Aisner 1987a.
| Study characteristics | ||
| Methods | Accrual dates October 1976 to February 1980 Multicentre national trial (USA) Sample size: 432 Randomisation by sealed envelope using a Latin square design balancing across and within institutions. Baseline comparability: No significant imbalance apparent or reported | |
| Participants | Female Over 80% had visceral or osseous metastatic disease 100% first line Median age: 57 (CAF), 55 (CAFVP) | |
| Interventions | CAF vs CMF vs CAFVP vs CAF+MER vs CMF+MER vs CAFVP+MER Arm I: (CAF) cyclophosphamide + doxorubicin + 5‐fluorouracil Arm II: (CAFVP) cyclophosphamide + doxorubicin + fluorouracil + vincristine + prednisone Arm III: (CMF) cyclophosphamide + 5‐fluorouracil + methotrexate Arm IV, V, VI as above each with the addition of MER Aisner 1987a: CAF vs CAFVP |
|
| Outcomes | Overall survival Time to treatment failure Response Toxicity | |
| Notes | 395/432 evaluable. 37 patients were unevaluable: ineligible (20), protocol violations (10), early deaths (4), inadequate records (2), improper randomisation(1) 6 arm trial. Randomisation to chemoimmunotherapy ceased after an interim evaluation showed no benefit & increased toxicity. Analysis was conducted using 395 evaluable patients (260/283 patients randomised to chemotherapy, 135/149 patients randomised to chemoimmunotherapy). Time‐to‐event data not extracted from published curves for inclusion in this review as unable to do so accurately to replicate reported study findings. Follow‐up details not reported. Estimated minimum follow‐up = 2 months. Estimated maximum follow‐up = 36 months. 8 treatment‐related deaths: 5 due to infection in arms CAF+MER, CAFVP+MER, CAF, CAFVP (2); 2 due to haemorrhage in arms CAF+MER, CMF; 1 due to cardiac toxicity in CAF arm. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A ‐ Adequate, Latin square design |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate, closed envelope |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | B ‐ Unclear |
| Incomplete outcome data (attrition bias) Response | Low risk | A ‐ Adequate |
| Incomplete outcome data (attrition bias) Toxicity | Low risk | A ‐ Adequate |
| Incomplete outcome data (attrition bias) Time to progression | Low risk | A ‐ Adequate |
| Incomplete outcome data (attrition bias) Overall survival | Low risk | A ‐ Adequate |
| Selective reporting (reporting bias) | Unclear risk | B ‐ Unclear, time to treatment failure results not included |
| Other bias | Low risk | A ‐ Other sources of bias not identified in methods |