Preoperative concomitant chemoradiotherapy with capecitabine in locally advanced rectal carcinoma

Abstract

e15134 Background: Preoperative concomitant chemoradiotherapy has shown to improve local control and sphincter preservation with decreased acute toxicity compared with postoperative treatment in locally advanced rectal carcinoma. The primary endpoint of this phase II trial was pathologic tumor response. Secondary endpoint was sphincter preservation and toxicity. Methods: Inclusion criteria: rectal adenocarcinoma <12 cms from anal verge, clinical stage T3–4, adequate renal, hematological and liver function. Planned sample for this trial was 40 patients. Treatment schedule: Pelvic radiotherapy (45 Gy : 2 Gy /day ) and chemotherapy: Capecitabine 850 mg/m2 b.i.d p.o: day 1 to 14 (2weeks of treatment followed by 1 week rest period (cycle repeated every 3 weeks). Surgery with TME was performed after the end of the second cycle of chemotherapy. Adjuvant chemotherapy with 5FULV2 was administered after surgery Results: 15 patients have been recruited between January and October 2007: 12 males/3 females. Median age 40 years (range 22–70). Clinical stage (determined by CT or RMI): T3: 70% and T4: 30%. Tumor location (from anal verge): < 6 cm in 8pts, >6 cm in 7pts. Surgery (performed in 14 patients) consisted of low anterior resection in 7pts and abdominal-perineal resection in 8pts. Tumor down staging was observed in 9pts (60%), including 5pts with complete pathological response (33.3%). Main adverse effects (NCI-CTC): diarrhea G3–4: 15.2%, nausea/vomiting G3–4: 13%, Anemia G3- 4: 8.5%, neutropenia G3–4: 12.5%. Conclusions: Preliminary results show that preoperative concomitant chemoradiotherapy with Capecitabine is an effective regimen with an acceptable safety profile for locally advanced rectal cancer, leading to a high probability of tumor downstaging. No significant financial relationships to disclose.