Shahrzad Sheikh Hasani

, Afsane Maddah Safaei, Mohadese Rezaei
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, Zeinab Sinaeifar
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, setareh Akhavan, azamsadat mousavi, Narges Zamani, Leila Nazeri, Shakiba Sheykholeslamy, Amirmohammad Heydari Dehnoodasht, hanie Alambeygi, Elahe Rezayof
Abstract
Abstract background To describe early imaging response and documented acute toxicity in patients with high-risk locally advanced cervical cancer treated with a pembrolizumab-containing intensified multimodality regimen in routine clinical practice. Methods This observational single-center cohort study included 28 treated patients with non-surgical, high-risk locally advanced cervical cancer managed with induction weekly paclitaxel/carboplatin, definitive cisplatin-based chemoradiotherapy, brachytherapy, and pembrolizumab followed by maintenance therapy. Pelvic magnetic resonance imaging was performed before treatment and at approximately 3 and 6 months after completion of chemoradiotherapy. The main endpoint was imaging-based clinical complete response, defined as absence of residual primary tumor and radiologically active nodal disease. Acute adverse events were abstracted from routine clinical documentation. Results Mean age was 49.8±10.3 years. At 3 months, 27/28 patients (96.4%) were tumor-negative and 25/28 (89.3%) achieved clinical complete response. At 6 months, all 28 patients had tumor- and node-negative imaging. Adverse-event documentation was present in 12/28 patients (42.8%); CTCAE grade was explicitly recorded in 6/12 patients, with grade 3 toxicity documented in two patients. Conclusion In this real-world cohort, pembrolizumab-containing intensified multimodality therapy was feasible and associated with encouraging early radiologic response. Larger prospective studies with standardized response assessment, comprehensive adverse-event reporting, and longer follow-up are needed to determine whether these findings translate into durable clinical benefit.