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- Title
Phase II randomised trial of raltitrexed-oxaliplatin vs raltitrexed-irinotecan as first-line treatment in advanced colorectal cancer.
- Authors
Feliu, J.; Castañón, C.; Salud, A.; Mel, J. R.; Escudero, P.; Pelegrín, A.; López-Gómez, L.; Ruiz, M.; González, E.; Juárez, F.; Lizón, J.; Castro, J.; González-Barón, M.; Castañón, C; Pelegrín, A; López-Gómez, L; González, E; Juárez, F; Lizón, J; González-Barón, M
- Abstract
The purpose of this phase II randomised trial was to determine which of two schemes, raltitrexed-irinotecan or raltitrexed-oxaliplatin, offered better activity and less toxicity in patients with advanced colorectal cancer (CRC). A total of 94 patients with previously untreated metastatic CRC were included and randomised to receive raltitrexed 3 mg m−2 followed by oxaliplatin 130 mg m−2 on day 1 (arm A), or CPT-11 350 mg m−2 followed by raltitrexed 3 mg m−2 (arm B). In both arms treatment was repeated every 3 weeks. Intent-to-treat (ITT) analysis showed an overall response rate of 46% (95% CI, 29.5–57.7%) for arm A, and 34% (95% CI, 19.8–48.4%) for arm B. Median time to progression was 8.2 months for arm A and 8.8 months for arm B. After a median follow-up of 14 months, 69% of patients included in arm A were still alive, compared to 59% of those included in arm B. Overall, 31 patients (65%) experienced some episode of toxicity in arm A and 32 patients (70%) in arm B, usually grade 1–2. The most common toxicity was hepatic, with 29 patients (60%) in arm A and 24 patients (62%) in arm B, and was grade 3–4 in four (8%) and four (9%) patients, respectively. In all, 14 patients (29%) from arm A and 24 patients (52%) from arm B had some grade of diarrhoea (P<0.03). Neurologic toxicity was observed in 31 patients (64%) in arm A, and was grade 3–4 in five patients (10%), while a cholinergic syndrome was detected in nine patients (19%) in arm B. There were no differences in haematologic toxicity. One toxic death (2%) occurred in arm A and three (6.5%) in arm B. In conclusion, both schemes have high efficacy as first-line treatment in metastatic CRC and their total toxicity levels are similar. Regimens with raltitrexed seem a reasonable alternative to fluoropyrimidines.British Journal of Cancer (2005) 93, 1230–1235. doi:10.1038/sj.bjc.6602860 www.bjcancer.com Published online 1 November 2005
- Subjects
CLINICAL drug trials; CANCER treatment; CLINICAL trials; COLON cancer; DIARRHEA; ANTINEOPLASTIC agents; THERAPEUTIC use of antineoplastic agents; SULFUR compounds; RESEARCH; INTRAVENOUS therapy; HETEROCYCLIC compounds; CAMPTOTHECIN; COLORECTAL cancer; ORGANOPLATINUM compounds; TREATMENT effectiveness; COMPARATIVE studies; RANDOMIZED controlled trials; SURVIVAL analysis (Biometry)
- Publication
British Journal of Cancer, 2005, Vol 93, Issue 11, p1230
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/sj.bjc.6602860