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Publikacje naukowe

Brachyterapia HDR połączona z hipertermią śródtkankową w miejscowo zaawansownym raku szyjki macicy u pacjentek uprzednio leczonych radiochemioterapią: badanie kliniczne fazy 1

tytuł oryg.: HDR brachytherapy combined with interstitial hyperthermia in locally advanced cervical cancer patients initially treated with concomitant radiochemotherapy: A phase I study.
Wydawnictwo: International Journal of Hyperthermia
Autor główny: Agnieszka Zolciak-Siwinska
Pozostali autorzy: Joanna Jońska-Gmyrek, Jagna Staniaszek. Norbert Piotrkowicz, Wojciech Michalski
Data: 2012-09-17

DOI: 10.1016/j.radonc.2013.04.01

Język publikacji: angielski

Klasa publikacji: Badanie kliniczne

Rodzaj badania: Randomizowane, Jednoośrodkowe 1 fazy

Liczba pacjentów: 76

Rodzaj HT: ISHT RF

Rodzaj HT opis: Hipertermia śródtkankowa, fale radiowe

Aparatura: BSD-500

Jednostka chorobowa: Rak szyjki macicy

Symbol Jednostki chorobowej: CC

Stage: I-III

Typ skojarzenia HT stosowany w badaniu: HT+ISBT (Hipertermia + Brachyterapia)

Rodzaj CT: -

Abstract. Background and purpose: The aim of this study was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on acute and late side effects in patients with advanced cervical cancer. Local control (LC) and disease-free survival (DFS) were also analysed.
Materials and methods: Following the completion of radiochemotherapy, patients with cervical cancer (FIGO stages I–III) were assigned to two treatment groups, either ISBT combined with interstitial hyperthermia (ISHT) or ISBT alone as a control group. Selection criterion for the ISBT combined with HT group was advanced cervical cancer with poor response to external beam radiotherapy. A total of 76 patients were included in the statistical analysis. Once a week, HT (at a temperature above 42.5 C) was administered for 45 min before and during high dose rate (HDR) brachytherapy (BT) in 43 patients. Four HT treatments were administered.
Results: The median follow-up time was 43 months (range 4–73 months). Significant differences were not observed for the distribution of early and late complications between the HT and no HT groups. Despite this, LC was similar in both groups. The 5-year DFS for the BT and BT+HT groups was 73.6% and 65.8%, respectively. The 5-year LC for the BT and BT+HT groups was 89% and 83%, respectively. For the majority of patients the maximum temperature level of 44–45 C was achieved during the ISHT.
Conclusions: ISHT is well tolerated and does not affect treatment-related early or late complications.

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