| Intensive systemic chemotherapy combined with surgery for metastatic colorectal cancer: results of a phase II study. | |
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MedLine Citation:
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PMID: 15659495 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To evaluate the efficacy and tolerability of the metastatic irinotecan plus oxaliplatin (MIROX) strategy (adjuvant FOLFOX-7 followed by FOLFIRI), in patients with resectable metastatic colorectal cancer. PATIENTS AND METHODS: Forty-seven patients with resectable metastases of colorectal cancer were prospectively enrolled onto this study. Treatment consisted of six cycles of leucovorin 400 mg/m(2), oxaliplatin 130 mg/m(2) in a 120-minute infusion, and fluorouracil (FU) 2,400 mg/m(2) in a 46-hour infusion, every 2 weeks (FOLFOX-7), followed by six cycles of leucovorin 400 mg/m(2), irinotecan 180 mg/m(2) in a 90-minute infusion, bolus FU 400 mg/m(2), and FU 2,400 mg/m(2) as a 46-hour infusion, every 2 weeks (FOLFIRI). Surgery was performed before chemotherapy in 25 patients and after six cycles of FOLFOX-7 in 22 patients (six cycles of FOLFIRI were administered after surgery). RESULTS: All but one of the patients underwent curative surgery. Two patients refused postoperative chemotherapy. Tolerability was generally good. The main toxicities were grade 3 to 4 neutropenia (13%) and thrombocytopenia (11%); no febrile neutropenia or bleeding occurred, and there were no deaths caused by toxicity. Two pathologically confirmed complete responses and 15 partial responses were obtained with FOLFOX-7 in the 22 patients who received this regimen before surgery (overall response rate, 77%; 95% CI, 68 to 86). The median disease-free survival time was 21 months; the median overall survival has not yet been reached. The 2-year overall and disease-free survival rates were 89% and 47%, respectively. CONCLUSION: The MIROX strategy is feasible and well tolerated by patients with resectable metastatic colorectal cancer. Progression-free and overall survival rates are promising, with a median of 38 months of follow-up. This strategy currently is being compared with the leucovorin and FU regimen in a phase III trial. |
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Authors:
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Julien Taïeb; Pascal Artru; François Paye; Christophe Louvet; Nathalie Perez; Thierry André; Brice Gayet; Mohamed Hebbar; Frédérique Maindrault Goebel; Christophe Tournigand; Rolland Parc; Aimery de Gramont |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase II; Journal Article |
Journal Detail:
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Title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology Volume: 23 ISSN: 0732-183X ISO Abbreviation: J. Clin. Oncol. Publication Date: 2005 Jan |
Date Detail:
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Created Date: 2005-01-20 Completed Date: 2005-03-11 Revised Date: 2006-04-24 |
Medline Journal Info:
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Nlm Unique ID: 8309333 Medline TA: J Clin Oncol Country: United States |
Other Details:
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Languages: eng Pagination: 502-9 Citation Subset: IM |
Affiliation:
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Service d'hépatogastroentérologie, Groupe Hospitalier Pitié Salpétrière, 47-83 Boulevard de l'hôpital, 75013 Paris, France. jtaieb@club-internet.fr |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antineoplastic Combined Chemotherapy Protocols / administration & dosage, adverse effects, therapeutic use* Camptothecin / administration & dosage, analogs & derivatives Colorectal Neoplasms / drug therapy*, pathology, surgery* Combined Modality Therapy Disease-Free Survival Female Fluorouracil / administration & dosage Humans Infusions, Intravenous Injections, Intravenous Leucovorin / administration & dosage Male Middle Aged Neoplasm Metastasis Organoplatinum Compounds / administration & dosage Prospective Studies Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Folfox protocol; 0/IFL protocol; 0/IROX protocol; 0/Organoplatinum Compounds; 51-21-8/Fluorouracil; 58-05-9/Leucovorin; 7689-03-4/Camptothecin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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