M-VAC (methotrexate, vinblastine, doxorubicin and cisplatin) for poor prognosis patients with urothelial tumors and effect of dose intensity

Abstract

41人の患者を術後補助化学療法24人, 術前補助化学療法5人, 救済化学療法12人の3グループに分け, 各群について調査した.平均の治療強度は術後補助化学療法群77±11%, 術前補助化学療法群73±4%, 救済化学療法群74±12%であった.他因死を除いた5年生存率は補助化学療法では69%であった.術前補助化学療法の5例中2例は治療開始より23ヵ月で癌なし生存, 救済化学療法の全例は33ヵ月以内に癌死或いは副作用で死亡した.生存期間の中央値は術後補助化学療法群で38ヵ月, 術前補助化学療法群で21ヵ月, 救済化学療法群で7ヵ月であった.75%以上の治療強度は各群において生存率を改善しなかった

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 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.