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

Tahara M, Kiyota N, Mizusawa J, Nakamura K, Hayashi R, Akimoto T, Hasegawa Y, Iwae S, Monden N, Matsuura K, Fujii H, Onozawa Y, Homma A, Kubota A, Fukuda H, Fujii M - Cancer Sci. (2015)

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.

View Article: PubMed Central - PubMed

Affiliation: Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

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Related in: MedlinePlus

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.
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fig01: 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.

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.


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

Tahara M, Kiyota N, Mizusawa J, Nakamura K, Hayashi R, Akimoto T, Hasegawa Y, Iwae S, Monden N, Matsuura K, Fujii H, Onozawa Y, Homma A, Kubota A, Fukuda H, Fujii M - Cancer Sci. (2015)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4471783&req=5

fig01: 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.
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.

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.

View Article: PubMed Central - PubMed

Affiliation: Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Show MeSH
Related in: MedlinePlus