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. 2010 Nov 10;2010(11):CD003368. doi: 10.1002/14651858.CD003368.pub3

Pannuti 1984.

Study characteristics
Methods Accrual dates: not reported
Sample size: 46
Randomisation method not reported
Baseline comparability: no significant imbalance apparent or reported
Participants Female
100% MBC (87% with metastases of bone or viscera)
Unclear if prior chemotherapy received by 17% was for MBC
Age range: 36‐74 years
Median age: 55 (both arms)
Interventions CMF vs R14
Arm I: (CMF) cyclophosphamide + methotrexate + 5‐fluorouracil
Arm II: (R14) arm I + vincristine + vinblastine + doxorubicin
Outcomes Overall survival
Response (defined as ≥ 50% reduction in tumour size)
Toxicity
Notes 46/46 included in analysis
Follow‐up details not reported:
‐estimated minimum follow‐up 5.5 months
‐estimated maximum follow‐up 45 months (from survival curve)
Time‐to‐event data extracted directly from time‐to‐event curve.
Treatment related deaths not reported.
Doses of the same chemotherapy agent are markedly different between treatment arms.
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 Unclear risk B ‐ Unclear
Selective reporting (reporting bias) Low risk A ‐ Adequate, outcomes reported
Other bias High risk C ‐ Inadequate, higher proportion of R14 group premenopausal, small study groups