Original Article
Preoperative capecitabine and pelvic radiation in locally advanced rectal cancer: preliminary results (Mansoura experience)
Abstract
Purpose: The aim of the study was to evaluate the efficacy and tolerance of pre-operative chemoradiotherapy with oral capecitabine in patients with locally advanced, resectable rectal cancer.
Patients and methods: Thirty six patients, 23 males and 13 females with a median age of 53 years (range, 19-68 years), with potentially resectable T3N0 (17%), T3N1 (64%) and T4N0-1 (19%) rectal cancer, were treated with capecitabine (825 mg/m2, twice daily for 5 days/week) with concomitant radiotherapy (45 Gy/25 fractions) for 5 weeks. Approximately 6 weeks after completion of the chemoradiation, patients underwent resection according to the principles of total mesorectal excision followed by adjuvant chemotherapy consisting of oxaliplatin based regimen. The primary end points were to determine the clinical and pathological response, safety profile, preservation of the sphincter mechanism and rate of peri-operative complications.
Results: Down staging rate was 67% (22/33) on CT, MRI and/or endorectal ultrasonography, and 61% (20/33) on pathology findings. Pathological complete response rate was 21% (7/33). Two patients had grade 3/4 toxicity, which consisted of diarrhea (6%). Grade 1/2 toxicity was frequent, but always reversible. Sphincter-preserving surgery was possible in twenty-five patients (76%). Peri-operative complications were seen in 9 (27%) patients and included mechanical ileus (6%), delayed wound healing (12%), wound infection (3%), anastomotic leakage (3%) and pelvic collection (3%).
Conclusions: Pre-operative chemoradiotherapy with oral capecitabine in locally advanced, resectable rectal cancer achieves significant rates of tumor downstaging and sphincter preservation with a favorable safety profile.
Patients and methods: Thirty six patients, 23 males and 13 females with a median age of 53 years (range, 19-68 years), with potentially resectable T3N0 (17%), T3N1 (64%) and T4N0-1 (19%) rectal cancer, were treated with capecitabine (825 mg/m2, twice daily for 5 days/week) with concomitant radiotherapy (45 Gy/25 fractions) for 5 weeks. Approximately 6 weeks after completion of the chemoradiation, patients underwent resection according to the principles of total mesorectal excision followed by adjuvant chemotherapy consisting of oxaliplatin based regimen. The primary end points were to determine the clinical and pathological response, safety profile, preservation of the sphincter mechanism and rate of peri-operative complications.
Results: Down staging rate was 67% (22/33) on CT, MRI and/or endorectal ultrasonography, and 61% (20/33) on pathology findings. Pathological complete response rate was 21% (7/33). Two patients had grade 3/4 toxicity, which consisted of diarrhea (6%). Grade 1/2 toxicity was frequent, but always reversible. Sphincter-preserving surgery was possible in twenty-five patients (76%). Peri-operative complications were seen in 9 (27%) patients and included mechanical ileus (6%), delayed wound healing (12%), wound infection (3%), anastomotic leakage (3%) and pelvic collection (3%).
Conclusions: Pre-operative chemoradiotherapy with oral capecitabine in locally advanced, resectable rectal cancer achieves significant rates of tumor downstaging and sphincter preservation with a favorable safety profile.