Yoko Harima1, Takayuki Ohguri2, Hajime Imada3, Hideyuki Sakurai4, Tatsuya Ohno5, Yoshiyuki Hiraki6, Koh Tuji7, Masahiro Tanaka8, Hiromi Terashima9. 1. a Department of Radiology , Kansai Medical University , Moriguchi City , Japan ; 2. b Department of Radiology , University of Occupational and Environmental Health , Kitakyusyu City , Japan ; 3. c Cancer Therapy Center, Tobata Kyoritsu Hospital , Kitakyusyu City , Japan ; 4. d Department of Radiation Oncology , University of Tsukuba , Tsukuba City , Japan ; 5. e Department of Radiation Oncology , Gunma University Heavy Ion Medical Center , Maehashi City , Japan ; 6. f Department of Radiology , Kagoshima University , Kagoshima City , Japan ; 7. g Department of Radiology , National Hospital Organization Minami Wakayama Medical Center , Tanabe City , Japan ; 8. h Department of Radiation Oncology , Osaka City General Hospital , Osaka City , Japan ; 9. i Department of Radiology , Harasanshin Hospital , Fukuoka City , Japan.
Abstract
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), disease-free 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.
RCT Entities:
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), disease-free 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.
Authors: H Petra Kok; Erik N K Cressman; Wim Ceelen; Christopher L Brace; Robert Ivkov; Holger Grüll; Gail Ter Haar; Peter Wust; Johannes Crezee Journal: Int J Hyperthermia Date: 2020 Impact factor: 3.914
Authors: Matthias W Beckmann; Frederik A Stübs; Martin C Koch; Peter Mallmann; Christian Dannecker; Anna Dietl; Anna Sevnina; Franziska Mergel; Laura Lotz; Carolin C Hack; Anne Ehret; Daniel Gantert; Franca Martignoni; Jan-Philipp Cieslik; Jan Menke; Olaf Ortmann; Carmen Stromberger; Karin Oechsle; Beate Hornemann; Friederike Mumm; Christoph Grimm; Alina Sturdza; Edward Wight; Kristina Loessl; Michael Golatta; Volker Hagen; Timm Dauelsberg; Ingo Diel; Karsten Münstedt; Eberhard Merz; Dirk Vordermark; Katja Lindel; Christian Wittekind; Volkmar Küppers; Ralph Lellé; Klaus Neis; Henrik Griesser; Birgit Pöschel; Manfred Steiner; Ulrich Freitag; Tobias Gilster; Alexander Schmittel; Michael Friedrich; Heidemarie Haase; Marion Gebhardt; Ludwig Kiesel; Michael Reinhardt; Michael Kreißl; Marianne Kloke; Lars-Christian Horn; Regina Wiedemann; Simone Marnitz; Anne Letsch; Isabella Zraik; Bernhard Mangold; Jochen Möckel; Céline Alt; Pauline Wimberger; Peter Hillemanns; Kerstin Paradies; Alexander Mustea; Dominik Denschlag; Ulla Henscher; Reina Tholen; Simone Wesselmann; Tanja Fehm Journal: Geburtshilfe Frauenheilkd Date: 2022-02-11 Impact factor: 2.915