Gastric Cancer

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials.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 ≥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.

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.

A look back at all the FDA news in oncology from the month of February 2019, including several new approvals, priority review designations, and an orphan drug desgination.

Based on data from the phase III TAGS trial, TAS-102 has been approved by the FDA as a treatment for&nbsp;adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

General Cancer

Treatment with&nbsp;TAS-102 led to an improvement in overall survival among patients with&nbsp;metastatic gastric/gastroesophageal junction cancer. The improvement was also seen both in patients who had and had not undergone prior gastrectomy, according to a subgroup analysis from the phase III TAGS study.&nbsp;

ASLAN Pharmaceuticals, the company developing varlitinib (ASLAN001), has announced that a phase II frontline trial investigating the&nbsp;pan-HER inhibitor added to mFOLFOX6 in patients with HER1/HER2 co-expressing advanced or metastatic gastric cancer has missed its primary endpoint.

Hendrik-Tobias Arkenau, MD, PhD, discusses the rationale for using TAS-102 (trifluridine/tipiracil; Lonsurf) as a treatment for patients with gastric cancers.

James L. Wade III, MD, FACP, FASCO, discusses the importance of clinical trials in the community.