Palbociclib in Patients With Pancreatic and Biliary Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study

Al Baghdadi, Tareq; Halabi, Susan; Garrett-Mayer, Elizabeth; Mangat, Pam K.; Ahn, Eugene R.; Sahai, Vaibhav; Alvarez, Ricardo H.; Kim, Edward S.; Yost, Kathleen J.; Rygiel, Andrew Lawrence; Antonelli, Kaitlyn R.; Butler, Nicole L.; Bruinooge, Suanna S.; Schilsky, Richard L.

doi:10.1200/po.19.00124

Cited by 94Pancreatic and Hepatic Oncology ResearchAdvanced Breast Cancer TherapiesCancer Genomics and Diagnostics

Palbociclib in Patients With Pancreatic and Biliary Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study

Al Baghdadi, Tareq, Halabi, Susan, Garrett-Mayer, Elizabeth, Mangat, Pam K., Ahn, Eugene R., Sahai, Vaibhav, Alvarez, Ricardo H., Kim, Edward S. +6 more·2019·JCO Precision Oncology

DOI 10.1200/po.19.00124

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Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study identifies signals of antitumor activity of commercially available targeted agents in patients with advanced cancers that harbor genomic alterations known as drug targets. In this article, data from two cohorts of patients with pancreatic and biliary cancers with CDKN2A loss or mutation treated with palbociclib are reported. METHODS: Eligible patients age 12 years and older with advanced measurable or evaluable solid tumors are provided treatment according to protocol-specified genomic matching rules. The primary study end point is objective response or stable disease of at least 16 weeks duration. For each cohort, a Simon two-stage design was used with a futility evaluation after 10 patients. Secondary end points include safety, progression-free survival (PFS), and overall survival (OS). RESULTS: Between July 2016 and November 2017, 12 and 10 patients with pancreatic and biliary cancer, respectively, with CDKN2A loss or mutation were treated with palbociclib. Twenty evaluable patients (10 per cohort) were included in the analysis. No patients had objective response or stable disease at 16 weeks, and both cohorts were closed. Two patients, neither with response, were determined to be ineligible. All patients were evaluated for safety, PFS, and OS. A median PFS of 7.2 weeks (90% CI, 4.0 to 8.0 weeks) and median OS of 12.4 weeks (90% CI, 4.7 to 23.1 weeks) were observed in the pancreatic cohort. A median PFS of 7.3 weeks (90% CI, 3.9 to 7.9 weeks) and median OS of 11.1 weeks (90% CI, 5.1 to 14.0 weeks) were observed in the biliary cohort. No unexpected toxicities were observed. CONCLUSION: Palbociclib monotherapy does not have clinical activity in patients with advanced pancreatic or biliary cancers with CDKN2A loss or mutation. Toxicity is similar to reported experience with palbociclib in other tumor types.

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Clinical activity of CDK4/6 inhibitors was not seen in early-phase trials.
“A therapeutic approach targeting CDKN2A in KRAS-mutated PDAC is under investigation; however, clinical activity of CDK4/6 inhibitors was not seen in early-phase trials55,56.”
From Impact of KRAS mutations and co-mutations on clinical outcomes in pancreatic ductal adenocarcinoma (2024) · cites this paper as [56]
A therapeutic approach targeting CDKN2A in KRAS-mutated PDAC is under investigation.
“A therapeutic approach targeting CDKN2A in KRAS-mutated PDAC is under investigation; however, clinical activity of CDK4/6 inhibitors was not seen in early-phase trials55,56.”
From Impact of KRAS mutations and co-mutations on clinical outcomes in pancreatic ductal adenocarcinoma (2024) · cites this paper as [56]

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Authors: Al Baghdadi, T., Halabi, S., Garrett-Mayer, E., Mangat, P. K., Ahn, E. R., Sahai, V., Alvarez, R. H., Kim, E. S., Yost, K. J., Rygiel, A. L., Antonelli, K. R., Butler, N. L., Bruinooge, S. S., & Schilsky, R. L.
Affiliations: Michigan Cancer Research Consortium, Ypsilanti, MI
Duke Medical Center (US)
American Society of Clinical Oncology (US)
Cancer Treatment Centers of America (US)
U-M Rogel Cancer Center (US)
Cancer Treatment Centers of America, Atlanta, GA
Levine Cancer Institute (US)
Cancer Research Consortium of West Michigan, Grand Rapids, MI
ORCID: Halabi, Susan
Garrett-Mayer, Elizabeth
Mangat, Pam K.
Ahn, Eugene R.
Sahai, Vaibhav
Kim, Edward S.
Yost, Kathleen J.
Antonelli, Kaitlyn R.
Butler, Nicole L.
Bruinooge, Suanna S.
Schilsky, Richard L.
Venue: JCO Precision Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2019-12
Volume: 3
Issue: 3
Pages: 1-8
ISSN: 2473-4284 (ISSN-L)
DOI: 10.1200/po.19.00124
OpenAlex: W2968474136
Cited by: 94
References: 27
Citations by year: 2026: 6 · 2025: 6 · 2024: 17 · 2023: 23 · 2022: 18 · 2021: 15 · 2020: 9
FWCI: 4.42
Type: journal article
Language: en
Open access: closed
Locations: JCO Precision Oncology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
Keywords: palbociclib, CDKN2A mutation, CDKN2A loss, pancreatic cancer, biliary tract cancer, targeted therapy, genomic profiling, anticancer activity, progression-free survival, overall survival, drug safety

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Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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Palbociclib in Patients With Pancreatic and Biliary Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study

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