5-Year Outcomes of Moderately Hypofractionated Whole Pelvic Radiotherapy with Concurrent Chemotherapy and Image Guided High Dose Rate Brachytherapy for Locally Advanced Cervical Carcinoma
Mené sur 50 patientes atteintes d'un carcinome épidermoïde du col de l'utérus de stade localement avancé (âge médian : 50 ans ; durée médiane de suivi : 60,8 mois), cet essai de phase II évalue la toxicité d'une radiothérapie externe modérément hypofractionnée en combinaison avec du cisplatine et suivie d'une curiethérapie
Purpose: Although moderately hypofractionated external beam radiotherapy (H-EBRT) has been practiced for locally advanced cervical carcinoma (LACC), prospective evidence remains limited. We evaluated the role of H-EBRT in the definitive management of LACC in terms of toxicities and clinical outcomes.
Materials and Methods: In this prospective phase II 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 Gray 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 2-4 applications. Acute and late toxicities were recorded per CTCAE v4.0. Locoregional recurrence-free (LRRFS), disease-free (DFS), and overall survival (OS) were estimated by the Kaplan-Meier method.
Results: Median patient age was 50 years. According to FIGO 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 (OTT) was 7.1 weeks (range, 5.4-11.6 weeks). Acute ≥ Grade 2 and ≥ Grade 3 gastrointestinal (GI), genitourinary (GU), anaemia, 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%), 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 GU toxicities occurred in 2(4%) and 1 (2%) patients, respectively. The 5-year LRRFS, DFS and OS were 85%, 80% and 77.8%, respectively.
Conclusion: H-EBRT followed by brachytherapy yields acceptable long-term clinical outcomes and late toxicities, albeit with slightly higher acute GI toxicity.
International Journal of Radiation Oncology, Biology, Physics , résumé, 2025