Gatzemeier 1994.
| 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: Not described GRADE ASSESSMENT QUALITY RATING: Low TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY INCLUSION CRITERIA: Histologic diagnosis of SCLC; good performance status [Eastern Coorperative Oncology Group (ECOG) 0 to 2]; no evidence of central nervous system metastases; age between 18 and 75 years; life expectancy of at least 3 months; adequate bone marrow, renal and hepatic functions; and extensive disease (ED). EXCLUSION CRITERIA: N SCREENED: 344 N RANDOMISED: 317 (CEV ‐ 156; EV ‐ 161) ASSESS STAGE: Yes ED only (N LIMITED): (N EXTENSIVE): 317 M: 235 (CEV ‐ 117; EV ‐ 118) F: 82 (CEV ‐ 39; EV ‐ 43) AGE: median: CEV ‐ 58.5; EV ‐ 62 (range: CEV ‐ 33 to 76; EV ‐ 18 to 75) | |
| Interventions | TYPE: Chemotherapy
REGIMENS:
CEV ‐ carboplatin 300 mg/m2 on day 1, etoposide 140 mg/m2 on days 1 to 3 and vincristine 1.4 mg/m2 on days 1, 8 and 15
EV ‐ etoposide 200 mg/m2 on days 1 to 3, and vincristine 1.4 mg/m2 on days 1 and 8. Chemotherapy cycles in each treatment arm were repeated every 4 weeks. CO‐INTERVENTIONS: |
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| Outcomes | OUTCOMES MEASURED:
Tumour response
Survival
Toxicity FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Tumour response Survival Toxicity |
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| 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 | 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 | Unclear risk | N/A |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information |
| Other bias | Low risk | Adequate |