Phase II study of preoperative radiotherapy and concomitant weekly intravenous oxaliplatin combined with oral capecitabine for stages II-III rectal cancer
Clinical and Translational Oncology, 07/17/2012
Salazar R et al. – The pathologic complete response (pCR) rate observed with oxaliplatin plus capecitabine and radiotherapy (RT) did not reach the pre–specified criteria of efficacy in this trial, which is in line with recent results of randomized phase III trials.Methods
- Patients with histologically confirmed stages II–III (T3–T4 and/or N+) resectable rectal adenocarcinoma were eligible.
- Capecitabine was administered at 825mg/m2 twice daily for 5days/week and oxaliplatin at 50mg/m2 on day 1 weekly for 5weeks starting the first day of RT (before RT).
- RT consisted of a total dose of 45Gy delivered in 25 fractions of 1.8Gy, 5days per week, for 5weeks.
- A total of 46 patients were included (35 male, 10 female, median age 62years).
- TNM Stage was T3 in 43 patients and T4 in 2.
- Twenty-eight patients had suspected nodal involvement.
- The intended chemoradiation treatment was completed in 94 % patients.
- Grade 3/4 toxicity included lymphocytopenia (6 patients), diarrhea (4 patients), emesis (2 patients), asthenia (3 patients), anorexia (1 patient), and hepatic toxicity (1 patient).
- Grade 1 neurotoxicity occurred in 18 patients, Grade 2 neurotoxicity in 3, and Grade 1 palmoplantar erythrodysesthesia in 2.
- Forty-two patients underwent surgery (complete resection 95 %, sphincter-saving operation 55 %).
- The overall pathologic response rate was 83 %, with a pathologic complete response (pCR) rate of 11.9 % (95 % CI 4.0–25.6).