Abstract
Simple SummaryWe demonstrated that a 13.56 MHz modulated electro-hyperthermia (mEHT) boost is feasible in neoadjuvant treatment for rectal cancer. Herein, we attempted to present the long-term results for this phase 2 trial. Although there are many reports on the usefulness of thermoradiochemotherapy for loco-regional control, so far, only a few cases of survival benefit exist. Thus, this study assessed whether this limitation of hyperthermia could be overcome through the mEHT method featuring an applied energy variable. Following a median follow-up of 58 months for 60 patients, mEHT boost showed comparable results with conventional hyperthermia; potential therapeutic effects were also observed. Moreover, mEHT could be considered a useful tool in combination treatment with radiotherapy owing to its low thermotoxicity and improved treatment compliance.We evaluated the effect of 13.56 MHz modulated electro-hyperthermia (mEHT) boost in neoadjuvant treatment for cT3-4- or cN-positive rectal cancer. Sixty patients who completed the mEHT feasibility trial (ClinicalTrials.gov Identifier: NCT02546596) were analyzed. Whole pelvis radiotherapy of 40 Gy, mEHT boost twice a week during radiotherapy, and surgical resection 6–8 weeks following radiotherapy were performed. The median age was 59. The median follow-up period was 58 (6–85) months. Total/near total tumor regression was observed in 20 patients (33.3%), including nine cases of complete response. T- and N-downstaging was identified in 40 (66.6%) and 53 (88.3%) patients, respectively. The 5-year overall and disease-free survival were 94.0% and 77.1%, respectively. mEHT energy of ≥3800 kJ potentially increased the overall survival (p = 0.039). The ypN-stage and perineural invasion were possible significant factors in disease-free (p = 0.003 and p = 0.005, respectively) and distant metastasis-free (p = 0.011 and p = 0.034, respectively) survival. Tumor regression, resection margin status, and other molecular genetic factors showed no correlation with survival. Although a limited analysis of a small number of patients, mEHT was feasible considering long-term survival. A relatively low dose irradiation (40 Gy) plus mEHT setting could ensure comparable clinical outcomes with possible mEHT-related prognostic features.
Highlights
Considering neoadjuvant treatment for rectal cancer, hyperthermia boost to radiochemotherapy reportedly produces excellent local control results; the long-term survival effects
The evaluation period of acute toxicity was from the start of neoadjuvant treatment to 90 days after ending radiotherapy, and toxic events that occurred thereafter were classified as late toxicity
In this study that assessed the follow-up results of the impact of modulated electro-hyperthermia (mEHT) boost on survival in a single-arm, non-inferiority trial, the primary endpoint assessment was by pathologic downstaging and tumor regression grade [7]
Summary
Considering neoadjuvant treatment for rectal cancer, hyperthermia boost to roaf d15iochemotherapy reportedly produces excellent local control results; the long-term survival effects have not been sufficiently proven [1].
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.