Journal of Clinical Oncology, Vol 16, 3720-3730, Copyright © 1998 by American Society of Clinical Oncology
Combination chemotherapy versus single-agent therapy as first- and second-line treatment in metastatic breast cancer: a prospective randomized trial
H Joensuu, K Holli, M Heikkinen, E Suonio, AR Aro, P Hietanen and R Huovinen
Department of Oncology, Helsinki University Central Hospital, Finland.
PURPOSE: We report results of a randomized prospective study that compared
single agents of low toxicity given both as the first-line and second-line
chemotherapy with combination chemotherapy in advanced breast cancer with
distant metastases. PATIENTS AND METHODS: Patients in the single-agent arm
(n = 153) received weekly epirubicin (E) 20 mg/m2 until progression or
until the cumulative dose of 1,000 mg/m2, followed by mitomycin (M) 8 mg/m2
every 4 weeks, and those in the combination chemotherapy arm (n = 150) were
first given cyclophosphamide 500 mg/m2, E 60 mg/m2, and fluorouracil 500
mg/m2 three times per week (CEF) followed by M 8 mg/m2 plus vinblastine (V)
6 mg/m2 every 4 weeks. Exclusion criteria included age greater than 70
years, World Health Organization (WHO) performance status greater than 2,
prior chemotherapy for metastatic disease, and presence of liver metastases
in patients younger than 50. RESULTS: An objective response (complete [CR]
or partial [PR]) was obtained in 55%, 48%, 16%, and 7% of patients treated
with CEF, E, M, and MV, respectively. A response to CEF tended to last
longer than a response to E (median, 12 v 10.5 months; P = .07).
Treatment-related toxicity was less in the single- agent arm and
quality-of-life (QOL) analysis favored the single-agent arm. No significant
difference in time to progression or survival was found between the two
arms. Similarly, no difference in survival was found when the patients who
received both the planned first-and second- line treatments were compared
or when survival was calculated from the beginning of the second-line
therapy. CONCLUSION: Patients treated with single-agent E followed by
single-agent M had similar survival, but less treatment-related toxicity
and better QOL as compared with those treated with CEF followed by MV.
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