FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer.
This article summarizes FDA decision-making and data supporting the approval of palbociclib for the treatment of male patients with HR-positive, HER2-negative advanced or metastatic breast cancer. PMID: 31649043 [PubMed - as supplied by publisher]
Abstract BACKGROUND: The results of the Trial Assigning IndividuaLized Options for Treatment (TAILORx) suggested that approximately 70% of T1-2N0M0, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients can avoid chemotherapy and receive only adjuvant endocrine therapy. We conducted a retrospective analysis of the clinicopathologic features and prognostic factors of patients with breast cancer who met the inclusion criteria of the TAILORx trial. METHODS: According to the enrollment criteria of the TAILORx trial, a retrospective analysis was performed on pat...
AbstractPurpose of ReviewThis review will discuss recent important trials for the treatment of HER2-positive breast cancer, emphasize ongoing areas of development, and highlight areas of unmet need.Recent FindingsAdvances for early-stage treatment have been driven by key clinical trials with pertuzumab, neratinib, and TDM-1. In the adjuvant setting, dual HER2 targeting with trastuzumab and pertuzumab has demonstrated modest improvement in disease-free survival. Neratinib also showed modest benefit in the extended adjuvant setting after prior trastuzumab. Finally, for patients who did not achieve pathologic complete respons...
CONCLUSIONS: Despite evidence that first-line HER2-targeted therapy, chemotherapy, and sequential endocrine therapy improves survival in patients with HR-positive, HER2-positive disease, only 34.9% of patients in this real-world setting received such treatment. Patients with low tumor HR positivity (1%-9%) had lower endocrine therapy use and worse survival than those with high tumor HR positivity (10%-100%). PMID: 31772121 [PubMed - as supplied by publisher]
A new study confirms that a CDK4/6 blocker plus endocrine therapy is better than chemotherapy in young women with HR+, HER2- metastatic disease.Medscape Medical News
In a new study, patients with HR+/HER2- early stage breast cancer completed 2 years of adjuvant palbociclib with a similar toxicity profile as that observed in the metastatic setting.Annals of Oncology
Condition: Cancer Metastatic Interventions: Drug: Paclitaxel injection; Drug: Capecitabine tablets; Drug: Letrozole 2.5mg; Drug: Anastrozole 1mg; Drug: Fulvestrant Prefilled Syringe; Drug: Abemaciclib Sponsor: UNICANCER Not yet recruiting
Conclusions: Despite encouraging pre-clinical evidence, there is a lack of clinical data to inform CNS-specific response rates to CDK4/6 inhibitors among patients with metastatic breast cancer. Given that the treatment of patients with breast cancer brain metastases represents an area of unmet medical need, enrollment of patients with CNS metastases in ongoing clinical trials should be encouraged; innovative trials that examine response of CNS metastases to CDK4/6 inhibitors are also of interest. PMID: 31695840 [PubMed]
CONCLUSIONS: LPBC was marginally associated with higher pCR rate than non-LPBC in LT treated HER2+ BC patients. Quantitative assessment of the immune infiltrate by m-IF is feasible and may help correlate individual immune cell subpopulations and immune cell profiles with treatment response. PMID: 31653641 [PubMed - as supplied by publisher]