Higher risk of major adverse cardiovascular events and cancers with tofacitinib

 

During the recently held Pharmacovigilance Risk Assessment Conference (PRAC), the European Medicines Agency (EMA) revealed results from a study indicating that patients "taking tofacitinib for rheumatoid arthritis and who were at risk of heart disease were more likely to experience a major cardiovascular problem...and had a higher risk of developing cancer."  In 3 nearly equivalent patient groups (1455 patients received 5mg of tofacitinib twice daily; 1456 received 10mg of tofacitinib twice daily; 1451 received a TNF inhibitor), incidences of cancer were higher (2.4% for 5mg; 4.2% for 10mg) for those administered tofacitinib vs. 2.5% who received a TNF inhibitor. 

To learn more about this study, click here.  

Source mentioned: Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. N Engl J Med 2022;386:316-326.

Blog postings will resume week of March 2, 2022

 To all Grey Horizon readers, 

Please note that blog postings will resume the week of March 2, 2022. 

Thank you, take care, and stay well.  

Greater severity of adverse events in women across multiple anticancer treatment modalities

 Results of 202 phase II and III clinical trials conducted between 1989 and 2019 on 23, 296 cancer patients has revealed "greater severity of both symptomatic adverse events and haematology adverse events in women across multiple treatment modalities."  Researchers at the SWOG Cancer Research Network determined that of the 23, 296 patients studies (8,838/37.9% women and 14,458/62.1% men) female patients "had a 34% increased risk of adverse events [across various cancer therapies administered] compared to men."  

To learn more about this study, click here. 

Source mentioned: Unger JM, Vaidya R, Albain KS, et al. Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials. JCO; Published online 4 February 2022. DOI: 10.1200/JCO.21.02377

Trial alert from the PACIFIC study: Robust and sustained survival benefit with consolidation durvalumab after concurrent chemoradiotherapy for unresectable, stage III non-small-cell lung cancer

 Recently released results on survival analyses from the PACIFIC study focusing on the benefits of durvalumab in patients with unresectable, stage iii non-small-cell lung cancer (NSCLC) and no cancer progression following concurrent chemoradiotherapy treatment indicated that "42.9% of patients randomly assigned to durvalumab remain alive at 5 years and 33.1^ of patients remain alive and free of disease progression. 

Click here to read more about this study, the first to "demonstrate a survival advantage with immune checkpoint inhibitor in a curative-intent setting."

Source mentioned: Spigel DR, Faivre-Finn C, Gray JE, et al. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer. JCO; Published online 2 February 2022. DOI: 10.1200/JCO.21.01308

Personalized immunotherapy for metastatic breast cancer

 Results from an ongoing clinical trial conducted at the National Cancer Institute's (NCI) Center for Cancer Research, has found that "many people with metastatic breast cancer can mount an immune reaction against their tumors."  The clinical trial conducted on 42 women with metastatic breast cancer showed that 67% (28 of the 42 trial participants) had an immune response towards their cancer affliction.  As such, the immune reaction approach was applied to treat 6 of the 28 women, "half of whom experienced measurable tumor shrinkage."  

To read more about the results of this trial, click here. 

Source mentioned: Zacharakis N, Lutfi LM, Seitter SJ, et al. Breast Cancers Are Immungenic: Immunologic Analyses and a Phase II Pilot Clinical Trial Using Mutation-Reactive Autologous Lymphocytes. February 1, 2022. JCO. DOI: 10.1200/JCO.21.02170.