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  • [Neoplasma.] Feasibility of Modulated Electro-Hyperthermia in Preoperative Treatment for Locally Advanced Rectal Cancer: Early Phase 2 Clinical Results

    [Neoplasma.] Feasibility of Modulated Electro-Hyperthermia in Preoperative Treatment for Locally Advanced Rectal Cancer: Early Phase 2 Clinical Results

    연세의대 / 김성현, 유세환*

  • 출처
    Neoplasma.
  • 등재일
    2020 May
  • 저널이슈번호
    67(3):677-683. doi: 10.4149/neo_2020_190623N538. Epub 2020 Feb 9.
  • 내용

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    Abstract
    Despite advances in the multimodal approach for rectal cancer, treatment-related side effects remain an important issue. From this perspective, a prospective trial was performed to investigate the feasibility of modulated electro-hyperthermia (mEHT) as a concomitant boost to preoperative chemoradiation in locally advanced rectal cancer. Seventy-six patients with cT3-4 or cT2N+ rectal cancer were enrolled consecutively. Whole pelvic radiotherapy of 40 Gy was delivered with a 2-Gy daily fraction. mEHT with 13.56 MHz frequency was boosted on a twice-weekly schedule concurrently with intravenous 5-fluorouracil or oral capecitabine. Surgical resection was planned 6-8 weeks after radiotherapy. The primary endpoint was the non-inferior treatment response rate assessed by pathologic downstaging and tumor regression. The secondary endpoint was acceptable toxicity during the preoperative treatment period. Sixty patients completed the planned treatment schedule. T- and N-downstaging was demonstrated in 40 patients (66.7%) and 53 patients (88.3%), respectively. Pathologic complete response was noted in 15.0% (9 patients) and 76.7% (46 patients) for T-stage and N-stage, respectively. Total or near total tumor regression was observed in 20 patients (33.3%). Grade ≥3 toxicity occurred only in hematologic assessment; one case (1.7%) of leukopenia and one case (1.7%) of anemia. Sixteen patients (26.7%) developed thermal toxicity, which was mostly Grade 1 (15 patients, 93.8%). The relatively low dose of 40 Gy radiation showed comparable pathologic treatment outcomes and tolerable toxicity profiles with the addition of mEHT, which may potentially replace part of the radiation dose in neoadjuvant treatment for rectal cancer.

     

     

     

    Affiliation

    S H You  1 , S Kim  1
    1 Radiation Oncology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea.

  • 키워드
    rectal cancer, hyperthermia, neoadjuvant therapy
  • 연구소개
    종양치료에서 보조적 요법으로 시행 가능한 고주파온열치료에 대한 체계적 고찰을 하고자 계획된 연구입니다. 최근의 온열치료는 열화상 등의 문제가 개선되어 보편화되고 있으나 질환별 표준화는 아직 요원한 상태이므로 단일 질환인 직장암에 대하여 임상적 결과를 확인하는 것은 의미가 있을 것으로 생각되었습니다. 연구를 통하여 직장암 환자에 대해 수술적 절제 전 시행하는 항암, 방사선치료에서 고주파온열치료를 추가하였을 경우 치료효과에 있어 긍정적인 요소들을 확인할 수 있었습니다. 특히, 기존의 방사선치료 선량에 비해 상대적으로 저용량을 사용했음에도 열등하지 않은 결과와 함께 고주파온열치료가 방사선의 일부를 대체할 수 있는 가능성을 보인 것은 가장 큰 수확이라 할 수 있겠습니다. 치료성적 뿐 아니라 삶의 질 측면에서 고주파온열치료의 역할이 있을 것으로 생각하지만 아직까지 이에 대한 근거는 미흡한 편입니다. 국내 여건 상 당장은 IRB 심의와 환자 등록 등 여러 과정이 순탄치 않겠지만 향후 보다 많은 관심 속에 심도 있는 연구가 이어지기를 희망합니다.
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