HRQOL Not Consistently Assessed in Studies on NSCLC Treatment Efficacy

Across studies assessing the efficacy of immune checkpoint inhibitors (ICIs) or tyrosine kinase inhibitors (TKIs) in early-stage non–small cell lung cancer (NSCLC), researchers found that health-related quality of life (HRQOL) was not evaluated consistently.¹

Although advances in NSCLC have improved long-term prognosis for those who catch it in early stages,² NSCLC can still affect the QOL for those living with the condition, both physically and mentally. Measuring HRQOL can help to assess how the patients are doing as they receive treatment, which in turn can help to improve the care process. However, measuring HRQOL is less common in NSCLC compared with other types of cancer, which could leave treatment of NSCLC at a disadvantage when looking at holistic approaches to care. This review aimed to assess how many studies measured HRQOL as an end point of the study, specifically in clinical trials that assess the efficacy of ICIs or TKIs.¹

The researchers used PubMed and EMBASE to collect studies for the review, with all studies published through October 2024 considered for the study. Studies were eligible for the review if they were phase 2 or 3 randomized controlled trials containing patients with early-stage NSCLC; were trials testing ICIs or TKIs in an adjuvant, neoadjuvant, or perioperative setting; and were written in English. If studies included other forms of treatment, they were excluded from the review. Retrospective trials, trials for unresectable cancers, trials testing nonpharmacological therapies, phase 1 trials, brief reports, studies testing only chemotherapy, and trials of supportive care were also excluded.

The primary outcome was to assess if HRQOL was reported in the studies and how they were reported.

There were 25 phase 2 and 3 studies included in the final analysis. Open-label designs were used for 16 of the trials, and double-blind design was used for 9 of the trials; 16 of the trials were phase 3 trials and 9 of the studies were phase 2 trials. A total of 20 of the trials met their primary end point.

HRQOL was not included as a primary end point in any of the studies but was included as a secondary end point in 8 of the trials, an exploratory end point in 4 of the trials, and both a secondary and exploratory end point in 1 trial. This left 12 studies that did not include HRQOL as an end point. Open-label studies, phase 2 trials, and studies testing experimental treatment more commonly did not evaluate HRQOL. HRQOL was also not an end point among 8 of the studies that had positive results.

Only 3 of the 22 trials that had a primary publication included data on HRQOL, equaling 100% of the phase 2 trials and 79% of the phase 3 trials. Only 2 of the 19 trials included HRQOL data in the secondary publication, and 2 more included HRQOL data in conference abstracts.

There were some limitations to the study. The only trials included in the analysis were those that evaluated the efficacy of ICIs and TKIs, which could limit the review by excluding trials that evaluated chemotherapy regimens. This also resulted in a smaller sample size. The effect of treatment on HRQOL domains was not assessed in this review, which only focused on the measuring of HRQOL overall. Studies from the most recent international conferences were not included, and studies from Asia could have been excluded due to all studies requiring the English language.

“In conclusion, although ICIs and TKIs have revolutionized the management of early-stage NSCLC, it remains unclear how these therapies affect patients’ everyday functioning and well-being,” the authors concluded. “Future studies should prioritize the integration and transparent reporting of HRQOL outcomes to ensure that therapeutic advancements translate into meaningful benefits from the patient’s perspective.”

References

1. Salomone F, Novero G, Ciani O, et al. Health-related quality of life assessment in trials testing tyrosine kinase inhibitors or immune checkpoints inhibitors in early-stage NSCLC. Oncologist. Published online October 7, 2025. doi:10.1093/oncolo/oyaf339

2. Lung cancer survival rates. American Cancer Society. Updated June 27, 2025. Accessed October 8, 2025. https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html