate analysisfor OS only in participants with good PS, including those older than 65 years. No other outcomes were reported for the elderly subgroup. However, the trial was not planned for elderly subgroup analysis, and we considered it to have low risk of reporting bias
Other bias	High risk	No data were provided on unplanned elderly subgroup analysis. OS analysis was performed only for the subgroup of participants with good PS, which included only participants older than 65 years