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  • [Gynecol Oncol .] High-dose (60 Gy) intensity-modulated radiotherapy with concurrent weekly cisplatin followed by intracavitary radiation in locally advanced cervical cancer: A phase II prospective clinical trial국소진행 자궁경부암에서 고선량 IMRT와 동시 항암치료 후 강내방사선치료의 전향적 2상 임상연구

    가톨릭의대 / 이효천, 이종훈*

  • 출처
    Gynecol Oncol .
  • 등재일
    2023 Oct
  • 저널이슈번호
    177:142-149. doi: 10.1016/j.ygyno.2023.08;
  • 내용

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    Abstract
    Objective: Radiotherapy dose-escalation using intensity-modulated radiotherapy (IMRT) has been necessary to improve treatment results in cervical cancer.

    Methods: This was a phase II prospective clinical trial. 88 patients with FIGO II-IVa cervical cancer were enrolled in a single center. They received high-dose (60 Gy) IMRT with weekly cisplatin to the primary tumor and clinically positive nodes followed by intracavitary radiation. The primary endpoint was 30-month PFS rate (Target; 82%, an increase of 20% compared to GOG 120 trial using standard-dose radiotherapy). Secondary endpoints were tumor response, toxicity, recurrence, distant metastasis, and overall survival.

    Results: Progression-free survival rate at 30 months was 82.8%. Overall survival, locoregional recurrence, distant metastasis, and para-aortic recurrence rates at 30 months were 93.6%, 8.2%, 9.2%, and 2.4%, respectively. Forty-five (51.1%) of 88 patients achieved downstaging on MRI during radiotherapy and 80 (90.9%) patients had clinically complete response at three months after high-dose IMRT and intracavitary radiotherapy. The 30-month recurrence-free survival (92.9% vs. 73.1%, P = 0.009) and overall survival (100% vs. 87.0%, P = 0.006) were significantly higher in the downstaged group than in the non-downstaged group during radiotherapy. Grade 3 or higher hematologic toxicity was found in 11 (12.5%) patients and grade 3 or higher non-hematologic toxicity was found in 3 (3.4%) patients. Fourteen had chronic urinary (8.0%), intestinal (5.7%) toxicity, pelvic insufficiency fracture (2.3%) or vesicovaginal fistula (2.3%).

    Conclusion: High-dose (60 Gy) IMRT with concurrent weekly cisplatin in locally advanced cervical cancer yielded favorable progression-free survival outcome. Tumor response during radiotherapy can be a significant prognostic factor for PFS.

    Clinical trial information: This prospective trial is registered at ClinicalTrials.gov Identifier: NCT02993653.

     

     

    본 연구에서 시행된 치료의 개요도입니다.

     

     

    Affiliations

    Hyo Chun Lee 1, Jae Won Jeong 1, Joo Hwan Lee 1, Sung Hwan Kim 1, Dong Chun Park 2, Joo Hee Yoon 2, Sang Il Kim 2, Jong Hoon Lee 3
    1Department of Radiation Oncology, St. Vincet's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
    2Department of Obstetrics and Gynecology, St. Vincet's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
    3Department of Radiation Oncology, St. Vincet's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: koppul@catholic.ac.kr.

  • 키워드
    Cervix cancer; Chemoradiation; High dose; Recurrence; Survival.
  • 연구소개
    자궁경부암에서 항암방사선동시치료를 시행할 때 세기변조방사선치료를 통해 종양에 좀 더 높은 선량을 조사하여 치료효과를 높이고자 했습니다.
  • 편집위원

    자궁경부암의 동시항암방사선치료에 있어 외부방사선치료 방사선량을 높임(60 Gy)으로써 얻을 수 있는 치료 효과 향상을 보고한 연구로, 무병생존율 향상에 긍정적인 효과를 보였다고 결론 냄.

    2023-12-05 17:08:13

  • 편집위원2

    전향적 2상 임상연구로 세기조절방식을 이용한 고선량 방사선치료와 강내방사선치료의 결과임. 치료 중 downstaging이 이루어진 환자에서 생존율이 높음을 확인하였으며, 고선량 방사선치료시 grade 3이상의 부작용의 비율도 함께 보고하여 참고할 수 있음.

    2023-12-05 17:12:17

  • 편집위원3

    Stage II-VA 자궁경부암 환자에서 IMRT를 이용한 고선량 치료시 기존연구대비 좋은 치료성적과 낮은 부작용을 보고한 전향적 연구입니다. Primary endpoint를 만족하였지만 median follow-up이 31.9개월인 것을 고려하면 추후 장기적인 치료성적을 보고하기를 기대합니다.

    2023-12-05 17:15:44

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