Purpose: Although immune checkpoint inhibitors have been shown to be effective in many clinical trials, real-world data remain limited. We investigated the outcomes of non-small cell lung cancer (NSCLC) patients who received nivolumab, with an emphasis on hyper-progressive disease (HPD).
Methods: This retrospective study enrolled stage IV NSCLC patients who received nivolumab after progression on prior chemotherapy between July 2016 and June 2018 at a single center in Korea. HPD was defined by response evaluation criteria in solid tumors as progression at the first evaluation, with a ≥ two-fold increase in the tumor growth rate during nivolumab treatment.
Results: A total of 83 patients with a median age of 60 years were enrolled [squamous, 25(30%) and non-squamous, 58(70%)]. The median progression-free survival (PFS) and overall survival (OS) were 2.6 months [95% confidence interval (CI) 0.82-4.31] and 8.6 months (95% CI 5.56-11.59), respectively. HPD developed in 16 (19.2%). The median OS of HPD patients was 2.2 months (95% CI 0.92-3.75) compared with 4.1 months for progressive disease (PD) patients without HPD (95% CI 1.54-6.67). Among patients with pleura or pericardium metastasis, increased effusion was seen more frequently in HPD patients compared with PD patients without HPD [90% (9/10) vs. 28.6% (4/14); p = 0.005]. HPD patients also showed a significant decrease in circulating albumin after treatment with nivolumab (p = 0.030).
Conclusion: Although the efficacy of nivolumab in real-world patients was comparable to that seen in clinical trials, clinicians should be aware of HPD because it is not uncommon and represents a worse prognosis.
Keywords: Albumin; Efficacy; Hyper-progression; Immune checkpoint inhibitor; Pleura.