Five-Year Outcomes of Moderately Hypofractionated Whole Pelvic Radiation Therapy with Concurrent Chemotherapy and...

Although moderately hypofractionated external beamradiation therapy (H-EBRT) has been practiced for locally advanced cervical carcinoma, prospective evidence remains limited. We evaluated the role of H-EBRT in the definitive management of locally advanced cervical carcinoma in terms of toxicities and clinical outcomes.

In this prospective phase 2 trial (December 2018-December 2021), 50 patients with histologically confirmed squamous cell carcinoma of the cervix were enrolled. Patients received H-EBRT of 40 Gy in 16 fractions over 3.1 weeks with a sequential boost of 10 Gy in 4 fractions to pelvic lymph nodes, and concurrent weekly cisplatin 40 mg/m². This was followed by brachytherapy of 28 Gy in 4 fractions delivered over 2 to 4 applications. Acute and late toxicities were recorded per National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0). Locoregional recurrence-free survival, disease-free survival, and overall survival were estimated by the Kaplan-Meier method.

Median patient age was 50 years. According to FIGO (International Federation of Gynecology and Obstetrics) 2018 staging, stages IB3, II, IIIA, IIIB, and IIIC1 were present in 5 (10%), 24 (48%), 2 (4%), 10 (20%), and 9 (18%) patients, respectively. The median number of concurrent chemotherapy cycles was 4. Median overall treatment time was 7.1 weeks (range, 5.4-11.6 weeks). Acute ≥grade 2 and ≥grade 3 gastrointestinal (GI), genitourinary, anemia, leucopenia, and thrombocytopenia occurred in 20 (40%) and 10 (20%), 5 (10%) and 3 (6%), 10 (20%) and 3 (6%), 15 (30%) and 4 (8%), and 6 (12%) and 3 (6%) patients, respectively. The median follow-up was 60.8 months (range, 14.7-79.8 months). Late grade 2 and grade 3 GI toxicities were seen in 4 (8%) and 5 (10%) patients, respectively. Late grade 2 and grade 3 genitourinary toxicities occurred in 2(4%) and 1 (2%) patients, respectively. The 5-year locoregional recurrence-free survival, disease-free survival, and overall survival were 85%, 80%, and 77.8%, respectively.

H-EBRT followed by brachytherapy yields acceptable long-term clinical outcomes and late toxicities, albeit with slightly higher acute GI toxicity.