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In real-world studies in patients with advanced non-small cell lung cancer (NSCLC), first-line (1L) nivolumab plus iplimab (NIVO + IPI) therapy is as safe as other approved combination therapies. It turns out that there is. Immuno-oncology (IO) drugs and chemotherapy.
Retrospective observational analysis published in future of oncologysought to determine the safety profile of 1L NIVO + IPI. Although this regimen has been declared safe by the FDA, some patients still experience adverse events. Additionally, there is limited information regarding the side effects of this treatment in real-world settings.
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The researchers collected data from the Flatiron Health database, which only exists through October 2021. The database included unstructured data from health records and physician notes and other documents. Patients registered in the Advanced NSCLC Core Registry after January 1, 2011 and who received one of the following 1L therapies by April 30, 2021 are eligible for inclusion:
- Cohort 1: NIVO + IPI
- Cohort 2: NIVO + IPI and chemotherapy
- Cohort 3: Another approved IO drug and chemotherapy
Overall, 262 patients were enrolled (cohort 1, n = 137; cohort 2, n = 46; cohort 3, n = 79). Patients in Cohorts 1 and 2 were included in the Flatiron Health database, while patients in Cohort 3 were randomly selected from all eligible patients receiving chemotherapy with other approved IO agents. Ta. The mean (SD) age of each cohort was 71.4 years (9.9 years), 68.8 years (9.4 years), and 68.7 years (8.5 years), respectively. Men comprised the majority of the total cohort (female, 46.7% vs. 391% vs. 45.6%), and most patients were white (72.3% vs. 60.9% vs. 72.2%).
Across the entire cohort, most patients were diagnosed with stage IV disease, had an Eastern Cooperative Oncology Group performance status of 0 or 1, and had non-squamous NSCLC. Furthermore, when comparing Cohorts 1 and 2 with Cohort 3, similar proportions of patients had tumor PD-L1 expression levels below 1% (29.2% vs. 35.4%) and levels between 1% and 49% (38.7% vs. 29.1%). , had levels ≥50% (17.5% vs. 13.9%), and had unknown tumor PD-L1 expression levels (14.6% vs. 21.5%). Median (IQR) treatment duration was 3.7 (1.3-8.5) months for cohorts 1 and 2 and 3.0 (2.8-4.3) months for cohort 3.
The most common adverse events in patients receiving NIVO +IPI were fatigue (67.9%), pain (66.4%), dyspnea (47.4%), weight loss (43.8%), and decreased appetite (40.1%). ), diarrhea (38.7%), nausea/vomiting (35.8%), cough (35.0%), constipation (32.1%), and rash (29.9%). Additionally, 17.5% of patients who received this treatment experienced a lung infection during treatment.
Most patients in Cohorts 1 and 2 experienced adverse events, with 26.3% of patients requiring hospitalization, 24.8% of patients continuing treatment due to an adverse event, and 24.8% of patients requesting a dose or schedule change. 4.4% received treatment to manage adverse events, including 9.5% of patients who discontinued. process.
The most common adverse events in patients in cohort 3 were fatigue (77.2%), pain (60.8%), nausea/vomiting (51.9%), decreased appetite (45.6%), constipation (45.6%), and weight loss (44.3%). %) was. %), dyspnea (43.0%), cough (43.0%), diarrhea (36.7%), rash (29.1%), and peripheral edema (29.1%). An additional 15.2% encountered lung infections.
Almost all (96.2%) patients in cohort 3 who experienced adverse events received treatment to manage them. Overall, 25.3% of patients experienced AEs leading to hospitalization, 30.4% required treatment withholding due to AEs, 12.7% experienced changes in treatment dose or treatment schedule, and 16.5% discontinued treatment.
The authors noted that similar hospitalization rates suggest similar clinical and economic burdens between cohorts.
This study had several limitations, including focusing only on first-line therapy in assessing adverse events, lack of grading data, and small sample size for the overall cohort. did. The authors cautioned against comparing safety data using descriptive analyses, highlighting the possibility that other clinically significant adverse events, such as anemia and hepatitis, may be overlooked within predefined limits.
reference
Betts KA, Gao S, Ray S, Schoenfeld AJ. Real-world safety of first-line immuno-oncology combination therapy for advanced non-small cell lung cancer. Future Oncor. Published online on January 19, 2024. doi:10.2217/fon-2023-0612
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