Academic Journal
A Phase II Study of Abemaciclib for Patients with Retinoblastoma-Positive, Metastatic Triple-Negative Breast Cancer.
| Τίτλος: | A Phase II Study of Abemaciclib for Patients with Retinoblastoma-Positive, Metastatic Triple-Negative Breast Cancer. |
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| Συγγραφείς: | Goel S; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts., Jovanović B; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts., Chu X; Department of Data Science, Dana-Farber Cancer Institute, Boston, Massachusetts., Hughes M; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts., Erick TK; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts., Russo D; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.; Department of Data Science, Dana-Farber Cancer Institute, Boston, Massachusetts., DiLullo M; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts., Wrabel E; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts., Jeselsohn R; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts., Lin NU; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts., Tayob N; Harvard Medical School, Boston, Massachusetts.; Department of Data Science, Dana-Farber Cancer Institute, Boston, Massachusetts., Mittendorf E; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts., Schnitt S; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.; Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts., Tolaney SM; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts. |
| Πηγή: | Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2025 Apr 14; Vol. 31 (8), pp. 1427-1436. |
| Τύπος έκδοσης: | Journal Article; Clinical Trial, Phase II |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: American Association for Cancer Research Country of Publication: United States NLM ID: 9502500 Publication Model: Print Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Denville, NJ : American Association for Cancer Research, c1995- |
| Ιατρικοί όροι (MeSH): | Benzimidazoles*/administration & dosage , Benzimidazoles*/adverse effects , Benzimidazoles*/therapeutic use , Aminopyridines*/administration & dosage , Aminopyridines*/adverse effects , Aminopyridines*/therapeutic use , Triple Negative Breast Neoplasms*/drug therapy , Triple Negative Breast Neoplasms*/pathology , Triple Negative Breast Neoplasms*/mortality , Triple Negative Breast Neoplasms*/genetics , Retinoblastoma Protein*/genetics , Retinoblastoma Protein*/metabolism, Humans ; Female ; Middle Aged ; Adult ; Aged ; Neoplasm Metastasis ; Treatment Outcome ; Biomarkers, Tumor |
| Περίληψη: | Purpose: Cyclin-dependent kinase 4/6 inhibitors can significantly extend survival when given in combination with endocrine therapy in patients with hormone receptor-positive metastatic breast cancer. However, their activity has been relatively underexplored in patients with metastatic triple-negative breast cancer (mTNBC). Patients and Methods: We conducted a single-arm phase II study of abemaciclib monotherapy in patients with Rb-positive mTNBC. Patients were treated with abemaciclib 200 mg orally twice daily until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the objective response rate; secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate, disease control rate, and safety and tolerability. Results: A total of 27 patients were enrolled before the trial was closed early because of slow accrual. Patients had received a median of two lines of systemic therapy in the metastatic setting prior to enrollment. After a median follow-up of 28.5 months, the objective response rate was 0%, the clinical benefit rate was 14.8%, and the disease control rate was 22.2%. The median PFS was 1.94 months (95% confidence interval, 1.84-11.47), and the median OS was 8.44 months (95% confidence interval, 4.57-15.57). Median PFS and OS did not differ significantly based on androgen receptor and PD-L1 status. Pretreatment gene expression profiling of tumor tissue provided some hypothesis-generating insights into biological features associated with clinical benefit in this study. The most common treatment-related adverse events of grade 2 or higher were diarrhea (40.7%), neutropenia (40.7%), anemia (29.6%), and nausea (29.6%). Conclusions: Abemaciclib monotherapy did not show clinical activity in patients with pretreated Rb-positive mTNBC. (©2025 The Authors; Published by the American Association for Cancer Research.) |
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| Grant Information: | Eli Lilly and Company (Lilly); OOFOS; GNT1177357 National Health and Medical Research Council (NHMRC); SF2020-47 Snow Medical (SnowMedical) |
| Substance Nomenclature: | 0 (Benzimidazoles) 0 (Aminopyridines) 60UAB198HK (abemaciclib) 0 (Retinoblastoma Protein) 0 (Biomarkers, Tumor) |
| Entry Date(s): | Date Created: 20250205 Date Completed: 20250414 Latest Revision: 20250416 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC11995003 |
| DOI: | 10.1158/1078-0432.CCR-24-2647 |
| PMID: | 39908010 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1557-3265 |
|---|---|
| DOI: | 10.1158/1078-0432.CCR-24-2647 |