Vogel 1984.
| Study characteristics | ||
| Methods | Accrual dates: not reported (submitted for publication August 1983, accepted for publication December 1983) Number of centres unknown (USA) Sample size: 187 Randomisation method not defined. 'projected 2:1 randomisation in favour of CAF+CAMELEON arm Baseline comparability: 'no significant differences reported' ‐ baseline characteristics not displayed | |
| Participants | Female Age range: not reported 100% visceral MBC % first‐line not reported. Unclear if this is a first‐line trial for MBC 'prior chemotherapy with any of the study drugs rendered a patient ineligible' | |
| Interventions | CAF vs CAF+CAMELEON Arm I CAF: cyclophosphamide + doxorubicin + 5‐fluorouracil Arm II CAF+CAMELEON: arm I plus cytosine arabinoside + methotrexate + oncovin |
|
| Outcomes | Overall survival Response Toxicity Overall duration of disease control Remission duration | |
| Notes | 157/187 evaluable ‐ 8 on CAF arm and 22 on CAF+CAMELEON arm inevaluable. Reasons for this include patient ineligibility (2 CAF, 6 CAF+CAMELEON), early removal from study (4 CAF, 5 CAF+CAMELEON), patient refusal (3 CAF+CAMELEON), insufficient data (1 CAF, 1 CAF+CAMELOEN), protocol violation (1 CAF, 6 CAF+CAMELEON), drug toxicity (1 CAF+CAMELEON). Follow‐up details not reported. Evaluable patients only included in time‐to‐event analyses. Time‐to‐event calculated from date of entry into study. Time‐to‐event data estimated from statistics presented in trial publication. Follow‐up details not reported. Overall duration of disease control will be interpreted as progression free survival. 2 toxic related deaths reported, 1 due to renal failure (CAF+CAMELEON arm) and 1 due to granulocytopenia and sepsis (CAF arm). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | B ‐ Unclear |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| 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) Overall survival | Low risk | A ‐ Adequate |
| Incomplete outcome data (attrition bias) Duration of response | Low risk | A ‐ Adequate |
| Selective reporting (reporting bias) | Low risk | A ‐ Adequate, outcomes reported |
| Other bias | Low risk | A ‐ Adequate |