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

Buccheri 1997.

Methods Randomized phase III trial
Eligible patients
  • Cytologically or histologically confirmed NSCLC

  • No previous chemotherapy

  • Locally advanced, metastatic, or recurrent disease

  • Zubrod PS < 3

  • No previous chemotherapy

  • ≤ 75 years of age

  • Adequate bone marrow, hepatic, and renal function

  • Measurable or assessable site of disease


Exclusion criteria
  • Active cardiac disease

  • Serious intercurrent medical illness

  • History of prior malignant tumor

  • Inoperable single, small cancer lesion (maximum diameter < 4 cm), if suitable for small‐field radical radiotherapy

Participants MACC arm: 78 ITT population ‐ median age 64 years/no information on inclusion of elderly patients
MVP arm: 78 ITT population ‐ median age 65 years/no information on inclusion of elderly patients
Interventions MACC arm: methotrexate 40 mg/m2; doxorubicin 40 mg/m2 i.v.; cyclophosphamide 400 mg/m2 i.v. infusion, and lomustine 30 mg/m2 per os on day 1, every 3 weeks
MVP arm: mitomycin C 10 mg/m2; vinblastine 6 mg/m2, and cisplatin 40 mg/m2 i.v. on day 1, every 3 weeks
Outcomes Outcomes measured (no definition of which are primary or secondary outcomes)
  • Survival

  • Response to treatment (according to Miller el al)

  • Dose intensity

  • Toxicity (according to Miller et al)

  • Subjective tolerance; physical and psychological well‐being

Notes No information on numbers of elderly participants nor on specific subgroup analysis performed, despite multiple attempts to contact study authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central office stratified participants according to stage of disease and ECOG, to ensure balanced distribution between treatment groups, then randomly assigned participants within each stratum
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 Unclear risk Only 45, 58, and 29 participants completed QoL instrument at 6, 12, and 18 weeks
Selective reporting (reporting bias) Low risk No evidence of reporting bias
Other bias High risk Study closed to further accrual before target sample of 183 enrolled (with 156 patients) was reached, as 125 patients had already died Study designed for general population; elderly subgroup analysis not planned