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

Sweeney 2001.

Methods Inclusion:
Eligible participants had to meet the following criteria:
  • confirmed stage IIIB (pleural effusion) or stage IV NSCLC;

  • ECOG PS 2;

  • no prior chemotherapy;

  • adequate haematological, hepatic, and renal function.


Participants with clinically stable brain metastases managed by surgery or radiotherapy (or both) were eligible.
Exclusion:
Patients were ineligible if they had:
  • pregnancy or breastfeeding;

  • other active malignancy;

  • clinically significant neuropathy by history or physical examination;

  • prior radiotherapy to site of indicator lesion unless subsequent disease progression;

  • small cell anaplastic elements;

  • diagnosis based on sputum cytology alone;

  • prior treatment with a biological response modifier or chemotherapeutic agent;

  • serious active uncontrolled infection;

  • significant cardiovascular disease or other serious medical condition.

Participants Arm I: 18 people
Arm IV: 15 people
Interventions Arm I: paclitaxel (135 mg/m2) iv over 24 hours on day 1 and cisplatin (75 mg/m2) on day 2, every 3 weeks
 Arm IV: paclitaxel (225 mg/m2) over 3 hours on day 1 and carboplatin (AUC 6 mg/mL X minutes) on day 1, every 3 weeks
Outcomes Primary outcome:
  • toxicity and adverse events


Secondary outcomes:
  • response rate

  • time to progression

  • overall survival

Notes Arms II and III were not used in this review.
Arm II: gemcitabine (1 g/m2) on days 1, 8, and 15 and cisplatin (100 mg/m2) on day 1, every 4 weeks
Arm III: docetaxel (75 mg/m2) on day 1 and cisplatin (75 mg/m2) on day 1, every 3 weeks
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants are stratified by weight loss within the past 6 months, disease stage, and presence of brain metastases.
Allocation concealment (selection bias) Low risk Participants were allocated using a computer‐generated random list into 1 of 4 arms.
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 data
Selective reporting (reporting bias) Low risk No evidence of selective reporting bias
Other bias High risk This report represents a final analysis of a subgroup of people with PS of 2 who seem to have a poorer prognosis compared with people with PS 0 or 1.