Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group.

Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print Cited Medium: Print ISSN: 0732-183X (Print) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE

Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology
Original Publication: New York, N.Y. : Grune & Stratton, c1983-

Taxoids*; Antineoplastic Agents/*therapeutic use ; Breast Neoplasms/*drug therapy ; Mitomycins/*therapeutic use ; Paclitaxel/*analogs & derivatives ; Vinblastine/*therapeutic use; Adult ; Aged ; Analysis of Variance ; Antineoplastic Agents/administration & dosage ; Breast Neoplasms/pathology ; Disease Progression ; Docetaxel ; Drug Administration Schedule ; Drug Resistance, Neoplasm ; Female ; Health Status ; Humans ; Middle Aged ; Mitomycins/administration & dosage ; Neutropenia/chemically induced ; Paclitaxel/administration & dosage ; Paclitaxel/therapeutic use ; Patient Compliance ; Proportional Hazards Models ; Prospective Studies ; Survival Analysis ; Thrombocytopenia/chemically induced ; Vinblastine/administration & dosage

Purpose: This phase III study compared docetaxel with mitomycin plus vinblastine (MV) in patients with metastatic breast cancer (MBC) progressing despite previous anthracycline-containing chemotherapy.
Patients and Methods: Patients (n=392) were randomized to receive either docetaxel 100 mg/m2 intravenously (i.v.) every 3 weeks (n=203) or mitomycin 12 mg/m2 i.v. every 6 weeks plus vinblastine 6 mg/m2 i.v. every 3 weeks (n=189), for a maximum of 10 3-week cycles.
Results: In an intention-to-treat analysis, docetaxel produced significantly higher response rates than MV overall (30.0% v 11.6%; P < .0001), as well as in patients with visceral involvement (30% v 11%), liver metastases (33% v 7%), or resistance to previous anthracycline agents (30% v 7%). Median time to progression (TTP) and overall survival were significantly longer with docetaxel than MV (19 v 1 weeks, P=.001, and 1 1.4 v 8.7 months, P=.0097, respectively). Neutropenia grade 3/4 was more frequent with docetaxel (93.1 % v62.5%; P < .05); thrombocytopenia grade 3/4 was more frequent with MV (12.0% v 4.1%; P < .05). Severe acute or chronic nonhematologic adverse events were infrequent in both groups. Withdrawal rates because of adverse events (MV, 10.1%; docetaxel, 13.8%) or toxic death (MV, 1.6%; docetaxel, 2.0%) were similar in both groups. Quality-of-life analysis was limited by a number of factors, but results were similar in both groups.
Conclusion: Docetaxel is significantly superior to MV in terms of response, TTP, and survival. The safety profiles of both therapies are manageable and tolerable. Docetaxel represents a clear treatment option for patients with MBC progressing despite previous anthracycline-containing chemotherapy.

0 (Antineoplastic Agents)
0 (Mitomycins)
0 (Taxoids)
15H5577CQD (Docetaxel)
5V9KLZ54CY (Vinblastine)
P88XT4IS4D (Paclitaxel)

Date Created: 19990520 Date Completed: 19990527 Latest Revision: 20220331

20240829

10.1200/JCO.1999.17.5.1413

10334526