Abstract | BACKGROUND: PATIENTS AND METHODS: Seventy-one patients received oxaliplatin 130 mg/m(2) and raltitrexed 3 mg/m(2) intravenously on an outpatient basis every 3 weeks. All patients had histologically proven metastatic colorectal adenocarcinoma, performance status <or=2 and good baseline organ function. Most (56%) had only one disease site. All patients were assessed for safety, and 66 of 69 eligible patients were assessed for response. RESULTS: A total of 404 cycles were administered, with a median of six cycles per patient (range 1-12 cycles). Relative dose intensities were 0.98 and 0.98 for oxaliplatin and raltitrexed, respectively. The most common grade 3-4 toxicities (National Cancer Institute Common Toxicity Criteria) among treated patients were as follows: neutropenia (21 patients, 30%), asthenia (eight, 11%), diarrhea (12, 17%), liver function test abnormalities (24, 34%), nausea (nine, 13%) and vomiting (nine, 13%). Two treatment-related deaths occurred (hematotoxicity in one patient and gastrointestinal toxicity in the other) and two further deaths were possibly related to treatment (hepatic dysfunction in one patient and neuropathy in the other). Thirty-seven objective responses (one complete) were obtained [objective response rate 54%; 95% confidence interval (CI) 42% to 65%] in eligible patients. The median response duration was 8.5 months (95% CI 6.7-12.2 months), while median progression-free and overall survival among eligible patients were 6.2 (95% CI 5.1-6.9 months) and 14.6 months (95% CI 11.0-18.9 months), respectively. CONCLUSIONS:
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Authors | J-F Seitz, J Bennouna, B Paillot, E Gamelin, E François, T Conroy, J-L Raoul, Y Becouarn, F Bertheault-Cvitkovic, M Ychou, S Nasca, A Fandi, P Barthelemy, J-Y Douillard |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 13
Issue 7
Pg. 1072-9
(Jul 2002)
ISSN: 0923-7534 [Print] England |
PMID | 12176786
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Organoplatinum Compounds
- Pyridines
- Quinazolines
- Thiophenes
- oxiplatin
- raltitrexed
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Topics |
- Adenocarcinoma
(drug therapy, mortality, pathology)
- Adult
- Aged
- Ambulatory Care
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Biopsy, Needle
- Colorectal Neoplasms
(drug therapy, mortality, pathology, secondary)
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Infusions, Intravenous
- Male
- Middle Aged
- Neoplasm Staging
- Organoplatinum Compounds
(administration & dosage)
- Pyridines
(administration & dosage)
- Quinazolines
(administration & dosage)
- Survival Analysis
- Thiophenes
(administration & dosage)
- Treatment Outcome
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