We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
P7: A phase 2 study of abemaciclib in patients with brain metastases secondary to HR+, HER2- metastatic breast cancer.
- Authors
Anders, Carey; Le Rhun, Emilie; Bachelot, Thomas; Yardley, Denise; Awada, Ahmad; Conte, Pier Franco; Kabos, Peter; Bear, Melissa; Zhengyu Yang; Yanyun Chen; Tolaney, Sara M.; Sarhan, Mostafa
- Abstract
Background: Abemaciclib is a selective CDK4 and 6 inhibitor approved to treat HR+, HER2- metastatic breast cancer (MBC) patients on a continuous dosing schedule as monotherapy or in combination with endocrine therapy (ET). Clinical data demonstrate abemaciclib penetrates the blood-brain barrier resulting in comparable concentrations in tissues and plasma. Methods: JPBO is a Simon 2-stage trial evaluating abemaciclib in 6 patient cohorts with brain metastases (BM) secondary to HR+ MBC, non-small cell lung cancer, or melanoma. Here, we report on HR+, HER2- MBC patients. Eligible patients had ≥1 new or not previously irradiated measurable BM ≥10mm or a progressive previously irradiated BM. Patients receiving ET at the time of enrollment were permitted to continue the same ET provided that extracranial disease was stable ≥3 months and the CNS progression occurred on the ET. Abemaciclib was orally administered 200mg BID. Primary endpoint was objective intracranial response rate (OIRR; [complete response (CR) + partial response (PR)]) based on Neuro-Oncology BM response assessment criteria (RANO-BM). Secondary endpoints included intracranial clinical benefit rate, progression-free survival (PFS), and safety Results: 58 HR+, HER2- MBC patients were enrolled and 52 patients were evaluable. Patients had a median of 4 prior systemic therapies, 75% of patients had prior chemotherapies (0-6, median 2), and 71% of patients had prior ET (0-4, median 1) in the metastatic setting. 50% of patients had prior whole-brain radiotherapy, 39% stereotactic radiosurgery, and 8% surgical resection of BM. Median time from radiation to study enrollment was 9.4 months. Out of the 52 evaluable patients, 3 patients had a confirmed intracranial response (6% OIRR), and 38% of patients showed a decrease in the sum of their intracranial target lesions. Intracranial clinical benefit rate (CR+PR+stable disease persisting for ≥6 months) was 25%. Median PFS was 4.4 months (95% CI, 2.6-5.5). Safety and tolerability were similar to previous reports for abemaciclib. Conclusions: Abemaciclib demonstrated intracranial clinical benefit in heavily pretreated HR+, HER2- MBC patients with BM in this study. Further evaluations are ongoing to identify ABC patients with BM who might benefit most from abemaciclib.
- Subjects
ABC Television Network; METASTATIC breast cancer; BRAIN metastasis; NON-small-cell lung carcinoma; SURGICAL excision; STEREOTACTIC radiosurgery
- Publication
Pan Arab Journal of Oncology, 2019, Vol 12, Issue 3, p57
- ISSN
2070-254X
- Publication type
Article