Pre-operative radiochemotherapy with raltitrexed for resectable locally-advanced rectal cancer: a phase II study
Leonardi, M.Cristina.; Zampino, M.Giulia.; Luca, F.; Jereczek-Fossa, B.Alicja.; Petazzi, E.; Tatani, B.; Lazzari, R.; Biffi, R.; Lorizzo, K.; Magni, E.; Scanniffio, D.; Orsi, F.; Bonomo, G.; Petralia, G.; Trovato, C.; Crosta, C.; Andreoni, B.; Orecchia, R.
Anticancer Research 26(3b): 2419-2423
2006
ISSN/ISBN: 0250-7005 PMID: 16821626 Document Number: 598877
Background: The aim of the study was to evaluate the response to and toxicity of pre-operative radio-chemotherapy containing raltitrexed (Tomudex) for resectable rectal adenocarcinoma. Patients and Methods: From November 2000 to June 2002, 18 consecutive patients staged T3 N0/N+ were treated with pre-operative chemotherapy (3 mg/m(2) of raltitrexed on days 1, 19, 38) and concurrent radiotherapy (RT) (50.4 Gy) in 6 weeks, followed by radical surgery within 8 weeks. Results: The treatment compliance was high. No major acute toxicity was reported. Concerning late toxicity, genitourinary adverse effects were prevalent. A complete response was observed in one patient (6%), partial response in eight (47%), stable disease in seven (41%) and progression in one case. Three-year actuarial disease free and overall survival rates were 37% and 87.5%, respectively. Conclusion: Raltitrexed did riot increase the pathological response rate compared with the rates obtained with use of preoperative RT alone and reported in the literature. Acute morbidity was low and acceptable, while late toxicity was considerable, prevalently concerning sexual dysfunction and urinary complications.