New RSV Vaccination Recommendations for Older Adults
Respiratory syncytial virus (RSV) poses a major risk to older adults, especially during the fall and winter months. In response, the Advisory Committee on Immunization Practices (ACIP) initially recommended RSV vaccination for U.S. adults age 60 and older in June 2023. However, due to new evidence and postlicensure data, the ACIP updated its guidance on June 26, 2024. The revised recommendation advises a single dose of any FDA-approved RSV vaccine for all adults age 75 and older and for those ages 60 to 74 who are at higher risk for severe RSV disease. This update aims to improve vaccination coverage and target those who would benefit most.
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As of spring 2024, RSV vaccination uptake among adults 60 and older was about 20% to 25%. The updated recommendations were informed by new clinical trial data and postlicensure studies, including those for Moderna's mResvia, which showed an efficacy of about 78.7% initially, though it waned over time. Safety data indicated more severe reactions compared to placebo but didn't show a significant increase in serious adverse events. For other vaccines like GlaxoSmithKline's Arexvy and Pfizer's Abrysvo, effectiveness ranged from 75% to 82% in preventing RSV-related hospitalizations, with some safety concerns about Guillain-Barré syndrome, though not conclusively linked to the vaccines.
The ACIP's updated recommendations aim to simplify vaccination guidelines based on age and risk. The committee will continue to assess and update recommendations as new evidence emerges and will consider the need for additional doses in the future. (Britton, A., et al. (2024). Use of respiratory syncytial virus vaccines in adults aged ≥60 years: Updated recommendations of the Advisory Committee on Immunization Practices: United States, 2024. MMWR Weekly, 73(32), 696–702. Retrieved August 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7332e1.htm?s_cid=mm7332e1_w)
Released: September 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Osimertinib Improves Progression-Free Survival in EGFR-Mutated NSCLC
Patients with epidermal growth factor receptor (EGFR) mutations tend to experience shorter progression-free survival and higher incidence of distant metastases compared to those without mutations. For patients with unresectable stage III non-small-cell lung cancer (NSCLC) with EGFR mutations, the current standard treatment involves concurrent chemoradiotherapy followed by consolidation with durvalumab. However, targeted treatments are lacking, and previous studies suggest poorer outcomes for these patients.
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LAURA, an international, phase 3, double-blind, placebo-controlled trial, evaluated the efficacy and safety of osimertinib, an EGFR tyrosine-kinase inhibitor, in EGFR-mutated unresectable stage III NSCLC. The study ran from August 2018 through July 2022 and enrolled 216 patients. Eligible participants had completed chemoradiotherapy and showed no progression. They were randomized to receive either osimertinib (80 mg once per day) or placebo. The primary endpoint was progression-free survival.
Results showed that osimertinib significantly improved progression-free survival compared to placebo, with a median of 39.1 months versus 5.6 months, respectively, and demonstrated a substantial reduction in the risk of disease progression or death (hazard ratio, 0.16). The treatment also showed lower rates of local progression, distant metastases, and new lesions, particularly brain lesions, compared to placebo.
Adverse events with osimertinib included radiation pneumonitis and diarrhea. Although the incidence of interstitial lung disease was higher with osimertinib compared to placebo, most cases were mild. Despite the higher incidence of some adverse effects, osimertinib's overall safety profile was manageable.
The results of the LAURA trial indicate that osimertinib may be a promising postchemoradiotherapy option for patients with unresectable stage III EGFR-mutated NSCLC compared to placebo, suggesting a shift in treatment strategies for this specific patient group. (Lu, S., et al. (2024). Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. NEJM, 391, 585–597. Retrieved August 2024 from https://www.nejm.org/doi/10.1056/NEJMoa2402614?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed)
Released: September 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Olanzapine for Nausea and Vomiting in Moderately Emetogenic Chemotherapy
Chemotherapy-induced nausea and vomiting (CINV) remain significant challenges for cancer patients undergoing treatment, impacting their quality of life (QOL). Guidelines for antiemetic prophylaxis (AEP) have evolved to address these issues, but clinical studies indicate that breakthrough CINV remains a problem, prompting further research.
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Olanzapine, an atypical antipsychotic, has shown promise in controlling nausea and vomiting in highly emetogenic chemotherapy regimens. A recent phase 3 trial aimed to determine if incorporating olanzapine into standard AEP protocols could enhance complete response (CR) rates in patients receiving moderately emetogenic chemotherapy (MEC) regimens, including oxaliplatin, carboplatin, or irinotecan, and to assess its impact on patient-reported outcomes.
Conducted from March 2019 to August 2023, this multicenter trial involved 560 chemotherapy-naïve patients receiving MEC regimens. Participants were randomized to receive either standard AEP or the same regimen with the addition of olanzapine. The study included randomization and blinding of medical professionals and statisticians to ensure accurate results. Patients recorded their symptoms and treatment responses, and QOL was measured using the Functional Living Index - Emesis questionnaire.
The trial found that adding olanzapine significantly improved CR rates compared to standard AEP alone, with a notable benefit in the delayed phase of CINV. Specifically, 91% of patients in the olanzapine group achieved CR compared to 82% in the observation group, and this improvement was maintained during the later assessment period. The olanzapine group also experienced better nausea and CINV control and used fewer rescue medications.
QOL assessments confirmed these results, with fewer patients in the olanzapine group experiencing deterioration in QOL related to CINV. Although the addition of olanzapine didn't significantly change nausea control compared to the observation group, it did improve overall control of nausea and vomiting combined.
Study limitations include the absence of a placebo control and the lack of evaluation for lower doses of olanzapine. Also, the predominance of GI cancer patients receiving oxaliplatin could influence the findings. Nonetheless, the trial supports the incorporation of olanzapine into AEP protocols for MEC regimens, suggesting that it could become a standard part of antiemetic therapy. (Ostwal, V., et al. (2024). Olanzapine as antiemetic prophylaxis in moderately emetogenic chemotherapy: A phase 3 randomized clinical trial. JAMA Network Open, 7(8), Article e2426076. Retrieved August 2024 from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822027)
Released: September 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Enfortumab Vedotin Plus Pembrolizumab for Urothelial Cancer
Enfortumab vedotin, an antibody-drug conjugate targeting nectin-4, combined with pembrolizumab, a programmed death-1 inhibitor, has shown promise in treating advanced urothelial carcinoma. Based on positive phase 1b/2 trial results showing high response rates and durable outcomes, the FDA granted accelerated approval for this combination for patients who are ineligible for cisplatin-based chemotherapy.
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The EV-302 trial, a global phase 3 study, aimed to compare the effectiveness and safety of enfortumab vedotin plus pembrolizumab versus platinum-based chemotherapy in patients with previously untreated advanced urothelial carcinoma. The trial included 886 patients, median age 69 years, with a range of histologic types. Patients were randomly assigned to either the combination therapy or the chemotherapy group and treated accordingly.
Results from the trial showed that enfortumab vedotin and pembrolizumab significantly improved progression-free survival compared to chemotherapy, with a median of 12.5 months versus 6.3 months, respectively. Overall survival was longer in the combination group as well, with a median of 31.5 months compared to 16.1 months in the chemotherapy group.
Adverse events associated with enfortumab vedotin and pembrolizumab, such as skin reactions and peripheral neuropathy, were still present, but manageable. The combination therapy also resulted in fewer severe adverse events compared to chemotherapy, despite the longer duration of treatment.
The EV-302 trial demonstrated that enfortumab vedotin and pembrolizumab offer significant benefits over platinum-based chemotherapy for untreated advanced or metastatic urothelial carcinoma. The improved survival and response rates make this combination a compelling alternative, potentially changing the standard treatment paradigm for this challenging cancer. (Levitan, D. (2024). Enfortumab vedotin plus pembrolizumab offer improved survival without detriment to quality of life. American Society of Clinical Oncology, Daily News. Retrieved August 2024 from https://dailynews.ascopubs.org/do/enfortumab-vedotin-plus-pembrolizumab-offer-improved-survival-without-detriment-quality; Powles, T., et al. (2024). Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. NEJM, 390, 875–888. Retrieved August 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2312117)
Released: September 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer