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.

Short-course preoperative radiotherapy combined with chemotherapy, delayed surgery and local hyperthermia for rectal cancer: a phase II study.

PURPOSE: The aim of this study was to investigate the feasibility of short-course radiotherapy with oral capecitabine, hyperthermia and delayed surgery for neoadjuvant treatment of rectal cancer. METHODS: Patients with clinically staged T2-3N0-2M0 primary rectal cancer were included. All patients received short-course 25 Gy in 5 Gy fractions radiotherapy with capecitabine, local hyperthermia and metronidazole. Capecitabine 1000 mg/m2 twice a day was given on days 1-14. Local hyperthermia, 41-45 °C for 60 min, was performed on days 3-5. Metronidazole 10 g/m2 was administered per rectum on days 3 and 5. The time interval to surgery was not less than four weeks after neoadjuvant treatment. The primary end-point was pathological complete response (pCR). Secondary end-points included neoadjuvant treatment toxicity, tumour regression, surgical and oncological outcomes. RESULTS: A total of 81 patients were included in the analysis. Ten (12.3%) patients had grade 3 toxicity and one (1.2%) patient had grade 4 toxicity. Sphincter-sparing surgery was performed for 78 (96.3%) patients. There was no postoperative mortality. Postoperative complications occurred in 11 (13.8%) patients. Sixteen (20%) patients had a pCR. The median follow-up was 40.9 months. There were no local recurrences. Nine (11.1%) patients developed distant metastases. Three-year overall survival was 97% and the three-year disease-free survival was 85%. CONCLUSIONS: Short-course radiotherapy with chemotherapy, radiosensitizers and delayed surgery is a feasible treatment for rectal cancer and may lead to tumour regression rate comparable with long-course chemoradiation.

Short-term outcomes after transanal and laparoscopic total mesorectal excision for rectal cancer.

BACKGROUND: Transanal total mesorectal excision (taTME) has potential benefits of better visual control, especially in male patients with a high body mass index and low rectal cancer. However, this method has not yet been validated in clinical trials. The aim of this study was to compare the short-term outcomes of transanal and laparoscopic (lap) TME. METHODS: From October 2013 to January 2015, consecutive patients undergoing transanal or laparoscopic TME for biopsy-proven mrT1-4aN0-2M0 rectal cancer were included in a prospective database. Patients with Eastern Cooperative Oncology Group performance status 2 and higher and patients undergoing partial mesorectal excision were excluded. This analysis focused on short-term surgical outcomes. RESULTS: From October 2013 to January 2015, 22 taTME procedures and 23 laparoscopic TME procedures were performed. Patient characteristics were comparable between groups, but more patients in the taTME group underwent neoadjuvant (chemo) radiotherapy (87 vs. 48 %, p = 0.006). Median operative time was 320 min in the taTME group and 305 min in the lapTME group. There was one conversion in each group, but the transanal procedure was converted to laparoscopic resection. Transanal specimen extraction was performed in 86 versus 48 % patients in taTME and lapTME groups accordingly (p = 0.021). There was no post-operative mortality and post-operative morbidity in the taTME and lapTME groups was similar (27 vs. 26 %). One patient in the taTME group had positive circumferential resection margins. Oncologic results from resected specimens were comparable. CONCLUSIONS: Our initial experience demonstrates comparable short-term results for taTME and lap TME. Further investigation is necessary to assess long-term functional and oncologic outcomes.

Phase II study of concomitant chemoradiotherapy with local hyperthermia and metronidazole for locally advanced fixed rectal cancer.

AIM: Locally advanced fixed T4 rectal cancer has a poor prognosis and no standard treatment strategy. The aim of this study was to investigate the safety and efficacy of neoadjuvant chemoradiotherapy using hypofractionated radiotherapy combined with local hyperthermia, capecitabine, oxaliplatin and metronidazole. METHOD: Radiotherapy was given to a total dose of 40 Gy in 10 fractions. Capecitabine 650 mg/m(2) twice a day was given on days 1-22 and intravenous oxaliplatin 50 mg/m(2) was administered on days 3, 10 and 17. Local hyperthermia, 41-45°C for 60 min, was performed on days 8, 10, 15 and 17. Metronidazole 10 g/m(2) was administered per rectum on days 8 and 15. Surgery was carried out within 6-8 weeks after neoadjuvant treatment. The primary end-point was R0 resection rate. Secondary end-points included 2-year disease-free survival, 2-year overall survival, local recurrence rate, grade III-IV tumour regression (Dworak) and treatment toxicity. RESULTS: From July 2006 to February 2011, 64 previously untreated patients were enrolled. R0 resection was carried out in 59 (92.2%). Five (7.8%) remained inoperable. Seven (10.9%) patients had grade IV and 30 (46.9%) had grade III regression. The main grade III toxic events included diarrhoea (15.6%, n = 10), vomiting (3.1%, n = 2), proctitis (3.1%, n = 2) and skin reaction (1.6%, n = 1). Only one (1.6%) patient had grade IV diarrhoea and vomiting. The median follow-up was 24.9 months. Two-year overall survival was 91% and 2-year disease-free survival was 83%. CONCLUSION: Hyperthermia combined with chemotherapy to produce radiosensitization for locally advanced fixed primary rectal cancer is followed by a high R0 resection rate, with toxicity comparable with standard regimens.