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Publikacje naukowe

Wieloośrodkowe randomizowane badanie kliniczne z chemioterapią i hipertermią w porównaniu do samej chemioterapii u pacjentek z miejscowo zaawansowanym rakiem szyjki macicy

tytuł oryg.: A multicentre randomised clinical trial of chemoradiotherapy plus hyperthermia versus chemoradiotherapy alone in patients with locally advanced cervical cancer
Wydawnictwo: International Journal of Hyperthermia
Autor główny: Yoko Harima
Pozostali autorzy: Takayuki Ohguri, Hajime Imada, Hideyuki Sakurai, Tatsuya Ohno, Yoshiyuki Hiraki, Koh Tuji, Masahiro Tanaka & Hiromi Terashima
Data: 2016-09-11

DOI: 10.1080/02656736.2016.1213430

Język publikacji: angielski

Klasa publikacji: Badanie kliniczne

Rodzaj badania: Randomizowane, wieloośrodkowe

Liczba pacjentów: 101

Rodzaj HT: LRHT Capacitive

Rodzaj HT opis: HT miejscowa, głęboka, pojemnościowa

Aparatura: Thermotron RF-8

Jednostka chorobowa: Rak szyjki macicy miejscowo zaawansowany

Symbol Jednostki chorobowej: LACC

Stage: IIA-IVA

Typ skojarzenia HT stosowany w badaniu: HT+RT+CT

Rodzaj CT: 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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