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01-12-2020 | NSCLC | Original Research Article

Cetuximab in Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer Without KRAS, NRAS, or BRAF Mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Authors: Julie G. Fisher, David Tait, Elizabeth Garrett-Mayer, Susan Halabi, Pam K. Mangat, Julian C. Schink, Ricardo H. Alvarez, Dan Veljovich, Timothy L. Cannon, Pamela A. Crilley, Theodore Pollock, Carmen J. Calfa, Tareq Al Baghdadi, Ramya Thota, Nicole Fleming, Jared A. Cotta, Andrew L. Rygiel, Sasha L. Warren, Richard L. Schilsky

Published in: Targeted Oncology | Issue 6/2020

Abstract

Background

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study, a phase II basket study, evaluates anti-tumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known as drug targets.

Objective

With no known genomic targets predictive of sensitivity to cetuximab, cetuximab was evaluated in patients with breast cancer (BC), non-small cell lung cancer (NSCLC), and ovarian cancer (OC), without KRAS, NRAS, or BRAF mutations.

Patients and Methods

Eligible patients with advanced BC, NSCLC, and OC received a cetuximab loading dose, then weekly infusions (250 mg/m² over 60 min). A Simon two-stage design, requiring ten patients in stage I, was employed per each disease-specific cohort. The primary endpoint was disease control (objective response or stable disease for at least 16 weeks). If two or more patients in stage I achieved disease control, the cohort would enroll 18 more patients in stage II. Power and alpha of the design are 85% and 10%, respectively. Secondary endpoints included progression-free survival, overall survival, and safety.

Results

Patients with BC (n = 10), NSCLC (n = 10), and OC (n = 29) were enrolled between June 2016 and September 2018. No objective responses or stable disease for at least 16 weeks were observed in the BC and NSCLC cohorts. No objective responses and four patients with stable disease for at least 16 weeks were observed in the OC cohort. Six of 49 patients reported grade 3 or higher adverse events or serious adverse events at least possibly related to cetuximab.

Conclusions

Cetuximab does not have clinical activity in patients with advanced BC, NSCLC, and OC without KRAS, NRAS, or BRAF mutations.

Clinical Trial Registration

NCT02693535 (26 February, 2016).

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Title: Cetuximab in Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer Without KRAS, NRAS, or BRAF Mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Authors: Julie G. Fisher
David Tait
Elizabeth Garrett-Mayer
Susan Halabi
Pam K. Mangat
Julian C. Schink
Ricardo H. Alvarez
Dan Veljovich
Timothy L. Cannon
Pamela A. Crilley
Theodore Pollock
Carmen J. Calfa
Tareq Al Baghdadi
Ramya Thota
Nicole Fleming
Jared A. Cotta
Andrew L. Rygiel
Sasha L. Warren
Richard L. Schilsky
Publication date: 01-12-2020
Publisher: Springer International Publishing
Keywords: NSCLC
Breast Cancer
Ovarian Cancer
Ovarian Cancer
NSCLC
Breast Cancer
Cetuximab
Published in: Targeted Oncology / Issue 6/2020
Print ISSN: 1776-2596
Electronic ISSN: 1776-260X
DOI: https://doi.org/10.1007/s11523-020-00753-7

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Abstract

Background

Objective

Patients and Methods

Results

Conclusions

Clinical Trial Registration

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