A multicentre randomised clinical trial of chemoradiotherapy plus hyperthermia versus chemoradiotherapy alone in patients with locally advanced cervical cancer

Publishing house: International Journal of Hyperthermia
Main author: Yoko Harima
Other authors: Takayuki Ohguri, Hajime Imada, Hideyuki Sakurai, Tatsuya Ohno, Yoshiyuki Hiraki, Koh Tuji, Masahiro Tanaka & Hiromi Terashima
Date: 2016-09-11

DOI: 10.1080/02656736.2016.1213430

Language: english

Publication class: Clinical study

Research type: Randomized, multicenter

Number of patients: 101

HT type: LRHT Capacitive

Description of HT type: Local HT, deep, capacitive

Device: Thermotron RF-8

Disease entity: Locally advanced cervical cancer

Symbol of disease entity: LACC

Stage: IIA-IVA

Types of combination with HT: HT+RT+CT

CT type: Cisplatin

Abstract. Background and purpose: To evaluate the effectiveness of whole-pelvic hyperthermia (HT) added to standard chemoradiotherapy (CRT) in locally advanced cervical cancer (CC), by investigating the clinical response and survival of patients treated with cisplatin-based CRT vs. CRT with HT (CRTþHT).
Materials and methods: This study was conducted at five hospitals in Japan between September 2001 and March 2015 in patients with the International Federation of Gynecology and Obstetrics stage IB (bulky)–IVA CC undergoing definitive CRT. After giving a written informed consent, patients were randomly allocated to two treatment groups: CRT and CRTþHT group. Overall survival (OS), diseasefree survival (DFS), local relapse-free survival (LRFS), complete response (CR) rate and tolerability were evaluated.
Results: In total, 101 patients were treated. Patient characteristics, total dose of cisplatin and radiotherapy were similar for both groups. Although not statistically significant, the 5-year OS, DFS and LRFS in the CRTþHT group (77.8%, 70.8% and 80.1%, respectively) were better than those in the CRT group (64.8%, 60.6% and 71.0%, respectively). CR was significantly more likely to be achieved in patients in the CRTþHT group than in the CRT group (88% vs. 77.6%; adjusted odds ratio, 3.993; 95% confidence interval, 1.018–15.67; p¼.047). CRTþHT was well tolerated and caused no additional acute or longterm toxicity compared with CRT alone.
Conclusions: HT combined with CRT improved the CR rate of CRT in patients with locally advanced CC, however, could not improve survival outcomes. Further studies in larger samples are warranted.

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