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EGFR-TKIs Exhibit Safety and Tolerability in Patients with NSCLC
First-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) were examined in combination with concurrent chemotherapy in patients with treatment-naïve advanced non-small-cell lung cancer (NSCLC) and sensitive EGFR mutations. (J Inflamm Res. 2021 Jun 16;14:2557-2567.).
21 patients were enrolled to the open-label, single-arm, phase II clinical trial and received gefitinib 250 mg orally daily with a 3-week cycle of carboplatin plus pemetrexed for 4 to 6 cycles, followed by gefitinib maintenance until disease progression or unacceptable toxicity.
Progression-free survival (PFS) was the primary endpoint. Key secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety.
16 patients exhibited an ORR (76%), and all 21 patients showed a DCR. Notably, a higher ORR was observed in patients with EGFR 21L858R mutations versus 19del mutations.
Median OS was 26 months and median PFS was 15 months with a numerically longer PFS rate in patients with EGFR 21L858R mutations than in those with 19del mutations.
“There were 15 NSCLC patients without cerebral metastases at baseline, with 4 cases developing cerebral metastases during treatment. The six-, twelve-, and twenty-four-month cumulative incidence rates of the central nervous system metastasis were 7%, 13%, and 27%, respectively,” wrote investigators from the Fujian Medical University Cancer Hospital, Fuzhou City, China.
Further, 17 patients with progressive diseases tested for EGFR T790M mutations with 11 positive cases of T790M mutations.
“The combination of first-generation EGFR-TKIs and chemotherapy achieves a satisfactory PFS, ORR, DCR, and well-tolerated toxicity in advanced NSCLC patients with EGFR mutations, notably in patients with EGFR L858R mutations,” concluded the investigators. – Alexa Stoia
