Adjuvant Osimertinib and Advanced EGFR-Mutated NSCLC | NEJM
Summary
TLDRA phase 3 clinical trial has shown that osimertinib, an EGFR tyrosine kinase inhibitor, significantly improves progression-free survival in patients with unresectable stage III non-small-cell lung cancer with EGFR mutations. The trial, involving 216 patients, demonstrated a median progression-free survival of 39.1 months for osimertinib versus 5.6 months for placebo. Although 36-month overall survival did not show a significant difference, the treatment reduced the risk of disease progression, with adverse events occurring in 35% of the osimertinib group. These findings are published on NEJM.org.
Takeaways
- 🚫 Patients with unresectable stage III non-small-cell lung cancer (NSCLC) and an EGFR mutation previously had no approved targeted treatments available.
- 💊 Osimertinib, an EGFR tyrosine kinase inhibitor, is a recommended adjuvant treatment for resected EGFR-mutated NSCLC but was being tested for unresectable cases in this trial.
- 🔬 The trial was a phase 3, randomized, double-blind, placebo-controlled study involving 216 patients with stage III disease.
- 📈 Patients were assigned in a 2-to-1 ratio to receive daily oral osimertinib or placebo, following chemoradiotherapy without progression.
- 📊 The primary endpoint, median progression-free survival, was significantly longer with osimertinib at 39.1 months compared to 5.6 months with placebo.
- 📉 Interim data showed no statistically significant difference in 36-month overall survival between the osimertinib and placebo groups.
- ⚠️ Adverse events of grade 3 or higher occurred in 35% of patients in the osimertinib group, compared to 12% in the placebo group.
- 🌐 Radiation pneumonitis was a common adverse event but was mostly mild or moderate in severity.
- 🎯 Osimertinib demonstrated an improvement in progression-free survival for patients with unresectable EGFR-mutated stage III NSCLC.
- 📚 Full trial results are available for further review at NEJM.org, providing comprehensive data on the study's findings.
Q & A
What is the current status of targeted treatments for unresectable stage III non-small-cell lung cancer with an EGFR mutation?
-There are no approved targeted treatments available for patients with unresectable stage III non-small-cell lung cancer with an EGFR mutation.
What is the role of osimertinib in treating EGFR-mutated non-small-cell lung cancer?
-Osimertinib is an EGFR tyrosine kinase inhibitor and is recommended as an adjuvant treatment for resected EGFR-mutated non-small-cell lung cancer.
What was the purpose of the new trial mentioned in the script?
-The new trial aimed to assess the efficacy and safety of adjuvant osimertinib among patients with unresectable, EGFR-mutated advanced disease.
How was the trial designed to test the efficacy of osimertinib?
-The trial was a phase 3, randomized, double-blind, placebo-controlled trial involving 216 patients with stage III disease.
What was the ratio of patients assigned to receive osimertinib versus placebo in the trial?
-Patients were randomly assigned in a 2-to-1 ratio to receive daily oral osimertinib or placebo.
What was the primary endpoint of the trial?
-The primary endpoint of the trial was median progression-free survival.
What were the results for median progression-free survival with osimertinib and placebo?
-The median progression-free survival was 39.1 months with osimertinib and 5.6 months with placebo.
What was the interim data regarding the 36-month overall survival between the two groups?
-According to interim data, the between-group difference in 36-month overall survival was not statistically significant.
What was the incidence of grade 3 or higher adverse events in the osimertinib and placebo groups?
-Grade 3 or higher adverse events occurred in 35% of the patients in the osimertinib group and 12% of those in the placebo group.
Was radiation pneumonitis a common adverse event in the trial? If so, what was its severity?
-Yes, radiation pneumonitis was common, but most cases were mild or moderate in severity.
What conclusion did the authors draw from the trial regarding osimertinib's impact on patients with unresectable EGFR-mutated stage III non-small-cell lung cancer?
-The authors concluded that osimertinib improved progression-free survival among patients with unresectable EGFR-mutated stage III non-small-cell lung cancer.
Where can the full trial results be found?
-The full trial results are available at NEJM.org.
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