VYZULA, Rostislav, Ilona KOCÁKOVÁ, Regina DEMLOVÁ, Igor KISS, Ladislav DUŠEK and Jiří JARKOVSKÝ. Raltitrexed plus oxaliplatin in the second-line treatment of metastatic colorectal cancer. Neoplasma. 2006, vol. 53, No 2, p. 119-127. ISSN 0028-2685.
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Basic information
Original name Raltitrexed plus oxaliplatin in the second-line treatment of metastatic colorectal cancer.
Name in Czech Raltitrexed plus oxaliplatin in the second-line treatment of metastatic colorectal cancer.
Authors VYZULA, Rostislav (203 Czech Republic, guarantor), Ilona KOCÁKOVÁ (203 Czech Republic), Regina DEMLOVÁ (203 Czech Republic), Igor KISS (203 Czech Republic), Ladislav DUŠEK (203 Czech Republic) and Jiří JARKOVSKÝ (203 Czech Republic).
Edition Neoplasma, 2006, 0028-2685.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30200 3.2 Clinical medicine
Country of publisher Slovakia
Confidentiality degree is not subject to a state or trade secret
Impact factor Impact factor: 1.247
RIV identification code RIV/00216224:14110/06:00039991
Organization unit Faculty of Medicine
UT WoS 000236399400006
Keywords in English colorectal cancer; palliative chemotherapy; raltitrexed oxaliplatin
Tags Colorectal cancer, palliative chemotherapy, raltitrexed oxaliplatin
Changed by Changed by: prof. RNDr. Ladislav Dušek, Ph.D., učo 670. Changed: 1/4/2010 10:00.
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/m(2) as a 15-minute intravenous (IV) infusion followed 45 minutes later by oxaliplatin 130 mg/m(2) 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. A total of 51 patients, all with WHO performance 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.
Abstract (in Czech)
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/m(2) as a 15-minute intravenous (IV) infusion followed 45 minutes later by oxaliplatin 130 mg/m(2) 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. A total of 51 patients, all with WHO performance 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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