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Title: Phase I study of oral S-1 and concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer

Abstract

Purpose: The primary objective of this study was to determine the maximum-tolerated dose (MTD) of S-1, an oral fluoropyrimidine derivative, with concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer. Methods and Materials: Patients with histopathologically proven, unresectable, locally advanced pancreatic cancer were eligible. Radiotherapy was delivered in 1.8 Gy daily fractions to a total dose of 50.4 Gy over 5.5 weeks. S-1 was administered orally twice a day from Day 1 to 14 and 22 to 35 at escalating doses from 60 to 80 mg/m{sup 2}/day. Results: Sixteen patients were enrolled in this study. Three patients received S-1 at 60 mg/m{sup 2}/day, 3 at 70 mg/m{sup 2}/day, and 10 at 80 mg/m{sup 2}/day. Though 1 patient at the final dose level (80 mg/m{sup 2}/day) experienced a dose limiting toxicity (biliary infection with Grade 3 neutropenia), the MTD was not reached in this study. The most common toxicities were anorexia and leukocytopenia, with Grade 3 toxicity occurring in 31% and 6.3% of the patients, respectively. Conclusions: The recommended dose of S-1 with concurrent radiotherapy was determined to be 80 mg/m{sup 2}/day from Day 1 to 14 and 22 to 35 in patients with locally advanced pancreatic cancer. Oral S-1more » and radiotherapy is well tolerated and feasible and should be further investigated.« less

Authors:
 [1];  [1];  [1];  [1];  [1];  [1];  [2];  [2];  [2];  [1]
  1. Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba (Japan)
  2. Department of Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba (Japan)
Publication Date:
OSTI Identifier:
20850317
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 67; Journal Issue: 1; Other Information: DOI: 10.1016/j.ijrobp.2006.08.046; PII: S0360-3016(06)02806-9; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ANOREXIA; CARCINOMAS; PANCREAS; PATIENTS; RADIATION DOSES; RADIOTHERAPY; TOXICITY

Citation Formats

Sudo, Kentaro, Yamaguchi, Taketo, Ishihara, Takeshi, Nakamura, Kazuyoshi, Shirai, Yoshihiko, Nakagawa, Akihiko, Kawakami, Hiroyuki, Uno, Takashi, Ito, Hisao, and Saisho, Hiromitsu. Phase I study of oral S-1 and concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer. United States: N. p., 2007. Web. doi:10.1016/j.ijrobp.2006.08.046.
Sudo, Kentaro, Yamaguchi, Taketo, Ishihara, Takeshi, Nakamura, Kazuyoshi, Shirai, Yoshihiko, Nakagawa, Akihiko, Kawakami, Hiroyuki, Uno, Takashi, Ito, Hisao, & Saisho, Hiromitsu. Phase I study of oral S-1 and concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer. United States. https://doi.org/10.1016/j.ijrobp.2006.08.046
Sudo, Kentaro, Yamaguchi, Taketo, Ishihara, Takeshi, Nakamura, Kazuyoshi, Shirai, Yoshihiko, Nakagawa, Akihiko, Kawakami, Hiroyuki, Uno, Takashi, Ito, Hisao, and Saisho, Hiromitsu. 2007. "Phase I study of oral S-1 and concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer". United States. https://doi.org/10.1016/j.ijrobp.2006.08.046.
@article{osti_20850317,
title = {Phase I study of oral S-1 and concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer},
author = {Sudo, Kentaro and Yamaguchi, Taketo and Ishihara, Takeshi and Nakamura, Kazuyoshi and Shirai, Yoshihiko and Nakagawa, Akihiko and Kawakami, Hiroyuki and Uno, Takashi and Ito, Hisao and Saisho, Hiromitsu},
abstractNote = {Purpose: The primary objective of this study was to determine the maximum-tolerated dose (MTD) of S-1, an oral fluoropyrimidine derivative, with concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer. Methods and Materials: Patients with histopathologically proven, unresectable, locally advanced pancreatic cancer were eligible. Radiotherapy was delivered in 1.8 Gy daily fractions to a total dose of 50.4 Gy over 5.5 weeks. S-1 was administered orally twice a day from Day 1 to 14 and 22 to 35 at escalating doses from 60 to 80 mg/m{sup 2}/day. Results: Sixteen patients were enrolled in this study. Three patients received S-1 at 60 mg/m{sup 2}/day, 3 at 70 mg/m{sup 2}/day, and 10 at 80 mg/m{sup 2}/day. Though 1 patient at the final dose level (80 mg/m{sup 2}/day) experienced a dose limiting toxicity (biliary infection with Grade 3 neutropenia), the MTD was not reached in this study. The most common toxicities were anorexia and leukocytopenia, with Grade 3 toxicity occurring in 31% and 6.3% of the patients, respectively. Conclusions: The recommended dose of S-1 with concurrent radiotherapy was determined to be 80 mg/m{sup 2}/day from Day 1 to 14 and 22 to 35 in patients with locally advanced pancreatic cancer. Oral S-1 and radiotherapy is well tolerated and feasible and should be further investigated.},
doi = {10.1016/j.ijrobp.2006.08.046},
url = {https://www.osti.gov/biblio/20850317}, journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 1,
volume = 67,
place = {United States},
year = {Mon Jan 01 00:00:00 EST 2007},
month = {Mon Jan 01 00:00:00 EST 2007}
}