Hibi H, Okamura K, Takashi M, Shimoji T, Miyake K
Department of Urology, Nagoya University School of Medicine.
Hinyokika Kiyo. 1997 Feb;43(2):89-96.
The effects of the M-VAC (methotrexate, vinblastine, doxorubicin and cisplatin) regimen, which has been reported to improve the outcome of patients with urothelial cancers, were studied on 41 patients treated at our hospital. The patients were divided into adjuvant (24 patients), neoadjuvant (5 patients), and salvage (12 patients) groups. We investigated the dose intensity, the cause-specific survival, response rate and toxicities in the three groups. Although 36 patients received > or = 95% of the initial doses projected, the mean dose intensity (+/-standard deviation) in the adjuvant, neoadjuvant, and the salvage groups was 77 (+/-11), 73 (+/-4), and 74 (+/-12)%, respectively. The five-year cause-specific survival in the adjuvant group was 69% (95% confidence limit: 50-88%). Only 2 of the 5 patients (40%) in the neoadjuvant group survived 23 months after the initiation of the treatment, and all patients in the salvage group died of cancer or treatment-related toxicity within 33 months. The median survival was 38 months in the adjuvant group, 21 months in the neoadjuvant group, and 7 months in the salvage group. A dose intensity > or = 75% did not improve survival in any group. The overall response rate was 33% in 15 patients with evaluable lesions. A complete response was noted in 1 patient and a partial response was noted in 1 patients. Two patients died of treatment-related complications. Nausea and vomiting were observed in all patients. Leukopenia, thrombocytopenia and anemia > or = WHO grade 3 were observed in 25 (61%), 4 (10%), and 7 (17%) patients, respectively. Thrombocytopenia, anemia, and pyrexia > or = grade 3 were seen relatively more often in the patients receiving a dose intensity < 75%. Stomatitis > or = grade 3 appeared to be more frequent in the patients receiving a dose intensity > or = 75%. Adjuvant M-VAC might be beneficial, while its efficacy was limited in the neoadjuvant and salvage settings. Although dose intensity is considered to be important, it did not appear to be related to survival, the response rate, or the toxicity of M-VAC.
据报道，甲氨蝶呤、长春花碱、阿霉素和顺铂（M-VAC）方案可改善尿路上皮癌患者的预后，我们对我院治疗的41例患者进行了该方案疗效的研究。患者分为辅助治疗组（24例）、新辅助治疗组（5例）和挽救治疗组（12例）。我们调查了三组的剂量强度、病因特异性生存率、缓解率和毒性。虽然36例患者接受了预计初始剂量的≥95%，但辅助治疗组、新辅助治疗组和挽救治疗组的平均剂量强度（±标准差）分别为77（±11）%、73（±4）%和74（±12）%。辅助治疗组的五年病因特异性生存率为69%（95%置信区间：50-88%）。新辅助治疗组的5例患者中只有2例（40%）在开始治疗后存活了23个月，挽救治疗组的所有患者均在33个月内死于癌症或治疗相关毒性。辅助治疗组的中位生存期为38个月，新辅助治疗组为21个月，挽救治疗组为7个月。剂量强度≥75%在任何一组中均未改善生存率。15例可评估病变患者的总体缓解率为33%。1例患者达到完全缓解，1例患者达到部分缓解。2例患者死于治疗相关并发症。所有患者均出现恶心和呕吐。25例（61%）、4例（10%）和7例（17%）患者分别出现≥世界卫生组织3级的白细胞减少、血小板减少和贫血。血小板减少、贫血和≥3级发热在剂量强度<75%的患者中相对更常见。≥3级口腔炎在剂量强度≥75%的患者中似乎更频繁出现。辅助性M-VAC可能有益，但其在新辅助治疗和挽救治疗中的疗效有限。虽然剂量强度被认为很重要，但它似乎与M-VAC的生存率、缓解率或毒性无关。
