PROGNOSTIC SUBGROUPS - THE KEY FACTOR FOR TREATMENT OUTCOME IN METASTATIC BREAST-CANCER - RESULTS OF A 3-ARM RANDOMIZED MULTICENTER TRIAL COMPARING DOXORUBICIN, EPIRUBICIN AND MITOXANTRONE EACH IN COMBINATION WITH CYCLOPHOSPHAMIDE

Background: Since prolongation of survival by chemotherapy has been qu estioned, palliation balanced with an acceptable quality of life is th e primary aim in treating patients with metastatic breast cancer. Pati ents and Methods: 224 patients from 11 centers were randomized to trea tment with 40 mg/m2 of Adriamycin or with 40 mg/m2 of epirubicin or wi th 12 mg/m2 of mitoxantrone each in combination with 600 Mg/M2 of cycl ophosphamide every 3 weeks. A special monitoring system including foll ow-up until death guaranteed valid information on response criteria, s urvival and quality of life. Results: Treatment outcome was not statis tically different between the three groups in terms of best response r ate, response duration, time to progression or survival. There were, h owever, statistically significant differences between the three treatm ent groups in terms of toxicity and quality of life. Most important, t reatment outcome was influenced by the following negative prognostic f actors: disease-free interval less than 18 months; metastases at more than one organ site; performance status according to WHO > 1; prior ad juvant chemotherapy; age less than 40 years. Conclusions: This meticul ously monitored prospectively randomized study shows that prognostic f actors are more important than the chosen treatments for the outcome i n metastatic breast cancer patients.