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

摘要: 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 resistance. Bortezomib a proteasome inhibitor that inactivates NF-κB. Patients Methods We performed randomized phase II trial bortezomib on days 1, 4, 8, 11 irinotecan 1 8 each 21-day cycle or cycle. The addition to was allowed patients who progressed alone. Results The response rate 13%. One patient had partial alone (response 3%). No responses were seen at time progression bortezomib. Conclusions The bortezomib-based regimens evaluated this study have minimal recurrent metastatic cancer. Head Neck, 2013