Phase I/II study of cetuximab in combination with cisplatin or carboplatin and fluorouracil in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Details

Serval ID
serval:BIB_86450352562D
Type
Article: article from journal or magazin.
Collection
Publications
Title
Phase I/II study of cetuximab in combination with cisplatin or carboplatin and fluorouracil in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Journal
Journal of Clinical Oncology
Author(s)
Bourhis J., Rivera F., Mesia R., Awada A., Geoffrois L., Borel C., Humblet Y., Lopez-Pousa A., Hitt R., Vega Villegas M.E., Duck L., Rosine D., Amellal N., Schueler A., Harstrick A.
ISSN
1527-7755 (Electronic)
ISSN-L
0732-183X
Publication state
Published
Issued date
2006
Peer-reviewed
Oui
Volume
24
Number
18
Pages
2866-2872
Language
english
Notes
Publication types: Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled TrialPublication Status: ppublish
Abstract
PURPOSE: This was an open, randomized, multicenter, phase I/II study to investigate the safety and tolerability of cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).
PATIENTS AND METHODS: Treatment comprised cetuximab (initial dose 400 mg/m2 with subsequent weekly doses of 250 mg/m2) in combination with 3-week cycles of either cisplatin (100 mg/m2) or carboplatin (area under the curve, 5), each in combination with a 5-day infusion of fluorouracil (FU) at escalating doses of 600, 800, and 1,000 mg/m2/d. The study was divided into two phases: A, the first two cycles (6 weeks) focusing on the safety and tolerability of combination therapy; and B, the remaining time for those benefiting from therapy until disease progression or intolerable toxicity.
RESULTS: Fifty-three patients were enrolled onto the study. The incidence of dose-limiting toxicities in phase A was acceptable. The most common grade 3/4 adverse events in both groups were leucopenia (38%), asthenia (25%), vomiting (14%), and thrombocytopenia (15%), which are consistent with the known safety profiles of cetuximab, cisplatin/carboplatin, and FU. The overall response rate among patients was 36%, with no clear trend toward an increased efficacy at the highest dose of FU, and no impact of the concomitant chemotherapy regimens on cetuximab pharmacokinetics.
CONCLUSION: The combination of cetuximab, cisplatin/carboplatin, and FU was reasonably well tolerated and active in recurrent/metastatic SCCHN, and merits additional investigation. An FU dose of 1,000 mg/m2/d in combination with cisplatin or carboplatin can be recommended for additional studies.
Keywords
Adult, Aged, Antibodies, Monoclonal/administration & dosage, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carboplatin/administration & dosage, Carcinoma, Squamous Cell/drug therapy, Carcinoma, Squamous Cell/secondary, Cisplatin/administration & dosage, Female, Fluorouracil/administration & dosage, Head and Neck Neoplasms/drug therapy, Head and Neck Neoplasms/pathology, Humans, Male, Middle Aged, Neoplasm Recurrence, Local/drug therapy, Survival Analysis
Pubmed
Create date
01/12/2014 17:37
Last modification date
20/08/2019 14:45
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