Document Detail

Intensive systemic chemotherapy combined with surgery for metastatic colorectal cancer: results of a phase II study.
MedLine Citation:
PMID:  15659495     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Clinical Trial; Clinical Trial, Phase II; Journal Article    
Journal Detail:
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:
Created Date:  2005-01-20     Completed Date:  2005-03-11     Revised Date:  2006-04-24    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  502-9     Citation Subset:  IM    
Service d'hépatogastroentérologie, Groupe Hospitalier Pitié Salpétrière, 47-83 Boulevard de l'hôpital, 75013 Paris, France.
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MeSH Terms
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
Fluorouracil / administration & dosage
Infusions, Intravenous
Injections, Intravenous
Leucovorin / administration & dosage
Middle Aged
Neoplasm Metastasis
Organoplatinum Compounds / administration & dosage
Prospective Studies
Treatment Outcome
Reg. No./Substance:
0/Folfox protocol; 0/IFL protocol; 0/IROX protocol; 0/Organoplatinum Compounds; 51-21-8/Fluorouracil; 58-05-9/Leucovorin; 7689-03-4/Camptothecin

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