Perng 1997.
Methods | Randomized multi‐centerphase III trial Eligible patients were
Exclusion criteria
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Participants | G arm: 27 participants (ITT population) ‐ median age (range): 63 (36 to 75) years/number of elderly participants not reported EP arm: 26 participants (ITT population) ‐ median age (range): 60 (35 to 75) years/number of elderly participants not reported |
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Interventions | G arm: gemcitabine 1250 mg/m2 over 30‐minute i.v. infusion on days 1, 8, and 15, every 4 weeks. Dexamethasone and metoclopramide were given before gemcitabine infusion as antiemetic prophylaxis EP arm: cisplatin 80 mg/m2 over 1‐hour i.v. infusion on day 1 and etoposide 80 mg/m2 over 60‐minute i.v. infusion on days 1, 2, and 3 of each 28‐day cycle. In EP arm, chemotherapy administered after hospitalization. Granisetron, dexamethasone, metoclopramide, and lorazepam given before cisplatin as antiemetic prophylaxis. Dexamethasone and metoclopramide used on days 2 and 3 as antiemetics |
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Outcomes | Neither planned primary nor secondary outcomes reported | |
Notes | No information on inclusion of elderly patients nor specific subgroup analysis was obtained, despite multiple attempts to contact study authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Eligible participants randomly assigned to GEM and EP regimens by a statistical office not involved in the trial, using a computer‐ generated list of random numbers |
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 |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | No information on blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Two patients in the EP arm were excluded from analysis due to protocol violation. One patient suffered grade 3 hearing impairment before entering the trial and the other patient was found to have brain metastases on the second day of the first cycle of treatment" |
Selective reporting (reporting bias) | Low risk | No evidence of reporting bias |
Other bias | Unclear risk | No separate elderly subgroup analysis |