Radiation therapy combined with hyperthermia versus cisplatin for locally advanced cervical cancer: Results of the randomized RADCHOC trial

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• 作者：Ludy C.H.W. Lutgens^a ; ^{ludy.lutgens@maastro.nl" class="auth_mail" title="E-mail the corresponding author} ; Peter C.M. Koper^d ; Jan J. Jobsen^c ; Elzbieta M. van der Steen-Banasik^b ; Carien L. Creutzberg^e ; Hetty A. van den Berg^f ; Petronella B. Ottevanger^g ; Gerard C. van Rhoon^h ; ⁱ ; Helena C. van Doorn^j ; Ruud Houben^a ; Jacoba van der Zee^h ; ⁱ
• 关键词：Cervical cancer ; Concurrent chemoradiation ; Regional hyperthermia
• 刊名：Radiotherapy and Oncology
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：120
• 期：3
• 页码：378-382
• 全文大小：485 K

文摘

Chemoradiation (RT-CT) is standard treatment for locally advanced cervical cancer (LACC). This study tried to establish if radiotherapy combined with hyperthermia (RT-HT) should be preferred in bulky and/or FIGO-stage ⩾III.

Methods

In this open-label, multicenter randomized trial, patients with LACC were randomly assigned by a computer-generated, biased coin minimization technique to RT-CT or RT-HT. Central randomization was done with stratification by FIGO-stage, tumour diameter and nodal status. Primary endpoint was event free survival (EFS). Secondary endpoints were pelvic recurrence free survival (PRFS), overall survival (OS) and treatment related toxicity. Analysis was done by intention to treat.

Results

The trial was closed prematurely (87 of 376 planned patients enrolled: 43 RT-CT; 44 RT-HT). Median follow-up time was 7.1 years. The cumulative incidence of an event was 33% in the RT-CT group and 35% in the RT-HT group. The corresponding hazard rate (HR) for EFS was 1.15 (CI: 0.56–2.36, m>p = m>0.7). Also the hazards for PRFS (0.94; CI 0.36–2.44) and OS (1.04; CI 0.48–2.23) at 5 years were comparable between both treatment arms as was grade ⩾3 radiation related late toxicity (6 RT-CT and 5 RT-HT patients).

Conclusion

After 25% of intended accrual, data suggest comparable outcome for RT-CT and RT-HT.