International journal of radiation oncology, biology, physics · 2025
Five-Year Outcomes of Moderately Hypofractionated Whole Pelvic Radiation Therapy with Concurrent Chemotherapy and Image Guided High Dose Rate Brachytherapy for Locally Advanced Cervical Carcinoma.
СтатьяКлиническое исследование II фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Gandhi Ajeet Kumar, Rastogi Madhup, Khurana Rohini, Hadi Rahat, Srivastava Anoop Kumar, Mishra Vachaspati Kumar, Verma Rakhi, Bhutia Tenzing Dahla, Ramola Deepika, Burman Siddharth, Yadav Pankaj, Das Pravin Kumar, Raj Gaurav, Singh Neetu, Singh Pradyumn
Аннотация
PURPOSE: 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.
METHODS AND MATERIALS: 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.
RESULTS: 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.
CONCLUSIONS: H-EBRT followed by brachytherapy yields acceptable long-term clinical outcomes and late toxicities, albeit with slightly higher acute GI toxicity.
METHODS AND MATERIALS: 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.
RESULTS: 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.
CONCLUSIONS: H-EBRT followed by brachytherapy yields acceptable long-term clinical outcomes and late toxicities, albeit with slightly higher acute GI toxicity.