INTRODUCTION: To assess pathologic complete response, sphincter preservation rates and toxicity profile of preoperative chemoradiation with capecitabine in resectable locally advanced rectal cancer. MATERIALS AND METHODS: 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.
INTRODUCTION: To assess pathologic complete response, sphincter preservation rates and toxicity profile of preoperative chemoradiation with capecitabine in resectable locally advanced rectal cancer. MATERIALS AND METHODS: 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.
Authors: Rolf Sauer; Heinz Becker; Werner Hohenberger; Claus Rödel; Christian Wittekind; Rainer Fietkau; Peter Martus; Jörg Tschmelitsch; Eva Hager; Clemens F Hess; Johann-H Karstens; Torsten Liersch; Heinz Schmidberger; Rudolf Raab Journal: N Engl J Med Date: 2004-10-21 Impact factor: 91.245
Authors: E Van Cutsem; C Twelves; J Cassidy; D Allman; E Bajetta; M Boyer; R Bugat; M Findlay; S Frings; M Jahn; J McKendrick; B Osterwalder; G Perez-Manga; R Rosso; P Rougier; W H Schmiegel; J F Seitz; P Thompson; J M Vieitez; C Weitzel; P Harper Journal: J Clin Oncol Date: 2001-11-01 Impact factor: 44.544
Authors: P Piedbois; P Rougier; M Buyse; J Pignon; L Ryan; R Hansen; B Zee; B Weinerman; J Pater; C Leichman; J Macdonald; J Benedetti; J Lokich; J Fryer; G Brufman; R Isacson; A Laplanche; E Levy Journal: J Clin Oncol Date: 1998-01 Impact factor: 44.544
Authors: C Bengala; S Bettelli; F Bertolini; S Salvi; S Chiara; C Sonaglio; L Losi; N Bigiani; G Sartori; C Dealis; N Malavasi; R D'Amico; G Luppi; B Gatteschi; A Maiorana; P F Conte Journal: Ann Oncol Date: 2008-12-18 Impact factor: 32.976
Authors: J E Krook; C G Moertel; L L Gunderson; H S Wieand; R T Collins; R W Beart; T P Kubista; M A Poon; W C Meyers; J A Mailliard Journal: N Engl J Med Date: 1991-03-14 Impact factor: 91.245