Cisplatin and irinotecan in squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group.
Cisplatin and irinotecan in squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group.
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顺铂和伊立替康治疗宫颈鳞状细胞癌：妇科肿瘤组的一项 II 期研究。
DOI：
10.1016/j.ygyno.2004.05.018
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发表时间：
2004
影响因子：
4.7
通讯作者：
Monk,BradleyJ
中科院分区：
文献类型：
--
作者：
Muggia,FrancoM;Blessing,JohnA;McGehee,Ramon;Monk,BradleyJ
Objectives评估顺铂和伊立替康作为一线治疗晚期，持续性或复发性鳞状细胞癌患者的cervical.MethodsPatients没有预先治疗转移性疾病，存在可测量的肿瘤，性能状态为0或1，和足够的骨髓，肾，肝功能的组合可能有资格参加这项试验。顺铂和伊立替康每周一次给药，起始剂量分别为25和65 mg/m2，连续3周。每28天重复一个周期，根据需要调整剂量。患者的累积是基于一个两阶段的设计，至少有7个反应的28例患者在第一阶段需要进行第二阶段的累积寻求40%或更好的反应率。ResultsOf 34例患者进入研究，31个符合条件，27个可评价的反应。10例既往接受过含顺铂的放化疗。在观察到的5例（2例完全缓解和3例部分缓解）中，2例属于既往接受过放化疗的患者亚组。这一活动水平被认为不足以保证进行第二阶段的应计制。主要毒性是骨髓抑制和胃肠道症状，虽然6例患者没有经历这些不良反应.ConclusionAt这些剂量，每周顺铂和伊立替康未能表现出足够的活性进行III期研究。尽管在本研究中不明显，但既往放化疗可能影响对含铂联合治疗的反应，在未来试验的设计中应考虑其影响。
ObjectiveTo evaluate the combination of cisplatin and irinotecan as first-line treatment of patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.MethodsPatients with no prior treatment for metastatic disease, presence of measurable tumors, performance status of 0 or 1, and adequate bone marrow, renal, and hepatic functions were potentially eligible for this trial. Cisplatin and irinotecan were given weekly at starting doses of 25 and 65 mg/m2, respectively, for three consecutive weeks. Cycles were to be repeated every 28 days with dose adjustments as required. Patient accrual was based on a two-stage design with at least seven responses out of 28 patients in the first stage required to proceed to a second stage of accrual seeking a response rate of 40% or better.ResultsOf 34 patients entered onto the study, 31 were eligible and 27 were evaluable for response. Ten had received prior chemoradiation containing cisplatin. Among the five (two complete and three partial) observed responses, two were in the subset of patients who had received prior chemoradiation. This level of activity was deemed insufficient to warrant a second stage of accrual. Predominant toxicities were myelosuppression and gastrointestinal symptoms, although six patients experienced none of these adverse effects.ConclusionAt these doses, weekly cisplatin and irinotecan failed to demonstrate sufficient activity to undertake a phase III study. Although not apparent in this study, prior chemoradiation may affect response to platinum-based combinations and its impact should be considered in the design of future trials.