Buccheri 1997.

Methods	Randomized phase III trial Eligible patients Cytologically or histologically confirmed NSCLC No previous chemotherapy Locally advanced, metastatic, or recurrent disease Zubrod PS < 3 No previous chemotherapy ≤ 75 years of age Adequate bone marrow, hepatic, and renal function Measurable or assessable site of disease Exclusion criteria Active cardiac disease Serious intercurrent medical illness History of prior malignant tumor Inoperable single, small cancer lesion (maximum diameter < 4 cm), if suitable for small‐field radical radiotherapy
Participants	MACC arm: 78 ITT population ‐ median age 64 years/no information on inclusion of elderly patients MVP arm: 78 ITT population ‐ median age 65 years/no information on inclusion of elderly patients
Interventions	MACC arm: methotrexate 40 mg/m2; doxorubicin 40 mg/m2 i.v.; cyclophosphamide 400 mg/m2 i.v. infusion, and lomustine 30 mg/m2 per os on day 1, every 3 weeks MVP arm: mitomycin C 10 mg/m2; vinblastine 6 mg/m2, and cisplatin 40 mg/m2 i.v. on day 1, every 3 weeks
Outcomes	Outcomes measured (no definition of which are primary or secondary outcomes) Survival Response to treatment (according to Miller el al) Dose intensity Toxicity (according to Miller et al) Subjective tolerance; physical and psychological well‐being
Notes	No information on numbers of elderly participants nor on specific subgroup analysis performed, despite multiple attempts to contact study authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central office stratified participants according to stage of disease and ECOG, to ensure balanced distribution between treatment groups, then randomly assigned participants within each stratum
Allocation concealment (selection bias)	Unclear risk	No information on allocation concealment analysis
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome	Unclear risk	Open‐label study, considered to have unclear influence 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	Only 45, 58, and 29 participants completed QoL instrument at 6, 12, and 18 weeks
Selective reporting (reporting bias)	Low risk	No evidence of reporting bias
Other bias	High risk	Study closed to further accrual before target sample of 183 enrolled (with 156 patients) was reached, as 125 patients had already died Study designed for general population; elderly subgroup analysis not planned