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首页> 外文期刊>Annals of oncology: official journal of the European Society for Medical Oncology >Brachytherapy versus radical hysterectomy after external beam chemoradiation with gemcitabine plus cisplatin: A randomized, phase III study in IB2-IIB cervical cancer patients
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Brachytherapy versus radical hysterectomy after external beam chemoradiation with gemcitabine plus cisplatin: A randomized, phase III study in IB2-IIB cervical cancer patients

机译：吉西他滨联合顺铂外照射放化疗后的近距离放射治疗与根治性子宫切除术：一项针对IB2-IIB宫颈癌患者的随机III期研究

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摘要

Background: The aim of the present study was to demonstrate that radical hysterectomy (RH) leads to improved survival outcomes in FIGO stage IB2-IIB cervical cancer when compared with standard brachytherapy (BCT) after identical external beam chemoradiation (EBRT-CT). Patients and methods: EBRT-CT treatment consisted of six courses of cisplatin at 40 mg/m2 and gemcitabine at 125 mg/m2 per week concurrent with 50.4 Gy of radiation. In the BCT arm, EBRT-CT was followed by BCT to reach a point A dose of 85 Gy, whereas in the experimental arm, a type III RH with bilateral pelvic lymph node dissection andpara-aortic lymph node sampling (RH) was carried out within 4-6 weeks after EBRT-CT.Results: Between May 2004 and June 2009, 211 patients were enrolled (BCT, 100 and RH, 111). At a median followup time of 36 months (3-80), progression-free survival (PFS) and overall survival (OS) rates were similar in both the arms. PFS rates were 74.8% and 71.7% in the BCT and RH arms [HR 0.6516 (95% confidence interval (CI)0.3504-1.2116)], P = 0.186. OS rates were 76.3% in the BCT versus 74.5% in the surgical arm [HR 0.6981(95% CI 0.3106-1.3439)], P = 0.236. No differences were observed in the pattern of local and systemic failures.Conclusions: This study failed to demonstrate that RH after EBRT-CT is superior to standard BCT.
机译：背景：本研究的目的是证明，与标准近距离放射疗法（BCT）在相同的体外束化学放疗（EBRT-CT）后相比，根治性子宫切除术（RH）可改善FIGO IB2-IIB期宫颈癌的生存结果。患者和方法：EBRT-CT治疗包括六个疗程的顺铂（每周40 mg / m2）和吉西他滨（每周125 mg / m2），并伴有50.4 Gy放射。在BCT组中，EBRT-CT之后是BCT，达到A点剂量为85 Gy，而在实验组中，进行了具有双侧盆腔淋巴结清扫和主动脉旁淋巴结取样（RH）的III型RH结果：从2004年5月至2009年6月，在EBRT-CT术后4-6周内入组211例患者（BCT，100，RH，111）。中位随访时间为36个月（3-80），两组的无进展生存期（PFS）和总生存期（OS）率相似。 BCT和RH组的PFS率为74.8％和71.7％[HR 0.6516（95％置信区间（CI）0.3504-1.2116）]，P = 0.186。 BCT的OS率为76.3％，而手术臂的OS率为74.5％[HR 0.6981（95％CI 0.3106-1.3439）]，P = 0.236。结论：这项研究未能证明EBRT-CT后的RH优于标准BCT。

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