Veronesi 1994.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES: Italy, multicentric
DURATION OF STUDY: September 1986 to December 1991
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: Adequate GRADE ASSESSMENT QUALITY RATING: High TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY
INCLUSION CRITERIA:
Histologically‐proven small cell lung cancer
Age < 75 years
Karnofsky Performance status > 40
Normal serum creatinine values
Adequate cardiac function
Adequate liver function EXCLUSION CRITERIA: Brain metastases Previous treatment N SCREENED: 139 N RANDOMISED: 136 ASSESS STAGE: Yes (N LIMITED): 55 (CEV ‐ 33; PE 22) (N EXTENSIVE): 81 (CEV ‐ 33; PE ‐ 48) M: 119 (CEV ‐ 59; PE ‐ 60) F: 17 (CEV ‐ 7; PE ‐ 10) AGE: Median: CEV ‐ 60 (41 to 70); PE ‐ 61 (41 to 70) |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
CEV ‐ cyclophosphamide 1000 mg/m2 IV, epirubicin 70 mg/m2 IV, vincristine 1.2 mg/m2 IV every 3 weeks. This was repeated for 6 cycles. PE ‐ cisplatin 20 mg/m2 IV for 5 consecutive days, every 3 weeks, and etoposide 75 mg/m2 IV given as a 45‐min IV infusion on the same days, plus 1000ml of IV fluids with 100 g of mannitol daily. This was repeated for 6 cycles. CO‐INTERVENTIONS: After 3 cycles, responding patients received radiotherapy to the chest (45 Gy/15 sessions) and to the brain (30 Gy/10 sessions ‐ only in patients with limited disease achieving complete remission). CLASSIFICATION OF INTERVENTION (ADJUVANT/NEO‐ADJUVANT/PALLIATIVE): Palliative |
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| Outcomes | OUTCOMES MEASURED:
Overall survival
Tumour response
Duration of response
Toxicity FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Overall survival Tumour response 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 | 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) | Low risk | Adequate |
| Other bias | Low risk | Adequate |