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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Wednesday, October 30, 2024
For patients with stage I to IIIA non–small cell lung cancer (NSCLC), neoadjuvant treatment with the third-generation EGFR tyrosine kinase inhibitor osimertinib may be a potential therapeutic strategy, according to a phase II clincal trial published in the Journal of Clinical Oncology. Despite this therapeutic intervention not meeting its primary endpoint—major pathologic response rate—it was found to be well tolerated by and safe for patients, explained Collin M. Blakely, MD, PhD, of the University of California, San Francisco, and colleagues.
A total of 27 patients with surgically resectable NSCLC were recruited for the study. Tissue biopsies from the tumor were collected to confirm EGFR-mutant status. All patients were treated with 80 mg of osimertinib for up to two 28-day cycles. Following pharmacologic treatment, patients underwent surgical resection of their tumors.
The study authors reported that 89% of patients underwent surgical resection, and 11% were treated with definitive chemoradiotherapy. After treatment, the major pathologic response rate was 14.8%. However, no complete pathologic responses were observed. In addition, the objective response rate and median disease-free survival were 52% and 40.9 months, respectively. Treatment-related adverse events did not prevent patients from undergoing surgical resection or delay surgical intervention. Furthermore, co-occurring TP53 (42%) and RBM10 (21%) genetic alterations were the most commonly identified across patient tumors.
“The major limitations of this trial include the small samples size, the lack of a chemotherapy control arm, and insufficient pretreatment and posttreatment tumor tissue available for comprehensive biomarker analyses,” the investigators acknowledged. Additional investigative efforts are now aimed at evaluating the clinical efficacy of combined neoadjuvant platinum doublet chemotherapy and osimertinib therapy in improving major pathologic response rates in this patient population.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
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