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

作者：Harima Yoko^*; Ohguri Takayuki; Imada Hajime; Sakurai Hideyuki; Ohno Tatsuya; Hiraki Yoshiyuki; Tuji Koh; Tanaka Masahiro; Terashima Hiromi

来源：International Journal of Hyperthermia, 2016, 32(7): 801-808.

DOI：10.1080/02656736.2016.1213430

• Cervical cancer
• chemoradiotherapy
• hyperthermia
• randomisation

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 (CRT_HT).
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 CRT_HT 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 CRT_HT 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 CRT_HT group than in the CRT group (88% vs. 77.6%; adjusted odds ratio, 3.993; 95% confidence interval, 1.018-15.67; p = .047). CRT_HT was well tolerated and caused no additional acute or long-term 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.

• 出版日期2016