Masahiro Tsuboi, MD

Masahiro Tsuboi, MD, a surgeon at the National Cancer Center Hospital East in Japan, discusses the findings from the phase 3 ADAURA clinical trial of osimertinib (Tagrisso) as treatment of patients with 

-mutated non–small cell lung cancer (NSCLC).

In terms of safety, the adverse event (AE) profile was consistent with the known profile of osimertinib, the EGFR tyrosine kinase inhibitor. The most common AEs were primarily grades 1 or 2, and the incidence of grade 3 AEs was low with osimertinib, according to Tsuboi.

Osimertinib induced a highly significant and clinically meaningful improvement in disease-free survival and reduced the risk of distant recurrence. The disease-free survival was especially notable in the population of patients with completed resected stage 1/2b/3a 

-mutant NSCLC. Tsuboi says he has observed a wave if precision medicine in the post-operative space.

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Masahiro Tsuboi, MD, discusses the findings from the phase 3 ADAURA clinical trial of osimertinib as treatment of patients with EGFR-mutated non–small cell lung cancer.

Phase 3 ADAURA Study Highlights Role for Precision Medicine in EGFR-Positive NSCLC

Masahiro Tsuboi, MD, a surgeon at the National Cancer Center Hospital East in Japan, discusses treatment with osimertinib (Tagrisso) for patients with 

-mutated non–small cell lung cancer (NSCLC) and central nervous system (CNS) disease recurrence.

EGFR tyrosine kinase inhibitors (TKIs) are standard of care for patients with NSCLC and 

 mutations in the adjuvant setting. Previous studies have suggested their use in the resectable setting, according to Tsuboi. Disease recurrence can be local or distant for patients with resected NSCLC, and the type of recurrence impacts outcome after surgery. Local recurrence is associated with a longer survival outcome compared with distant recurrence.

CNS metastases are common for patients with 

 mutations. Tsuboi says an example of this is the adjuvant RADIANT study (NCT00373425), where 77% of the recurrence in patients with NSCLC receiving erlotinib (Tarceva) had CNS involvement. CNS metastases indicate a poor prognosis for these patients and remains an unmet need in this setting. By preventing CNS recurrence, patient outcomes will improve, Tsuboi says.

Osimertinib has shown clinical significance for exposure in the brain compared with other EGFR TKIs and has shown greater penetration of the blood-brain barrier.

Masahiro Tsuboi, MD, discusses treatment with osimertinib for patients with EGFR-mutated non–small cell lung cancer and central nervous system disease recurrence.

Osimertinib Plays a Role for Patients With EGFR-Mutant NSCLC

Masahiro Tsuboi, MD, a surgeon at Japan’s National Cancer Center Hospital East, discusses the key takeaways from the 

findings for osimertinib (Tagrisso) in patients with early-stage 

 (NSCLC) following a complete tumor resection in the phase 3 ADAURA clinical trial (NCT02511106), which were presented during the 2020 European Society for Medical Oncology (ESMO) Virtual Congress.

According to these results, adjuvant osimertinib demonstrated a clinically meaningful improvement in central nervous system disease-free survival compared with placebo. Treatment with osimertinib following complete tumor resection reduced the risk for central nervous system death or progression by 82%. Tsuboi says low rates of recurrence, particularly in the brain, were also observed in the study.

Based on the findings from this study, adjuvant osimertinib would be an effective and practice-changing treatment approach for patients with early-stage 

Masahiro Tsuboi, MD, discusses the key takeaways from the findings for osimertinib in patients with early-stage EGFR-mutant non–small cell lung cancer following a complete tumor resection in the phase 3 ADAURA clinical trial.

Masahiro Tsuboi, MD | Authors

Articles

Phase 3 ADAURA Study Highlights Role for Precision Medicine in EGFR-Positive NSCLC

Osimertinib Plays a Role for Patients With EGFR-Mutant NSCLC

ADAURA Study Demonstrates Promising Efficacy for Osimertinib in EGFR-Mutant NSCLC