Highlights
- •Patient-reported outcomes were assessed using the Lung Cancer Symptom Scale and EQ-5D in CheckMate 9LA.
- •Risk of symptom deterioration was lower with nivolumab + ipilimumab + chemo versus chemo.
- •1L nivolumab + ipilimumab + chemo maintained quality of life in patients versus chemo.
- •Data confirm clinical benefit of 1L nivolumab + ipilimumab + chemo in metastatic non-small cell lung cancer.
Abstract
Background
In CheckMate 9LA (NCT03215706), first-line nivolumab plus ipilimumab with chemotherapy
(2 cycles) significantly improved overall survival versus chemotherapy (4 cycles)
in patients with metastatic non-small cell lung cancer and no known sensitising epidermal growth factor receptor/anaplastic lymphoma kinase alterations. We present exploratory patient-reported outcomes (PROs; minimum follow-up,
2 years).
Methods
In patients (N = 719) randomised 1:1 to nivolumab plus ipilimumab with chemotherapy or chemotherapy
alone, disease-related symptom burden and health-related quality of life were assessed
using the Lung Cancer Symptom Scale (LCSS) and 3-level EQ-5D (EQ-5D-3L). Treatment-phase
changes in LCSS average symptom burden index (ASBI), LCSS three-item global index
(3-IGI) and EQ-5D-3L visual analogue scale (VAS) and utility index (UI) over time
were analysed descriptively and using mixed-effect model repeated measures. Time-to-deterioration/improvement
analyses were conducted.
Results
Treatment-phase PRO questionnaire completion rates were >80%. Mean treatment-phase
changes showed no deterioration from baseline in both arms for LCSS ASBI/3-IGI and
EQ-5D-3L VAS/UI; however, minimally important differences were not met. Mixed-effect
model repeated measures analyses showed overall reduction in symptom burden from baseline
for both arms; changes from baseline for LCSS 3-IGI and EQ-5D-3L VAS/UI were numerically
improved with nivolumab plus ipilimumab with chemotherapy versus chemotherapy, but
minimally important differences were not met. Nivolumab plus ipilimumab with chemotherapy
delayed time-to-definitive-deterioration versus chemotherapy (LCSS ASBI: hazard ratio,
0.62 [95% confidence interval, 0.45–0.87]); results were similar across PRO measures.
Conclusions
At 2-year minimum follow-up, first-line nivolumab plus ipilimumab with chemotherapy
reduced the risk of definitive deterioration in disease-related symptom burden and
health-related quality of life versus chemotherapy and maintained QoL in patients
with metastatic non-small cell lung cancer.
Clinical trial registration: ClinicalTrials.gov Identifier, NCT03215706.
Keywords
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Article info
Publication history
Published online: January 28, 2023
Accepted:
January 14,
2023
Received in revised form:
January 10,
2023
Received:
October 25,
2022
Footnotes
☆Prior presentation: Presented at the ESMO Congress 2020, Virtual, 18th September 2020, LBA59.
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