Annals of Oncology 24 (Supplement 9): ix31–ix65, 2013 doi:10.1093/annonc/mdt459.50
Oral Session O1–120
TWO-WEEK COURSE OF PREOPERATIVE CHEMORADIOTHERAPY FOR RECTAL CANCER: A PHASE II MULTI-INSTITUTIONAL CLINICAL TRIAL
J. H. Lee1, D. Y. Kim2, H. C. Park3, E. K. Chie4, H. S. Jang1 1 Department of Radiation Oncology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, 2Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Go-Yang, Korea, 3 Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, 4Department of Radiation Oncology, Seoul National University College of Medicine, Seoul, Korea
abstracts
Purpose: The aim of this study was to evaluate the efficacy and safety of a two-week schedule of radiotherapy with oral capecitabine in locally advanced rectal cancer.
Patients and Methods: Eighty patients with rectal cancer located in the mid to low rectum, staged cT3-4N0-2M0, were prospectively enrolled. They underwent preoperative chemoradiotherapy and curative surgery. A radiation dose of 33 Gy in 10 fractions was delivered to the pelvis for 2 weeks. One cycle of oral capecitabine was administered at a dose of 1,650 mg/m2/day during radiotherapy. Tumor response and toxicity were the study endpoints. This study was registered at ClinicalTrials.gov (number, NCT01431599). Results: All included patients underwent total mesorectal excisions including 12 cases of robot assisted surgery and 50 cases of laparoscopic surgery. Of the 80 patients, 28 (35%) achieved downstaging (ypT0-2N0) of a rectal tumor and 11 (13.8%) had a pathologically complete response (ypCR). Downstaging rates were 45% for T classification and 65% for N classification. Sphincter saving was achieved in 73 (91.3%) of the 80 patients. Of the 80 patients, 3 (3.8%) experienced grade 3 hematologic toxicity, and 2 (2.5%) had grade 3 postoperative complications such as ileus and wound dehiscence. There was no grade 4 toxicity. Conclusion: A two-week schedule of radiotherapy with oral capecitabine in locally advanced rectal cancer patients showed low toxicity profiles and promising results in terms of tumor response and sphincter preservation.
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