Neoplasma Vol.53, p.119-127, 2006
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Title: Raltitrexed plus oxaliplatin in the second-line treatment of
metastatic colorectal cancer
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Author: R., VYZULA
; I., KOCAKOVA
; R., R. DEMLOVA
; I., KISS
; L., DUSEK
; J., JARKOVSKY
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Abstract: The primary endpoint of this study was to evaluate the efficacy
(objective response rate; ORR) of combined chemotherapy
with raltitrexed plus oxaliplatin as second-line treatment in
patients with metastatic colorectal cancer (CRC). Secondary
endpoints were overall survival (OS), time to progression (TTP)
and toxicity (NCI-CTC criteria).
The target population were patients with metastatic colorectal
adenocarcinoma who progressed after first-line chemotherapy.
Treatment consisted of raltitrexed 3 mg/m2 as a 15-minute
intravenous (IV) infusion followed 45 minutes later by
oxaliplatin 130 mg/m2 IV as a 2-h infusion on Day 1, repeated
every 3 weeks until further disease progression (PD), unacceptable
toxicity or the decision of the patient.
Atotal of 51 patients, all withWHOperformance status 0–2 received
a median of 6 treatment cycles (range 1–11). After 3
cycles, 8 of the 47 evaluable patients (17%) had experienced an
ORR, 28 patients (59.6%) had experienced stable disease
(SD) and 11 patients (23.4%) had PD. After 6 cycles, 1 of the 29
evaluable patients (3.5%) had an ORR, 13 patients (44.8%)
had SD and 15 patients (51.7%) had PD. After a median follow-up of
48.9 weeks, median TTP was 18 weeks and median
overall survival was 54.4 weeks. Treatment was well tolerated;
grade 3 toxicities occurred in only 5/51 patients (9.8%). The
most common toxicities were paraesthesia (62.7%), diarrhoea
(23.5%), nausea (41.2%), vomiting (33.3%), hepatotoxicity
(25.5%), and hematological toxicity (41.2%).
In conclusion, the combination of oxaliplatin plus raltitrexed
appears to be effective and well tolerated as second-line
therapy in patients with disseminated CRC.
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Keywords: colorectal cancer, palliative chemotherapy, raltitrexed,
oxaliplatin
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Year: 2006, Volume: 53, Issue: |
Page From: 119, Page To: 127 |
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