October 1, 1988Journal of Clinical Oncology
A randomized multicenter trial comparing mitoxantrone, cyclophosphamide, and fluorouracil with doxorubicin, cyclophosphamide, and fluorouracil in the therapy of metastatic breast carcinoma.
Why the study?
Does the CNF regimen compared to the CAF regimen improve survival or response rates in women with metastatic breast cancer?
Population
331 women with metastatic breast cancer, with no prior chemotherapy for metastatic disease.
Comparison
CNF regimen: cyclophosphamide 500 mg/m2… vs CAF regimen: cyclophosphamide 500 mg/m2…
Design
RCT, Randomized
Follow-up
Median survival 377-385 days
Authors
Discussion
Loading...
Member takes
Implication
CNF matches CAF efficacy with less cardiotoxicity; supports its use as a viable alternative and extends options beyond anthracyclines in metastatic breast cancer.
Key Points
- To compare the antitumor efficacy and toxicity profile of cyclophosphamide, mitoxantrone, and fluorouracil (CNF) against cyclophosphamide, doxorubicin, and fluorouracil (CAF) in patients with metastatic breast carcinoma.
- Randomized multicenter trial evaluating 331 women with metastatic breast cancer receiving either CNF (mitoxantrone 10 mg/m², cyclophosphamide 500 mg/m², fluorouracil 500 mg/m²) or CAF (doxorubicin 50 mg/m², cyclophosphamide 500 mg/m², fluorouracil 500 mg/m²) intravenously every 3 weeks.
- Eligible patients had no prior chemotherapy for metastatic disease, though prior adjuvant chemotherapy was permitted.
- Primary endpoints evaluated included objective response rate, response duration, time to treatment failure (TTF), and overall survival.
- Objective response rates were 29% (95% CI: 22%–37%) for CNF versus 37% (95% CI: 29%–45%) for CAF, with median survival times of 377 days and 385 days, respectively, showing no statistically significant differences in survival or time to treatment failure (125 vs 147 days).
- CNF resulted in significantly lower rates of severe alopecia (4% vs 39%), stomatitis/mucositis (10% vs 19%), and cardiotoxicity compared to CAF, while rates of nausea and vomiting were 80% and 81%, respectively.
Structured PICO
Does the CNF regimen compared to the CAF regimen improve survival or response rates in women with metastatic breast cancer?
P
Population
331 women with metastatic breast cancer, with no prior chemotherapy for metastatic disease (prior adjuvant chemotherapy was acceptable).
I
Intervention
CNF regimen: cyclophosphamide 500 mg/m2, mitoxantrone 10 mg/m2, and fluorouracil 500 mg/m2 administered intravenously on day 1, repeated every 3 weeks.
C
Comparator
CAF regimen: cyclophosphamide 500 mg/m2, doxorubicin 50 mg/m2, and fluorouracil 500 mg/m2 administered intravenously on day 1, repeated every 3 weeks.
O
Outcome
Response rate, duration of response, time to progression or death, time to treatment failure (TTF), and survival.hard clinical
The CNF regimen provides identical survival to the CAF regimen with significantly less cardiotoxicity and alopecia, offering a viable alternative for patients wishing to avoid anthracycline-related side effects.
Cite This Study
Bennett et al. (1988) studied this question.