Main Session
Sep
30
SS 42 - Gyn 4: GYN Clinical Trials - Challenging the Paradigm in Gynecologic Cancers
341 - Survival Outcomes of Induction Immunotherapy Combined with Platinum-Based Doublet Chemotherapy Followed by Immunotherapy and Chemoradiotherapy in High-Risk Locally Advanced Cervical Cancer: A Phase II Clinical Trial
Presenter(s)
Yidi Yuan, MD - Peking University Cancer Hospital and Institute, Beijing, Beijing
Y. Yuan, J. You, X. Gu, W. H. Wang, and X. F. Li; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China
Purpose/Objective(s):
High-risk locally advanced cervical cancer (LACC) is associated with poor prognosis and high recurrence rates. This study aimed to evaluate the survival outcomes of a novel treatment approach combining induction immunotherapy with platinum-based doublet chemotherapy, followed by immunotherapy and chemoradiotherapy in high-risk LACC.Materials/Methods:
This single-center, single-arm, prospective phase II trial enrolled patients with newly diagnosed stage IIIB, IIIC1, IIIC2, and IVA (2018 FIGO staging) squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma with tumor diameter >4 cm. Treatment consisted of two cycles of induction therapy with PD-1 monoclonal antibody (sintilimab 200 mg) combined with platinum-based doublet chemotherapy (nab-paclitaxel 260 mg/m² and cisplatin 75 mg/m² every three weeks). This was followed by concurrent immunotherapy and chemoradiotherapy, including definitive image-guided volumetric modulated arc therapy (VMAT) and intracavity brachytherapy, along with chemo-immunotherapy (two cycles of sintilimab 200 mg, nab-paclitaxel 220 mg/m², and cisplatin 60 mg/m² every three weeks). Maintenance therapy with sintilimab 200 mg every three weeks was administered for 29 cycles.Results:
Between July 2022 to December 2023, a total of 30 patients enrolled in this study. The median maximum diameter of the cervical tumor was 56mm(40-94mm) and 17.5mm(0-59mm) before any treatment and after induction treatment, respectively. After induction treatment, 20 patients (66.7%) showed no tumor for pathological biopsy. Ten patients (33.3%) showed CR and 19 patients (66.7%) showed PR according to RECIST 1.1 by investigator. With a median follow-up of 22.8 months (range: 14.7-31.1 months), three patients experienced disease recurrence,including one with pelvic wall recurrence and two with distant metastasis. The 2-year overall survival and progression-free survival rates were 100.0% and 89.0%, respectively. The 2-year local-recurrence-free survival and distant-metastasis-free survival rates were 96.7% and 92.4%, respectively.Conclusion:
The combination of induction immunotherapy with platinum-based doublet chemotherapy followed by immunotherapy and chemoradiotherapy demonstrates promising local and distant metastasis control in high-risk locally advanced cervical cancer, warranting further investigation in larger clinical trials.