Open AccessA Phase II Study of Genexol‐PM and Cisplatin as Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Author(s) -
Keam Bhumsuk,
Lee KeunWook,
Lee SeHoon,
Kim JinSoo,
Kim Jin Ho,
Wu HongGyun,
Eom KeunYong,
Kim Suzy,
Ahn SoonHyun,
Chung EunJae,
Kwon Seong Keun,
Jeong WooJin,
Jung Young Ho,
Kim JiWon,
Heo Dae Seog
Publication year - 2019
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2019-0070
Subject(s) - medicine , cisplatin , neutropenia , oncology , head and neck squamous cell carcinoma , regimen , chemotherapy , induction chemotherapy , chemoradiotherapy , phases of clinical research , toxicity , radiation therapy , surgery , head and neck cancer
Lessons Learned Induction chemotherapy with Genexol‐PM and cisplatin demonstrated modest tumor response in locally advanced head and neck squamous cell carcinoma. Considering favorable toxicity profiles and promising survival data, further studies on this regimen are warranted in patients with head and neck squamous cell carcinoma.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/m 2 ) and cisplatin (60 mg/m 2 ) every 3 weeks as IC. After three cycles of IC, definitive treatment of either concurrent chemoradiotherapy (CCRT) with weekly cisplatin (30 mg/m 2 ) or surgery was performed. The primary endpoint was overall 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 Genexol‐PM and cisplatin 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 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 (PFS) and overall survival (OS) at 3 years were 54.3% and 71.3%, respectively. Conclusion IC with Genexol‐PM and cisplatin demonstrated modest tumor response with well‐tolerated toxicity profiles for patients with LA‐HNSCC.