Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: A gynecologic oncology group study
Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: A gynecologic oncology group study
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DOI：
10.1200/jco.2004.04.170
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发表时间：
2004-08-01
影响因子：
45.3
通讯作者：
Rocereto, TF
中科院分区：
文献类型：
--
作者：
Moore, DH;Blessing, JA;Rocereto, TF
目的：探讨顺铂联合紫杉醇（C+P）治疗IVB期、复发性或持续性宫颈鳞状细胞癌患者是否比单用顺铂治疗能提高有效率、无进展生存期（PFS）或生存率。患者和方法：符合条件的可测量疾病、性能状态（PS）为0 - 2，血液学、肝脏和肾功能正常的患者每3周接受顺铂50mg /m(2)或C+P(顺铂50mg /m（2)加紫杉醇135 mg/m(2)）治疗，共6个周期。在每个治疗周期前进行肿瘤测量和生活质量（QOL）评估。结果在280例入组患者中，6%不符合条件。在264例符合条件的患者中，134例接受顺铂治疗，130例接受C+P治疗。各组在年龄、种族、PS、肿瘤分级、疾病部位和接受的周期数方面匹配良好。大多数患者既往有放射治疗（顺铂，92%;C+P, 91%）。接受顺铂的患者中有19%（6%完全+ 13%部分）有客观反应，而接受C+P的患者中有36%（15%完全+ 21%部分）有客观反应（P = 0.002）。顺铂组与C+P组的中位PFS分别为2.8和4.8个月（P < 0.001）。中位生存期（8.8个月vs 9.7个月）无差异。3 - 4级贫血和中性粒细胞减少症在联合用药组更为常见。尽管不成比例的患者（顺铂组，n = 50； C+P组，n = 33）退出了生活质量部分，但生活质量评分没有显著差异，可能是因为疾病增加、健康状况恶化或过早死亡。结论c +P在缓解率、PFS和持续生活质量方面均优于单用顺铂。(C) 2004年由美国临床肿瘤学会出版。
PurposeTo determine whether cisplatin plus paclitaxel (C+P) improved response rate, progression-free survival (PFS), or survival compared with cisplatin alone in patients with stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix.Patients and MethodsEligible patients with measurable disease, performance status (PS) 0 to 2, and adequate hematologic, hepatic, and renal function received either cisplatin 50 mg/m(2) or C+P (cisplatin 50 mg/m(2) plus paclitaxel 135 mg/m(2)) every 3 weeks for six cycles. Tumor measurements and quality-of-life (QOL) assessments were obtained before each treatment cycle.ResultsOf 280 patients entered, 6% were ineligible. Among 264 eligible patients, 134 received cisplatin and 130 received C+P. Groups were well matched with respect to age, ethnicity, PS, tumor grade, disease site, and number of cycles received. The majority of all patients had prior radiation therapy (cisplatin, 92%; C+P, 91%). Objective responses occurred in 19% (6% complete plus 13% partial) of patients receiving cisplatin versus 36% (15% complete plus 21% partial) receiving C+P (P = .002). The median PFS was 2.8 and 4.8 months, respectively, for cisplatin versus C+P (P < .001). There was no difference in median survival (8.8 months v 9,7 months). Grade 3 to 4 anemia and neutropenia were more common in the combination arm. There was no significant difference in QOL scores, although a disproportionate number of patients (cisplatin, n = 50; C+P, n 33) dropped out of the QOL component, presumably because of increasing disease, deteriorating health status, or early death.ConclusionC+P is superior to cisplatin alone with respect to response rate and PFS with sustained QOL. (C) 2004 by American Society of Clinical Oncology.