前瞻性随机研究比较局部晚期宫颈癌同期放化疗中每周顺铂联合紫杉醇与每周顺铂的疗效。

Prospective randomized study comparing concomitant chemoradiotherapy using weekly cisplatin & paclitaxel versus weekly cisplatin in locally advanced carcinoma cervix.

机构信息

1 Department of Radiation Oncology, Regional Cancer Centre, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India ; 2 Department of Radiation Oncology, Regional Cancer Centre, Post graduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Ann Transl Med. 2016 Feb;4(3):48. doi: 10.3978/j.issn.2305-5839.2015.11.19.

DOI:10.3978/j.issn.2305-5839.2015.11.19

PMID:26904570

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4740006/

Abstract

BACKGROUND

To evaluate the benefit with the addition of paclitaxel to cisplatin-based concurrent chemoradiotherapy (C-CRT) for the treatment of locally advanced carcinoma of the uterine cervix in terms of local control, disease free survival (DFS) and overall survival (OS).

METHODS

From 1/7/2011 to 31/5/2012, 81 women (median age of 50 years) with newly diagnosed, histopathologically proven carcinoma cervix with FIGO stages IIA to IIIB were randomized to two arms-cisplatin 40 mg/m(2)/week for 5 weeks was given in single agent cisplatin (control arm), while cisplatin 30 mg/m(2)/week and paclitaxel 50 mg/m(2)/week for 5 weeks were given in cisplatin and paclitaxel (study arm). External beam radiotherapy (EBRT) was delivered to a total dose of 50 Gray (Gy) in 25 fractions (#) followed by intracavitary (I/C) brachytherapy or supplement EBRT at 20 Gy/10# with 2 cycles of respective chemotherapy. This prospective trial was registered with clinicaltrials.gov (NCT01593306).

RESULTS

Patients (n=81) had a maximum follow up of 36 months with a median follow up of 29 months. At first follow up study arm showed complete response in 84% vs. 75.6% in control arm (P=0.4095). An increase in toxicities was observed in the study arm in comparison to the control arm in terms of haematological grade II (35% vs. 12.2%), gastrointestinal (GI) grade III (20% vs. 7.4%) and GI grade IV (12.5% vs. 2.4%) toxicities. At median follow-up, the study arm demonstrated enhanced outcomes over the control arm in terms of DFS (79.5% vs. 64.3%; P=0.07) and OS (87.2% vs. 78.6%; P=0.27).

CONCLUSIONS

Despite the expected increase in manageable toxicities, these early results reveal promise with the inclusion of paclitaxel into the standard cisplatin based chemoradiation regime. Larger multi-institutional studies are justified to confirm a potential for the enhancement of response rates and survival.

摘要

背景

评估紫杉醇联合顺铂同期放化疗（C-CRT）治疗局部晚期宫颈癌的疗效，包括局部控制、无病生存（DFS）和总生存（OS）。

方法

2011 年 7 月 1 日至 2012 年 5 月 31 日，81 例新诊断的宫颈鳞癌患者（中位年龄 50 岁），国际妇产科联盟（FIGO）分期为 IIA 至 IIIB 期，随机分为两组：顺铂 40mg/m2/周（单药顺铂组），顺铂 30mg/m2/周联合紫杉醇 50mg/m2/周（顺铂联合紫杉醇组），共 5 周。外照射放疗（EBRT）剂量为 50Gy/25 次（#），随后行腔内（I/C）近距离放疗或补充外照射放疗 20Gy/10#，2 个周期的相应化疗。这项前瞻性试验在临床试验.gov（NCT01593306）上注册。

结果

81 例患者（n=81）的随访时间最长为 36 个月，中位随访时间为 29 个月。首次随访时，研究组完全缓解率为 84%，对照组为 75.6%（P=0.4095）。与对照组相比，研究组的血液学 2 级毒性（35% vs. 12.2%）、胃肠道（GI）3 级毒性（20% vs. 7.4%）和 GI 4 级毒性（12.5% vs. 2.4%）发生率更高。中位随访时，研究组在 DFS（79.5% vs. 64.3%；P=0.07）和 OS（87.2% vs. 78.6%；P=0.27）方面的结果优于对照组。