Phase I – study from Charite Berlin on fever-range whole-body hyperthermia in recurrent head&neck tumors
Zschaeck S et al: Fever range whole body hyperthermia for re-irradiation of head and neck squamous cell carcinomas: Final results of a prospective study. Oral Oncol. 2021 Feb 21;116:105240.
Rogasch J, Beck M, Stromberger C et al. PET measured hypoxia and MRI parameters in re-irradiated head and neck squamous cell carcinomas: findings of a prospective pilot study [version 2; peer review: 2 approved]. F1000Research 2021, 9:1350
OPEN ACCESS https://doi.org/10.12688/f1000research.27303.2
Based on U.S. experimental data on improved oxygenation of head and neck tumors by fever-range whole body hyperthermia (FRWBH), Charité Berlin, Department of Radiation Oncology, conducted a phase 1 pilot study of 10 patients on the feasibility and toxicity of combined thermoradiochemotherapy for unresectable, pre-irradiated head and neck squamous cell carcinomas with an unfavorable prognosis.
- hyperfractionated re-irradiation with 1.2 Gy, 2x daily, total dose of 66 Gy
- concomitant chemotherapy, usually cisplatin
- 5 FRWBH treatments using heckel-HT3000, 1x/week, concomitant with re-irradiation.
In 5 patients, all planned FRWBH treatments could be performed. 1 patient developed an acute infection during radiochemotherapy which was an exclusion criterion for the administration of further FRWBH, 1 patient aborted FRWBH after the second session due to claustrophobia, 2 patients received only one resp. no treatment due to poor compliance, 1 recruited patient could not be treated due to Covid19 restrictions. The combination of radiochemotherapy with FRWBH did not increase acute toxicity. No detrimental effect on tumor control or survival was observed. Especially in the patients who were able to complete the full protocol, positive trends were observed regarding therapy outcomes and quality of life.
The study hypothesis that FRWBH counteracts hypoxia in recurrent head / neck tumors could not be verified because in most recruited patients hypoxia was not measured even before starting the treatment protocol. This unexpected finding is described in detail in the second publication (Rogasch et al.).
Personal assessment and outlook:
In patients with far advanced disease and very unfavorable prognosis, discontinuation of the strenuous whole-body hyperthermia treatment associated with thermoregulatory stress must be expected.
The small number of patients does not allow any statement on the efficacy of the combined therapy. However, the positive observations described above have aroused interest at Charite Berlin in further studies, which are in concrete preparation.