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. 2015 Aug 2;2015(8):CD006849. doi: 10.1002/14651858.CD006849.pub3

Quoix 2005.

Methods STUDY DESIGN: Parallel study
 LOCATION, NUMBER OF CENTRES: Canada and Europe; multicentric
 DURATION OF STUDY:
 CONCEALMENT OF ALLOCATION: D
 DESCRIBED AS RANDOMISED: Yes
 DESCRIBED AS DOUBLE BLIND: No
 METHOD OF RANDOMISATION WELL‐DESCRIBED/APPROPRIATE: Not described
 METHOD OF BLINDING WELL‐DESCRIBED/APPROPRIATE: Not described
 DESCRIPTION OF WITHDRAWALS/DROP‐OUTS: Not described
GRADE ASSESSMENT QUALITY RATING: Low
 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT
Participants ELIGIBILITY
 INCLUSION CRITERIA: Aged at least 18 years; histologically proven ED SCLC; no prior chemotherapy or immunotherapy; written informed consent from patients, in accordance with local and national guidelines for the centre; at least one non‐ CNS indicator lesion, which was bi‐dimensionally measurable; an Eastern Cooperative Oncology Group performance status score ? 2; life expectancy of at least 3 months; adequate bone marrow reserves (haemoglobin >= 9.0 g/dL, white blood cells >= 3.5 x 109/L, neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L) and adequate renal and hepatic function (creatinine <= 1.5 mg/dL, creatinine clearance >= 60 mL/min, serum bilirubin <= 2.0 mg/ dL, aspartate transaminase [AST], alanine transaminase [ALT] and alkaline phosphatase <= 2 times the upper limit of normal, or <= 5 times the upper limit of normal if liver metastases were present.) Patients with brain and/or leptomeningeal metastases scan were included, provided they were asymptomatic on neurological examination and were not receiving corticosteroid therapy.
 EXCLUSION CRITERIA:
 N RANDOMISED: 82 (T/C ‐ 41; T/E ‐ 41)
 ASSESS STAGE: Yes (ED only)
 (N LIMITED):
 (N EXTENSIVE): 82
 M: 57
 F: 25
 AGE: median: 61 (range: T/C ‐ 33 to 78; T/E ‐ 25 to 78)
Interventions TYPE: Chemotherapy
 REGIMENS:
 T/C‐ topotecan 1.25 mg/m2 as a 30 min intravenous (IV) infusion daily for 5 consecutive days, followed by cisplatin 50 mg/m2 as a 3‐hour infusion after the 5th dose of topotecan. Patients also received fluids for hydration (before and for 24 hours after cisplatin) and antiemetic prophylaxis.
 T/E ‐ topotecan 0.75 mg/m2 as a 30‐minute IV infusion daily for 5 consecutive days and etoposide 60 mg/m2 as a 30 to 60‐minute IV infusion, daily before each topotecan infusion.
Treatment was repeated every 21 days
CO‐INTERVENTIONS:
 Use of therapeutic G‐CSF was allowed but not prophylactically
Outcomes OUTCOMES MEASURED:
 Tumour response (evaluated according by strict radiological criteria)
 Disease progression
 Survival
 Toxicity
 Quality of life
FOLLOW UP ASSESSMENT POINTS:
 OUTCOMES INCLUDED IN ANALYSES:
 Tumour response (evaluated according by strict radiological criteria)
 Survival
 Toxicity
 Quality of life
Notes Patients who required delays in treatment of more than 2 weeks were considered for alternative cytotoxic therapy off‐protocol
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 Participants Unclear risk Not reported
Blinding (performance bias and detection bias) 
 Investigators Unclear risk Not reported
Blinding (performance bias and detection bias) 
 Survival Unclear risk Not reported
Blinding (performance bias and detection bias) 
 Tumour Response Unclear risk Not reported
Blinding (performance bias and detection bias) 
 Toxicity Unclear risk Not reported
Blinding (performance bias and detection bias) 
 Quality of Life Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 Survival High risk Reasons for withdrawals, drop‐outs and exclusions not reported
Incomplete outcome data (attrition bias) 
 Tumour Response High risk Reasons for withdrawals, drop‐outs and exclusions not reported
Incomplete outcome data (attrition bias) 
 Toxicity High risk Reasons for withdrawals, drop‐outs and exclusions not reported
Incomplete outcome data (attrition bias) 
 Quality of Life High risk Reasons for withdrawals, drop‐outs and exclusions not reported
Selective reporting (reporting bias) Unclear risk Insufficient information
Other bias Low risk Adequate