Phase II study of preoperative chemoradiotherapy (CRT) with irinotecan plus S-1 in locally advanced rectal cancer
Received 5 October 2009; received in revised form 31 December 2009; accepted 1 February 2010. published online 08 March 2010.
Abstract
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 40mg/m2 irinotecan were intravenously administered once per week during weeks 1–5 of radiotherapy. S-1 (70mg/m2) was given from Monday to Friday in all weeks of radiotherapy. 3-D conformal radiotherapy was given at daily fractions of 1.8Gy for 5days for a total dose of 50.4 (45+5.4)Gy. Surgery was performed 4–6weeks 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.
aDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
bDepartment of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea
cDepartment of Radiation Oncology, Yonsei University College of Medicine, Seoul, Republic of Korea
dDepartment of Pathology, Yonsei University College of Medicine, Seoul, Republic of Korea
eDepartment of Diagnostic Radiology, Yonsei University College of Medicine, Seoul, Republic of Korea
Corresponding author. Address: Yonsei Cancer Center, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, Republic of Korea.
ABSTRACT