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Cited by 41Colorectal Cancer Treatments and StudiesHER2/EGFR in Cancer ResearchLung Cancer Treatments and Mutations

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Pertuzumab plus trastuzumab (P+T) in patients (Pts) with colorectal cancer (CRC) with ERBB2 amplification or overexpression: Results from the TAPUR Study.

Gupta, Ranju, Garrett-Mayer, Elizabeth, Halabi, Susan, Mangat, Pam K., D'Andre, Stacy D., Meiri, Eyal, Shrestha, Sagun, Warren, Sasha L., Ranasinghe, Shamika, Schilsky, Richard L.·2020·Journal of Clinical Oncology
DOI 10.1200/jco.2020.38.4_suppl.132
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Abstract

132 Background: TAPUR is a phase II basket trial evaluating anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. Results in a cohort of CRC pts with ERBB2 overexpression or amplification treated with P+T are reported. Methods: Eligible pts had advanced CRC, no standard treatment (tx) options, measurable disease, ECOG PS 0-2, and adequate organ function. Genomic testing was performed in CLIA-certified, CAP-accredited site selected labs. Pts had ERBB2 overexpression or amplification, or certain ERBB2 mutations. Recommended dosing after initial dosing was P, 420 mg IV over 30-60 mins every 3 weeks (wks) and T, 6 mg/kg over 30-60 mins every 3 wks. Simon two-stage design was used to test a null rate of 15% vs. 35% (power = 0.85; α = 0.10). If ≥2 of 10 pts in stage 1 have disease control (DC) (objective response (OR) or stable disease at 16+ wks per RECIST (SD16+)), 18 more pts enrolled. If ≥7 of 28 pts have DC, the tx is worthy of further study. Secondary endpoints are progression-free survival (PFS), overall survival (OS) and safety. Results: Twenty-eight pts enrolled from November 2016 to September 2018 were evaluable for efficacy and safety. Demographics and outcomes are summarized in Table. All pts had ERBB2 amplification; 1 also had an ERBB2 mutation. 79% of pts had at least 3 prior txs. Four PR and 10 SD16+ were observed for DC and OR rates of 50% (90% CI, 36% to 60%) and 14% (95% CI, 4% to 33%), respectively. Two pts had at least one grade 3 AE or SAE at least possibly related to P+T including anemia, infusion reaction, and left ventricular dysfunction. Conclusions: The combination of P+T showed anti-tumor activity in heavily pre-treated CRC pts with ERBB2 amplification . Additional analyses by RAS mutation status are pending. Further study is warranted to confirm efficacy of P+T in this population. Clinical trial information: NCT02693535. [Table: see text]

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Authors
Gupta, R., Garrett-Mayer, E., Halabi, S., Mangat, P. K., D'Andre, S. D., Meiri, E., Shrestha, S., Warren, S. L., Ranasinghe, S., & Schilsky, R. L.
Affiliations
  • Lehigh Valley Health Network (US)
  • Medical University of South Carolina (US)
  • Duke Medical Center (US)
  • American Society of Clinical Oncology (US)
  • Sutter Medical Group, Sacramento, CA;
  • Cancer Treatment Centers of America (US)
  • Southwestern Reg Medcl Ctr, Tulsa, OK;
ORCID
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2020-02-01
Volume
38
Issue
4_suppl
Pages
132-132
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2020.38.4_suppl.132
OpenAlex
W3004698092
Cited by
41
References
0
Citations by year
2025: 1 · 2024: 4 · 2023: 10 · 2022: 14 · 2021: 7 · 2020: 5
Type
conference abstract
Language
en
Open access
closed
Locations
Journal of Clinical Oncology (publishedVersion)
Funders
Genentech
Topics
  • Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
  • Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Keywords
pertuzumab, trastuzumab, colorectal cancer, ERBB2 amplification, HER2 overexpression, HER2 mutation, HER2-targeted therapy, advanced colorectal cancer, objective response rate, progression-free survival, left ventricular dysfunction, drug safety, heavily pretreated patients, RAS mutation status, targeted therapy

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