Due to the rarity and heterogeneity of recurrent and/or metastatic head and neck non-squamous cell carcinoma (R/M HN non-SCC), no standard chemotherapy for this condition has yet been established. This multicenter phase II trial evaluated the efficacy and safety of docetaxel and cisplatin combination (DC) in R/M HN non-SCC.
Eligibility criteria were R/M HN non-SCC; progressive disease within the last 6 months; no prior systemic therapy, or interval of at least 24 weeks since the last induction chemotherapy or chemoradiotherapy with curative intent; measurable disease; and ECOG performance status of 0 or 1. Patients (pts) received docetaxel (75 mg/m2 on day 1) and cisplatin (75 mg/m2 on day 1), repeated every 21 days for 6 cycles. The primary endpoint was objective response rate (ORR).
From Nov 2012 to Oct 2016, a total of 23 pts were enrolled, characterized as 15 females, median age 57 years (range, 32-76), and 96% metastatic. Among 22 evaluable pts, ORR was 45.5% (95% confidential interval [CI], 24.4-67.8%), and the lower bound of the 95% CI of 24.4% exceeded the predefined hypothesis of 10%. ORRs according to primary tumor site and histology are shown in the table below. With a median follow-up period of 18.8 months, median progression-free survival and overall survival were 6.7 and 20.1 months, respectively. Grade 3/4 adverse events included neutropenia (91%), febrile neutropenia (FN) (39%), anemia (22%), appetite loss (17%), and fatigue (13%). The FN rate was significantly lower in the pts with prophylactic antibiotics (57 vs 11%, P = 0.04). No treatment-related deaths were observed.Table: 1066P
Objective response rates according to primary tumor site and histology
|Adenoid cystic carcinoma||Aadenocarcinoma, not otherwise specified||Salivary duct carcinoma||Sebaceous carcinoma||Mucoepidermoid carcinoma||NUT midline carcinoma||Acinic cell carcinoma||Total|
|Nasal cavity/paranasal sinus||1/3||1/3|
This phase II study of DC met its primary endpoint. This DC regimen is effective and represents a new treatment option in the treatment of progressive R/M HN non-SCC, although prophylactic antibiotics for FN should be considered.
Clinical trial identification
Legal entity responsible for the study
Kobe University Hospital.
Has not received any funding.
All authors have declared no conflicts of interest.