Raltitrexed concomitant with radiotherapy as neoadjuvant treatment in patients with locally advanced rectal carcinoma: a phase II study

OBJECTIVES We aimed to evaluate the treatment response and toxic effects of the recommended dose of raltitrexed when delivered concurrently with preoperative radiotherapy in patients with locally advanced rectal carcinoma. METHODS This open-labeled, prospective and non-comparative study was conducted with 49 patients. Radiotherapy (50.4 Gy) was delivered in 1.8 Gy daily fractions five times per week for 5-6 weeks. Single doses of 2.6 mg/m(2) raltitrexed were infused over 15 minutes 1 hour prior to radiotherapy on days 1 and 22. Treatment response and toxicity were clinically assessed by hematological and biochemical tests and World Health Organization performance status scoring. RESULTS Overall treatment response was 42.9%. Post-treatment resectability opportunity was achieved in 67.3% patients. Raltitrexed was found to be related to 52.6% of the total adverse events. CONCLUSION The combination of raltitrexed and radiotherapy appears promising as neoadjuvant therapy in patients with inoperable rectal cancer with higher but manageable gastrointestinal toxicity.