Chen 2002.
Methods | Randomized phase II trial Eligible patients
Exclusion criteria
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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 |
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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 |
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Outcomes | Primary outcome
Secondary outcomes
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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 |