Practical Considerations for Integrating Biosimilars Into Clinical Practice.

The development of innovator biologics and now their biosimilars has created some unique challenges in oncology practice. The oncology advanced practitioner (OAP) must understand the key differences between the innovator biologic and biosimilars in regard to efficacy, safety, and immunogenicity. In addition, the OAP must be able to evaluate and successfully navigate factors that may affect the adoption of biosimilars, such as the perceived cost-benefit and clinician and patient acceptance.

Immune checkpoint inhibitors: Significant advancements in non-small cell lung cancer treatment.

PURPOSE: This article explores the efficacy, toxicity, place in therapy, and considerations for use of recently approved immune checkpoint inhibitors (ICIs) in the treatment of non-small cell lung cancer (NSCLC). SUMMARY: Lung cancer is the leading cause of cancer mortality in the United States and is responsible for more cancer-related deaths than breast, prostate, and colorectal cancer combined. The landscape for lung cancer treatment is evolving with the approval of new and exciting novel therapies. Within the last decade numerous ICIs have been approved for use in the management of the most common subtype of lung cancer, NSCLC. The ICI agents currently approved by the Food and Drug Administration (FDA) for use in NSCLC include ipilimumab, pembrolizumab, nivolumab, durvalumab, and atezolizumab. These agents are approved for specific indications; therefore, they are not interchangeable. This review focuses on the landmark trials that led to each FDA-approved indication, as well as common toxicities seen with use of these agents. It also discusses the use of ICIs in special populations and unique considerations prior to initiation of treatment with these novel therapies in a patient with NSCLC. CONCLUSION: ICIs can provide a breakthrough treatment option for the management of NSCLC and are rapidly being adopted into clinical practice. It is important to be familiar with appropriate selection of an ICI therapy option for each patient based on approved indication, unique considerations, and anticipated toxicities.

Alpelisib: A Novel Therapy for Patients With PIK3CA-Mutated Metastatic Breast Cancer.

In the United States, 1 in 8 women will be diagnosed with invasive breast cancer in her lifetime. Breast cancer death rates are higher for women in the United States than any other cancer, followed by lung cancer (National Cancer Institute, 2019). More than 70% of breast cancers are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative, and of those patients, 40% have driver mutations in the gene phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) resulting in damaged phosphatidylinositol 3-kinase (PI3K) and uncontrolled cell growth (Mollon et al., 2018; Setiawan et al., 2009). These patients are initially treated with endocrine therapy, but resistance remains an issue. Inhibition of PI3K is a promising new approach to overcome resistance to endocrine therapy in breast cancer. Previous trials of PI3K inhibitors (pictilisib [GDC-0941], buparlisib [BMK120], and taselisib [GDC-0032]) in breast cancer have shown little efficacy secondary to toxicities due to their nonselectivity to PI3K subunits. Alpelisib is a selective inhibitor of PI3K for patients with HR-positive, HER2-negative, PIK3CA-mutated breast cancer who have progressed on endocrine therapy. This drug review will discuss the pharmacology of alpelisib, current data supporting its place in therapy, management of adverse events, and the clinical implications for advanced practitioners treating patients with HR-positive, HER2-negative breast cancer.

Apalutamide: A new agent in the management of prostate cancer.

Apalutamide is a competitive inhibitor of the androgen receptor and binds directly to the ligand-binding domain. The US Food and Drug Administration approved apalutamide on 14 February 2018 for use in patients with nonmetastatic castration-resistant prostate cancer based upon results from the phase III SPARTAN trial demonstrating significantly longer metastasis-free survival over placebo. The SPARTAN trial evaluated 1207 patients with nonmetastatic castration-resistant prostate cancer who were randomized 2:1 to apalutamide or placebo in combination with androgen deprivation therapy. Patients who received apalutamide experienced statistically significantly longer metastasis-free survival (40.5 versus 16.2 months, hazard ratio 0.28 (95% confidence interval = 0.23-0.35); P < 0.0001), which was the major efficacy outcome. Rash, hypothyroidism, and fracture were reported to occur more frequently with apalutamide than placebo. Based upon these results, apalutamide was deemed a safe and effective treatment option for patients with nonmetastatic castration-resistant prostate cancer. Clinical trials are ongoing to expand its indication in the metastatic setting, and identify additional roles for apalutamide in the management of prostate cancer such as in the castrate-sensitive metastatic setting.