KEY TAKEAWAYS
- Phase 3 CheckMate 743 (NCT02899299) analysis of nivolumab+ipilimumab helped in OS in patients with unresectable MPM.
- The aim of the study was to evaluate chemotherapy or nivolumab+ipilimumab patients in disease-related symptom burden and HRQol for LCSS-Meso.
- The MMRM and time deterioration analyses were conducted for better results.
- Completion rates were more than 80%. LCSS-Meso ASBI changes from baseline improved with nivolumab + ipilimumab and deteriorated with chemotherapy.
- Nivolumab + ipilimumab helps to decrease the deterioration risk in HRQoL and disease-related symptoms.
Completion rates were generally more than 80%. LCSS-Meso ASBI mean changes from baseline trended to improve over time with nivolumab + ipilimumab and deteriorate with chemotherapy but did not meet clinically important difference thresholds [±10 score change]. EQ-5D-3L VAS mean scores improved with nivolumab + ipilimumab; by week 60, patients had scores consistent with United Kingdom normal population values. MMRM analyses favored nivolumab + ipilimumab for all individual symptoms except cough. Nivolumab + ipilimumab delayed time to definitive deterioration in HRQoL (hazard ratio 0.52 [95% confidence interval 0.36-0.74]) showed a trend in symptom delay versus chemotherapy.
Nivolumab + ipilimumab significantly increased overall survival in patients with unresectable malignant pleural mesothelioma (MPM) in the CheckMate 743 (NCT02899299) study. Patient-reported outcomes (PROs) are presented. Nivolumab + ipilimumab (N = 605) or chemotherapy was randomly assigned to patients. Researchers used LCSS (The Lung Cancer Symptom Scale) Meso (Mesothelioma) ASBI (average symptom burden index).
LCSS-Meso 3-item global index (3-IGI), 3-level EuroQol 5-dimensional (EQ-5D-3L) visual analog score (VAS), and EQ-5D-3L utility index were used for descriptive evaluation of changes in disease-related symptom burden and HRQoL. Researchers evaluated patients’ perceptions of their progress at the beginning of treatment, then every 2 (nivolumab + ipilimumab) or 3 weeks (chemotherapy) for the first 12 weeks, every 6 weeks for the next 12 months, and every 12 weeks after that. Time-to-deterioration and mixed-effect model repeated-measures analyses were performed.
In most cases, completion rates were above 80%. Clinically meaningful differences [10 score change] were not reached between nivolumab + ipilimumab and chemotherapy. Both treatments showed a trend toward improvement in the LCSS-Meso ASBI. By week 60, individuals treated with nivolumab and ipilimumab had achieved EQ-5D-3L VAS mean scores comparable to those found in the general population of the United Kingdom. All symptoms, excluding cough, preferred nivolumab + ipilimumab in MMRM analysis. There was a trend for later onset of symptoms with nivolumab + ipilimumab compared to chemotherapy (hazard ratio 0.52 [95% confidence interval 0.36-0.74]).
Patients with unresectable MPM who received nivolumab and ipilimumab instead of chemotherapy saw a reduction in the probability of worsening disease-related symptoms and HRQoL.
Source: https://pubmed.ncbi.nlm.nih.gov/35367910/
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT02899299
Scherpereel, A., Antonia, S., Bautista, Y., Grossi, F., Kowalski, D., Zalcman, G., Nowak, A. K., Fujimoto, N., Peters, S., Tsao, A. S., Mansfield, A. S., Popat, S., Sun, X., Lawrance, R., Zhang, X., Daumont, M. J., Bennett, B., McKenna, M., & Baas, P. (2022). First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743. Lung cancer (Amsterdam, Netherlands), 167, 8–16. https://doi.org/10.1016/j.lungcan.2022.03.012
