Phase II study of preoperative chemoradiotherapy (CRT) with irinotecan plus S-1 in locally advanced rectal cancer

Sang Joon Shin, Nam Kyu Kim, Ki Chang Keum, Ho Geun Kim, Jun Seok Im, Hye Jin Choi, Seung Hyuk Baik, Jae Hee Choen, Hei Cheul Jeung, Sun Young Rha, Jae Kyung Roh, Hyun Cheol Chung, Joong Bae Ahn

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24 Citations (Scopus)


Background and purpose: The aim of this study is to evaluate the efficacy and safety of preoperative radiation therapy combined with S-1 and irinotecan (SI) in LARC. Materials and methods: Patients were considered LARC if they had a T3/T4 lesion or node positive. Weekly doses of 40 mg/m2 irinotecan were intravenously administered once per week during weeks 1-5 of radiotherapy. S-1 (70 mg/m2) was given from Monday to Friday in all weeks of radiotherapy. 3-D conformal radiotherapy was given at daily fractions of 1.8 Gy for 5 days for a total dose of 50.4 (45 + 5.4) Gy. Surgery was performed 4-6 weeks following the completion of chemoradiation. Results: Between June 2006 and November 2007, 43 pts were enrolled. The stage was: cT3 24 patients, cT4 6 patients; 28 patients were cN+. Forty-one patients completed the chemoradiation and 42 patients underwent operation: a low anterior resection was performed in 36 patients, a total colectomy in 1 patient, and an abdominal perineal resection in 5 patients. T downstaging was observed in 50%; 23 N+ patients became N- (55%). The complete pathological response was observed in 9 patients (21%). The 3-year locoregional failure rate, distant failure rate, disease-free survival, and overall survival were 9.5%, 18.6%, 72.1%, and 94.3%, respectively. Only three patients experienced G3 diarrhea; one had G3 sepsis and two had septic shock. Hematological toxicity (G3-G4) was observed in five patients. Conclusions: This study demonstrated the efficacy of preoperative CRT with S-1 and irinotecan with 21% of complete response. However, prompt recognition and management of infection is needed to use it in patients with locally advanced rectal cancer.

Original languageEnglish
Pages (from-to)303-307
Number of pages5
JournalRadiotherapy and Oncology
Issue number3
Publication statusPublished - 2010 Jun

Bibliographical note

Funding Information:
This work was supported by a Korea Science and Engineering Foundation (KOSEF) grant funded by the Ministry of Science and Technology (MOST) of Korea ( R11-2000-082-02008-0 ).

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology
  • Radiology Nuclear Medicine and imaging


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