Tolerability of Raltitrexed ('Tomudex') in elderly patients with colorectal cancer.
OBJECTIVE
Colorectal cancer (CRC) is one of the major health problems of the Western world and the proportion of elderly patients with CRC is growing. Raltitrexed ('Tomudex'), a specific thymidylate synthase inhibitor, has shown efficacy and manageable toxicity in elderly CRC patients. In this retrospective study, the tolerability of raltitrexed in patients with CRC was examined in relation to age.


METHODS
Toxicity parameters, graded according to World Health Organization criteria, were assessed in two patient groups: < 70 and > or = 70 years old. In total, 56% (50 out of 90) of patients treated with raltitrexed (3 mg/m2 as a 15-minute intravenous infusion every 3 weeks) were aged > 70 years (M:F 28:22; Eastern Cooperative Oncology Group performance status 0-1:2 38:12).


RESULTS
Overall, 437 cycles of chemotherapy were administered and grade 3-4 toxicity was reported in < 10% of patients. There were no clinically significant differences between the two age groups, apart from grade 3-4 asthenia, which was reported by 6% and 0% of patients aged > or = 70 and < 70 years, respectively. This was in spite of a significantly lower calculated mean creatinine clearance in patients aged > or = 70 years compared with those patients < 70 years of age.


CONCLUSIONS
The raltitrexed toxicity profile does not appear to be significantly influenced by age; however caution is recommended in the management of elderly patients, particularly in the presence of impaired renal function.
Romiti
Adriana
A
National Cancer Institute of Genoa, Section of Rome, Department of Experimental Medicine and Pathology, La Sapienza University of Rome, Rome, Italy. adriana.romi@tin.it
Tonini
Giuseppe
G
Santini
Daniele
D
Di Seri
Marisa
M
Masciangelo
Raffaele
R
Mezi
Silvia
S
Verì
Attilio
A
Santuari
Lucia
L
Vincenzi
Bruno
B
Brescia
Antonio
A
Marchei
Paolo
P
Frati
Luigi
L
Tomao
Silverio
S
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000378:metabolism; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D003404:Creatinine / Q000097:blood / Q000652:urine; D005260:Female; D006801:Humans; D007668:Kidney / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D012189:Retrospective Studies; D012737:Sex Factors; D013876:Thiophenes / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use
D000964:Antimetabolites, Antineoplastic; D011799:Quinazolines; D013876:Thiophenes; D003404:Creatinine; C068874:raltitrexed