Evidence map›Paper›PMID 31981071›Full record

Trial reportInvestigational new drugs2020

A multi-center phase II trial evaluating the efficacy of palbociclib in combination with carboplatin for the treatment of unresectable recurrent or metastatic head and neck squamous cell carcinoma.

Paul L Swiecicki, Greg Durm, Emily Bellile, Apurva Bhangale, J Chad Brenner, Francis P Worden

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.9field-weighted citation impact, top 7% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 29 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Cyclin-dependent kinase (CDK) inhibitors in solid tumors: a review of clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
    Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. 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

6 authors at 2 institutions in 1 country.

Paul L SwiecickiDepartment of Internal Medicine, Division of Hematology/Oncology, University of Michigan Medical School, 300 N Ingalls St, SPC 5419, Ann Arbor, MI, 48109, USA. pswiecic@med.umich.edu.ORCID http://orcid.org/0000-0003-2286-3555
Greg DurmDepartment of Internal Medicine, Division of Hematology/Oncology, Indiana University, Indianapolis, IN, USA.
Emily BellileDepartment of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.
Apurva BhangaleDepartment of Otolaryngology-Head and Neck Surgery, University of Michigan Medical School, University of Michigan Health System, Ann Arbor, MI, USA.
J Chad BrennerRogel Cancer Center, University of Michigan Medical School, Ann Arbor, MI, USA.
Francis P WordenDepartment of Internal Medicine, Division of Hematology/Oncology, University of Michigan Medical School, 300 N Ingalls St, SPC 5419, Ann Arbor, MI, 48109, USA.
University of Michigan · USIndiana University – Purdue University Indianapolis · US

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Alexey I Nesvizhskii · 1988 to 2026
$178.2M
NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

Background Palbociclib is a selective inhibitor of CDK4/6 approved in metastatic breast cancer as well as evidence of activity in malignancies with CDK4-amplifications. Extensive preclinical evidence has demonstrated synergy of CDK4/6 inhibitors with platinum chemotherapy suggesting a potential role for clinical synthetic lethality. Given the sensitivity to platinum therapy as well as the landscape of genomic alterations, concurrent treatment with platinum chemotherapy and palbociclib is of significant interest as a novel treatment approach. Patients and Methods Patients with unresectable, recurrent, or metastatic head and neck cancer (R/M HNC) were enrolled. Eligible patients were required to have no previous treatment with cytotoxic chemotherapy in the recurrent/metastatic setting. This was a multicenter phase II trial in which patients were administered carboplatin in addition to concurrent palbociclib. The primary endpoint of this trial was 12-week disease control rate (DCR). Results Twenty-one patients were enrolled and 18 were evaluable for response. Grade 3/4 treatment related toxicities were seen in 79% of patients of which the most common were related to myelosuppression. 12-week DCR was 33% (5 patients with stable disease, 1 with a partial response). Median progression free survival was 2.9 months (range: 1.2-13.3) and overall survival was 4.6 months (range: 1.4-14.8). Conclusion The combination of carboplatin and palbociclib is associated with significant treatment related toxicity and insufficient anti-tumor activity.

Indexed as

AdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinFemaleHead and Neck NeoplasmsHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm Recurrence, LocalPiperazinesProtein Kinase InhibitorsPyridinesSquamous Cell Carcinoma of Head and NeckAntineoplastic AgentsCarboplatinpalbociclibPiperazinesProtein Kinase InhibitorsPyridinesCarboplatinCDK4/6Head and neck neoplasmHNSCCMetastatic head and neck cancerPalbociclib

Identifiers

PMID31981071
PMCPMC9487892
OpenAlexW3001505345

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.