Pre-operative radiochemotherapy with raltitrexed for resectable locally-advanced rectal cancer: a phase II study.
BACKGROUND
The aim of the study was to evaluate the response to and toxicity of pre-operative radiochemotherapy containing raltitrexed (Tomudex) for resectable rectal adenocarcinoma.


METHODS
From November 2000 to June 2002, 18 consecutive patients staged T3 NO0N+ were treated with pre-operative chemotherapy (3 mg/m2 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.


CONCLUSIONS
Raltitrexed did not 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.
Leonardi
Maria Cristina
MC
Division of Radiation Oncology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy. cristina.leonardi@ieo.it
Zampino
Maria Giulia
MG
Luca
Fabrizio
F
Jereczek-Fossa
Barbara Alicja
BA
Petazzi
Elena
E
Tatani
Brunilda
B
Lazzari
Roberta
R
Biffi
Roberto
R
Lorizzo
Katia
K
Magni
Elena
E
Scanniffio
Diego
D
Orsi
Franco
F
Bonomo
Guido
G
Petralia
Giuseppe
G
Trovato
Cristina
C
Crosta
Cristiano
C
Andreoni
Bruno
B
Orecchia
Roberto
R
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011300:Preoperative Care; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*
D000964:Antimetabolites, Antineoplastic; D011799:Quinazolines; D013876:Thiophenes; C068874:raltitrexed