Phase II trial of chemoradiotherapy with S-1 plus cisplatin for unresectable locally advanced head and neck cancer (JCOG0706).
Bottom Line: 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.
Affiliation: Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.Show MeSH
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Mentions: The protocol treatment consisted of concurrent CRT, adjuvant chemotherapy, and salvage surgery if applicable (Fig.1). First, patients received concurrent CRT with S-1 plus CDDP. Chemotherapy consisted of S-1 twice daily at a dose of 60 mg/m2/day on days 1–14, and a 2-h infusion of CDDP at 20 mg/m2/day on days 8–11, repeated twice with a 5-week interval. The rationale for the divided doses of CDDP is described in our previous phase I study.8 Prophylactic use of granulocyte-colony stimulating factor was not permitted. Radiation therapy was carried out once daily with 70 Gy/35 fractions over 7 weeks using high-energy photons of 4–10 MV X-rays and 3-D radiotherapy planning, starting on day 1. Intensity-modulated radiotherapy was unavailable during this study. The GTV included the volumes of both the primary tumor and metastatic cervical lymph nodes with a short axis of 1 cm or larger. The CTV1 included GTV and bilateral regional cervical lymph node area with a 1–2 cm margin, and CTV2 included GTV with a 0.5–2 cm margin. The PTVs for CTV1 and CTV2 (PTV1 and PTV2) were defined as CTV plus 0.5–1-cm margins around CTV to compensate for set-up variations and internal organ motion. A total of 40 Gy was delivered toward PTV1, and then an additional 30 Gy was boosted to PTV2.
Affiliation: Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.