Survival Outcomes of Clinical Trials in Patients With Recurrent Cervical Cancer

Christa I. Nagel, William N. Denson, Debra L. Richardson, Siobhan M. Kehoe, David S. Miller, Jayanthi S. Lea
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引用次数: 1

Abstract

Introduction

A large proportion of patients with cervical cancer have a lower socioeconomic background with inherent barriers to clinical trial participation. The present authors hypothesized that patients participating in a clinical trial would have better outcomes compared with those not enrolled in a trial. The objective was to review the clinical outcomes of women with recurrent cervical cancer treated on a clinical trial versus those treated off trial.

Patients and Methods

This was a retrospective cohort study of women treated for recurrent cervical cancer on versus off clinical trial between 1998 and 2010. Women participating in Gynecologic Oncology Group clinical trials for recurrent cervical cancer were identified and matched 1:1 with women treated off trial based on age within 10 years, ethnicity, stage at initial diagnosis, histology, primary treatment, and baseline renal function.

Results

A total of 60 women with recurrent cervical cancer were identified; 30 were treated for their recurrence on a clinical trial and were matched to 30 treated off trial. The median number of salvage regimens was 1.0 for the trial group (range, 1-5) and 1.5 for the off-trial group (range, 1-5) (P = .74). There was no significant difference in the number of cycles of chemotherapy completed on versus off trial (7.5 vs. 5.9; P = .44). There was also no significant difference in progression-free and overall survival from time of recurrence on trial and off trial (4.2 vs. 3.1 months [P = .75] and 15.0 vs. 13.8 months [P = .64], respectively).

Conclusion

This study found that the progression-free survival and overall survival are similar between women treated with chemotherapy on or off trial for cervical cancer.

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宫颈癌复发患者临床试验的生存结局
很大一部分宫颈癌患者的社会经济背景较低,这对参与临床试验具有固有的障碍。目前的作者假设,参加临床试验的患者比没有参加试验的患者有更好的结果。目的是回顾在临床试验中接受治疗的复发性宫颈癌妇女与在试验外接受治疗的妇女的临床结果。患者和方法这是一项回顾性队列研究,对1998年至2010年期间接受复发性宫颈癌治疗的妇女进行了对照临床试验。参与妇科肿瘤学组复发性宫颈癌临床试验的妇女根据10年内的年龄、种族、初诊阶段、组织学、初次治疗和基线肾功能,与试验外治疗的妇女进行1:1匹配。结果共发现60例宫颈癌复发妇女;其中30人在临床试验中接受复发治疗,30人在试验外接受治疗。试验组救助方案的中位数为1.0个(范围,1-5),非试验组为1.5个(范围,1-5)(P = 0.74)。试验前后完成化疗的周期数无显著差异(7.5 vs 5.9;P = .44)。试验前后的无进展生存期和总生存期也无显著差异(分别为4.2个月对3.1个月[P = 0.75]和15.0个月对13.8个月[P = 0.64])。结论本研究发现宫颈癌患者化疗前后的无进展生存期和总生存期相似。
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