Abstract | BACKGROUND: METHODS: The 5-FU dose was selected on the basis of dose-limiting toxicities (DLTs) during part I of the study. Patients received cetuximab (400 mg/m2 initial dose and 250 mg/m2/week thereafter) and every 2 weeks irinotecan (180 mg/m2), FA (400 mg/m2) and 5-FU (either low dose [LD], 300 mg/m2 bolus plus 2,000 mg/m2 46-hour infusion, n = 7; or, high-dose [HD], 400 mg/m2 bolus plus 2,400 mg/m2; n = 45). RESULTS: Only two DLTs occurred in the HD group, and HD 5-FU was selected for use in part II. Apart from rash, commonly observed grade 3/4 adverse events such as leucopenia, diarrhoea, vomiting and asthenia occurred within the expected range for FOLFIRI. Among 52 patients, the overall response rate was 48%. Median progression-free survival (PFS) was 8.6 months (counting all reported progressions) and the median overall survival was 22.4 months. Treatment facilitated the resection of initially unresectable metastases in fourteen patients (27%): of these, 10 patients (71%) had no residual tumour after surgery, and these resections hindered the estimation of PFS. CONCLUSION: The combination of cetuximab and FOLFIRI was active and well tolerated in this setting. Initially unresectable metastases became resectable in one-quarter of patients, with a high number of complete resections, and these promising results formed the basis for the investigation of FOLFIRI with and without cetuximab in the phase III CRYSTAL trial.
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Authors | Jean-Luc Raoul, Jean-Luc Van Laethem, Marc Peeters, Catherine Brezault, Fares Husseini, Laurent Cals, Johannes Nippgen, Anja-Helena Loos, Philippe Rougier |
Journal | BMC cancer
(BMC Cancer)
Vol. 9
Pg. 112
(Apr 14 2009)
ISSN: 1471-2407 [Electronic] England |
PMID | 19366444
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Irinotecan
- Cetuximab
- Leucovorin
- Fluorouracil
- Camptothecin
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Topics |
- Adult
- Aged
- Antibodies, Monoclonal
(administration & dosage, adverse effects)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Camptothecin
(administration & dosage, adverse effects, analogs & derivatives)
- Cetuximab
- Colorectal Neoplasms
(drug therapy, pathology)
- Diarrhea
(chemically induced)
- Disease Progression
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Exanthema
(chemically induced)
- Female
- Fluorouracil
(administration & dosage, adverse effects)
- Follow-Up Studies
- Humans
- Infusions, Intravenous
- Irinotecan
- Leucovorin
(administration & dosage, adverse effects)
- Leukopenia
(chemically induced)
- Male
- Middle Aged
- Neoplasm Metastasis
- Survival Analysis
- Treatment Outcome
- Vomiting
(chemically induced)
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