Updated safety and efficacy analysis comparing elderly vs nonelderly patients treated with consolidation nivolumab or nivolumab plus ipilimumab after chemoradiation for unresectable stage III NSCLC from the BTCRC LUN 16-081 clinical trial.

Authors

null

Shobha Shahani

Indiana University School of Medicine, Indianapolis, IN

Shobha Shahani , Sandra K. Althouse , Nasser H. Hanna , Greg Andrew Durm

Organizations

Indiana University School of Medicine, Indianapolis, IN, Indiana University Simon Comprehensive Cancer Center, Indianapolis, IN, Indiana University Melvin and Simon Comprehensive Cancer Center, Indianapolis, IN, Indiana University, Indianapolis, IN

Research Funding

No funding sources reported

Background: Lung cancer is the leading cause of cancer related deaths. The median age of those diagnosed with lung cancer continues to increase as the overall population ages. Consolidation immunotherapy after chemoradiation has become the standard treatment for patients with unresectable stage III NSCLC. However, little has been reported regarding the safety and efficacy of this strategy in an elderly patient population. Methods: Data was analyzed from a randomized phase II clinical trial in patients with unresectable stage III non-small cell lung cancer (NSCLC) who were randomized to Nivolumab (N) or Nivolumab/Ipilimumab (NI) after concurrent chemoradiation. We performed an ad-hoc analysis comparing the efficacy and toxicity based on age groups <65 and ≥ 65. A total of 54 patients received N (480mg IV every 4 weeks for up to 6 cycles) and 51 patients received N (240mg IV every 2 weeks) + I (1mg/kg IV every 6 weeks for up to 4 cycles). Results: From 9/2017 to 4/2021, 105 patients were enrolled. Fifty-five were age <65 (26 in N and 29 in NI) and 50 were ≥65 (28 in N and 22 in NI). Patients were matched for baseline characteristics (Table). In the N alone group, pneumonitis was noted in 14 patients: 9 (34.6%) <65 and 5 (17.9%) age ≥ 65 (p=0.16). In the NI group, 19 patients experienced pneumonitis: 9 (31%) were<65 and 10 (45.5%) were ≥ 65 (p=0.29). Hospitalization was noted in 9 patients in the N group: 6 (23.1%) < 65 and 3 (10.7%) ≥ 65 (p=0.28). In the NI group, 20 patients were hospitalized: 9 (31%) were <65 and 11(50%) were ≥ 65 (p=0.16). At 24 months, the PS for all patients <65 was 61.3% and 60.5% for patients ≥65(p=0.62). PFS was 46.8% for <65 and 73.8% for ≥65 (p=0.15) in the N group and 75.4% for <65 and 45.4% for ≥65 in the NI group(p=0.02). OS for patients <65 was 84% at 24 months and 73% for ≥65 for both groups (p=0.466). For individual groups, OS was 72.5% in <65 and 81.4% for ≥65 (p=0.27) in the N group and 92.8% for <65 and 68.2% for ≥65 in the NI group (p=0.029). Conclusions: Adverse events in both age groups were comparable but overall higher in NI arm in both younger and elderly patients. OS estimates were similar for both age groups in N while higher in younger patients compared to older adults in NI.

Patient CharacteristicsNivolumabNivolumab+Ipilimumab
Age groups<65≥ 65<65> 65
Median age59 years70 years60 years70 years
#patients in each arm26282922
Gender
Male
Female

12(46.2%)
14(58.3%)

12(42.9%)
16(57.1%)

17(58.6%)
12(41.4%)

12(54.5%)
10(45.5%)
Stage IIIA15(57.7%)20(71.4%)16(55.2%)15(68.2%)
Stage IIIB11(42.3%)8(28.6%)13(44.8%)7(31.8%)
Treatment completed18(69.2%)22(78.6%)17(58.6%)8(36.4%)

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Abstract Details

Meeting

2024 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Care Delivery/Models of Care

Track

Care Delivery and Quality Care

Sub Track

Geriatric Models of Care

Citation

J Clin Oncol 42, 2024 (suppl 16; abstr e13770)

DOI

10.1200/JCO.2024.42.16_suppl.e13770

Abstract #

e13770

Abstract Disclosures