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

Jill Gilbert, Ju Whei Lee, Athanassios Argiris, Missak Haigentz, Lawrence Eric Feldman, Minyoung Jang, Pattatheyil Arun, Carter Van Waes, Arlene A. Forastiere

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

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

Original languageEnglish (US)
Pages (from-to)942-948
Number of pages7
JournalHead and Neck
Volume35
Issue number7
DOIs
StatePublished - Jul 2013

Fingerprint

irinotecan
Proteasome Inhibitors
Arm
Head and Neck Neoplasms
Bortezomib
Carcinoma, squamous cell of head and neck

Keywords

  • bortezomib
  • chemotherapy
  • head and neck cancer
  • irinotecan
  • phase II

ASJC Scopus subject areas

  • Otorhinolaryngology

Cite this

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, Jill; Lee, Ju Whei; Argiris, Athanassios; Haigentz, Missak; Feldman, Lawrence Eric; Jang, Minyoung; Arun, Pattatheyil; Van Waes, Carter; Forastiere, Arlene A.

In: Head and Neck, Vol. 35, No. 7, 07.2013, p. 942-948.

Research output: Contribution to journalArticle

@article{3cba8345b92a44a2b8b43cb466556c63,
title = "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",
abstract = "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",
keywords = "bortezomib, chemotherapy, head and neck cancer, irinotecan, phase II",
author = "Jill Gilbert and Lee, {Ju Whei} and Athanassios Argiris and Missak Haigentz and Feldman, {Lawrence Eric} and Minyoung Jang and Pattatheyil Arun and {Van Waes}, Carter and Forastiere, {Arlene A.}",
year = "2013",
month = "7",
doi = "10.1002/hed.23046",
language = "English (US)",
volume = "35",
pages = "942--948",
journal = "Head and Neck",
issn = "1043-3074",
publisher = "Wiley-Liss Inc.",
number = "7",

}

TY - JOUR

T1 - 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)

T2 - A trial of the Eastern Cooperative Oncology Group

AU - Gilbert, Jill

AU - Lee, Ju Whei

AU - Argiris, Athanassios

AU - Haigentz, Missak

AU - Feldman, Lawrence Eric

AU - Jang, Minyoung

AU - Arun, Pattatheyil

AU - Van Waes, Carter

AU - Forastiere, Arlene A.

PY - 2013/7

Y1 - 2013/7

N2 - 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

AB - 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

KW - bortezomib

KW - chemotherapy

KW - head and neck cancer

KW - irinotecan

KW - phase II

UR - http://www.scopus.com/inward/record.url?scp=84879420939&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879420939&partnerID=8YFLogxK

U2 - 10.1002/hed.23046

DO - 10.1002/hed.23046

M3 - Article

C2 - 22791234

AN - SCOPUS:84879420939

VL - 35

SP - 942

EP - 948

JO - Head and Neck

JF - Head and Neck

SN - 1043-3074

IS - 7

ER -