Phase I study of oral S-1 and concurrent radiotherapy in patients with head and neck cancer

This study investigated the maximum tolerated dose (MTD) of S-1 with concurrent radiotherapy in patients with head and neck cancer, based on the frequency of dose-limiting toxicities (DLT). S-1 was administered orally at escalating doses from 40 mg/m2 b.i.d. on the days of delivering radiotherapy, w...

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Bibliographic Details
Published in:Journal of radiation research 2013-07, Vol.54 (4), p.679-683
Main Authors: Nakata, Kensei, Sakata, Koh-ichi, Someya, Masanori, Miura, Katsutoshi, Hayashi, Junichi, Hori, Masakazu, Takagi, Masaru, Himi, Tetsuo, Kondo, Atsushi, Hareyama, Masato
Format: Article
Language:English
Subjects:
Administration, Oral
Aged
Aged, 80 and over
Anorexia - chemically induced
Antimetabolites, Antineoplastic - administration & dosage
Antimetabolites, Antineoplastic - adverse effects
Cancer patients
Cancer research
Carcinoma, Squamous Cell - drug therapy
Carcinoma, Squamous Cell - radiotherapy
Care and treatment
Combined Modality Therapy - methods
Dose-Response Relationship, Drug
Drug Combinations
Female
Head and neck cancer
Head and Neck Neoplasms - drug therapy
Head and Neck Neoplasms - radiotherapy
Humans
Male
Maximum Tolerated Dose
Middle Aged
Oncology
Oxonic Acid - administration & dosage
Oxonic Acid - adverse effects
Radiotherapy
Rhabdomyolysis - chemically induced
Tegafur - administration & dosage
Tegafur - adverse effects
Treatment Outcome
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Summary:This study investigated the maximum tolerated dose (MTD) of S-1 with concurrent radiotherapy in patients with head and neck cancer, based on the frequency of dose-limiting toxicities (DLT). S-1 was administered orally at escalating doses from 40 mg/m2 b.i.d. on the days of delivering radiotherapy, which was given at a total dose of 64-70 Gy in 32-35 fractions over 6-7 weeks. A total of 12 patients (3 patients at 40 mg/m2, 6 patients at 60 mg/m2, and 3 patients at 80 mg/m2) were enrolled in this trial. At the dose of 80 mg/m2, two of the three patients developed DLT (Grade 3 anorexia and rhabdomyolysis) due to S-1, so the MTD was determined to be 80 mg/m2. Among the 12 enrolled patients, 9 (75%) showed a complete response and 3 (25%) showed a partial response. The overall response rate was 100%. The recommended dose of S-1 with concurrent radiotherapy is 60 mg/m2.
ISSN:0449-3060
1349-9157
DOI:10.1093/jrr/rrs133