Tsukada 2007.

Methods	Randomized phase III trial Eligible patients Stage III/IV ≥ 70 years of age Chemotherapy‐naive Unfit for bolus platinum administration PS: 0 to 1 Exlcusion criteria not presented
Participants	D arm: 63 elderly participants randomly assigned/56 assessable participants for interim analysis DP arm: 63 elderly participants randomly assigned/56 assessable participants for interim analysis Demographics for study population: median age: 76 years, < 75 years/≥ 75 years: 39%/61%; male/female: 77%/23%; PS 0/1: 39%/61%; stage III/IV or relapsed: 30%/70%
Interventions	D arm: docetaxel 25 mg/m2 .i.v. infusion on days 1, 8, and 15, every 4 weeks DP arm: docetaxel 20 mg/m2 i.v. infusion and cisplatin 25 mg/m2 i.v. infusion on days 1, 8, and 15, every 4 weeks
Outcomes	Primary outcome Overall survival (no definition available) ‐ planned to accrue 230 participants to provide power of 80% to detect improvement in OS, with HR 0.667 for DP to D arm, 2.5% one‐sided alpha Secondary outcomes Not reported
Notes	Study prematurely stopped after first interim analysis showed strong interaction in favor of DP arm in participants between 70 and 74 years of age
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information on random sequence generation
Allocation concealment (selection bias)	Unclear risk	No information on allocation concealment
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome	Unclear risk	No information on blinding of assessor but study considered to have unclear impact on mortality outcomes
Blinding of outcome assessment (detection bias) Other outcomes	Unclear risk	No information on blinding of assessors for other outcomes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information for attrition bias analysis
Selective reporting (reporting bias)	High risk	Results presented in abstract form only. OS reported only for a subgroup of participants between 70 and 74 years of age. ITT analysis retrieved in slide from ASCO meeting presentations. Only limited data available. No other outcomes reported
Other bias	High risk	Study prematurely stopped after first interim analysis showed strong interaction in favor of DP arm for participants between 70 and 74 years of age