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Phase II Trial of Palbociclib in Recurrent Retinoblastoma-Positive Anaplastic Oligodendroglioma: A Study from the Spanish Group for Research in Neuro-Oncology (GEINO)
- Source :
- TARGETED ONCOLOGY, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, r-FISABIO. Repositorio Institucional de Producción Científica, Digital.CSIC. Repositorio Institucional del CSIC, Targeted Oncology, r-FHPC. Repositorio Institucional de Producción Científica de la Fundación del Hospital Provincial de Castellón
- Publication Year :
- 2020
- Publisher :
- SPRINGER, 2020.
-
Abstract
- [Background]: The cell cycle checkpoint G1/S, dependent on cyclin-dependent kinase (CDK) 4 amplification/overexpression and retinoblastoma phosphorylation, is altered in most anaplastic oligodendrogliomas (AOs). [Objective]: We aimed to evaluate the efficacy of palbociclib, an oral inhibitor of CDK4/6 with proven efficacy in breast cancer, in patients with AO. The primary endpoint was progression-free survival at 6 months. [Patients and Methods]: We conducted a multicenter, open-label, phase II trial evaluating the efficacy and safety of palbociclib in patients with AO who progressed on radiotherapy and chemotherapy with histologically and molecularly confirmed grade 3 oligodendroglioma and conserved retinoblastoma protein (pRb) expression by immunohistochemistry. Patients were treated with palbociclib (125 mg/day) for 3/1 weeks on/off. [Results]: Overall, 34 patients were enrolled across 10 hospitals in the Spanish Group of Neuro-Oncology (GEINO) study. The study was stopped early owing to the lack of efficacy, with 74% of evaluable patients progressing within 6 months, which was insufficient to consider palbociclib as an active drug in this population. Within the median follow-up of 12 months, the median progression-free survival was 2.8 months [95% confidence interval (CI) 2.6–3.1] and the median overall survival was 32.1 months (95% CI 5.1–59.2). There were no partial or complete responses; only 13 patients (38%) achieved stable disease as the best response. Palbociclib was well tolerated, with neutropenia (grade 3 or higher: 58.8%) and thrombocytopenia (grade 3 or higher: 14.7%) as the most common adverse events (AEs). Both AEs had no significant impact. [Conclusion]: Despite the good tolerance, palbociclib monotherapy did not show favorable efficacy against recurrent AO.<br />Palbociclib was provided by Pfizer under a cooperative research agreement with the Spanish Group for Research in NeuroOncology (GEINO). Funding research was supported by Pfzer under the Investigator-Initiated Research Award, number WI174842.
- Subjects :
- 0301 basic medicine
Oncology
Adult
Male
Cancer Research
medicine.medical_specialty
Pyridines
medicine.medical_treatment
Population
Oligodendroglioma
Neutropenia
Palbociclib
Piperazines
03 medical and health sciences
0302 clinical medicine
Breast cancer
Internal medicine
Clinical endpoint
Medicine
Humans
Pharmacology (medical)
education
Adverse effect
Protein Kinase Inhibitors
Aged
education.field_of_study
Chemotherapy
business.industry
Retinoblastoma
Middle Aged
medicine.disease
030104 developmental biology
Treatment Outcome
030220 oncology & carcinogenesis
Female
Neoplasm Recurrence, Local
business
Subjects
Details
- ISSN :
- 17762596 and 1776260X
- Database :
- OpenAIRE
- Journal :
- TARGETED ONCOLOGY, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, r-FISABIO. Repositorio Institucional de Producción Científica, Digital.CSIC. Repositorio Institucional del CSIC, Targeted Oncology, r-FHPC. Repositorio Institucional de Producción Científica de la Fundación del Hospital Provincial de Castellón
- Accession number :
- edsair.doi.dedup.....815aef705a238f3bad753381a3c1ca47