Klaassen U, Wilke H, Weyhofen R, Harstrick A, Eberhardt W, Müller C, Korn M, Hanske M, Diergarten K, Seeber S
Department of Internal Medicine (Cancer Research), West German Cancer Center, University of Essen.
Anticancer Drugs. 1998 Mar;9(3):203-7. doi: 10.1097/00001813-199803000-00002.
Results from our previous phase II study demonstrating high efficacy and low toxicity for a weekly schedule of 5-fluorouracil (5-FU)/leucovorin in intensively pretreated patients with metastatic breast cancer prompted addition of paclitaxel and cisplatin to this regimen for a phase II study of outpatient first-line treatment of metastatic breast cancer. (MBC). Twenty-eight patients with metastatic breast cancer have been evaluated. Pretreatment comprised adjuvant CTX in 24 out of 28 patients, but no prior CTX for MBC. Patients were treated with 5-FU 2 g/m2 (24 h infusion) plus leucovorin 500 mg/m2 (2 h infusion prior to 5-FU) weekly for 6 weeks (days 1, 8, 15, 22, 29 and 36); in addition, paclitaxel 175 mg/m2 (3 h infusion) was administered on days 0 and 21, and cisplatin 50 mg/m2 (1 h infusion) on days 1 and 22 prior to 5-FU/leucovorin, repeated every 50 days. All patients were treated as outpatients using Port-a-Cath systems and portable pumps. Aside from common total alopecia, neutropenia was common but only of short duration. No episodes of febrile neutropenia occurred. Non-hematologic toxicities (NCl CTC grade, percent of patients) consisted of mild to moderate diarrhea (2+3, 47%), mucositis (2, 14%), and nausea and vomiting (2+3, 60%). Out of 28 patients with bidimensionally measurable disease 25% (seven out of 28) achieved a CR, 57% (16 out of 28) achieved a PR, 11% (three out of 28) had a SD and 7% (two out of 28) had a PD. Overall RR was 82% (95% confidence interval 66-100%). Median remission duration was 8 months, median time to progression 9 months and median survival time 28 months with a median follow-up of 21 months. We conclude that the combination of paclitaxel, cisplatin and 5-FU/leucovorin is an effective non-anthracycline-containing regimen for the first-line treatment of MBC.
我们之前的II期研究结果表明，对于接受过强化预处理的转移性乳腺癌患者，每周一次的5-氟尿嘧啶（5-FU）/亚叶酸钙方案具有高效和低毒性，这促使在该方案中加入紫杉醇和顺铂，进行转移性乳腺癌门诊一线治疗的II期研究。已对28例转移性乳腺癌患者进行了评估。28例患者中有24例预处理包括辅助性环磷酰胺，但之前没有针对转移性乳腺癌的环磷酰胺治疗。患者接受5-FU 2 g/m²（24小时输注）加亚叶酸钙500 mg/m²（在5-FU之前2小时输注），每周一次，共6周（第1、8、15、22、29和36天）；此外，在第0天和第21天给予紫杉醇175 mg/m²（3小时输注），在5-FU/亚叶酸钙之前的第1天和第22天给予顺铂50 mg/m²（1小时输注），每50天重复一次。所有患者均使用植入式静脉输液港系统和便携式泵作为门诊患者进行治疗。除了常见的完全脱发外，中性粒细胞减少很常见，但持续时间较短。未发生发热性中性粒细胞减少事件。非血液学毒性（NCI CTC分级，患者百分比）包括轻度至中度腹泻（2+3级，47%）、粘膜炎（2级，14%）以及恶心和呕吐（2+3级，60%）。在28例具有双维度可测量疾病的患者中，25%（28例中的7例）达到完全缓解（CR），57%（28例中的16例）达到部分缓解（PR），11%（28例中的3例）病情稳定（SD），7%（28例中的2例）疾病进展（PD）。总体缓解率为82%（95%置信区间66-100%）。中位缓解持续时间为8个月，中位疾病进展时间为9个月，中位生存时间为28个月，中位随访时间为21个月。我们得出结论认为，紫杉醇、顺铂和5-FU/亚叶酸钙联合方案是转移性乳腺癌一线治疗的一种有效的不含蒽环类药物的方案。
