Open AccessPhase II trial of chemoradiotherapy with S‐1 plus cisplatin for unresectable locally advanced head and neck cancer ( JCOG 0706)
Author(s) -
Tahara Makoto,
Kiyota Naomi,
Mizusawa Junki,
Nakamura Kenichi,
Hayashi Ryuichi,
Akimoto Tetsuo,
Hasegawa Yasuhisa,
Iwae Shigemichi,
Monden Nobuya,
Matsuura Kazuto,
Fujii Hirofumi,
Onozawa Yusuke,
Homma Akira,
Kubota Akira,
Fukuda Haruhiko,
Fujii Masato
Publication year - 2015
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.12657
Subject(s) - mucositis , medicine , neutropenia , chemoradiotherapy , head and neck cancer , cisplatin , phases of clinical research , chemotherapy , clinical endpoint , febrile neutropenia , gastroenterology , radiation therapy , nausea , surgery , oncology , clinical trial
We conducted a phase II study to evaluate the efficacy and safety of chemoradiotherapy concurrent with S‐1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck. Chemotherapy consisted of S‐1 twice daily on days 1–14 at 60 mg/m 2 /day and cisplatin at 20 mg/m 2 /day on days 8–11, repeated twice at a 5‐week interval. Single daily radiation of 70 Gy in 35 fractions was given concurrently starting on day 1. For patients achieving an objective response after chemoradiotherapy, two additional cycles of chemotherapy were administered. Of the 45 enrolled patients, the percentage of clinical complete remission, the primary endpoint, was 64.4% (8 complete response, 21 good partial response) on central review. After a median follow‐up of 3.52 years, 3‐year local progression‐free survival was 62.2%, with 3‐year progression‐free survival of 60.0%, 3‐year overall survival of 64.4%, and 3‐year time to treatment failure of 48.9%. Grade 3 or 4 toxicity included pharyngeal mucositis (46.7%), oral mucositis (44.4%), dysphagia (46.7%), anorexia (42.2%), radiation dermatitis (26.7%), neutropenia (26.7%), and febrile neutropenia (4.4%). No treatment‐related deaths were observed. This combination showed promising efficacy with acceptable toxicities.