Chen 2002.

Methods	Randomized phase II trial Eligible patients Histologically or cytologically confirmed NSCLC Stage IIIB (including patients with malignant pleural effusion) or IV disease Bi‐dimensionally measurable disease No previous chemotherapy, immunotherapy, or radiotherapy 18 to 80 years of age PS 0 to 2 (WHO scale) Adequate bone marrow function Exclusion criteria Signs or symptoms of brain metastases Recent myocardial infarction > 3 months before date of diagnosis Unstable angina Inadequate liver function (bilirubin > 1.5 times and ALT/AST > 3 times upper normal limit) Inadequate renal function with creatinine > 2.0 mg/dL Second primary malignancies, except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, excluded from the study
Participants	PG arm: 45 ITT population ‐ median age (range): 67 (35 to 80) years/number of elderly participants not reported CP arm: 45 ITT population ‐ median age (range): 64 (37 to 77) years/number of elderly participants not reported
Interventions	PG arm: paclitaxel 175 mg/m2 over 3‐hour i.v. infusion on day 1 and gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion on days 1 and 8, every 3 weeks CP arm: paclitaxel 175 mg/m2 over 3‐hour i.v. infusion on day 1 and carboplatin AUC7 (predicted using measured clearances and the Calvert formula) over 1‐hour i.v. infusion on day 1, every 3 weeks All participants received dexamethasone (10 mg i.v. at –12 and –6 hours), cimetidine (300 mg i.v.), and diphenhydramine (50 mg i.v.) before paclitaxel administration Metoclopramide (40 mg i.v.) given before paclitaxel plus carboplatin or gemcitabine as antiemetic prophylaxis. Dexamethasone (10 mg i.v.) and metoclopramide (20 mg i.v.) given before gemcitabine treatment (day 8) as antiemetic prophylaxis
Outcomes	Primary outcome Cost and time required for each treatment (cost‐effectiveness) Secondary outcomes Overall survival Time‐to‐disease progression Response rate Toxicity
Notes	No information on inclusion of elderly patients nor on specific subgroup analysis, despite multiple attempts to contact study authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Eligile participants randomly assigned to paclitaxel plus carboplatin regimen or paclitaxel plus gemcitabine regimen by a statistical office not involved in the trial with use of computer‐generated list of random numbers
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	Low risk	No evidence of attrition bias
Selective reporting (reporting bias)	Low risk	No evidence of reporting bias
Other bias	High risk	Study designed for general population; elderly subgroup analysis not planned. Neither numbers nor outcomes available for this subgroup