Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 521
© 2005 American Society of Clinical Oncology

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Abstract

Phase III trial of doxorubicin (A)/cyclophosphamide (C) (AC), docetaxel (D), and alternating AC and D (AC-D) as front-line chemotherapy for metastatic breast cancer (MBC): Japan Clinical Oncology Group trial (JCOG9802)

National Cancer Ctr Hosp, Tokyo, Japan; National Cancer Ctr Hosp East, Chiba, Japan; Shikoku Cancer Ctr, Ehime, Japan; Saitama Cancer Ctr, Saitama, Japan; Niigata Cancer Ctr, Niigata, Japan; Osaka National Hosp, Osaka, Japan; Tochigi Cancer Ctr, Tochigi, Japan; Keio Univ Hosp, Tokyo, Japan; Intl Medcl Ctr of Japan, Tokyo, Japan

521

Background: Anthracycline-containing chemotherapy remains a standard treatment for MBC. We compared AC, single agent D and alternating AC-D as front-line chemotherapy for patients with MBC. Methods: Patients (pts) with MBC resistant to endocrine therapy were randomized to either 6 courses of AC (A 40mg/m² day1, C 500mg/m² day1) q21 days, 6 courses of D (D 60mg/m² day1) q21 days, or 3 courses of AC-D (A 40mg/m² day1, C 500mg/m² day1, D 60mg/m² day22) q42 days with minimization method balancing recurrent/advanced, previous chemotherapy+/-, hepatic metastasis+/-, and institution. At time of failure or progression after the front-line chemotherapy, chemotherapy was crossed over to another therapy in arm AC and D, and the same regimen was resumed in arm AC-D. Eligibility included preserved organ function, aged 20–75, and Performance Status 0–3. Primary endpoint was time to treatment failure (TTF) of front-line chemotherapy to be compared by log-rank test. Assuming 150 eligible pts in each arm, the study had 0.9 power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs. AC-D. Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03. Major grade 3–4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and 35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7 months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was shown by the adjusted Cox model. Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D tended to be superior to AC in response rate and overall survival. Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting