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Submitted: 05 May 2026
Revision: 27 Jul 2026
Accepted: 28 Jul 2026
ePublished: 21 Sep 2026
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Pharm Sci. Inpress.
  Abstract View: 7

Original Article

Early MRI Response and Acute Toxicity After Pembrolizumab-Containing Multimodality Therapy in High-Risk Locally Advanced Cervical Cancer: A Real-World Single-Center Cohort Study

Shahrzad Sheikh Hasani ORCID logo, Afsane Maddah Safaei, Mohadese Rezaei* ORCID logo, Zeinab Sinaeifar* ORCID logo, setareh Akhavan, azamsadat mousavi, Narges Zamani, Leila Nazeri, Shakiba Sheykholeslamy, Amirmohammad Heydari Dehnoodasht, hanie Alambeygi, Elahe Rezayof
*Corresponding Authors: Email: [email protected]; Email: [email protected]

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.
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