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 |
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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 |
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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 |
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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 |