Durvalumab (Imfinzi) is an FDA-approved PD-L1-blocking antibody effective in non-small cell lung cancer treatment. FDA approvals span from February 2018 for stage III advanced cases to late-stage metastatic NSCLC in November 2022, culminating in a recent August 2024 approval for early-stage resectable cases. Promising trial results underscore its efficacy while patient safety and monitoring remain paramount.
Durvalumab, known as Imfinzi, is gaining traction in treating non-small cell lung cancer (NSCLC). This PD-L1-blocking antibody has three distinct FDA approvals. First, in February 2018, it was approved for stage III unresectable NSCLC post platinum-based chemotherapy and radiation. Then, in November 2022, it was given the green light, coupled with tremelimumab and platinum chemotherapy for stage IV metastatic cases. The most recent approval in August 2024 allows its use in early-stage NSCLC alongside neoadjuvant chemotherapy before surgery.
The PACIFIC trial showcased impressive results for stage III patients. Those receiving durvalumab showed median progression-free survival (PFS) extending to 16.8 months, a significant leap from just 5.6 months in the placebo group. The results from the POSEIDON trial further bolstered durvalumab’s efficacy. Patients with EGFR/ALK wild-type metastatic NSCLC experienced improved PFS of 6.2 months when treated with durvalumab in combination with chemotherapy compared to 4.8 months for those on chemotherapy alone.
As for the AEGEAN trial, participants diagnosed with early-stage NSCLC treated with durvalumab in conjunction with chemotherapy yielded promising outcomes. The trial revealed that the median event-free survival was not reached for the durvalumab cohort, whereas it was only 25.9 months in the placebo group. The pathological complete response rates also favored the durvalumab arm (17% vs 4.3%).
In terms of usage, the FDA suggests administering 10 mg/kg of durvalumab every two weeks for stage III patients. For metastatic cases over 30 kg, the recommended dose is 1500 mg per cycle along with tremelimumab. Patients below the 30 kg threshold will receive 20 mg/kg and 1 mg/kg respectively.
Monitoring patients on durvalumab is crucial to detect adverse reactions. Common adverse events to keep track of include pneumonitis, hepatitis, colitis, and thyroid dysfunctions. For example, pneumonitis requires vigilance for shortness of breath and may need corticosteroids if symptoms worsen. It’s also essential to look for signs of infection, infusion reactions, and manage any abnormal lab values to avoid severe consequences.
Educating patients on self-monitoring during treatment is key. They should be informed to report any discomfort during infusions and comply with birth control measures due to embryo-fetal toxicity risks. Proper hand hygiene and infection prevention tactics should also be emphasized, alongside skin care routines to mitigate dermatological reactions.
Nurses administering durvalumab need to adhere to safety protocols, utilizing personal protective equipment despite it not being classified as a hazardous drug by existing standards. Keeping abreast of advancements in oncology nursing practices will enhance patient care overall.
Lastly, on June 1st, 2023, Seth Eisenberg discussed new strategies aimed at minimizing nurse exposure to hazardous drug contaminants in hospital settings, underscoring ongoing efforts in improving safety for nursing personnel.
Durvalumab’s multiple approvals for NSCLC signify a crucial advancement in treating this challenging cancer type. Its increased efficacy illustrated in several clinical trials emphasizes its role in managing both early and late-stage disease. Monitoring for adverse events is critical, and education for patients regarding this treatment is key. As ongoing nursing research addresses safety in drug handling, staying abreast of new methodologies is essential for healthcare providers.
Sumber Asli: www.oncnursingnews.com
