A randomized controlled trial comparing four versus six courses of adjuvant platinum-based chemotherapy in locally advanced cervical cancer patients previously treated with neo-adjuvant chemotherapy plus radical surgery
A randomized controlled trial comparing four versus six courses of adjuvant platinum-based chemotherapy in locally advanced cervical cancer patients previously treated with neo-adjuvant chemotherapy plus radical surgery
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DOI：
10.1016/j.ygyno.2015.09.082
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发表时间：
2015-12-01
影响因子：
4.7
通讯作者：
Panici, Pierluigi Benedetti
中科院分区：
文献类型：
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作者：
Angioli, Roberto;Plotti, Francesco;Panici, Pierluigi Benedetti
目标.本研究的目的是比较新辅助化疗加根治性手术后4个疗程与6个疗程的辅助化疗在总生存期（OS）、无病生存期（DFS）、复发率和毒性方面的差异。我们将200例IB 2-II B期宫颈癌患者随机分为两组，分别接受顺铂100 mg/mq和紫杉醇175 mg/mq治疗4个疗程（A组）和6个疗程（B组），每21天1次。4年随访时，复发率比较（p = 1; RR = 1.005; 95% CI = 0.87至1.161），OS（p = 0.906）和DFS（p = 0.825）两组间无统计学显著性差异。数据分析显示两组间白细胞减少症的发生率有统计学显著性差异（p = 0.0072; RR = 1.513; 95% CI = 1.127-2.03）、贫血（p = 0.048; RR = 1.188; CI = 1.012-1.395）和发热性中性粒细胞减少（p = 0.042; RR = 1.119; 95% CI = 1.014-1.235），有利于A组。关于非血液学毒性，在胃肠道症状方面没有统计学显著差异（p = 0.49; RR = 1.046; CI = 0.948-1.153）。相反，A组神经系统症状发生率（13%）低于B组（28%），差异有统计学意义（p = 0.014; RR = 1.208; CI = 1.046-1.395）。4或6个疗程铂类化疗的辅助治疗在OS和DSF方面显示出相似的结果，具有有利的毒性特征，有利于第一方案。(C)2015 Elsevier Inc. All rights reserved.
Objectives. The aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neo-adjuvant chemotherapy plus radical surgery in terms of overall survival (OS), disease-free survival (DFS), recurrence rate and toxicity profile.Methods. We randomly assigned 200 patients with IB2-IIB cervical cancer to receive 4 (Group A) or 6 (Group B) courses of cisplatin 100 mg/mq and paclitaxel 175 mg/mq every 21 days.Results. At 4-years follow-up, the comparison of recurrence rate (p = 1; RR = 1.005; 95% CI = 0.87 to 1.161), OS (p = 0.906) and DFS (p = 0.825) did not show statistically significant differences between the two groups.Data analysis showed statistically significant differences between the two groups in term of episodes of leukopenia (p = 0.0072; RR = 1.513; 95% CI = 1.127-2.03), anemia (p = 0.048; RR = 1.188; CI = 1.012-1.395) and febrile neutropenia (p = 0.042; RR = 1.119; 95% CI = 1.014-1.235), in favor of Group A. As regards non-hematological toxicities, there were no statistically significant differences in terms of gastrointestinal symptoms (p = 0.49; RR = 1.046; CI = 0.948-1.153. On the contrary, there was a statistically significant difference regarding neurological symptoms (p = 0.014; RR = 1.208; CI = 1.046-1.395), that were less frequent in Group A (13%) than in Group B (28%).Conclusions. Adjuvant treatment with 4 or 6 courses of platinum-based chemotherapy showed similar results in terms of OS and DSF, with a favorable toxicity profile in favor of the first regimen. (C) 2015 Elsevier Inc. All rights reserved.