BRAIN CANCER

An interim analysis of the phase II study of palbociclib for the treatment of patients with brain metastases harboring CDK alterations was presented at the 2019 Society for NeuroOncology Annual Meeting by Priscilla K. Brastianos, MD, director of the central nervous system brain metastasis program, Massachusetts General Hospital.<br /> &nbsp;

Patients with both high-grade and low-grade glioma harboring the <em>BRAF</em> V600E mutation demonstrated positive benefit in response, duration of response, and progression-free survival when given the combination of dabrafenib and trametinib in a phase IIa study.

Adding the PARP inhibitor veliparib to standard therapy for newly diagnosed patients with unmethylated MGMT glioblastoma multiforme was well-tolerated in a phase II trial, according to findings presented at the 24th Annual Meeting and Education Day of the Society of NeuroOncology.

A drug with a greater than 30-year history that was originally investigated as a treatment for trypanosomiasis has garnered interest from investigators seeking a treatment for the rare brain cancer anaplastic astrocytoma.<br /> &nbsp;

The FDA has approved a supplemental New Drug Application for a single dose of aprepitant injectable emulsion for intravenous use in patients receiving moderately emetogenic chemotherapy. The approval expands the dose for aprepitant to include a 130 mg single-dose regimen for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.<br /> &nbsp;

The addition of direct oral oral anticoagulants for the management of venous thromboembolism in patients with cancer is the latest change to previous guidelines issued by the American Society of Clinical Oncology.

Using a measure known as the growth modulation index, patients with TRK fusion&ndash;positive cancers who were treated with larotrectinib had a clinically meaningful improvement in progression-free survival compared with the time to progression on their prior treatment, an analysis of patients enrolled in 1 of 3 clinical trials has found.

Three clinical trials presented at the 2019 ESMO Congress show that the tropomyosin receptor kinase&nbsp;inhibitor larotrectinib continues to show anti-tumor activity, including long-lasting objective responses and low toxicity, according to results from an integrated analysis.

The addition of nivolumab to the standard of care temozolomide and radiation therapy was not additive in terms of progression-free survival compared with standard of care alone in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated, according to results released from the phase III CheckMate 548 trial.

Several presentations at the 2019&nbsp;American Society of Clinical Oncology Annual Meeting highlighted a hopeful new direction in the treatment of gliomas, demonstrating the relevance of <em>IDH1/2</em> mutational status and its feasibility as a target of therapy.

General Cancer

The FDA has approved Zirabev, a biosimilar to bevacizumab for 5 indications.&nbsp;Zirabev has been approved for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non&ndash;small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

The American Cancer Society, Dana-Farber Cancer Institute, Baptist Cancer Center, and the Mayo Clinic report&nbsp;that treatment patterns varied markedly by cancer type and care facility setting for patients with de novo metastatic disease who died within 1 month after diagnosis, based on an analysis of data from 100,848 patients collected from the National Cancer Database, a hospital-based cancer registry that captures 70% of patients in the United States with a new diagnosis.

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials. The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population &ge;10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.

Larotrectinib demonstrated efficacy across analyses for both pediatric patients and those with brain metastases or primary central nervous system tumors, whether pediatric or adult, with TRK fusions.

Final results from the phase III CheckMate 498 trial demonstrated that nivolumab in combination with radiation failed to demonstrate a significant improvement in overall survival compared with temozolomide and radiation in patients with newly diagnosed <em>MGMT</em>-unmethylated glioblastoma multiforme.

Before a community oncology practice considers getting involved in clinical trials research, there are many factorsto consider. Perhaps foremost is the fact that cancer clinical trials provide the evidence base for new advances in oncology.&nbsp;

Artificial intelligence has made inroads in many industries&mdash;banking, finance, security&mdash;but its adoption in healthcare has been lagging and real-world clinical implementation has yet to become a reality. Nonetheless, proponents say it is only a matter of time and pilot programs are starting to yield some practical results.&nbsp;

The healthcare community is still awaiting a response from the Centers for Medicare &amp; Medicaid Services to the opposition of the agency&rsquo;s proposal to substantially revise the Medicare Part D protected drug classes.

Overtreating men 70 years or older with prostate cancer cost Medicare more than $1.2 billion from 2004 to 2007, according to the results of a retrospective study using the Surveillance, Epidemiology, and End Results&ndash;Medicare linked database.

Despite encouraging results in other cancers, the use of immunotherapy to treat glioblastoma, which appeared promising in early-phase trials, has not panned out as well in larger, phase III trials. However, researchers continue to search and are optimistic about immunotherapy&rsquo;s prospects.