Postmus 1996.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES:
DURATION OF STUDY: September 1988 to February 1992
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: Yes GRADE ASSESSMENT QUALITY RATING: High TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY INCLUSION CRITERIA: Histologically or cytologically proven SCLC; no previous chemotherapy, normal renal function (creatinine clearance > 60 ml/min); normal bilirubin levels (< 25 µmol/L); an ECOG (Easter Cooperative Oncology Group) performance score <= 3; age < 75 years; normal numbers of leukocytes (> 3 × 109/L) and platelets (> 100 × 109/L); extensive disease; and informed consent obtained from all patients. EXCLUSION CRITERIA: N SCREENED: 148 (143 eligible) N RANDOMISED: 143 (CDE ‐ 73; CDE + VIMP ‐ 70) N COMPLETED: ASSESS STAGE: Yes (ED only) (N LIMITED): (N EXTENSIVE): M: 117 F: 26 AGE: median: CDE ‐ 61; CDE + VIMP ‐ 61 (range: CDE ‐ 41 to 73; CDE + VIMP ‐ 29 to 74) | |
| Interventions | TYPE: Chemotherapy
REGIMENS:
Standard therapy (CDE) ‐ 1 g/m2 cyclophosphamide intravenously (IV) on day 1, 45 mg/m2 doxorubicin IV on day 1 and 100 mg/m2 etoposide IV on days 1, 3 and 5. A maximum of 5 courses were given at 3‐week intervals between courses.
Alternating therapy (CDE + VIMP) ‐ 2 mg vincristine IV as a bolus dose on days 1 and 8, 400 mg/m2 carboplatin dissolved in 250 ml 5% dextrose and given as a 30 min IV infusion, 5 g/m2 ifosfamide given as a 24‐hour infusion and 0.6 g/m2 mesna given as an IV bolus with 200 ml mannitol (20%) before infusion with ifosfamide. During the ifosfamide infusion and over the following 12 hours, 3.75 g/m2 of mesna was given as a continuous infusion. Forced diuresis was established by giving 6 L of dextrose/saline in 38 hours. CDE was given during courses 1, 3 and 5 and VIMP during courses 2 and 4. The interval between CDE and VIMP was 3 weeks and between VIMP and CDE was 4 weeks. CO‐INTERVENTIONS: |
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| Outcomes | OUTCOMES MEASURED: Tumour response (defined according to standard criteria of the World Health Organization) Toxicity Survival FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Tumour response Toxicity Survival | |
| Notes | ||
| 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 | N/A |
| Incomplete outcome data (attrition bias) Survival | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Tumour Response | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Toxicity | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Quality of Life | Unclear risk | N/A |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information |
| Other bias | Low risk | Adequate |