Effect of nimotuzumab addition to neoadjuvant chemotherapy in pancreatic carcinoma: A retrospective study.

e16357 Background: Current conversion treatment regimens including gemcitabine-based therapy and 5FU-based chemotherapy have a limited rate of conversion success in patients (pts) with advanced pancreatic cancer: the resection rate was approximately 20-34% for pts with locally advanced pancreatic cancer. Nimotuzumab (nimo), anti-EGFR monoclonal antibody, has been approved for the indication of advanced pancreatic cancer in China, and basic research has confirmed its chemosensitization effect. In order to explore the efficacy and safety of nimo plus neoadjuvant chemotherapy for advanced pancreatic cancer (APC), we conducted this study. Methods: In this retrospective observational study, patients with APC were treated with nimo plus neoadjuvant chemotherapy (gemcitabine/nab-paclitaxel or FOLFIRINOX) in a real-world clinical setting. Demographic and clinical data of these patients were collected from electronic medical records of Sixth Affiliated Hospital, Sun Yat-sen University from September 2022 to September 2024. The primary endpoint was resection rate. Additional endpoints included investigator-assessed progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety. Results: Finally, 15 pts were included in the final analysis. The median age was 63.5 (range 50-70) years, 53% were male. All pts were administered nimotuzumab (400 mg, weekly; 400 mg, every 14 days; or 400 mg on days 1 and 8, every 21 days) in conjunction with gemcitabine/nab-paclitaxel or FOLFIRINOX (folinic acid, 5-FU, irinotecan, and oxaliplatin) regimens. As of September 2024, with a median follow-up of 9.69 months (95% CI: 3.52-NA), conversion resections were achieved in 50% (3/6) of the patients with locally advanced stage and 33% (3/9) of the patients with distant metastases, and all of them attained R0 resection. Thirteen pts were evaluable; the DCR was 84.6%. PFS and OS were not reached, with three PFS events (95% CI: 11.9-NA) and three OS events (95% CI: NA-NA). The safety profile indicated that, among the 15 pts, 3 cases experienced grade 1-2 adverse events, including self-limiting rash, bone marrow suppression, and elevated creatinine levels after chemotherapy, all of which were managed with symptomatic treatment. No adverse events of grade 3 or higher were reported. Conclusions: The incorporation of nimotuzumab into neoadjuvant therapy shows certain effect and safety in pancreatic cancers. Notably resulting in elevated conversion surgery rates and tolerable toxicity, thereby offering a viable option for pts with advanced disease. Additional research in larger cohorts is necessary.