Four Recent Articles Worth Reading From the Journal of Clinical Oncology

  • ASCO Statement on Biosimilars. One of the important developments in oncology in 2017 was the introduction of biosimilars for the treatment of patients with cancer. These agents have the potential to decrease the cost of cancer care and hopefully improve access to biological medicines. To date, the Food and Drug Administration (FDA) has approved eight biosimilar products for use in the United States, including three that are used in oncology. Among those, biosimilar granulocyte colony–stimulating factor (filgrastim-sndz) is used in supportive care, while two other biosimilars (bevacizumab-awwb, and trastuzumab-dkst) are alternatives for bevacizumab and trastuzumab, which are commonly used in the treatment of cancers such as colorectal, lung, breast, and gastric cancer. Biosimilars are approved for all indications of their reference product, although many indications are based on extrapolation. In response to these approvals, the American Society of Clinical Oncology (ASCO) has released a statement providing guidance for oncologists considering use of biosimilars. The statement reviews the regulation of these agents, evidence supporting their safety and efficacy, issues of substitution and interchangeability, economic value, and appropriate patient education. J Clin Oncol. 2018 Feb 14 [Epub ahead of print].
  • New ASCO Guidelines on the Management of Immune-Related Adverse Events. The introduction of immune checkpoint inhibitors has revolutionized the treatment of cancer. While these agents can produce durable responses and long-term survival, they are associated with a unique and sometimes difficult adverse event profile. To aid in management of immune-related adverse events (irAEs), ASCO has released a new clinical practice guideline. This guideline reviews the irAEs associated with immune checkpoint inhibitors and provides latest recommendations regarding both general and organ-specific management of irAEs, including corticosteroid dosing and tapering and use of other immunosuppressive agents. Close monitoring throughout treatment is important, as minimal changes in a patient’s baseline status may indicate an early irAE. In addition, the guideline highlights complexities in patients who have multiple chronic conditions or preexisting autoimmune diseases. J Clin Oncol. 2018 Feb 14 [Epub ahead of print].
  • ASCO Guidance on Management of Mesothelioma. Malignant pleural mesothelioma (MPM) is a rare and aggressive tumor with limited treatment options and poor prognosis. To assist clinicians who treat MPM, ASCO convened a multidisciplinary expert panel to evaluate available evidence. The resulting guideline provides recommendations on diagnosis, staging, and treatment of patients with MPM. The relative risks and benefits and appropriate patient selection for chemotherapy, surgical cytoreduction, and radiation therapy are discussed in detail, along with the management of any resulting complications. J Clin Oncol. 2018 Jan 18 [Epub ahead of print].
  • Pregnancy and Stopping Tyrosine Kinase Inhibitor Therapy in CML. In contrast to men with chronic myelogenous leukemia (CML), where tyrosine kinase inhibitor (TKI) therapy does not have deleterious effect on fertility, women with CML undergoing TKI treatment during pregnancy are faced with an increase in the incidence of miscarriage, stillbirth, and fetal malformations, making management of pregnant patients with CML particularly challenging. For women with CML who want to conceive, there are no clear recommendations for when to stop therapy, when to restart therapy, and what treatment can be used if treatment is needed during pregnancy. Stopping TKI therapy too soon may increase the risk of disease recurrence. In this review, the authors highlight recent trial results regarding stopping TKIs in CML, suggesting that women who have achieved and maintained major molecular response for at least one year may stop TKI and try to become pregnant. However, authors caution this approach may not be safe for every woman. J Clin Oncol. 2018 Feb 15 [Epub ahead of print].

 

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