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Phase I Study of S-1 and Nedaplatin for Patients with Recurrence of Head and Neck Cancer

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Phase I Study of S-1 and Nedaplatin for Patients with Recurrence of Head and Neck Cancer ANTICANCER RESEARCH 26: 2265-2268 (2006) Phase I Study of S-1 and Nedaplatin for Patients with Recurrence of Head and Neck Cancer TAKESHI KODAIRA, NOBUKAZU FUWA, HIROYUKI TACHIBANA and SATOSHI HIDANO Department of Therapeutic Radiation Oncology, Aichi Cancer Center Hospital, 464-8681 Nagoya, Aichi, Japan Abstract. A phase I study of chemotherapy was planned with toxicity, oral chemotherapeutic agents have been rigorously S-1 and nedaplatin to find the optimal dose for patients with tested in Japan. Recently the oral fluorouracil prodrugs recurrent head and neck cancer. Materials and Methods: Oral showed promising results for several solid tumors including administration of S-1 (days 1-14) and intravenous nedaplatin SCCHN (3). Oral administration of UFT (tegafur and uracil (day 8) were tested for patients with recurrent head and neck in a 1:4 molar concentration) showed a significant survival cancer in a phase-I setting. The dose of S-1 was fixed and the advantage in lung (4) and breast cancer (5). dose of nedaplatin was escalated from 80 mg/m2, with an S-1 (Taiho Pahrmaceutical Co., Ltd., Tokyo, Japan) is an increase of 10 mg/m2 per step, to find the maximum tolerated oral anticancer agent (tegafur, gimeracil and oteracil dose. Results: Nine patients were recruited in this trial. The potassium at a molar ratio 1:0.4:1) based on the biochemical maximum tolerated dose (MTD) of nedaplatin was 90 mg/m2. modulation of 5FU (6). S-1 is thought to be potentially At this dose level, dose-limiting toxicity (DLT) was observed more active than 5FU, and several clinical reports have in two out of three patients. One experienced grade 4 suggested encouraging clinical results in chemotherapy for thrombocytopenia and febrile grade 3 neutropenia, while the SCCHN (7, 8). other suffered myelosuppression causing more than a two-week Nedaplatin (NDP) is a platinum complex also developed delay of the second chemotherapy cycle. Myelosuppression was in Japan, and believed to be an active agent for SCCHN (9). the DLT of this regimen. Conclusion: The recommended This agent is thought to have an equivalent treatment effect, phase II dose of nedaplatin combined with oral S-1 was but with less renal and gastrointestinal toxicity compared identified as 80 mg/m2. with cisplatin, and so more convenient administration could be achieved even on an out-patient basis. NDP was also About two-thirds of squamous cell carcinoma of the head reported to be efficacious and feasible combined with the and neck (SCCHN) present with locally advanced disease. pre-administration of 5FU (10). Therefore, improving the outcome of radiotherapy and Combination chemotherapy using S-1 and NDP, both surgery still remains an important issue. Concurrent highly active agents for SCCHN, is expected to have a chemoradiotherapy showed a significant survival advantage promising outcome with sufficient compliance even in the compared with radiotherapy for patients with locally out-patient setting. To the best of our best knowledge, this advanced SCCHN (1). Thus, chemotherapy is believed to be is the first phase I trial of S-1 and NDP in SCCHN. an important modality in the clinical practice for treating patients with locally advanced SCCHN. As for active agents, Materials and Methods 5-Fluorouracil (5FU) and cisplatin (CDDP) are most commonly used (2), but this treatment usually needs Eligibility. Patients with histologically confirmed head and neck cancer, excluding thyroid cancer, were enrolled in this trial. Written hospitalization because of the continuous infusion of these informed consent was obtained from each patient before agents and adequate support for gastrointestinal and renal enrollment. All patients were diagnosed as having recurrence with a toxicity. To improve compliance with treatment and reduce measurable region after their initial treatment. Previous treatments, including chemotherapy, radiotherapy and surgery, were allowed if the treatment had finished at least one month prior to registration for the present study. The specific eligibility criteria were: patients Correspondence to: Takeshi Kodaira, Department of Therapeutic were required to be within 20 to 75 years of age; to have an Eastern Radiation Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden Cooperative Oncology Group (ECOG) performance status of 0 to Chikusa-ku, 464-8681 Nagoya, Aichi, Japan. Tel: +81-52-762-6111, 1; to have adequate hematological, hepatic and renal function Fax: +81-52-752-8390, e-mail: [email protected] (WBCs >3,500/Ìl, neutrophil count >2,000/Ìl, platelet count >100,000/Ìl and hemoglobin level >9 g/dL; AST and ALT <three Key Words: S-1, nedaplatin, head and neck. times normal values, total bilirubin <1.5 mg/dl and creatinine 0250-7005/2006 $2.00+.40 2265 ANTICANCER RESEARCH 26: 2265-2268 (2006) clearance >60 ml/min, respectively); and to have a life expectancy Table I. Patient characteristics. of at least three months. The patients also had to be able to comply with the oral administration of S-1. Patients enrolled 9 Gender Treatment schedule and dose escalation. S-1 was administered at male 7 fixed doses based on the body surface area of the patient. The female 2 following doses were administered orally: body surface area (BSA) Age 38-74 (median 60) less than 1.25 m2, 80 mg/day; BSA 1.25-1.5 m2, 100 mg/day; BSA Performance status (ECOG) 1.5 m2 or more, 120 mg/day. S-1 was administered orally twice a 19 Previous treatment day after breakfast and dinner, for 14 consecutive days, followed chemoradiotherapy 5 by a 2-week rest. NDP was administered intravenously over 1 h on chemoradiation and surgery 2 day 8. The starting dose of NDP was 80 mg/m2 (level 1). Additional Primary tumor location 2 2 increases by 10 mg/m up to 100 mg/m were permitted to find the nasopharynx 4 maximum tolerated dose (MTD). The schedule was repeated every hypopharynx 2 4 weeks until the occurrence of disease progression, unacceptable tongue 1 toxicity or the patient’s refusal. Treatment with antiemetics, maxillary sinus 1 antibiotics, sedatives, steroid, hematopoietic growth factors and hard palate 1 gastric protectors was permitted. An additional course was allowed Histopathology if WBCs >3,000/Ìl, platelet count >100,000/Ìl, serum creatinine squamous cell carcinoma 7 <1.2 times normal values, with febrile status and resolution of non- adenoid cystic carcinoma 2 hematological toxicity to be baseline or less than grade 1. Target region At least three patients were treated at each dose level. The primary region 4 dose-limiting toxicities (DLTs) were defined as grade 4 of the lung metastasis 2 National Cancer Institute common toxicity criteria (NCI-CTC) ver. mediastinal lymph nodes 2 3 for hematological toxicities, febrile neutropenia of grade 3, grade skin 1 3 of non-hematological toxicities excluding nausea and vomiting, grade 2 of serum creatinine and an over 2-week delay in the administration of the second cycle of chemotherapy. When the DLT appeared, three patients were added at the same dose level. The end-points to close the study were DLT in hematological or males and two females), with a median age of 60 years, were non-hematological toxicity if observed in two out of three or three out of six patients at the same dose levels. The previous dose level enrolled. Seven patients had been treated with to that at which the MTD appeared was considered to be the chemoradiotherapy before this protocol, while two patients recommended dose (RD). had received surgery followed by salvage treatment by chemoradiotherapy for recurrent disease. Table I gives Evaluation and follow-up. Baseline evaluation included a complete details of the patients and their treatment characteristics. medical history, physical examination, complete blood cell count, serum chemistry, cervical CT scan and chest X-ray. Blood chemistry and subjective/objective symptoms of toxicity were DLT. Table II shows the hematological toxicities observed monitored on a 2-weekly basis during treatment. The clinical at each dose level. At level 1 (NDP 80 mg/m2), one out of response was evaluated for each course of chemotherapy. three patients experienced a DLT of grade 4 neutropenia, Complete response (CR) was defined as the disappearance of all so an additional three patients were included at this dose clinically evident tumors and no new disease; a partial response level. At this dose level, one out of six patients experienced (PR) was defined as a greater than 50% reduction of the sum of DLT, then advanced to the next dose level. At dose level 2 the products of perpendicular tumor measurements and no new 2 disease; stable disease (SD) was defined as less than a partial (NDP 90 mg/m ), two out of three patients experienced response and less than a 25% increase in all dimensions of DLTs. One patient experienced grade 4 neutropenia and measurable disease; and progressive disease (PD) was defined as a grade 4 thrombocytopenia. One patient experienced more greater than 25% increase in all dimensions of measurable disease than a 2-week delay in the second chemotherapy. or new sites of disease. The survival time was calculated from the Table III shows the non-hematological toxicities observed initial date of the treatment to death from any cause or the last at each dose level. No patient experienced DLTs in this follow-up. Overall survival was assessed using the Kaplan-Meier category. In addition, at dose levels 1 and 2, no patient method starting from the date of treatment initiation. experienced grade 3 or above non-hematological toxicity. Results From these findings, it was concluded that dose level 2 (NDP 90 mg/m2) was the MTD. Characteristics of patients. Ten patients received this protocol from 2004 June to January 2005. However, one patient was Response and status.
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