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

被引：36

作者：

Fisher, Julie G. ^{[1
]}

Tait, David ^{[1
]}

Garrett-Mayer, Elizabeth ^{[2
]}

Halabi, Susan ^{[3
]}

Mangat, Pam K. ^{[2
]}

Schink, Julian C. ^{[4
]}

Alvarez, Ricardo H. ^{[5
]}

Veljovich, Dan ^{[6
]}

Cannon, Timothy L. ^{[7
]}

Crilley, Pamela A. ^{[8
]}

Pollock, Theodore ^{[9
]}

Calfa, Carmen J. ^{[10
]}

Al Baghdadi, Tareq ^{[11
]}

Thota, Ramya ^{[12
]}

Fleming, Nicole ^{[13
]}

Cotta, Jared A. ^{[10
]}

Rygiel, Andrew L. ^{[2
]}

Warren, Sasha L. ^{[2
]}

Schilsky, Richard L. ^{[2
]}

机构：

[1] Atrium Hlth, Levine Canc Inst, Charlotte, NC USA

[2] Amer Soc Clin Oncol, 2318 Mill Rd, Alexandria, VA 22314 USA

[3] Duke Univ, Med Ctr, Durham, NC USA

[4] Canc Treatment Ctr Amer, Chicago, IL USA

[5] Canc Treatment Ctr Amer, Atlanta, GA USA

[6] Swedish Canc Inst, Seattle, WA USA

[7] Inova Schar Canc Inst, Fairfax, VA USA

[8] Canc Treatment Ctr Amer, Philadelphia, PA USA

[9] Canc Treatment Ctr Amer, Tulsa, OK USA

[10] Univ Miami, Miller Sch Med, Sylvester Comprehens Canc Ctr, Miami, FL 33136 USA

[11] Michigan Canc Res Consortium, Ypsilanti, MI USA

[12] Intermt Precis Genom Canc Clin, Salt Lake City, UT USA

[13] Univ Texas MD Anderson Canc Ctr, Sugar Land, TX USA

来源：

TARGETED ONCOLOGY | 2020年 / 15卷 / 06期

关键词：

PREDICTIVE-VALUE; PHASE-II; CHEMOTHERAPY; PATHOGENESIS; EXPRESSION; THERAPY; PIK3CA; TRIAL;

D O I：

10.1007/s11523-020-00753-7

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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/m(2) 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.

引用

页码：733 / 741

页数：9

共 26 条

[21] Phase II trial of single agent cetuximab in patients with persistent or recurrent epithelial ovarian or primary peritoneal carcinoma with the potential for dose escalation to rash [J].