Protocol of the HISTOTHERM study: assessing the response to hyperthermia and hypofractionated radiotherapy in recurrent breast cancer

• DOI: 10.3389/fonc.2023.1275222
• Publication Date: 2023-12-19T15:15:37Z
• Authors: Andreas R. Thomsen; Jörg Sahlmann; Peter Bronsert; Oliver Schilling; Felicia Poensgen; Annette M. May; Sylvia Timme-Bron...; Anca-Ligia Grosu; Peter Vaupel; Jan-Olaf Gebbers; Gabriele Multhoff; Anne-Marie Lüchte...
• Keywords: longitudinal study; 610; predictive markers; Neoplasms. Tumors. Oncology. Including cancer and carcinogens; hypofractionated radiotherapy; hyperthermia; ddc:; 03 medical and health sciences; breast cancer; 0302 clinical medicine; Oncology; Oncology ; breast cancer ; hypofractionated radiotherapy ; hyperthermia ; predictive markers ; longitudinal study ; regression ; recurrent breast cancer ; re-irradiation; regression; RC254-282

Introduction Breast cancer is globally the leading in women, and despite high 5-year survival rate most frequent cause of related deaths. Surgery, systemic therapy radiotherapy are three pillars curative breast treatment. However, locoregional recurrences frequently occur after initial treatment often challenging to treat, amongst others due doses previous treatments. Radiotherapy can be combined with local hyperthermia sensitize tumor cells radiation thereby significantly reduce required dose. Therefore, combination mild hyperthermia, i.e. locally heating tissue 39-43°C, re-irradiation a reduced total dose relevant option for previously irradiated patients. The mechanisms this effect course date not well understood will investigated HISTOTHERM study. Methods analyses Patients or (loco)regional recurrent macroscopic tumors included Local control evaluated clinically histologically during 60 minutes superficial (39 - 43°C) using water-filtered infrared A (wIRA) irradiation, immediately followed by hypofractionated 20-24 Gy, administered weekly 4 Gy. Tumor stroma biopsies as blood samples collected prior treatment, (at 12 Gy) follow-up monitor response. represents standard operating procedure plus re-irradiation. Various blood-based markers analyzed. We aim at pinpointing key response which may help guiding decisions future. In addition, quality life assessed data evaluated. Registration study registered German Clinical Trials Register, Deutsches Register Klinischer Studien (DRKS00029221).