Francini Guido, Petrioli Roberto, Messinese Simona, Pozzessere Daniele, Marsili Stefania, Correale Pierpaolo, Sabatino Marianna, Fiaschi Anna Ida
Institute of Internal Medicine, Medical Oncology Division, University of Siena, Policlinico le Scotte, Viale Bracci 11, 53100 Siena, Italy.
Cancer Chemother Pharmacol. 2002 Oct;50(4):271-6. doi: 10.1007/s00280-002-0495-6. Epub 2002 Jul 31.
To assess the activity and safety of combined folinic acid (FA), 5-fluorouracil (5-FU) and mitomycin C (MMC) in metastatic breast cancer patients previously treated with at least two chemotherapy regimens.
A total of 104 consecutive patients were enrolled for treatment with FA 100 mg/m(2) plus 5-FU 400 mg/m(2) i.v. on days 1-5, and MMC 3 mg/m(2) on days 3-5 (FFM). The cycles were repeated every 21 days until progression, severe toxicity or patient refusal.
Of the 104 patients, 96 were evaluable for response and toxicity. The overall response rate was 43% (95% confidence interval 32.8-53.2%); 40 patients achieved stable disease (42%) and 15 progressed (15%). In a retrospectively defined subgroup of patients with clinical resistance to taxanes (12 patients) or anthracyclines (14 patients), the response rate was 42%. The median time to progression was 8 months (3-18 months), and the median overall survival was 10.5+ months (2-36 months). The most common treatment-related adverse events were stomatitis, neutropenia, nausea/vomiting and diarrhea. Stomatitis, neutropenia and thrombocytopenia were the only grade 4 treatment-related adverse events, and occurred in no more than 3% of patients.
The tested FFM regimen seems to offer a valid option for patients with metastatic breast cancer who have been pretreated with two or more chemotherapeutic lines or who have failed on regimens containing anthracyclines or taxanes.
评估亚叶酸钙（FA）、5-氟尿嘧啶（5-FU）和丝裂霉素C（MMC）联合应用于既往接受过至少两种化疗方案治疗的转移性乳腺癌患者的活性和安全性。
共纳入104例连续患者，接受FA 100 mg/m²加5-FU 400 mg/m²静脉滴注，第1 - 5天给药，MMC 3 mg/m²，第3 - 5天给药（FFM方案）。每21天重复一个周期，直至病情进展、出现严重毒性反应或患者拒绝治疗。
104例患者中，96例可评估疗效和毒性反应。总缓解率为43%（95%置信区间32.8 - 53.2%）；40例患者病情稳定（42%），15例进展（15%）。在一个回顾性定义的对紫杉烷类（12例患者）或蒽环类药物（14例患者）临床耐药的亚组患者中，缓解率为42%。中位疾病进展时间为8个月（3 - 18个月），中位总生存期为10.5 +个月（2 - 36个月）。最常见的与治疗相关的不良事件为口腔炎、中性粒细胞减少、恶心/呕吐和腹泻。口腔炎、中性粒细胞减少和血小板减少是仅有的4级与治疗相关的不良事件，发生率不超过3%的患者。
对于接受过两种或更多化疗方案预处理或对含蒽环类或紫杉烷类方案治疗失败的转移性乳腺癌患者，所测试的FFM方案似乎是一种有效的选择。
