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 trial

Hyo Chun Lee; Jae Won Jeong; Joo Hwan Lee; Sung Hwan Kim; Dong Chun Park; Joo Hee Yoon; Sang Il Kim; Jong Hoon Lee

doi:10.1016/j.ygyno.2023.08.018

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 trial

Gynecol Oncol. 2023 Oct:177:142-149. doi: 10.1016/j.ygyno.2023.08.018. Epub 2023 Sep 7.

Authors

Hyo Chun Lee¹, Jae Won Jeong¹, Joo Hwan Lee¹, Sung Hwan Kim¹, Dong Chun Park², Joo Hee Yoon², Sang Il Kim², Jong Hoon Lee³

Affiliations

¹ Department of Radiation Oncology, St. Vincet's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
² Department of Obstetrics and Gynecology, St. Vincet's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
³ Department of Radiation Oncology, St. Vincet's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: koppul@catholic.ac.kr.

PMID: 37689018
DOI: 10.1016/j.ygyno.2023.08.018

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.

Keywords: Cervix cancer; Chemoradiation; High dose; Recurrence; Survival.

Associated data

ClinicalTrials.gov/NCT02993653