Evidence map›Paper›PMID 32045050›Full record

Trial reportThe oncologist2020

The PALBONET Trial: A Phase II Study of Palbociclib in Metastatic Grade 1 and 2 Pancreatic Neuroendocrine Tumors (GETNE-1407).

Enrique Grande, Alex Teulé, Teresa Alonso-Gordoa, Paula Jiménez-Fonseca, Marta Benavent, Jaume Capdevila, Ana Custodio, Ruth Vera, Javier Munarriz, Adelaida La Casta and 8 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.4field-weighted citation impact, top 6% 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

24 citing papers in PubMed, 41 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. 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
  15. Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 12 institutions in 1 country.

Enrique GrandeDepartment of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.
Alex TeuléDepartment of Medical Oncology, Catalan Institute of Oncology (Hospital Duran i Reynals), L'Hospitalet, Barcelona, Spain.
Teresa Alonso-GordoaDepartment of Medical Oncology, University Hospital Ramón y Cajal, IRYCIS, CIBERONC, Madrid, Spain.
Paula Jiménez-FonsecaDepartment of Medical Oncology, University Hospital Central de Asturias, Oviedo, Spain.
Marta BenaventDepartment of Medical Oncology, University Hospital Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBIS), Seville, Spain.
Jaume CapdevilaDepartment of Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), CIBERONC, Barcelona, Spain.
Ana CustodioDepartment of Medical Oncology, University Hospital La Paz, Centro de Investigación Biomédica en Red Cáncer CB16/12/00398, Madrid, Spain.
Ruth VeraDepartment of Medical Oncology, Complejo Hospitalario de Navarra, IdisNA, Pamplona, Spain.
Javier MunarrizDepartment of Medical Oncology, University Hospital General de Castellon, Castellon, Spain.
Adelaida La CastaDepartment of Medical Oncology, University Hospital Donostia, San Sebastián, Spain.
Juan José DíezDepartment of Endocrinology, University Hospital Puerta de Hierro Majadahonda, Department of Medicine, Faculty of Medicine, Universidad Autónoma, Madrid, Spain.
Pablo GajateDepartment of Medical Oncology, University Hospital Ramón y Cajal, IRYCIS, CIBERONC, Madrid, Spain.
Javier Molina-CerrilloDepartment of Medical Oncology, University Hospital Ramón y Cajal, IRYCIS, CIBERONC, Madrid, Spain.
Ignacio MatosDepartment of Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), CIBERONC, Barcelona, Spain.
Eva María CristóbalDepartment of Pathology, University Hospital Ramón y Cajal IRYCIS, CIBERONC, Madrid, Spain.
José C RuffinelliDepartment of Medical Oncology, Catalan Institute of Oncology (Hospital Duran i Reynals), L'Hospitalet, Barcelona, Spain.
José PalaciosDepartment of Pathology, University Hospital Ramón y Cajal, Departament of Medicine and Medical Specialties, Faculty of Medicine, University of Alcalá, IRYCIS, CIBERONC, Madrid, Spain.
Rocío García-CarboneroDepartment of Medical Oncology, University Hospital 12 de Octubre, IIS imas12, UCM, CNIO, CIBERONC, Madrid, Spain.
Centro de Investigación Biomédica en Red de Cáncer · ESInstituto Ramón y Cajal de Investigación Sanitaria · ESInstitut Català d'Oncologia · ESVall d'Hebron Hospital Universitari · ESBiogipuzkoa Health Research Institute · ESComplejo Hospitalario de Navarra · ESHospital General Universitari de Castelló · ESHospital Universitario 12 De Octubre · ESHospital Universitario Central de Asturias · ESHospital Universitario Puerta de Hierro Majadahonda · ESInstituto de Biomedicina de Sevilla · ESMD Anderson Cancer Center Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedPalbociclib demonstrated no detectable activity in molecularly unselected and heavily pretreated patients with advanced grade 1/2 pancreatic neuroendocrine tumors. Predictive biomarkers that improve patient selection should be investigated in future studies of palbociclib.

backgroundPalbociclib, a CDK4/6 inhibitor, has shown in vitro activity in pancreatic neuroendocrine tumor (pNET) cell lines. Here we prospectively assessed the activity and safety of palbociclib in monotherapy in metastatic refractory pNETs.

methodsThis was a nonrandomized, open-label, phase II study of patients with metastatic grade (G)1/2 pNETs recruited from 10 centers in Spain. Palbociclib 125 mg was orally administered once daily for 21 of 28 days until disease progression or unacceptable toxicity.

resultsTwenty-one patients were included; 52.4% were men, and median age was 57.4 years (range, 37.4-73.4). Patients had previously received a median of three prior lines of systemic therapy (range, 1-10) for advanced disease (somatostatin analogues, 71.4%; sunitinib, 81.0%; everolimus, 47.6%; chemotherapy, 47.6%). Nineteen patients were evaluated for objective response rate (ORR), with a median follow-up of 12.4 months (range, 7.53-19.33). No objective and confirmed responses were observed (0%); 11 (57.9%) patients had stable disease, and 6 of them lasted more than 6 months; 8 (42.1%) patients had disease progression as best response. Median progression-free survival (PFS) was 2.6 months (95% confidence interval [CI], 0-14.4) and median overall survival (OS) was 18.7 months (95% CI, 7.4-29.9; Fig. 1). Most frequent toxicities of any grade were asthenia (76.2%), neutropenia (42.9%), diarrhea (33.3%), and nausea (33.3%). Five (23.8%) patients developed G3-4 neutropenia and two (9.5%) patients developed G3-4 thrombocytopenia.

conclusionLack of activity was observed with palbociclib as a single agent in molecularly unselected and heavily pretreated patients with advanced G1/2 pNETs.

Indexed as

Neuroendocrine TumorsPancreatic NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedPiperazinesPyridinesSpainpalbociclibPiperazinesPyridines

Identifiers

PMID32045050
PMCPMC7485337
OpenAlexW3005666666

What OpenQuestion holds

Textmetadata
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.