Comparing the Effectiveness of Combined External Beam Radiation and Hyperthermia versus External Beam Radiation Alone in Treating Patients with Painful Bony Metastases : a Phase III Prospective Randomized Control Trial
Mené auprès de 57 patients présentant des métastases osseuses douloureuses, cet essai taïwanais de phase III évalue, du point de vue du taux de réponse complète à 3 mois (absence de douleur sans augmentation de la consommation d'analgésiques), l'intérêt d'ajouter à une radiothérapie externe une hyperthermie profonde par radiofréquences
Purpose : Clinical experience of combined radiofrequency-based deep hyperthermia (HT) and external beam radiotherapy (RT) with bony metastases is limited. We aimed to compare the response, duration of pain relief and time to achieve complete pain relief after RT with or without HT. Methods and Materials : Cancer patients with bony metastases and pain score ≥4 on Brief Pain Inventory (BPI) score were randomized into RT of 30 Gray in 10 fractions combined with HT (RT + HT) versus RT alone. HT was performed by Thermotron-RF8, with maintenance of targeted temperature for 40 mins per treatment within 2 hours after RT, twice a week for 2 weeks. Patients were stratified by lesion number (solitary or multiple), BPI score (4–6 vs. 7–10), and primary site. Primary endpoint was complete response (CR) (BPI = 0 with no increase of analgesics) within 3 months after treatment. This study was registered with Clinical Trials.gov. Results : The study was terminated early after an interim analysis of 57 patients, 3 years after the 1st enrollment (November 2013 to November 2016); 29 patients in the RT + HT group and 28 patients in the RT-alone group. The CR rate at 3 months after treatment was 37.9% in the RT + HT group vs. 7.1% in the RT-alone group (p = 0.006). The accumulated CR rate within 3 months after treatment was 58.6% in the RT + HT group vs. 32.1% in the RT-alone group (p = 0.045). Median time to pain progression was 55 days in patients with CR (n = 9) in the RT-alone group, while endpoint was not reached during the 24-week follow-up in the RT + HT group (p < 0.01). Conclusions : The addition of HT to RT significantly increase pain control rate and extend response duration compared to RT alone for painful bony metastases.
http://www.redjournal.org/article/S0360-3016(17)33930-5/fulltext