Abstract CT149: A Phase II study of Genexol-PM and cisplatin as induction chemotherapy in locally advanced head and neck squamous cell carcinoma

Abstract

Abstract Background Genexol-PM is a polymeric micellar formulation of paclitaxel without Cremophor EL. We investigated the efficacy and safety of Genexol-PM plus cisplatin as induction chemotherapy (IC) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Methods Patients received Genexol-PM (230 mg/m2) and cisplatin (60 mg/m2) every 3 weeks as IC. After 3 cycles of IC, definitive treatment of either concurrent chemoradiotherapy (CCRT) with weekly cisplatin (30 mg/m2) or surgery was performed. The primary endpoint was objective response rate (ORR) after IC. Results Of 52 patients enrolled, 47 completed three cycles of IC and the ORR was 55.8% (95% confidence interval, 42.3-69.3). Although there was one treatment-related death, toxicity profiles to IC were generally favorable and the most common grade 3 or 4 toxicities were neutropenia (15.4%), anorexia (7.7%) and general weakness (7.7%). Fifty one patients received the definitive treatment [CCRT (n=44) or radical surgery (n=7)]. The rate of complete response following CCRT was 81.8% (36/44). After a median follow-up of 39 months, estimates of progression-free survival and overall survival at 3 years were 54.3% and 71.3%, respectively. Conclusions IC with Genexol-PM and cisplatin demonstrated modest tumor response with well-tolerated toxicity profiles for patients with LA-HNSCC. Citation Format: Keun-Wook Lee, Bhumsuk Keam, Jin-Soo Kim, Se-Hoon Lee. A Phase II study of Genexol-PM and cisplatin as induction chemotherapy in locally advanced head and neck squamous cell carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT149.