Farris 1993.
| 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: Histologically confirmed undifferentiated small oat cell carcinoma EXCLUSION CRITERIA: N RANDOMISED: 113 (CEV ‐ 57, CDDP‐VP16/C‐E ‐ 57) ASSESS STAGE: Yes (N LIMITED): 52 (CEV ‐ 27; CDDP‐VP16/C‐E ‐ 25) (N EXTENSIVE): 61 (CEV ‐ 30; CDDP‐VP16/C‐E ‐ 31) M: 100 (CEV ‐ 50; CDDP‐VP16/C‐E ‐ 50) F: 13 (CEV ‐ 7; CDDP‐VP16/C‐E ‐ 6) AGE: Overall: median 61 (range: 43 to 74); CEV: 62 (45 to 74), CDDP‐VP16/C‐E: 60 (43 to 69) |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
CEV ‐ cyclophosphamide 1000 mg/m2, epirubicin 60 mg/m2 and vincristine 1 mg/m2 all administered on day 1 and cycles repeated every 21 days (all given IV) CDDP‐VP16/C‐E ‐ cisplatin 50 mg/m2 on days 1 and 2, etoposide 200 mg/m2 on days 3, 4 and 5 alternating every 28 days with cyclophosphamide 1000 mg/m2 on day 1 and epirubicin 60 mg/m2 on day 1 (all given IV, except for etoposide, which was given orally) CO‐INTERVENTIONS: Patients with limited disease experiencing complete remission received chest irradiation (45 Gy in 15 fractions over 3 weeks) and prophylactic irradiation of the skull. CLASSIFICATION OF INTERVENTION: (ADJUVANT/NEO‐ADJUVANT/PALLIATIVE): Palliative |
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| Outcomes | OUTCOMES MEASURED:
Tumour response
Survival
Toxicity FOLLOW UP ASSESSMENT POINTS: After the end of chemotherapy, assessable patients were re‐checked monthly for the first 3 months and then every 3 months thereafter. At each re‐check visit, each patient received a complete physical examination, a chest X‐ray and routine haematological and biochemistry tests 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 |