Quality assurance guidelines for interstitial hyperthermia.

Quality assurance (QA) guidelines are essential to provide uniform execution of clinical hyperthermia treatments and trials. This document outlines the clinical and technical consequences of the specific properties of interstitial heat delivery and specifies recommendations for hyperthermia administration with interstitial techniques. Interstitial hyperthermia aims at tumor temperatures in the 40-44 °C range as an adjunct to radiation or chemotherapy. The clinical part of this document imparts specific clinical experience of interstitial heat delivery to various tumor sites as well as recommended interstitial hyperthermia workflow and procedures. The second part describes technical requirements for quality assurance of current interstitial heating equipment including electromagnetic (radiative and capacitive) and ultrasound heating techniques. Detailed instructions are provided on characterization and documentation of the performance of interstitial hyperthermia applicators to achieve reproducible hyperthermia treatments of uniform high quality. Output power and consequent temperature rise are the key parameters for characterization of applicator performance in these QA guidelines. These characteristics determine the specific maximum tumor size and depth that can be heated adequately. The guidelines were developed by the ESHO Technical Committee with participation of senior STM members and members of the Atzelsberg Circle.

Salvage prostate HDR brachytherapy combined with interstitial hyperthermia for local recurrence after radiation therapy failure.

PURPOSE: The aim of the present retrospective study is to evaluate toxicity and early clinical outcomes of interstitial hyperthermia (IHT) combined with high-dose rate (HDR) brachytherapy as a salvage treatment in patients with biopsy-confirmed local recurrence of prostate cancer after previous external beam radiotherapy. PATIENTS AND METHODS: Between September 2008 and March 2013, 25 patients with local recurrence of previously irradiated prostate cancer were treated. The main eligibility criteria for salvage prostate HDR brachytherapy combined with interstitial hyperthermia were biopsy confirmed local recurrence and absence of nodal and distant metastases. All patients were treated with a dose of 30 Gy in 3 fractions at 21-day intervals. We performed 62 hyperthermia procedures out of 75 planned (83 %). The aim of the hyperthermia treatment was to heat the prostate to 41-43 °C for 60 min. Toxicity for the organs of the genitourinary system and rectum was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, v. 4.03). Determination of subsequent biochemical failure was based on the Phoenix definition (nadir + 2 ng/ml). RESULTS: The median age was 71 years (range 62-83 years), the median initial PSA level was 16.3 ng/ml (range 6.37-64 ng/ml), and the median salvage PSA level was 2.8 ng/ml (1.044-25.346 ng/ml). The median follow-up was 13 months (range 4-48 months). The combination of HDR brachytherapy and IHT was well tolerated. The most frequent complications were nocturia, weak urine stream, urinary frequency, hematuria, and urgency. Grade 2 rectal hemorrhage was observed in 1 patient. No grade 3 or higher complications were observed. The 2-year Kaplan-Meier estimate of biochemical control after salvage treatment was 74 %. The PSA in 20 patients decreased below the presalvage level, while 11 patients achieved a PSA nadir < 0.5 ng/ml. All patients are still alive. Of the 7 patients who experienced biochemical failure, bone metastases were found in 2 patients. CONCLUSION: IHT in combination with salvage HDR brachytherapy is a well tolerated and effective treatment.

Interstitial hyperthermia of the prostate in combination with brachytherapy : An evaluation of feasibility and early tolerance.

OBJECTIVE: A retrospective study to evaluate the feasibility and toxicity of interstitial hyperthermia (IHT) combined with high-dose-rate (HDR) brachytherapy as the initial treatment for low- and intermediate-risk prostate cancer, and as a salvage therapy in previously irradiated patients with local recurrence. PATIENTS AND METHODS: Between 18 December 2008 and 5 September 2012, 73  prostate cancer patients were treated with interstitial HDR brachytherapy of the prostate combined with IHT. In 54 patients this was the initial therapy for prostate cancer, while the other 19 were treated for local recurrence after previously undergoing external beam radiotherapy (EBRT). Toxicity for the organs of the genitourinary system and rectum was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03 within 3 months after treatment. RESULTS: Median follow-up was 15 months (range 3-46). The combination of HDR brachytherapy and IHT was well tolerated. The toxicity profile was similar to that of HDR brachytherapy when not combined with hyperthermia. The most common minor complications were urinary frequency (grade 1: 37 %; grade 2: 22 %), nocturia (three times per night: 29 %; four- or more times per night: 20 %) and transient weakening of the urine stream (grade 1: 36 %; grade 2: 11 %). No early rectal complications were observed in the patient group and the severity of genitourinary toxicity was only grade 1-2. CONCLUSION: Early tolerance of IHT in combination with HDR brachytherapy is good. Further prospective clinical studies should focus on the effects of combining IHT with HDR brachytherapy and the influence of this adjuvant therapy on biochemical disease-free survival, local control and overall survival.