Colozza M, Gori S, Mosconi A M, Anastasi P, Basurto C, Ludovini V, De Angelis V, Giansanti M, Tonato M
Medical Oncology Division, Policlinico Hospital, Perugia, Italy.
Breast Cancer Res Treat. 1996;38(3):277-82. doi: 10.1007/BF01806146.
From January 1992 to July 1993, 28 patients with metastatic breast cancer were entered in a phase II trial to assess the activity and toxicity of the combination of mitoxantrone, 5-fluoruracil, and leucovorin. Patients were eligible if they had progressive disease after either adjuvant (2 patients) or previous chemotherapy for metastatic disease (26 patients). Twenty-five patients (89.2%) had received previous anthracycline-based therapy. Predominant site of metastatic disease was visceral in 22 patients, bone in 2 patients, soft tissue in 4 patients, and the majority of patients (89.2%) had two or more sites of disease. The regimen was administered according to the following schedule: Mitoxantrone 9-12 mg/m2 i.v. on day 1; L-Leucovorin 150 mg i.v. over 1 hour before 5-Fluorouracil 350 mg/m2 i.v. push days, 1, 2 and 3. Courses were repeated every 21 days. Twenty-six patients were evaluable for response. We observed 2 complete responses, 5 partial responses with a median duration of 38 weeks (range 23-68). The objective response rate was 27% (95% C.I., 10% to 44%). Myelo-suppression was the most frequent toxicity, but it was mild in the majority of patients. Nine episodes of fever and neutropenia occurred in six patients but none of these episodes was fatal. No clinical evidence of cardiotoxicity was observed. At a median follow-up of 78 weeks, the median time to progression was 20.5 weeks and the median overall survival was 48 weeks. We conclude that this regimen is well tolerated and in our experience the objective response rate is similar to other salvage chemotherapy regimens.
1992年1月至1993年7月，28例转移性乳腺癌患者进入一项II期试验，以评估米托蒽醌、5-氟尿嘧啶和亚叶酸联合应用的活性及毒性。若患者在辅助治疗（2例）或先前针对转移性疾病的化疗（26例）后出现疾病进展，则符合入组条件。25例患者（89.2%）曾接受过基于蒽环类药物的先前治疗。转移性疾病的主要部位为22例患者的内脏、2例患者的骨、4例患者的软组织，且大多数患者（89.2%）有两个或更多疾病部位。该方案按以下时间表给药：第1天静脉注射米托蒽醌9 - 12 mg/m²；在第1、2和3天静脉推注5-氟尿嘧啶350 mg/m²前1小时，静脉滴注L-亚叶酸150 mg，持续1小时。每21天重复疗程。26例患者可评估疗效。我们观察到2例完全缓解、5例部分缓解，中位缓解持续时间为38周（范围23 - 68周）。客观缓解率为27%（95%置信区间，10%至44%）。骨髓抑制是最常见的毒性，但大多数患者症状较轻。6例患者发生9次发热性中性粒细胞减少，但这些发作均无致命情况。未观察到心脏毒性的临床证据。中位随访78周时，中位疾病进展时间为20.5周，中位总生存期为48周。我们得出结论，该方案耐受性良好，根据我们的经验，客观缓解率与其他挽救性化疗方案相似。
