Evidence map›Paper›PMID 40973049›Full record

ArticleThe oncologist2025

Phase I study of palbociclib with cisplatin or carboplatin in the management of patients with advanced pancreatic cancer.

Olatunji B Alese, Robert Donald Harvey, Christina Wu, Elise Hitron, Hannah Collins, Suzanne Scott, Conor Steuer, Mehmet A Bilen, Bradley C Carthon, Jeffrey M Switchenko and 2 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02897375 (A Phase 1 Study of Palbociclib in Combination With Cisplatin or Carboplatin in Advanced Solid Malignancies), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02897375 phase1completednot on this map

A Phase 1 Study of Palbociclib in Combination With Cisplatin or Carboplatin in Advanced Solid Malignancies

TypeinterventionalSponsorEmory UniversityRan2016 to 2021Enrolled71ConditionsSolid Neoplasm, Stage III Pancreatic Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung CancerArmsCarboplatin, Cisplatin, Palbociclib
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Olatunji B AleseDepartment of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta, GA 30322, United States.ORCID 0000-0001-8079-4725
Robert Donald HarveyDepartment of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta, GA 30322, United States.
Christina WuMayo Clinic, Phoenix, AZ 85054, United States.
Elise HitronWinship Cancer Institute, Emory University, Atlanta, GA 30322, United States.
Hannah CollinsWinship Cancer Institute, Emory University, Atlanta, GA 30322, United States.
Suzanne ScottWinship Cancer Institute, Emory University, Atlanta, GA 30322, United States.
Conor SteuerDepartment of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta, GA 30322, United States.
Mehmet A BilenDepartment of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta, GA 30322, United States.
Bradley C CarthonDepartment of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta, GA 30322, United States.
Jeffrey M SwitchenkoBiostatistics Shared Resource, Winship Cancer Institute, Emory University, Atlanta, GA 30322, United States.
Suresh S RamalingamDepartment of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta, GA 30322, United States.
Taofeek K OwonikokoDepartment of Medicine, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, MD 21201, United States.

Funding

Winship Cancer Institute Cancer Center Support GrantP30CA138292 · NCI · EMORY UNIVERSITY · PI Ragini Reiney Kudchadkar · 2009 to 2026
$47.5M
NCI NIH HHS P30 CA138292Pfizer
6 · The paper itself

Abstract

importanceThe addition of agents targeting critical signal mediators of cancer cell proliferation such as cyclin-dependent kinases (CDK) potentiates the efficacy of platinum chemotherapy.ObjectiveTo determine the safety and efficacy of palbociclib combined with cisplatin (cis) or carboplatin (carbo) in advanced solid malignanciesDesignEnrollment on dose escalation (part I) proceeded using the Bayesian adaptive design Escalation with Overdose Control (EWOC).SettingSingle institution investigator initiated trial.

participantsPatients with any advanced cancer after at least one prior therapy were enrolled on dose escalation to determine recommended phase II doses (RP2D). Expansion cohorts were then opened for pancreaticobiliary tract cancers.InterventionEscalating doses of palbociclib in combination with different doses of cisplatin or carboplatin.Main Outcomes and MeasuresPrimary endpoint was objective response rate (ORR). Secondary endpoints included safety, overall survival (OS), and progression-free survival (PFS).

resultsWe enrolled 39 patients on dose escalation (part I) and 32 additional patients on dose expansion (part II). RP2D of palbociclib 100 mg on Day 2-22 + Cisplatin (cis) 60 mg/m2 IV on Day 1 Q4W (Arm A); and palbociclib 75 mg on Day 2-22 + Carboplatin (carbo) AUC 6 IV on Day 1 Q4W (Arm B). ORR for Part I were 12.5% (Arm A) and 25% (Arm B). Median PFS and OS for dose expansion were 2.1 and 4.9 months, respectively. For PDAC, mPFS was 1.9 months (95% CI: 1.7, 2.4), and OS was 3.7 months (95% CI: 2.7, 5.7). Most common treatment-related adverse events (TRAEs-all grade %): Arm A-neutropenia (66%), thrombocytopenia (26%), nausea, fatigue, and anemia (20% each); Arm B-neutropenia (64.7%), thrombocytopenia (53%), and anemia (29%). There were no grade 4-5 TRAEs. CONCLUSIONS AND RELEVANCE: The combination of palbociclib with cisplatin or carboplatin had an acceptable safety profile and clinical responses in some treatment refractory advanced cancers. There was no objective response, but about half of PDAC patients had disease stabilization. Additional efforts are needed to exploit CDK abnormalities in these patients. Clinical trial registration number: NCT02897375.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarboplatinCisplatinPancreatic NeoplasmsPiperazinesPyridinesAdultAgedFemaleHumansMaleMiddle AgedCarboplatinCisplatinpalbociclibPiperazinesPyridinesCDKclinical trialpalbociclibpancreatic cancerphase Iplatinum

Identifiers

PMID40973049
PMCPMC12517333

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.