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

Saad 2017.

Methods Inclusion:
Eligible participants had to meet the following criteria:

  • histologically or cytologically confirmed stage IV squamous NSCLC;

  • ECOG PS 0 to 2;

  • adequate organ function (white blood cell count ≥ 3000 cells/μL, with an absolute neutrophil count ≥ 1500 cells/μL, platelets ≥ 100,000/μL, and haemoglobin ≥ 9.5 g/dL; total bilirubin ≤ 1.5 × the upper limit of normal (ULN), and aspartate aminotransferase and alanine aminotransferase concentrations ≤ 2.5 × ULN and serum creatinine ≤ 1.2 × ULN).


Exclusion:
Patients were ineligible if they had:

  • other primary malignancies;

  • previous chemotherapy;

  • clinically relevant coronary artery disease or uncontrolled congestive heart failure;

  • severe cognitive impairment;

  • National Cancer Institute‐Common Terminology Criteria for Adverse Events (NCI‐CTCAE) version 3.0 grade II or worse peripheral neuropathy.
Participants Arm I: 36 people
Arm II: 35 people
Interventions Arm I: gemcitabine 1000 mg/m2 plus cisplatin 40 mg/m2 on days 1 and 8 of a 3‐week schedule for up to 6 cycles
Arm II: gemcitabine 1000 mg/m2 iv on days 1 and 8 plus carboplatin at an AUC of 5 iv on day 1 of a 3‐week schedule for up to 6 cycles
Outcomes Primary outcome:

  • radiological response after 3 and 6 cycles of treatment


Secondary outcomes:

  • toxicity assessment

  • 1‐year progression‐free survival

  • 1‐year overall survival

  • QoL
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information was provided about randomisation methods.
Allocation concealment (selection bias) Unclear risk Eligible participants were simply randomised to either Gem/Cis group or Gem/Carb group.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label trial
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Open‐label trial
Incomplete outcome data (attrition bias) 
 All outcomes High risk Response evaluation was available for 60 and 40 participants after 3 and 6 cycles, respectively.
Selective reporting (reporting bias) Unclear risk No evidence of selective reporting bias
Other bias Unclear risk No other bias