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- Title
Phase II Feasibility Trial of Adjuvant Chemoradiotherapy with 3-weekly Cisplatin for Japanese Patients with Post-operative High-risk Squamous Cell Carcinoma of the Head and Neck.
- Authors
Kiyota, Naomi; Tahara, Makoto; Okano, Susumu; Kawashima, Mitsuhiko; Matsuura, Kazuto; Onozawa, Yuske; Nibu, Kenichi; Hayashi, Ryuichi; Yoshimura, Kenichi; Ohtsu, Atsushi
- Abstract
Objective The current standard of care for post-operative high-risk squamous cell carcinoma of the head and neck is concurrent chemoradiotherapy with a 3-weekly cycle of cisplatin (3W-CDDP/RT). In previous pivotal trials, the complete delivery rate of three cycles of cisplatin and radiation therapy was only ∼60%. Here, we evaluated the feasibility and safety of 3W-CDDP/RT in a Japanese population. Methods The study enrolled post-operative high-risk squamous cell carcinoma of the head and neck patients. High-risk factors were a microscopically incomplete resection, extracapsular extension and two or more lymph node metastases. Subjects received three cycles of cisplatin at a dose of 100 mg/m2 concomitant with radiation therapy (66 Gy/33 Fr). Results From August 2006 to May 2009, 25 eligible subjects were accrued, including 13 males, with a median age of 59 years, Eastern Cooperative Oncology Group performance status 0/1 (18/7), Stage III/IVA/IVB/recurrent (1/18/1/5) and oral cavity/oropharynx/hypopharynx/larynx (17/4/3/1). Protocol completion rate was 80%. The lower limit of the one-sided 90% confidence interval was 66%, which met the predefined statistical criteria. Grade 3/4 acute and late toxicities were almost identical to those in previous pivotal trials. No treatment-related deaths were observed. With a median follow-up of 39 months, 14 have had progression and 10 have died. Estimated 3-year locoregional control rate, relapse-free survival and overall survival were 74, 43 and 60%, respectively. On univariate analysis, oral cavity cancer and a cumulative cisplatin dose below 240 mg/m2 appeared to be poor prognostic factors. Conclusions This is the first Phase II feasibility trial of adjuvant chemoradiotherapy with 3-weekly cisplatin for post-operative high-risk squamous cell carcinoma of the head and neck in a Japanese population. This treatment was feasible and the safety profile was identical to those in pivotal Phase III trials.
- Publication
Japanese Journal of Clinical Oncology, 2012, Vol 42, Issue 10, p927
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hys128