Journal of Clinical Oncology, Vol 15, 1897-1905, Copyright © 1997 by American Society of Clinical Oncology
Cyclophosphamide and fluorouracil combined with mitoxantrone versus doxorubicin for breast cancer: superiority of doxorubicin
DJ Stewart, WK Evans, FA Shepherd, KS Wilson, KI Pritchard, ME Trudeau, JJ Wilson and K Martz
Division of Medical Oncology, Ottawa Regional Cancer Centre, Ontario, Canada. dstewart@octrf.on.ca
PATIENTS AND METHODS: We conducted a randomized, multicenter study of
intravenous cyclophosphamide 500 mg/m2 plus fluorouracil 500 mg/m2 combined
with either mitoxantrone (Novantrone, Lederle Cyanamid Canada Ltd,
Willowdale, Ontario) 10 mg/m2 (CNF) or doxorubicin (Adriamycin, Adria
Laboratories of Canada Ltd, Mississauga, Ontario) 50 mg/m2 (CAF) every 3
weeks in advanced breast cancer. RESULTS: The response rate in 249
randomized patients was 36% with CNF (44 of 121) and 48% with CAF (62 of
128) (P = .054), with complete remissions in 10 patients (8.3%) on CNF and
in 13 (10.2%) on CAF. If only fully assessable patients are considered, the
response rate was 48% (44 of 91) with CNF and 60% (62 of 103) with CAF (P =
.098). At time of analysis, all except 10 patients (one CNF and nine CAF)
had died. The median survival time with CAF was longer than with CNF (15.2
v 10.9 months; P = .003), and time to progression was also longer with CAF
(5.3 v 3.2 months; P < .03). Survival differences remained significant
(P = .006) if patients who failed to meet all eligibility criteria were
excluded. Favorable prognostic factors for survival in a Cox regression
model included good performance status (P < .0001); less than two organ
systems involved by tumor (P < .0001); no involvement of lung, liver, or
brain (P < .003); involvement of bone or bone marrow (P < .009),
prior surgery for breast cancer (P < .006); being premenopausal (P <
.03); > or = 3 years from diagnosis until randomization on this study (P
< .03); and treatment with CAF (P < .03). Alopecia > or = grade 3
was reported in 55% of patients with CAF and 12% of patients with CNF (P
< .001), while other > or = grade 3 toxicities did not differ
significantly. Priestman-Baum quality-of-life assessment was comparable on
the two study arms. CONCLUSION: In patients with advanced breast cancer,
CAF was associated with longer survival than was CNF, with an increase in
alopecia, but not in other toxicities.
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