Smith 1991.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES:
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: Yes GRADE ASSESSMENT QUALITY RATING: High TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY INCLUSION CRITERIA: Histologically confirmed small cell lung cancer. EXCLUSION CRITERIA: N RANDOMISED: 95 (VACE ‐ 48; CVACE ‐ 47) N COMPLETED: 78 ASSESS STAGE: Yes (N LIMITED): 60 (N EXTENSIVE): 35 M: 62 F: 33 AGE: median: VACE ‐ 61; CVACE ‐ 60 (range: 37 to 75; CVACE ‐ 46 to 72) | |
| Interventions | TYPE: Chemotherapy
REGIMENS:
VACE ‐ 6 cycles of the VACE combination; vincristine 1.2 mg/m2, doxorubicin 40 mg/m2 and cyclophosphamide 700 mg/m2 on day 1, plus etoposide 110 mg/m2 daily for 3 days. This cycle was repeated at 3‐weekly intervals.
CVACE ‐ etoposide 110 mg/m2 for 3 days plus cisplatin 100 mg/m2 with mannitol diuresis on the second day for the first 2 3‐weekly cycles.
VACE in the above doses was administered for the next 2 cycles; cycles 5 and 6, if given, consisted of etoposide and cisplatin in the same doses as before. The effects of the treatments were assessed formally at the end of cycle 4. CO‐INTERVENTIONS: 12 complete responders after cycle 6 received prophylactic cranial irradiation. Partial responders received further chemotherapy (with mitomycin C and procarbazine) or radiotherapy or no further treatment depending on individual circumstances. |
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| Outcomes | OUTCOMES MEASURED: Tumour response Survival Cause of death Effect of prophylactic cranial irradiation FOLLOW‐UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Tumour response Survival | |
| Notes | Patient withdrawal: of the VACE regimen ‐ 4 withdrew due to leukopenia; 1 due to severe vomiting, and of the CVACE regimen ‐ 1 due to renal failure, 4 due to nausea and vomiting or leukopenia and 1 due to cerebral metastases developed after 2 cycles of treatment. Patients who had not responded were withdrawn 3 weeks after cycle 4. |
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| 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 | N/A |
| 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 | Unclear risk | N/A |
| 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 |