Patient-reported outcomes with nivolumab in advanced solid cancers

Area of Science:

• Oncology
• Immunotherapy
• Patient-Reported Outcomes

Background:

• Recurrent or metastatic cancer often causes debilitating toxicities and symptoms, negatively impacting patients' health-related quality of life (HRQoL).
• Patient-reported outcomes (PROs) are crucial for understanding the patient experience in clinical trials.
• Nivolumab, a programmed death-1 receptor inhibitor, has shown survival benefits across various cancer types.

Purpose of the Study:

• To review published PRO analyses from clinical trials of nivolumab in melanoma, non-small cell lung cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN).
• To evaluate the impact of nivolumab on symptom burden, physical functioning, and HRQoL compared to standard of care.

Main Methods:

• Systematic review of PRO data from eight Phase II-IV clinical trials involving nivolumab.
• Utilized generic, cancer-specific, and tumor-specific validated PRO instruments to measure outcomes.
• Analyzed correlations between baseline HRQoL and clinical outcomes like overall survival and healthcare resource utilization.

Main Results:

• Nivolumab treatment generally led to sustained stabilization or clinically meaningful improvements in HRQoL across tumor types.
• Standard of care therapies frequently resulted in deteriorations in HRQoL.
• Exploratory analyses indicated a positive correlation between baseline HRQoL and overall survival in RCC, and with healthcare resource utilization in SCCHN.

Conclusions:

• Nivolumab demonstrates a favorable impact on patient-reported outcomes, including HRQoL, compared to standard treatments.
• PRO data, particularly baseline symptom burden, may hold significant clinical value in predicting survival and resource utilization.
• Future immuno-oncology trials should prioritize comprehensive PRO data collection to assess long-term treatment effects on HRQoL, addressing challenges like missing data.