GYNECOLOGIC CANCERS

A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.

According to results from a small clinical study, checkpoint&nbsp;inhibitors in combination with&nbsp;chimeric antigen receptor T-cell therapy showed promise for improving CAR T-cell persistance in some patients with relapsed B-cell acute lymphoblastic leukemia. &nbsp; &nbsp;&nbsp;<br /> &nbsp;

Patients with&nbsp;acute lymphoblastic leukemia saw a reduction in the risk for recurrence after receiving a stem cell transplant for the first time following treatment with CD19 chimeric antigen receptor T-cell therapy.

According to the findings from phase III JAVELIN Ovarian 200 trial, avelumab either alone or in combination with pegylated liposomal doxorubicin did not induce a statistically significant improvement in overall survival or progression-free survival in patients with platinum&ndash;resistant/refractory ovarian cancer&nbsp;compared to PLD monotherapy.

Maurie Markman, MD, president of Medicine and Science, Cancer Treatment Centers of America, discusses how the ovarian cancer treatment paradigm has evolved over the past 30 years.

The side effect profile of olaparib tablets and the low rate of treatment discontinuation make it suitable for maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer, according to safety assessments from the SOLO-2 trial.

Based on data from the phase III SOLO-1 trial, a supplemental new drug application for olaparib tablets has been granted a priority review by the FDA for use as a maintenance therapy in patients with newly-diagnosed,<em>&nbsp;BRCA</em>-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

Promising data with PARP inhibitors, specifically olaparib and niraparib, are showcasing this class of agents&rsquo; activity in early and later-line settings of ovarian cancer, explained Kathleen Moore, MD.&nbsp;

Susana M. Campos, MD, discusses her thoughts on the biggest advancements in ovarian cancer in 2018. PARP inhibitors are great at putting these patients in remission; however, the challenge with this lies in keeping them in remission.

The rate of the 3 most common adverse events reported by US patients on niraparib who were started on 200 mg/day in real-world clinical practice is markedly less than the rate of AEs experienced by those enrolled in the pivotal phase III ENGOT-OV6/NOVA trial, in which patients were started at a 300-mg daily dose of niraparib, according to data presented at the 2018 ESMO Congress.

Lurbinectedin did not improve progression-free survival over pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer, according to results of the phase III CORAIL trial.

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

Shannon N. Westin, MD, MPH, discusses resistance seen with PARP inhibitors in ovarian cancer and how this resistance can be overcome.

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.

Data from a posthoc analysis of the phase II QUADRA trial support the use of niraparib in later lines of therapy in patients with relapsed ovarian cancer who have&nbsp;<em>BRCA</em> mutations, said Kathleen N. Moore, lead investigator of the trial. According to findings reported at the 2018 ESMO Annual Congress, when used in the fourth line or later, niraparib exhibited an overall response rate of approximately 30% in this subset of patients.

As an add-on to bevacizumab, carboplatin plus pegylated liposomal doxorubicin significantly extended progression-free survival compared with carboplatin and gemcitabine in patients with recurrent ovarian cancer whose first disease recurrence was &gt;6 months after first-line platinum-based chemotherapy.

Groundbreaking developments in cancer therapies can change lives, extending survival and sending patients who previously thought their chances were slim into remission. But these therapies come at a cost, and many patients reel at the prospect of heavy financial burdens. To help patients and programs meet the challenges of affording cancer treatments, community cancer centers are expanding the role of financial advocates in their organizations.

Thomas A. Gallo, MS, MDA, president of the Association of Community Cancer Centers, discusses his mission as president to &ldquo;reflect, renew, and reignite&rdquo; in order to create a more resilient oncology team for the community.

Frontline maintenance therapy with olaparib demonstrated a statistically significant improvement in progression-free survival for women with&nbsp;<em>BRCA</em>-positive advanced ovarian cancer.

Larotrectinib induced an objective response rate of 80% in patients with advanced solid tumors who harbored&nbsp;<em>NTRK&nbsp;</em>gene fusions, according to results pooled from 3 small trials of the TRK inhibitor. Results were presented during the 2018 ESMO Congress.

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 &amp; 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.

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.