Nimotuzumab, a novel anti-EGFR with concurrent chemoradiotherapy in muscle invasive bladder cancer: A real-world experience from India.

e16592 Background: Muscle invasive bladder cancer (MIBC) shows 55-75% EGFR overexpression. Radical cystectomy (RC) with/without neoadjuvant chemotherapy is mainstay of treatment. Targeting with anti-EGFR therapy would be potential treatment option to preserve the organ in MIBC. Methods: Evaluation of medical records of patients with transitional cell carcinoma of urinary bladder who received concurrent cisplatin (40 mg/m 2 ) and radiotherapy (60 Gy) (CRT) with Nimotuzumab (200 mg) between 2012 and 2020 was done with prior consent of patients. Results: Medical records of 21 patients were analyzed of which 86% of male with average age of 64.6 years. Tobacco addiction was reported in 76% patients. Eighty-six percent of patients had locally advanced disease, of which 71% with grade III lesions. Treatment with CRT + Nimotuzumab was completed by all patients. Objective response rate was 100% (complete response 95% and partial response 5%) at 6-months post treatment. At the of follow-up was 59 months median overall survival (OS) and disease-free survival (DFS) was not reached. OS and DFS rates at 3-years were 100% and 90.4% respectively. Only two RC were performed subjecting to 90% organ preservation rate. There were no grade 3 or 4 adverse events, however grade 1-2 AEs Included neutropenia (28%), loose motion (76%) and skin reactions (47%). Conclusions: Concurrent CRT with Nimotuzumab could be a possible treatment option for organ preservation with improved outcomes and tolerable safety profile in patients with MIBC, and it can be evaluated further. Keywords: bladder cancer, MIBC, organ preservation, nimotuzumab, chemoradiation. Acknowledgment: We thank you Dr. Amit Y Jadhav for editorial support for this research project.