Vinante O, Bari M, Segati R, Azzarello G, Sampognaro E, Rosetti F, Pappagallo G L
Centro Oncologico Multizonale, ULSS17, Noale, Italia.
Oncology. 1993;50(1):1-4. doi: 10.1159/000227137.
Twenty-eight patients with stage IIIB-IV non-small-cell lung cancer were treated with mitomycin C, vinblastine and cisplatin (MVP) in a phase II--minimax 2-stage design--randomized trial (with cisplatin plus etoposide as control arm). As indicated by the study design, the accrual was stopped after the 11th responder, and the combination was considered as active at the 40% level. Forty-six percent of patients had an improvement of their initial Karnofsky performance score, lasting a median of 24 weeks, and about 38% had a complete relief of symptoms. Hematologic toxicity was moderate to severe in about 50% of patients, and neurologic toxicity in about 18%; no grade 4 toxicity was observed. The estimated median progression-free survival was of 25 weeks. The observed activity and manageability, together with the positive effect on patient quality of life, account for a positive evaluation of MVP as a palliative treatment in advanced non-small-cell lung cancer.
28例IIIB-IV期非小细胞肺癌患者接受了丝裂霉素C、长春碱和顺铂(MVP)治疗,该治疗采用II期——最小最大2阶段设计——随机试验(以顺铂加依托泊苷作为对照臂)。根据研究设计,在第11例缓解者出现后停止入组,该联合方案被认为在40%的水平上具有活性。46%的患者其初始卡诺夫斯基功能状态评分有所改善,持续时间中位数为24周,约38%的患者症状完全缓解。约50%的患者出现中度至重度血液学毒性,约18%的患者出现神经毒性;未观察到4级毒性。估计无进展生存期的中位数为25周。所观察到的活性和可管理性,以及对患者生活质量的积极影响,使得MVP作为晚期非小细胞肺癌的姑息治疗得到了积极评价。