Randomized clinical trials (RCTs) provide some of the highest levels of evidence about treatment for cancer, including safety and efficacy. But only 2% to 4% of patients with cancer are enrolled in RCTs, which underscores the need for additional data and evidence to drive the decision-making process in clinical practice.

Therefore, researchers sought to identify effectiveness and early discontinuation predictors in pretreated patients receiving nivolumab in the treatment of non-small cell lung cancer (NSCLC). In this real-world study, data from administrative health flows (AHFs) and clinical records were reviewed. The findings were published in The Oncologist.

The study objectives were to determine median time to treatment discontinuation (TTD) in a real-world population and median overall survival (OS) in patients with and without early treatment discontinuation; the clinical-pathological features that may predict early treatment discontinuation; and the budget impact of early treatment discontinuation.

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Prior to the advent of immune checkpoint inhibitors, docetaxel was the standard of care after failure of platinum-based chemotherapy for patients with advanced NSCLC. However, not all patients benefited from treatment with nivolumab. This study also reviewed clinical records to assess the median OS of nivolumab and docetaxel.

Information from AHFs of 237 patients with NSCLC treated with nivolumab revealed median TTD and median OS were 4.2 months and 9.8 months, respectively. The median survival in patients with and without early treatment discontinuation were 3.3 months and 19.6 months, respectively.

Clinical records from 162 patients treated with nivolumab (cohort 1) and 83 patients treated with docetaxel (cohort 2) were reviewed, with median follow-ups of 43.4 months and 73.6 months, respectively. Median TTD was 4.8 months and 2.6 months, respectively.

Predictors of early treatment discontinuation included body mass index (BMI) less than 25 kg/m2, an ECOG performance score higher than 1, a neutrophil-to-lymphocyte ratio (NLR) higher than 2.91, and concomitant treatment with antibiotics and glucocorticoids.

Median OS for cohort 1 and cohort 2 were 12 months and 6.2 months, respectively. Risk of death was significantly higher with docetaxel or nivolumab with early treatment discontinuation, compared with nivolumab without early treatment discontinuation. Other factors that negatively impacted OS were presence of liver, brain, adrenal, and bone metastases; disease progression to previous systemic treatment; and no systemic treatment after disease progression.

In terms of costs and budget impact, incremental cost-effectiveness ratio (ICER) of nivolumab was $3757.37 when the analysis included all patients treated with nivolumab, and $3171.47 when the analysis focused on patients without early treatment discontinuation.

The researchers determined that nivolumab made sense for many patients. “However, an appropriate selection of patients who may benefit from a longer treatment duration and subsequently a better outcome (eg, good [performance score], smokers, low-tumor load) is mandatory to avoid ineffective treatment and improve the cost-effectiveness of innovative drugs in oncology,” they concluded.

Integrating data from different sources, such as clinical records and administrative health flows, could be useful when applied to all innovative drugs in various settings.

Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Pasello G, Lorenzi M, Calvetti L, et al. Multicenter real-world study on effectiveness and early discontinuation predictors in patients with non-small cell lung cancer receiving nivolumab. Oncologist. 2022. Published online April 18, 2022. doi:10.1093/oncolo/oyac051