Misset J L, Metz R, Gil-Delgado M, Keiling R, Cappelaere P, Armand J P, Prévot G, Grimbert J, Mathé G, Hibberd M
Oncofrance, Service des Maladies Sanguines et Tumorales et I.C.I.G., Hôpital Paul-Brousse, Villejuif, France.
Anticancer Res. 1987 Jul-Aug;7(4B):737-40.
50 patients with advanced breast cancer were treated with the combination of Mitoxantrone 10mg/m2 IV day 2, 5-Fluorouracil 400mg/m2 IV and Cyclophosphamide 300mg/m2 IV day 3, 4, 5, 6 of each monthly cycle. 49 patients are evaluable for toxicity and 47 for efficacy after three months of treatment. Hematologic toxicity was substantial and dose-limiting, with one toxic death early in the trial. Other toxicities were moderate and manageable in this short-term study. The response rate after three cycles was 53% +/- 14% with 4 complete remissions, 21 partial remissions, 16 stable disease and 6 progressions. Using the fixed response rate hypothesis of Gehan generalised by Lee and Wesley, with an expected response rate of 60% consistent with the reported response rate of advanced breast cancer to Adriamycin containing regimens, we conclude that the combination studied is not less efficient for the induction of remissions in advanced breast cancer than comparable combinations with Adriamycin. As there is now substantial experimental and clinical evidence of reduced toxicity, mainly on the cardiac muscle, of Mitoxantrone as compared to Adriamycin, we feel that the routine substitution of the latter by the former in chemotherapy for advanced breast cancer is justifiable.
50例晚期乳腺癌患者接受米托蒽醌10mg/m²静脉注射第2天、氟尿嘧啶400mg/m²静脉注射以及环磷酰胺300mg/m²静脉注射，于每个月周期的第3、4、5、6天给药。49例患者可评估毒性，47例患者在治疗三个月后可评估疗效。血液学毒性严重且为剂量限制性，在试验早期有1例因毒性死亡。在这项短期研究中，其他毒性为中度且可控制。三个周期后的缓解率为53%±14%，其中4例完全缓解，21例部分缓解，16例病情稳定，6例进展。采用Lee和Wesley推广的Gehan固定缓解率假设，预期缓解率为60%，与报道的晚期乳腺癌对含阿霉素方案的缓解率一致，我们得出结论，所研究的联合方案在诱导晚期乳腺癌缓解方面的效率不低于与阿霉素相当的联合方案。由于现在有大量实验和临床证据表明，与阿霉素相比，米托蒽醌的毒性，主要是对心肌的毒性有所降低，我们认为在晚期乳腺癌化疗中用前者常规替代后者是合理的。
