Karampeazis 2010.

Methods	Randomized phase III trial Eligible patients Stage IIIB/IV NSCLC > 70 years of age PS: 0 to 2 No further eligibility nor exclusion criteria presented
Participants	G arm: 45 participants ‐ median age (range): 78 (70 to 92) years; 11 (21.2%) PS 2, 40 (76.9%) stage IV DG arm: 49 participants ‐ median age (range): 74 (70 to 84) years; 7 (13%) PS 2; 37 (68.5%) stage IV Imbalance between older participants in D arm vs DG arm (P value < 0.001). No imbalance observed for other participant characteristics. For the ITT population, 30 (55.5%) participants classified as fit in CGA, 18 (33.3%) as vulnerable, and 6 (11.1%) as frail. All participants scored 6 on ADL scale; 68% scored 7 to 8 on IADL scale
Interventions	G arm: gemcitabine 1200 mg/m2 on days 1 and 8 every 3 weeks DG arm: docetaxel 30 mg/m2 and gemcitabine 900 mg/m2 on days 1 and 8 every 3 weeks No further information available from abstract
Outcomes	Study authors did no report primary and secondary outcomes Comphrensive Geriatric Assessment (CGA) based on ADL, IADL, MMSE, CIRS‐G, and body mass index data collected
Notes	Study available in abstract form. Study authors provided additional unpublished data after direct contact. Characteristics of study population regarding age, performance status, stage, histology, and CGA provided, as well as summary data for OS, 1yOS, PFS, RR, and toxicity with longer follow‐up
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Chemotherapy‐naïve patients >70y old with stage IIIB/IV NSCLC and performance status (PS) 0‐2 were stratified according to stage and PS and randomised to either D 30 mg/m2 plus G 900mg/m2 (days 1 and 8) or G 1,200mg/m2 (days 1 and 8) every 21 days" ‐ no further information available on randomization process
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 assessors for OS and 1yOS; 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 on incomplete outcome data
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting bias. Additional data provided by study authors
Other bias	High risk	Study prematurely stopped for poor accrual. Data available from unpublished data; imbalance for age observed between treatment arms