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. 2020 Jan 13;2020(1):CD009256. doi: 10.1002/14651858.CD009256.pub3

Chen 2006.

Methods Inclusion:
Eligible participants had to meet following criteria:
  • cytological or histological diagnosis of stage IIIb with malignant effusion, or stage IV NSCLC;

  • 70 years or older;

  • no prior chemotherapy or immunotherapy;

  • PS of 0 to 2 on the WHO scale;

  • bi‐dimensionally measurable disease;

  • adequate bone marrow reserve.


Exclusion:
Patients were ineligible if they had:
  • signs or symptoms of brain metastases;

  • inadequate liver function (serum bilirubin > 1.5 times and alanine aminotransferase/aspartate transaminase > 3 times upper limit of normal);

  • inadequate renal function (serum creatinine > 1.5 times upper limit of normal).

Participants Arm I: 40 people
Arm II: 41 people
Interventions Arm I: paclitaxel (160 mg/m2) iv over 3 hours on day 1 and carboplatin (AUC 6 mg/mL X minutes) iv over 1 hour on day 1, every 3 weeks
 Arm II: paclitaxel (160 mg/m2) iv over 3 hours on day 1 and cisplatin (60 mg/m2) iv over 1 hour on day 1, every 3 weeks
Outcomes Primary outcome:
response rate
Secondary outcomes:
time to progression;
toxicity;
overall survival
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were stratified according staging and PS.
Allocation concealment (selection bias) Low risk Participants were randomised into the paclitaxel plus carboplatin or paclitaxel plus cisplatin treatment arm by an outside centre not involved in the study.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information about blinding process
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information about blinding process
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No evidence of incomplete outcome
Selective reporting (reporting bias) Low risk No evidence of selective reporting bias
Other bias High risk Phase II trial and a study of elderly people, so could be associated with higher response rate