Erschienen in:
01.11.2021 | Original Paper
Docetaxel plus cisplatin in recurrent and/or metastatic non-squamous-cell head and neck cancer: a multicenter phase II trial
verfasst von:
Yoshinori Imamura, Kaoru Tanaka, Naomi Kiyota, Hidetoshi Hayashi, Ichiro Ota, Akihito Arai, Shigemichi Iwae, Shujiro Minami, Katsunari Yane, Tomoko Yamazaki, Yoshiaki Nagatani, Masanori Toyoda, Takayuki Takahama, Kazuko Sakai, Kazuto Nishio, Naoki Otsuki, Ken-ichi Nibu, Hironobu Minami
Erschienen in:
Medical Oncology
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Ausgabe 11/2021
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Abstract
The clinical utility of systemic therapy and genomic profiling in non-squamous-cell head and neck cancer (NSCHNC) has not been fully elucidated. This phase II trial evaluated the efficacy and safety of docetaxel and cisplatin combination in the first-line setting. Eligibility criteria were recurrent and/or metastatic NSCHNC; progressive disease within the last 6 months; no prior systemic therapy; and ECOG performance status of 0–1. Patients 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 confirmed objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), and adverse events. Next-generation sequencing (NGS) was performed using the Ion AmpliSeq Cancer Hotspot Panel v2. Twenty-three patients were enrolled from November 2012 to October 2016, of whom 8 were male. Median age was 57 years. Ninety-six percent of cases were metastatic. Among 22 evaluable patients, confirmed ORR was 45% (95% confidential interval 24–68%). With a median follow-up period of 18.8 months, median PFS and OS were 6.7 and 20.1 months, respectively. Grade 3/4 adverse events included febrile neutropenia (39%) and anemia (22%). No treatment-related deaths were observed. NGS analysis revealed potential treatment targets, including ERBB2, KIT, and ALK. The docetaxel and cisplatin combination regimen can be considered a new treatment option in recurrent and/or metastatic NSCHNC, although primary prophylaxis for febrile neutropenia should be considered. Diverse genomic alterations may lead novel treatment options.
This trial was registered with the UMIN Clinical Trials Registry as UMIN000008333 on [September 1st, 2012].