A Multicenter Phase II Trial of S-1 With Concurrent Radiation Therapy for Locally Advanced Pancreatic Cancer
- Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba (Japan)
- Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka (Japan)
- Department of Radiation Oncology, National Cancer Center Hospital, Tokyo (Japan)
- Department of Epidemiology and Biostatistics, Translational Medical Center, National Center of Neurology and Psychiatry, Tokyo (Japan)
- Department of Clinical Oncology, Jichi Medical University, Tochigi (Japan)
- Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya (Japan)
- Department of Gastroenterology, Sapporo Kosei General Hospital, Sapporo (Japan)
- Hepatobiliary and Pancreatic Division, Cancer Institute Hospital, Tokyo (Japan)
- Department of Internal Medicine, Medical Oncology School of Medicine, Kyorin University, Tokyo (Japan)
- Kyoto Unit Center, Japan Environment and Children's Study, Kyoto University Graduate School of Medicine, Kyoto (Japan)
- Department of Biostatistics, Kyoto University School of Public Health, Kyoto (Japan)
- Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo (Japan)
Purpose: The aim of this trial was to evaluate the efficacy and toxicity of S-1 and concurrent radiation therapy for locally advanced pancreatic cancer (PC). Methods and Materials: Locally advanced PC patients with histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma, who had no previous therapy were enrolled. Radiation therapy was delivered through 3 or more fields at a total dose of 50.4 Gy in 28 fractions over 5.5 weeks. S-1 was administered orally at a dose of 80 mg/m{sup 2} twice daily on the day of irradiation during radiation therapy. After a 2- to 8-week break, patients received a maintenance dose of S-1 (80 mg/m{sup 2}/day for 28 consecutive days, followed by a 14-day rest period) was then administered until the appearance of disease progression or unacceptable toxicity. The primary efficacy endpoint was survival, and the secondary efficacy endpoints were progression-free survival, response rate, and serum carbohydrate antigen 19-9 (CA19-9) response; the safety endpoint was toxicity. Results: Of the 60 evaluable patients, 16 patients achieved a partial response (27%; 95% confidence interval [CI], 16%-40%). The median progression-free survival period, overall survival period, and 1-year survival rate of the evaluable patients were 9.7 months (95% CI, 6.9-11.6 months), 16.2 months (95% CI, 13.5-21.3 months), and 72% (95%CI, 59%-82%), respectively. Of the 42 patients with a pretreatment serum CA19-9 level of {>=}100 U/ml, 34 (81%) patients showed a decrease of greater than 50%. Leukopenia (6 patients, 10%) and anorexia (4 patients, 7%) were the major grade 3-4 toxicities with chemoradiation therapy. Conclusions: The effect of S-1 with concurrent radiation therapy in patients with locally advanced PC was found to be very favorable, with only mild toxicity.
- OSTI ID:
- 22149725
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 85, Issue 1; Other Information: Copyright (c) 2013 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
Similar Records
Phase II Study of Oral S-1 and Concurrent Radiotherapy in Patients With Unresectable Locally Advanced Pancreatic Cancer
Phase II Study of Consolidation Chemotherapy After Concurrent Chemoradiation in Cervical Cancer: Preliminary Results