Breast cancer is the most common cancer in women worldwide according to the World Cancer Research Fund International. With nearly 1.7 million new cases diagnosed in 2012 (second most common cancer overall). This represents about 12% of all new cancer cases and 25% of all cancers in women.
Clinical results like the one below reveal that both Chemotherapy and Radiation treatment are more effective when combined with Hyperthermia. Hyperthermia warms the tumor to temperatures in the "fever range" which makes the cancer cells more sensitive to treatment. Normal healthy cells recover while cancer cells die.
Results of five randomized controlled trials on radiation with or without hyperthermia in advanced or recurrent breast cancer were combined in one analysis.
Radiotherapy, dose and scheme depending on previous irradiation or not, and varying per trial. Superficial hyperthermia was applied once or twice weekly.
The combination of results in total 306 patients showed a significant improvement in complete response rate in the group treated with radiotherapy and hyperthermia: 59% vs 41%. This initial improvement in local tumor control was maintained during follow-up. In one of the trials (ESHO), all patients were treated after previous irradiation and reirradiated with 8 fractions of 4 Gy, two fractions per week. The difference in local tumor control between the two treatment arms was significant and remarkably high in this subgroup: CR rate was 39% without hyperthermia, and 79% with hyperthermia, with similar differences in local tumor control during follow-up. Not all trials cited used the BSD-500 specifically.
Evidence Level I Randomized Clinical Trial Results on 306 Patients (Vernon et al.):
- Complete Remission Rate without Hyperthermia: 41 %
- Complete Remission Rate with Hyperthermia: 59 %
Subgroup after previous irradiation and reirradiated (ESHO):
- Complete Remission Rate without Hyperthermia: 39 %
- Complete Remission Rate with Hyperthermia: 79 %
The combination of Radiotherapy and Hyperthermia is the treatment of choice for Breast Cancer (Level I Evidence) recommended by
- DEGRO German Society of Radiation Oncology
- DGS German Society of Senology, Germany
- NCCN National Comprehensive Cancer Network Guidelines
- Dutch Society for Radiation Oncology, The NetherlandsDutch Society for Radiation Oncology, The Netherlands
- ESHO European Society of Hyperhermic Oncology
- DKG German Cancer Society: Interdisziplinäre S3-Leitlinie für die Diagnostik, Therapie und Nachsorge des Mammakarzinoms, Germany
Hyperthermia and Radiotherapy:
When hyperthermia is combined with radiotherapy, general treatment guidelines of the ESHO European Society of Hyperthermic Oncology recommend:
- Target volume for hyperthermia: When the radiotherapy total dose is considered to be sufficient for a high probability of local control for microscopic disease, the target volume for hyperthermia is the gross tumor volume. When the radiotherapy total dose is lower, the target volume for hyperthermia is the clinical target volume.
- Sequence of treatment modalities: Hyperthermia is given after the radiotherapy fraction, once or twice weekly with a time interval between two hyperthermia treatments of minimum 72 hours. The time interval between radiotherapy and hyperthermia may vary from 30 minutes to five hours.
- Duration of hyperthermia treatment: Superficial hyperthermia total 60 minutes, deep hyperthermia maximally 90 minutes (including up to 30 minutes heating-up time) at temperatures of 40 to 44 °C in the whole target volume.
- Vernon et al. Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials. International Collaborative Hyperthermia Group. Int J Radiat Oncol Biol Phys. 1996 Jul 1;35(4):731-44.
- Jones et al. Randomized trial of hyperthermia and radiation for superficial tumors. J Clin Oncol. 2005 May 1;23(13):3079-85.
- Oldenburg et al. Elective re-irradiation and hyperthermia following resection of persistent locoregional recurrent breast cancer: A retrospective study. Int J Hyperthermia. 2010;26(2):136-44.
- Van der Zee et al. Reirradiation combined with hyperthermia in breast cancer recurrences: overview of experience in Erasmus MC. Int J Hyperthermia. 2010;26(7):638-48.
- NCCN Clinical Practice Guidelines in Oncology™ Breast Cancer, Version 2.2011
- S3-Leitlinie Brustkrebs aus dem Leitlinienprogramm Onkologie der AWMF, Deutschen Krebsgesellschaft e.V. und Deutschen Krebshilfe e.V.; Juli 2012; Seite 99
- Leitlinie „Diagnostik und Therapie primärer und metastasierter Mammakarzinome: Loko-regionäres Rezidiv“ der AGO e. V. in der DGGG e. V. sowie in der DKG e. V.: Guidelines Breast Version 2013.1D, 15-16