Highlights
- •Excellent oncological long-term outcomes despite high proportion of patients with high-risk features.
- •Long-term quality of life after hyperthermic radiochemotherapy comparable with QoL of patients treated with radiochemotherapy alone.
- •More pronounced tumor regression seen in patients who achieved higher temperatures.
Abstract
Purpose
The goal of the present study was to investigate the effect of deep regional hyperthermia
on early and long-term oncological outcomes in the context of preoperative radiochemotherapy
in rectal cancer.
Methods
In this prospective phase II trial, patients with locally advanced rectal cancer were
treated with 5-fluorouracil based preoperative radiochemotherapy with 50.4 Gy in 28
fractions. Deep regional hyperthermia was scheduled twice weekly. Pathological tumor
regression was scored according to the Dworak regression system. The primary endpoint
was pathological complete response (pCR). Further endpoints were local control (LC),
distant control (DC), disease-free survival (DFS) and overall survival (OS). Hyperthermia
was defined as feasible if 70% of patients received at least eight treatments. Quality
of life was assessed at follow-up by the EORTC-QLQ-C30 and QLQ-CR29 questionnaires.
Time to event data was analyzed according to Kaplan-Meier based on first-events. The
study was registered on clinicaltrials.gov (NCT02353858).
Results
From 2012 until 2017, 78 patients were recruited. Median follow-up was 54 months.
Based on magnetic resonance imaging, the mesorectal fascia was involved or threatened
in 60% of the patients. Compliance with radiotherapy was 99%, 91% received both cycles
of chemotherapy and 77% had eight or more hyperthermia treatments. Median time from
the end of radiotherapy to surgery was 6.7 weeks. A pathological complete response
was reported in 14% of the patients, 50% had either Dworak 4 (complete regression)
or Dworak 3 regression (scattered tumor cells only). Three year estimates for OS,
DFS, LC and DC were 94%, 81%, 96% and 87%. Patients with higher hyperthermia related
cumulative temperatures showed stronger tumor regression. Global health status based
on EORTC-QLQ-C30 was comparable with data from the general population.
Conclusion
Deep regional hyperthermia was feasible, did not compromise standard treatments and
resulted in promising long-term oncological outcomes and QoL.
Keywords
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Article info
Publication history
Published online: March 16, 2021
Accepted:
March 8,
2021
Received in revised form:
March 7,
2021
Received:
December 29,
2020
Identification
Copyright
© 2021 Elsevier B.V. All rights reserved.
