A phase i trial of S-1 with concurrent radiotherapy in patients with locally recurrent rectal cancer

Hitoshi Wada, Kenji Nemoto, Takuma Nomiya, Misako Murakami, Motohisa Suzuki, Yuuki Kuroda, Mayumi Ichikawa, Ibuki Ota, Yasuhito Hagiwara, Hisanori Ariga, Ken Takeda, Kenji Takai, Keisuke Fujimoto, Masahiro Kenjo, Kazuhiko Ogawa

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)

Abstract

Background: The purpose of this phase I trial of S-1 chemotherapy in combination with pelvic radiotherapy for locally recurrent rectal cancer was to determine the maximum tolerated dose (MTD), recommended dose (RD), and dose-limiting toxicity (DLT) of S-1. Methods: We enrolled 9 patients between April 2005 and March 2009. Radiotherapy (total dose, 60 Gy in 30 fractions) was given to the gross local recurrent tumor and pelvic nodal metastases using three-dimensional radiotherapy planning. We administered oral S-1 twice a day on days 1-14 and 22-35 during radiotherapy. The dose of S-1 was initially 60 mg/m2/day and was increased to determine the MTD and RD for this regimen. Results: DLT appeared at dose level 2 (70 mg/m2/day) in 2 patients, who experienced grade 3 enterocolitis and consequently required suspension of S-1 administration for longer than 2 weeks. Hematological toxicity was mild and reversible. At the initial evaluation, complete regression and partial regression were seen in 1 patient (11%) and 2 patients (22%), respectively. Conclusion: This phase I trial of S-1 chemotherapy with pelvic radiotherapy for locally recurrent rectal cancer revealed that the MTD for S-1 was 70 mg/m2/day and the RD was 60 mg/m2/day.

Original languageEnglish
Pages (from-to)273-278
Number of pages6
JournalInternational Journal of Clinical Oncology
Volume18
Issue number2
DOIs
Publication statusPublished - 2013 Apr

Keywords

  • Chemotherapy
  • Locally recurrent rectal cancer
  • Radiotherapy
  • S-1

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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