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Preoperative concurrent chemotherapy with S-1 and radiotherapy for locally advanced squamous cell carcinoma of the oral cavity: phase I trial.

ABSTRACT: BACKGROUND: This study was conducted to identify a recommended dose for S-1, used in combination with 40-Gy radiation. METHODS: Thirty patients, 15 each with stage III and IVA oral carcinoma, were enrolled. All patients received a total dose of 40-Gy. For the S-1 treatment, patients were given either the standard Japanese dose, calculated according to body surface area, or a reduced dose. Groups consisting of at least three patients were given S-1 according to one of 8 regimens. RESULTS: Hematologic toxicity was mild and reversible. The most common nonhematologic toxicity was mucositis. At level 8 that was the standard S-1 dose for 5 days per week for 4 weeks, dose-limiting toxicity was observed when 2 patients had grade 4 mucositis. This level was thus deemed the maximum tolerated dose for the regimen. CONCLUSIONS: The recommended dose of S-1 with concurrent radiotherapy was the reduced dose of S-1 given for 5 days per week, for 4 consecutive weeks. Preoperative S-1 and concurrent radiotherapy was well tolerate and feasible and warrants a phase II study.

SUBMITTER: Harada H

PROVIDER: S-EPMC2867809 | biostudies-other | 2010

REPOSITORIES: biostudies-other

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Preoperative concurrent chemotherapy with S-1 and radiotherapy for locally advanced squamous cell carcinoma of the oral cavity: phase I trial.

Harada Hiroyuki H Omura Ken K

Journal of experimental & clinical cancer research : CR 20100420

<h4>Background</h4>This study was conducted to identify a recommended dose for S-1, used in combination with 40-Gy radiation.<h4>Methods</h4>Thirty patients, 15 each with stage III and IVA oral carcinoma, were enrolled. All patients received a total dose of 40-Gy. For the S-1 treatment, patients were given either the standard Japanese dose, calculated according to body surface area, or a reduced dose. Groups consisting of at least three patients were given S-1 according to one of 8 regimens.<h4> ...[more]

PMID: 20406445

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Project description:ObjectivesThe objectives of this study were to assess the clinical effects of an integrated program consisting of concurrent preoperative combined paclitaxel and nedaplatin chemotherapy and three-dimensional conformal radiotherapy followed by surgery intended to cure oral squamous cell carcinoma and to determine whether this integrated program is feasible and effective with respect to the treatment of oral squamous cell carcinoma.MethodsA total of 104 biopsy-confirmed patients who presented with oral squamous cell carcinoma for the first time were included in this study. Concurrent preoperative combined paclitaxel and nedaplatin chemotherapy and three-dimensional conformal radiotherapy were administered to these patients. The most common treatment regimen consisted of infusions of paclitaxel (135-175 mg/m2/day), infusions of nedaplatin (150 mg; 80-100 mg/m2/day), and irradiation at doses ranging from 1.5 Gy twice daily to 30-40 Gy over 3-4 weeks. The clinical variables evaluated herein included the local recurrence rate, distant metastasis rate, postoperative survival rate, and degree of mouth opening restriction.ResultsThe median follow-up time for surviving patients was 60 months, and the median time to progression for all patients was 57.69 months (95% confidence interval, 56.09 to 59.29 months, and the 3-year disease-free survival probability was 97.11%). The effectiveness rate of the integrated program was 98.08%, and the surgery resection rate was 100%. Only a few postoperative adverse reactions were observed. The local recurrence and distant metastasis rates were 1.92% (2 patients) and 2.88% (3 patients), respectively. The titanium rejection and infection reaction rate that led to restriction of mouth opening was only 2.88% (3 patients). Finally, the 5-year post-surgery survival rate was 91.35% (95 patients).ConclusionPreoperative combined paclitaxel and nedaplatin chemotherapy and three-dimensional conformal radiotherapy have significant clinical effects leading to positive anti-tumor results in patients with oral squamous cell carcinoma. These treatments also increase the likelihood that patients will undergo successful surgical treatment. The integrated program described herein can increase long-term survival and surgery resection rates and is associated with only a limited number of adverse reactions.

Dataset Information

Preoperative concurrent chemotherapy with S-1 and radiotherapy for locally advanced squamous cell carcinoma of the oral cavity: phase I trial.

Publications

Preoperative concurrent chemotherapy with S-1 and radiotherapy for locally advanced squamous cell carcinoma of the oral cavity: phase I trial.

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