Prospective Phase II Study of Preoperative Chemoradiation with Capecitabine in Locally Advanced Rectal Cancer.
- Author:
Jin hong PARK
1
;
Jong Hoon KIM
;
Seung Do AHN
;
Sang wook LEE
;
Seong Soo SHIN
;
Jin Cheon KIM
;
Chang Sik YU
;
Hee Cheol KIM
;
Yoon Koo KANG
;
Tae Won KIM
;
Heung Moon CHANG
;
Min Hee RYU
;
Eun Kyung CHOI
Author Information
1. Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. jhkim2@amc.seoul.kr
- Publication Type:Original Article
- Keywords:
Rectal cancer;
Preoperative;
Chemoradiotherapy;
Capecitabine
- MeSH:
Adenocarcinoma;
Chemoradiotherapy;
Colonoscopy;
Humans;
Proctitis;
Prospective Studies*;
Radiation-Sensitizing Agents;
Rectal Neoplasms*;
Rectum;
Capecitabine
- From:Cancer Research and Treatment
2004;36(6):354-359
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: Capecitabine is an attractive oral chemotherapeutic agent that has a radiosensitizing effect and tumor-selectivity. This study was performed to evaluate the efficacy and toxicity of preoperative chemoradiation therapy, when used with oral capecitabine, for locally advanced rectal cancer. MATERIALS AND METHODS: A prospective phase II trial of preoperative chemoradiation for locally advanced adenocarcinomas of the lower two-thirds of the rectum was conducted. A radiation dose of 50 Gy over five weeks and a daily dose of 1650 mg/m2 capecitabine in two potions was administered during the entire course of radiation therapy. Surgery was performed with standardized total mesorectal excision four to six weeks after completion of the chemoradiation. RESULTS: Between January 2002 and September 2003, 61 patients were enrolled onto this prospective phase II trial. The pretreatment clinical stages were T3 in 64% (n=39), T4 in 36% (n=22) and N1-2 in 82% (n=50) of these patients. Fifty-six (92%) patients completed the chemoradiation as initially planned and a complete resection performed in 58 (95%). Down-staging was observed in 45 patients (74%) and a pathologic complete response in 6 (10%). Among the 37 patients with tumors located within 5 cm from the anal verge on colonoscopy, 27 (73%) underwent a sphincter-preserving procedure. No grade 3 and 4 proctitis or hematological toxicities were observed. CONCLUSION: Preoperative chemoradiation therapy with capecitabine achieved encouraging rates of tumor down-staging and sphincter preservation, with a low toxicity profile. This combined modality can be regarded as a safe and effective treatment for locally advanced rectal cancer.
