Multicenter phase II clinical trial of operative capecitabine with concurrent radiotherapy in patients with locally advanced rectal cancer
Clin. transl. oncol. (Print)
; 15(4): 294-299, abr. 2013. tab, ilus
Article
in English
| IBECS
| ID: ibc-127220
Responsible library:
ES1.1
Localization: BNCS
ABSTRACT
INTRODUCTION:
To assess pathologic complete response, sphincter preservation rates and toxicity profile of preoperative chemoradiation with capecitabine in resectable locally advanced rectal cancer. MATERIALS ANDMETHODS:
Fifty-eight patients from six Spanish centers were included (March 2004 to June 2005) with histological/cytological diagnosis of locally advanced rectal cancer, age between 18 and 80 years, ECOG 0-2, adequate bone marrow, renal and hepatic functions. Prior chemotherapy/radiotherapy was not allowed. Preoperative treatment was capecitabine 825 mg/m(2) bid concomitant to radiotherapy (45 + 5.4 Gy boost over 5.5 weeks). Surgery was performed 4-8 weeks after completion of chemoradiotherapy.RESULTS:
Fifty-eight patients were enrolled in this study 60.3 % males, median age of 64.5 (30.9-78.7) years, 28.6 % with ECOG 0 and 71.4 % with ECOG 1. Median distance of tumor from the anal verge was 7 (1-12) cm. Fifty-two (89.6. %) patients completed preoperative chemoradiotherapy. Primary tumor and node downstaging occurred in 61.1 and 69.6 % of patients, respectively. Surgery was performed in 55 patients (94.8 %) 80 % had negative lymph nodes and 72.7 % underwent sphincter-preserving procedures. A pathologic complete response was observed in 10.5 % (95 % CI 2.5-18.5) of the patients. Main grade I-II toxicities were leucopenia (43.1 %), neutropenia (24.1 %), anemia (36.2 %), diarrhea (32.8 %) and skin disorders (5.1 %), from which diarrhea (6.9 %), leucopenia (1.7 %) and skin disorders (1.7 %) reached grade III. There were no grade IV toxicities.CONCLUSIONS:
Preoperative capecitabine-based chemoradiation is a well-tolerated and effective neoadjuvant treatment for locally advanced rectal cancer that achieves encouraging rates of tumor downstaging (AU)
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Collection:
National databases
/
Spain
Health context:
Neglected Diseases
Health problem:
Diarrhea
Database:
IBECS
Main subject:
Rectal Neoplasms
/
Lymph Nodes
Type of study:
Diagnostic study
/
Evaluation study
Limits:
Aged
/
Humans
/
Male
Language:
English
Journal:
Clin. transl. oncol. (Print)
Year:
2013
Document type:
Article
Institution/Affiliation country:
Hospital Carlos Haya/Spain
/
Hospital Clínico San Carlos/Spain
/
Hospital Clínico Universitario San Carlos/Spain
/
Hospital Virgen de la Victoria/Spain
/
Hospital Virgen de las Nieves/Spain
/
Hospital de Alcazar/Spain
/
Hospital de Jerez/Spain
/
Hospital de Navarra/Spain