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Nivolumab in routine practice for older patients with advanced or metastatic non-small cell lung cancer
Renaud Sabatier1, Emanuel Nicolas1, Maria Paciencia2
1Department of Medical Oncology, Institut Paoli-Calmettes, 13009 Marseille, France; Aix-Marseille Univ, CNRS U7258, INSERM U1068, Institut Paoli-Calmettes, CRCM, 13009 Marseille, France.
Background:
Nivolumab is approved worldwide as second-line treatment for metastatic non-small cell lung cancer (NSCLC). Despite the fact that most of these cancers are being diagnosed in the older patients, few of the patients were included in pivotal trials. We aimed to describe efficacy and safety in a "real-world" older population.
Patients And Methods:
We retrospectively collected data from older patients (≥70 years old) with advanced or metastatic NSCLC treated with Nivolumab in our institution. We analyzed safety (CTCAE v4.0 criteria), efficacy (clinical benefit rate, progression-free survival, and overall survival), and correlated these features to geriatric parameters and PD-L1 expression. Along with this cohort, we assessed safety at a national level by retrieving all cases of Nivolumab (prescribed for NSCLC) induced adverse events analyzed by the French pharmacovigilance network during the inclusion period.
Results:
From July 2015 to September 2016, 30 patients were enrolled with a median age of 75.2. Clinical benefit rate was 30.6%. Median progression-free survival and overall survival were 3.3 and 7.1 months, respectively. Fifteen patients (50%) presented an immune-related adverse event (IrAE) of any grade, including four high grade IrAEs. Two hundred and eighty IrAEs had been notified to the French pharmacovigilance network including 91 (35.2%) concerning older patients. Frequency and pattern of IrAEs were similar for older patients and younger subjects.
Conclusions:
Even though frequency and patterns of IrAEs are different from pivotal studies, these results don't seem specific to older patients. Further prospective investigations are needed to better characterize and predict the impact of Nivolumab on older patients with NSCLC.
Insights
This study evaluated Nivolumab
Area of Science:
- Oncology
- Immunotherapy
- Geriatric Medicine
Background:
- Nivolumab is a standard second-line treatment for metastatic non-small cell lung cancer (NSCLC).
- Pivotal trials for Nivolumab have limited data on older patient populations (≥70 years).
- Real-world data is crucial for understanding treatment outcomes in elderly NSCLC patients.
Purpose of the Study:
- To assess the efficacy and safety of Nivolumab in older patients with advanced or metastatic NSCLC.
- To correlate clinical outcomes with geriatric parameters and PD-L1 expression.
- To compare safety data with a national pharmacovigilance database.
Main Methods:
- Retrospective analysis of 30 elderly patients (≥70 years) treated with Nivolumab.
- Evaluation of safety using CTCAE v4.0 criteria and efficacy via clinical benefit rate, PFS, and OS.
- National safety data collection of Nivolumab-induced adverse events from the French pharmacovigilance network.
Main Results:
- The clinical benefit rate was 30.6% with median PFS of 3.3 months and median OS of 7.1 months.
- 50% of patients experienced immune-related adverse events (IrAEs), with 4 high-grade events.
- National data showed similar IrAE frequency and patterns between older and younger patients.
Conclusions:
- Nivolumab demonstrates comparable safety and efficacy in older NSCLC patients compared to general populations.
- Observed IrAEs in older patients were not significantly different from younger counterparts.
- Further prospective studies are warranted to precisely define Nivolumab's impact in elderly NSCLC patients.
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