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. 2015 Oct 20;2015(10):CD010463. doi: 10.1002/14651858.CD010463.pub2

Hara 1990.

Methods Randomized trial
Eligible patients

  • Histologically proven adenocarcinoma of the lung

  • Measurable or evaluable lesion on physical examination or on chest roentgenogram

  • No prior chemotherapy or radiotherapy

  • ≤ 75 years of age

  • PS: 0 to 2 on ECOG scale

  • Adequate renal and hematological function
Participants MCT arm: 68 participants (ITT population) ‐ median age (range): 63 (37 to 75) ‐ number of elderly not reported
CAPM arm: 58 participants (ITT population) ‐ median age (range): 60 (27 to 75) ‐ number of elderly not reported
Interventions MCT arm: mitomycin C 4 mg/body i.v. infusion and cytosine arabinoside 30 mg/body on days 1, 4, 14, 21, and 28, and tegafur 600 mg orally every day
CAPM arm: cyclophosphamide 400 mg/m2 i.v. infusion on day 1, Adriamycin 30 mg/m2 i.v. infusion on day 1, cisplatin 60 mg/m2 i.v. infusion on day 1, and mitomycin C 3 mg/m2 i.v. infusion on day 1
Outcomes Neither primary nor secondary outcomes defined
Notes No contact established with study authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "The patients were divided at the time of registration into those with stage III and those with stage IV disease, according to the criteria set by the American Joint Commission on Staging, and then randomised to receive either CAPM or MCT regimens"
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 outcome assessment, although study considered to have unclear impact on mortality outcomes
Blinding of outcome assessment (detection bias) 
 Other outcomes Unclear risk No information on blinding of assessment
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 17 participants not evaluated: 14 received only 1 cycle or refused treatment; 3 were lost to follow‐up. No information provided for the elderly subgroup
Selective reporting (reporting bias) Low risk No evidence of reporting bias
Other bias Unclear risk No information on elderly subgroup planned; none could be retrieved