Academic Journal
Phase I/II Study of S-1 plus Cisplatin Combination Chemotherapy in Patients with Advanced/Recurrent Head and Neck Cancer
| العنوان: | Phase I/II Study of S-1 plus Cisplatin Combination Chemotherapy in Patients with Advanced/Recurrent Head and Neck Cancer |
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| المؤلفون: | Fujii, Masato, Tomita, Kitinobu, Nishijima, Wataru, Tsukuda, Mamoru, Hasegawa, Yasuhisa, Ishitoya, Junichi, Yamane, Hideo, Homma, Akihiro, Tomita, Toshiki |
| بيانات النشر: | Oxford University Press |
| سنة النشر: | 2010 |
| المجموعة: | HighWire Press (Stanford University) |
| مصطلحات موضوعية: | Head & Neck |
| الوصف: | Objective The objectives of this study were to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus cisplatin (CDDP) and to evaluate safety and efficacy using the defined RD in advanced/recurrent head and neck cancer (HNC). Methods S-1 was administered orally at 40 mg/m2 twice daily for 14 consecutive days, and CDDP was infused on day 8 at a dose of 60 and 70 mg/m2. Each course was repeated every 4 weeks. Results A total of 38 patients were registered, 10 patients for the Phase I study and an additional 28 patients for the Phase II study. Although no dose-limiting toxicity (DLT) was observed in the CDDP 60 mg/m2 (Level 1) group, two of six patients in the CDDP 70 mg/m2 (Level 2) group exhibited DLT (fatigue/diarrhea). The MTD was not achieved in the Phase I study. Level 2 was therefore determined as the RD. In the Phase II study, 34 patients, including 6 patients from the Phase I study, were evaluated. At the termination of treatment, the confirmed response rate was 44.1% (15/34, 95% CI: 27.4–60.8). The best response rate without an adequate duration time was 67.6% (95% CI: 51.9–83.4). The median survival period was 16.7 months, and the 1-year survival rate was 60.1%. The main toxicities of Grade 3 or above were anorexia (26.5%), nausea (14.7%), neutropenia/thrombocytopenia (11.8%) and anemia/fatigue (8.8%). Conclusions This is considered to be an effective regimen with acceptable toxicities for HNC. |
| نوع الوثيقة: | text |
| وصف الملف: | text/html |
| اللغة: | English |
| Relation: | http://jjco.oxfordjournals.org/cgi/content/short/40/3/214; http://dx.doi.org/10.1093/jjco/hyp153 |
| DOI: | 10.1093/jjco/hyp153 |
| الاتاحة: | http://jjco.oxfordjournals.org/cgi/content/short/40/3/214 https://doi.org/10.1093/jjco/hyp153 |
| Rights: | Copyright (C) 2010, Foundation for Promotion of Cancer Research |
| رقم الانضمام: | edsbas.C470E9BF |
| قاعدة البيانات: | BASE |
| DOI: | 10.1093/jjco/hyp153 |
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