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Clinical Trial
. 2015 Jun;106(6):726-733.
doi: 10.1111/cas.12657. Epub 2015 Apr 1.

Phase II trial of chemoradiotherapy with S-1 plus cisplatin for unresectable locally advanced head and neck cancer (JCOG0706)

Makoto Tahara  1 , Naomi Kiyota  2 , Junki Mizusawa  3 , Kenichi Nakamura  4 , Ryuichi Hayashi  5 , Tetsuo Akimoto  6 , Yasuhisa Hasegawa  7 , Shigemichi Iwae  8 , Nobuya Monden  9 , Kazuto Matsuura  10 , Hirofumi Fujii  11 , Yusuke Onozawa  12 , Akira Homma  13 , Akira Kubota  14 , Haruhiko Fukuda  3 , Masato Fujii  15
Affiliations
Clinical Trial

Phase II trial of chemoradiotherapy with S-1 plus cisplatin for unresectable locally advanced head and neck cancer (JCOG0706)

Makoto Tahara et al. Cancer Sci. 2015 Jun.

Abstract

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.

Keywords: Chemoradiotherapy; S-1; cisplatin; head and neck cancer; unresectable.

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Figures

Figure 1
Figure 1
Schema of a phase II study to evaluate the efficacy and safety of chemoradiotherapy concurrent with S-1 plus cisplatin (CDDP) in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (SCCHN). CR, complete response; PD, progressive disease; PR, partial response; PS, performance status; RT, radiotherapy; SD stable disease, stable disease.
Figure 2
Figure 2
Patient flow diagram of 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. CR, complete response; CRT, concurrent chemoradiotherapy; PD, progressive disease; PR, partial response; SD, stable disease.
Figure 3
Figure 3
Clinical outcomes in 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. (a) Overall survival. (b) Progression-free survival. (c) Locoregional progression-free survival. (d) Time to treatment failure.
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