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Annals of Oncology 15:433-439, 2004
© 2004 European Society for Medical Oncology

Original Paper

A randomized phase II study of combination, alternating and sequential regimens of doxorubicin and docetaxel as first-line chemotherapy for women with metastatic breast cancer

Received 7 August 2003; revised 2 December 2003; accepted 19 December 2003

Background:

This randomized phase II study was conducted to evaluate the efficacy of doxorubicin and docetaxel (DOC) administered either as a combination, an alternating or a sequential regimen in women with metastatic breast cancer. Secondary objectives included overall response, time to progression, survival and safety.

Patients and methods:

Patients with breast cancer (n = 123) were randomized to receive doxorubicin and DOC either in combination (60 mg/m2 of each drug), or by alternated or sequential schedule (100 mg/m2 DOC and 75 mg/m2 doxorubicin) every 3 weeks for a maximum of eight cycles as first chemotherapy for stage IV disease. A second randomization allocated patients from each arm to receive prophylactic oral ciprofloxacin or no therapy to prevent febrile neutropenia.

Results:

Patients received a median of eight cycles. In an intention-to-treat analysis, the overall response was 63%, 52% and 61% in the combination, alternating and sequential schedules, respectively. Corresponding rates of complete response were 15%, 14% and 11%. Grade 4 neutropenia was common in all arms (81%) and, together with febrile neutropenia, was significantly more frequent with the combination. Prophylaxis with ciprofloxacin did not reduce the incidence of febrile neutropenia or infection. Other frequent non-hematological adverse events included alopecia, nausea, vomiting, stomatitis and asthenia. Congestive heart failure only occurred in the combination arm (10%).

Conclusion:

All three schedules are feasible and endowed of good therapeutic activity. In view of the more pronounced toxicity and the risk of cardiac events because of the higher exposure to doxorubicin, the combination should be least favored when treating women with metastatic breast cancer. Prophylaxis with ciprofloxacin was ineffective and is not recommended.

S. Cresta1, G. Grasselli1, M. Mansutti2, A. Martoni3, G. Lelli4, G. Capri1, F. Buzzi5, G. Robustelli Della Cuna6, A. Jirillo7, E. Terzoli8, L. Frevola9, E. Tarenzi1, C. Sguotti9, N. Azli9, M. Murawsky9 and L. Gianni1,*

1 Department of Oncology, Istituto Nazionale Tumori, Milan; 2 Division of Medical Oncology, Ospedale Santa Maria della Misericordia, Udine; 3 Medical Oncology, Ospedale Sant’Orsola-Malpighi, Bologna; 4 Department of Oncology, Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo; 5 Department of Oncology, Ospedale Civile S. Maria, Terni; 6 Department of Oncology, Fondazione Maugeri, Pavia; 7 Division of Medical Oncology, Ospedale Busonera, Padova; 8 Division of Medical Oncology, Polo Oncologico "Regina Elena", Roma, Italy; 9 Aventis-Antony, France

Key words: docetaxel, doxorubicin, breast cancer


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