Phase II 2-arm trial of the proteasome inhibitor, PS-341 (bortezomib) in combination with irinotecan or PS-341 alone followed by the addition of irinotecan at time of progression in patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck (E1304): a trial of the Eastern Cooperative Oncology Group.

Gilbert J, Lee JW, Argiris A, Haigentz M, Feldman LE, Jang M, Arun P, Van Waes C, Forastiere AA
Head Neck. 2013 35 (7): 942-8

PMID: 22791234 · PMCID: PMC3689864 · DOI:10.1002/hed.23046

BACKGROUND - Constitutive activation of nuclear factor κB (NF-κB) is associated with poor prognosis. Irinotecan demonstrates single-agent activity in head and neck cancer but activates NF-κB, promoting cell survival and resistance. Bortezomib is a proteasome inhibitor that inactivates NF-κB.

PATIENTS AND METHODS - We performed a randomized phase II trial of bortezomib on days 1, 4, 8, and 11 and irinotecan on days 1 and 8 of each 21-day cycle or single-agent bortezomib on days 1, 4, 8, and 11 on a 21-day cycle. The addition of irinotecan to bortezomib was allowed in patients who progressed on bortezomib alone.

RESULTS - The response rate of bortezomib and irinotecan was 13%. One patient had a partial response to bortezomib alone (response rate 3%). No responses were seen in patients with addition of irinotecan at time of progression on bortezomib.

CONCLUSIONS - The bortezomib-based regimens evaluated in this study have minimal activity in recurrent or metastatic head and neck cancer.

Published 2012 Wiley Periodicals, Inc.

MeSH Terms (20)

Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols Boronic Acids Bortezomib Camptothecin Carcinoma, Squamous Cell Cytokines Disease Progression Female Head and Neck Neoplasms Humans Irinotecan Male Middle Aged NF-kappa B Pyrazines Squamous Cell Carcinoma of Head and Neck Treatment Outcome

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