Expert opinion on drug safety
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Expert Opin Drug Saf · Jun 2021
ReviewHow can we manage the cardiac toxicity of immune checkpoint inhibitors?
Introduction: Cancer immunotherapies with monoclonal antibodies (mAbs) against immune checkpoints (i.e. CTLA-4 and PD-1/PD-L1) have revolutionized antineoplastic treatments. Immune checkpoint inhibitors (ICIs) approved for cancer immunotherapy are mAbs anti-CTLA-4 (ipilimumab), anti-PD-1 (nivolumab, pembrolizumab, and cemiplimab), and anti-PD-L1 (atezolizumab, avelumab, and durvalumab). ⋯ Areas covered: In this paper, we start from examining the pathogenesis of cardiovascular adverse events from ICIs, and then we focus on risk factors and strategies to prevent and manage this cardiotoxicity. Expert opinion: There is a growing need for a multidisciplinary approach of ICI-associated cardiotoxicity, involving oncologists, cardiologists, and immunologists. Prevention and effective management of ICIs cardiotoxicity starts with an in-depth screening and surveillance strategies of high-risk patients, in order to improve early detection and appropriate management in a personalized approach.
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Expert Opin Drug Saf · Apr 2021
ReviewA safety review of approved intrathecal analgesics for chronic pain management.
Introduction: Intrathecal (IT) drug therapy is an effective treatment option for patients with chronic pain of malignant or nonmalignant origin, with an established safety profile and fewer adverse effects compared to oral or parenteral pain medications. Morphine (a μ-opioid receptor agonist) and ziconotide (a non-opioid calcium channel antagonist) are the only IT agents approved by the U. S. ⋯ Expert Opinion: Morphine and ziconotide are effective IT therapies for patients with chronic malignant or nonmalignant pain that is refractory to other interventions. IT ziconotide is recommended as a first-line therapy due to its efficacy and avoidance of many adverse effects commonly associated with opioids. The use of IT morphine is also considered first-line; however, the risks of respiratory depression, withdrawal with drug discontinuation or pump malfunction, and the development of tolerance require careful patient selection and management.
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Expert Opin Drug Saf · Aug 2020
ReviewA drug safety evaluation of atezolizumab in locally advanced or metastatic urothelial carcinoma.
Immune checkpoint inhibitors (ICIs) have rapidly changed the treatment landscape, demonstrating dramatic clinical efficacy in various cancers. ⋯ Atezolizumab is a drug with a favorable toxicity profile and will obtain more indications in the future in UC and other cancers. Treating physicians should be aware of treatment-related and immune-related adverse events associated with the drug.
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Expert Opin Drug Saf · Jun 2020
ReviewSafety evaluation of durvalumab for the treatment of non-small-cell lung cancer.
The development of immune checkpoint inhibitors (ICIs), such as anti-programmed death 1/programmed death ligand 1 (PD-1/PD-L1) inhibitors, has been a breakthrough in the treatment of non-small-cell lung cancer (NSCLC). Durvalumab, a PD-L1 inhibitor, has shown survival benefit as a maintenance therapy for patients with unresectable stage III NSCLC following definitive chemoradiotherapy, and is approved by the U.S. Food and Drug Administration and the European Medicines Agency. ⋯ ICIs, including durvalumab, cause unique side effects, known as immune-mediated adverse events, which are commonly manageable with standard treatment algorithms. The safety profile of durvalumab monotherapy is similar to those of other PD-1/PD-L1 inhibitors. In the PACIFIC trial, durvalumab after radiotherapy resulted in a slight increase in pulmonary toxicity, but most cases were mild. The enhanced effect of ICIs when used in combination therapies is accompanied by an increased risk of side effects. Therefore, the authors evaluated the safety profile and risk-benefit balance of durvalumab combined with various agents.