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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
Author(s) -
Gilbert Jill,
Lee Ju Whei,
Argiris Athanassios,
Haigentz Missak,
Feldman Lawrence Eric,
Jang Minyoung,
Arun Pattatheyil,
Van Waes Carter,
Forastiere Arlene A.
Publication year - 2013
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.23046
Subject(s) - bortezomib , irinotecan , medicine , proteasome inhibitor , oncology , pharmacology , multiple myeloma , cancer , colorectal cancer
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. Head Neck, 2013