October 2018

I think one of the most important advancements in biomedical technology that has improved our understanding of the complexities of cancer is the ability to sequence the cancer genome for any individual patient, in a rapid and cost-effective manner, to help us make treatment decisions in the clinic.

An overview of the regulatory activities of the Office of Oncology Drug Products and the Office of Hematology and Oncology Drug Products from 2008 to 2016 suggests that the FDA has made consistent use of regulatory mechanisms to expedite approvals during that period. Investigators from the Office of Biostatistics, Center for Drug Evaluation and Research completed an analysis to determine if changes in the laws, regulations, and the agency that occurred after 2007 had an effect on regulatory approvals.

Rising prescription drug prices continue to add to the burden of paying for quality healthcare. In an effort to confront such costs, the Centers for Medicare & Medicaid Services has rescinded a prohibition on step therapy for Medicare Advantage plans. But some contend such a policy will reduce patient access to optimal medication.

Nadeem R. Abu-Rustum, MD, discusses options and treatments that can allow women to maintain their reproductive ability.

With 2 CAR T-cell therapies now approved and more moving quickly through early-phase clinical trials, 4 healthcare experts reflected on the evolving field of CAR T-cell therapy, their understanding of its current and future applicability for patients, the process for administration and the challenges and obstacles that remain unaddressed during an Association of Community Cancer Centers interactive panel.<br /> &nbsp;

Findings from a recent study have suggested that wearable activity monitors could potentially replace performance status and functionability assessments going forward. This could lead to more accurate PS scores as evaluations of PS are difficult to determine objectively in the clinic.&nbsp;

Investigators have long known that the combination of antiangiogenic agents and immunotherapy could enhance antitumor response and improve outcomes for patients with certain cancers. But recently, this old idea has become the focus of new research in diseases such as hepatocellular carcinoma, urothelial carcinoma, and endothelial cancer.

In results presented at the European Society for Medical&nbsp;Oncology&rsquo;s 2018 Molecular Analysis for Personalised Therapy Congress, Marlene Kok, MD, PhD, said results from the phase II TONIC study showed that induction therapy with doxorubicin turned &ldquo;cold&rdquo; tumor cells &ldquo;hot,&rdquo; resulting in an objective response rate of 20% following treatment with nivolumab.

Tumor mutational burden, also referred to as tumor mutational load, is a measure of the number of mutations in tumor tissue taken from a patient. Recently, several studies have been investigating the utility of TMB as a biomarker to predict response to therapy in patients with non&ndash;small cell lung cancer.

The number of women who develop gestational trophoblastic neoplasia during pregnancy is limited, yet physicians believed that a greater understanding of how to manage this disease was necessary. New guidelines were recently issued by the National Comprehensive Cancer Network to help gynecologic oncologists understand how to treat this rare gestational cancer. Generally, the use of single-agent chemotherapy for most patients with low-risk disease is recommended, with the guidelines reserving surgery and combination chemotherapy for patients at high risk of GTN.¹

Douglas A. Levine, MD, has suggested that many cases of ovarian cancer are preventable, especially in the case of women with hereditary mutations that lead to an increased risk for developing the disease.

Combining the PD-1 checkpoint inhibitor nivolumab with the CTLA-4 checkpoint inhibitor ipilimumab led to superior survival rates compared to treatment with nivolumab alone in patients with persistent or recurrent ovarian cancer, according to findings from the phase II NRG-GY003 trial.

Until recently, few systemic therapies had been approved for the treatment of patients with liver cancer, as few agents could demonstrate significant benefit over placebo. Sorafenib was the first systemic therapy that extended median overall survival over placebo by nearly 3 months,¹ and, in December 2007, it became the first systemic therapy approved by the FDA for patients with unresectable hepatocellular carcinoma.