Toxicity Evaluation Of Capecitabine Concurrent Chemoradiotherapy For Stage Ii And Iii Rectal Cancer

15067 Background: Though preoperative chemoradiotherapy is associated with improved local control and less toxicity compared with postoperative chemoradiotherapy, 5-fluorouracil based postoperative concurrent chemoradiotherapy still remains a more acceptable treatment in China. Efforts are now being focused on developing new cytotoxic agents in combination with radiotherapy (RT) to maintain the treatment results and to decrease the toxicity. A phase II study was conducted to evaluate the acute toxicity and tolerance of capecitabine combination with RT. Methods: Radiotherapy was delivered postoperatively to the total dose of DT 50Gy in 5 weeks to the pelvic region, either in 3-field technique or 3-D conformal therapy. Capecitabine was administered concurrent with RT at a dosage of 1600 mg/m2/d for 2 weeks (1st cycle) followed by a 2nd cycle after a rest of 7 days. Primary endpoint was grade 3 or 4 hematological and non-hematological toxicity. Results: Between March 2005 and December 2006, a total of 75 patients with stage II and III rectal adenocarcinoma were treated, with median age of 53 years old and 50.7% of male patients. Grade 1–3 leukopenia, diarrhea and radiation- induced dermatitis were the most common toxic side effects, which accounted for 52 (69.3%), 49 (65.3%) and 33 (44.0%) out of 75 patients, although most were within Grade 1–2. However, the grade 3 toxicity were diarrhea (24.0%, 18/75), Leukopenia (6.7%, 5/75), dermatitis (2.7%, 2/75) and fatigue (1.3%, 1/75). Hand-foot syndrome was mild, only seen in 4 patients which was grade 1. Treatment was only interrupted in 3 and 2 patients in radiotherapy and chemotherapy respectively, due to grade 3 dermatitis (n = 1), diarrhea (n = 3) and incomplete obstruction (n = 1). All patients but 9 received adjuvant chemotherapy afterwards, mainly were oxaliplatin based regimen. Up to December 1, 2007, there were 9 recurrence, including 1 local, 7 distant and 1 regional plus distant metastasis. Conclusions: In patients with stage II and III rectal adenocarcinoma treated with concurrent capecitabine chemoradiotherapy, the toxicity is well tolerated. Diarrhea is the most common and severe toxicity but with no interruption of treatment. With very close follow up, only 9 of 75 patients develop recurrence, mainly in distance. No significant financial relationships to disclose.