Annals of Oncology Advance Access published online on March 2, 2009
Annals of Oncology, doi:10.1093/annonc/mdn781
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Phase III trial of doxorubicin plus cyclophosphamide (AC), docetaxel, and alternating AC and docetaxel as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802)
1 Department of Medical Oncology, National Cancer Center Hospital, Tokyo
2 Department of Medical Oncology, Hamamatsu Oncology Center, Hamamatsu
3 Department of Medicine, Kobe University Graduate School of Medicine, Kobe
4 Department of Breast Oncology, Shikoku Cancer Center, Matsuyama
5 Department of Medical Oncology, Saitama Cancer Center, Saitama
6 Department of Breast Surgery, Niigata Breast Exam Center, Niigata
7 Department of Surgery, Osaka National Hospital, Osaka
8 Department of Breast Surgery, Tochigi Cancer Center, Utsunomiya
9 Department of Surgery, Teikyo University Hospital
10 Japan Clinical Oncology Group Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan
* Correspondence to: Dr N. Katsumata, Department of Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. Tel: +81-3-3542-2511; Fax: +81-3-3542-3815; E-mail: nkatsuma{at}ncc.go.jp
Background: This randomized, multicenter, phase III trial compared doxorubicin plus cyclophosphamide (AC), single-agent docetaxel (D), and an alternating regimen of AC and docetaxel (AC–D) as first-line chemotherapy in metastatic breast cancer (MBC).
Patients and methods: Patients with MBC resistant to endocrine therapy were entered in a randomized study to receive either six cycles of AC (doxorubicin 40 mg/m2 plus cyclophosphamide 500 mg/m2), D (60 mg/m2), or alternating treatment with AC–D (i.e. three cycles of AC and three cycles of D). Treatment was administered every 3 weeks.
Results: A total of 441 patients were entered in a randomized study. Response rates were 30% for AC, 41% for D, and 35% for AC–D. The median times to treatment failure (TTFs) were 6.4, 6.4, and 6.7 months (one-sided log-rank test, P = 0.13 for AC versus D, P = 0.14 for AC versus AC–D) and median overall survival (OS) was 22.6, 25.7, and 25.0 months (P = 0.09 for AC versus D, P = 0.13 for AC versus AC–D) in the AC, D, and AC–D, respectively.
Conclusion: There was no difference in the TTF among the three arms. However, there was a trend toward a better response and better OS in the D than in the AC.
cyclophosphamide, docetaxel, doxorubicin, metastatic breast cancer, phase III
Received for publication September 11, 2008. Revision received December 12, 2008. Accepted for publication December 12, 2008.