Abstract
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are used for treating EGFR-mutated lung cancer, and osimertinib is effective in cases that acquired T790M mutations after treatment with the first- and second-generation EGFR-TKIs. However, no study has evaluated its safety and efficacy in older patients. This phase II trial (jRCTs071180002) evaluated osimertinib in T790M mutation-positive Japanese patients who were ≥75 years old and had experienced relapse or progression after previous EGFR-TKI treatment. Our previous report that enrolled 36 patients showed the overall response rate (58.3%) and disease control rate (97.2%), while this report describes the results for the progression-free survival (PFS), overall survival (OS), and safety analyses. The median PFS was 11.9 months (95% confidence interval (CI): 7.9–17.5), and the median OS was 22.0 months (95% CI: 16.0 months–not reached). The most frequent adverse events were anemia/hypoalbuminemia (27 patients, 75.0%), thrombocytopenia (21 patients, 58.3%), and paronychia/anorexia/diarrhea/neutropenia (15 patients, 41.7%). Pneumonitis was observed in four patients (11.1%), including two patients (5.6%) with Grade 3–4 pneumonitis. These results suggest that osimertinib was relatively safe and effective for non-small cell lung cancer that acquired T790M mutations after previous EGFR-TKI treatment, even among patients who were ≥75 years old.
Highlights
Treatment for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) typically involves EGFR tyrosine kinase inhibitors (EGFR-TKIs)
Osimertinib is a third-generation EGFR-TKI that was developed to address this issue [12], and he AURA3 study revealed that it provided significantly longer progression-free survival (PFS) compared to platinum-based chemotherapy among patients with T790M-mutated lung cancer [13]
The FLAURA trial conducted on first-line treatment revealed that osimertinib administered as an initial treatment for EGFR-mutated cases significantly prolonged PFS and overall survival (OS) compared with the first-generation EGFR-TKIs, with a median OS of >3 years [14,15]
Summary
Treatment for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) typically involves EGFR tyrosine kinase inhibitors (EGFR-TKIs). Afatinib and dacomitinib are the second-generation EGFR-TKIs that provide significantly longer progression-free survival (PFS) compared to that of platinum-based chemotherapy and first-generation EGFR-TKIs, the second-generation EGFR-TKIs did not significantly improve overall survival (OS) [7,8,9,10,11] These drugs are associated with more severe toxicity profiles, such as skin disorders, relative to the first-generation EGFR-TKIs. Various mechanisms are responsible for resistance to the first-generation and second-generation EGFR-TKIs, with more than one-half of the cases involving the EGFR exon 20 T790M mutation [12]. Osimertinib is a third-generation EGFR-TKI that was developed to address this issue [12], and he AURA3 study revealed that it provided significantly longer PFS compared to platinum-based chemotherapy among patients with T790M-mutated lung cancer [13].
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