Randomized trial of cisplatin versus cisplatin plus mitolactol versus cisplatin plus ifosfamide in advanced squamous carcinoma of the cervix: A gynecologic oncology group study
Randomized trial of cisplatin versus cisplatin plus mitolactol versus cisplatin plus ifosfamide in advanced squamous carcinoma of the cervix: A gynecologic oncology group study
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DOI：
10.1200/jco.1997.15.1.165
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发表时间：
1997-01-01
影响因子：
45.3
通讯作者：
Anderson, B
中科院分区：
文献类型：
--
作者：
Omura, GA;Blessing, JA;Anderson, B
目的：顺铂、mitolactol（二溴卫矛醇）和异环磷酰胺是迄今为止妇科肿瘤组（GOG）确定的宫颈鳞状细胞癌中最活跃的单药。将顺铂加异环磷酰胺和顺铂加米托洛尔的组合与顺铂单药进行前瞻性比较。患者随机接受顺铂50 mg/m2或一定剂量的顺铂+米托洛尔（C + M）180 mg/m2口服，第2 - 6天，或顺铂加异环磷酰胺（CIFX）5 g/m2，24小时输注，在异环磷酰胺输注期间和输注后12小时内给予美司钠6 g/m2，每3周一次，最多6个疗程。在454名患者中，有438名符合条件，并进行了反应和生存分析。CIFX保持了较高的缓解率（31.1% vs 17.8%，P = .004）和更长的无进展生存期（PFS）时间（P = 0.003）与顺铂单药相比，中位进展或死亡时间分别为4.6和3.2个月，与顺铂单药治疗相比，C + M治疗在这些参数方面没有显著改善。生存率与初始性能评分（PS; 0更有利; P <0.001）和年龄（年轻人不利，P = 0.025）相关。顺铂和任何一种联合治疗的总生存期无显著差异。CIFX组白细胞减少、肾毒性、外周神经毒性和中枢神经系统毒性发生率更高（P <0.05）。结论：与顺铂单药治疗相比，CIFX可改善晚期宫颈癌的缓解率和PFS持续时间，但其代价是毒性更大，且生存期无改善。(C)1997年，美国临床肿瘤学会。
Purpose: Cisplatin, mitolactol (dibromodulcitol), and ifosfamide have been the most active single agents in squamous carcinoma of the cervix identified so far by the Gynecologic Oncology Group (GOG). Combinations of cisplatin plus ifosfamide and cisplatin plus mitolactol are prospectively compared with cisplatin alone.Patients and Methods: patients were randomized to receive cisplatin 50 mg/m(2) or the some dose of cisplatin plus mitolactol (C + M) 180 mg/m(2) orally on days 2 to 6, or cisplatin plus ifosfamide (CIFX) 5 g/m(2) given as a 24-hour infusion plus mesna 6 g/m(2) during and for 12 hours after the ifosfamide infusion, every 3 weeks for up to six courses. Of 454 patients entered, 438 were eligible and analyzed for response and survival.Results: CIFX held ct higher response rate (31.1% v 17.8%, P = .004) and longer progression-free survival (PFS) time (P = .003) compared with cisplatin alone, The median times to progression or death were 4.6 and 3.2 months, respectively, C + M showed no significant improvement in these parameters compared with cisplatin alone, Survival was associated with initial performance score (PS; 0 was more favorable; P < .001) and with age (younger was unfavorable, P = .025). There was no significant difference in overall survival between cisplatin and either of the combinations. Leukopenia, renal toxicity, peripheral neurotoxicity, and CNS toxicity were more frequent with CIFX (P < .05).Conclusion: CIFX improved the response rate and PFS duration in advanced cervix cancer compared with cisplatin alone, but at the cost of greater toxicity and with no improvement in survival. (C) 1997 by American Society of Clinical Oncology.