DFS boost with adjuvant erlotinib in EGFR mutation-positive NSCLC
medwireNews: Adjuvant treatment with erlotinib is associated with improved disease-free survival (DFS) versus chemotherapy in Chinese patients with epidermal growth factor receptor (EGFR)-mutated, stage IIIA non-small-cell lung cancer (NSCLC), indicate phase II trial results.
The EGFR–tyrosine kinase inhibitor (TKI) also had “a better tolerability profile” than chemotherapy, say the study authors who believe that the findings point to “a potentially important role” for TKIs as an adjuvant treatment option in this patient population.
They admit, however, that mature overall survival (OS) data are needed, for which follow-up is ongoing.
The EVAN investigators enrolled 102 patients who had undergone complete (R0) resection and randomly allocated them to receive either oral erlotinib at a daily dose of 150 mg for 2 years or four 21-day cycles of intravenous vinorelbine 25 mg/m2 (on days 1 and 8) plus intravenous cisplatin 75 mg/m2 (on day 1).
In the intention-to-treat (ITT) population, the primary endpoint of 2-year DFS was achieved by 81.4% of 51 erlotinib-treated patients and 44.6% of their 51 counterparts given chemotherapy, a significant difference. The corresponding median DFS times were 42.4 and 21.0 months, and equated to a significant 73% reduced risk of disease recurrence or death with erlotinib.
Additionally, the 3-year DFS was also significantly higher with erlotinib than chemotherapy, at 54.2% and 19.8%, respectively, but the research team notes that this was an exploratory analysis.
Changli Wang (Tianjin Medical University Cancer Institute and Hospital, China) and fellow EVAN researchers note that the results of the per-protocol analysis, which included a respective 46 and 33 participants in the erlotinib and chemotherapy arms, were consistent with those of the ITT analysis.
They add that the median OS had not been reached in either group at a median follow-up of 33 months, but “mortality seemed to be lower in the erlotinib group than in the chemotherapy group” over the course of the study.
The incidence of adverse events (AEs) of at least grade 3 was lower among erlotinib-treated patients than those given chemotherapy, at 12% versus 26%, as was the rate of AE-related dose reductions and interruptions, at 12% versus 30%.
But a comparable proportion discontinued treatment as a result of AEs, at 8% of erlotinib-treated patients and 7% of those given chemotherapy. And there were no AE-related deaths in either group, according to the report published in The Lancet Respiratory Medicine.
Together, the efficacy and safety data are indicative of the clinical potential of adjuvant erlotinib therapy, say the EVAN investigators.
However, they and the author of an accompanying commentary question the generalisability of the findings given that the trial was limited to Chinese patients with stage IIIA disease.
In addition, the commentator also questions the validity of the control group, citing the major protocol violations that led to just 33 of the 51 participants receiving treatment. He also wonders about the burden and costs associated with 2 years of erlotinib therapy compared with 12 weeks of chemotherapy.
Jacek Jassem, from the Medical University of Gdańsk in Poland, says the EVAN results are “intriguing”, but until data from larger trials including non-Asian patients become available, he believes that “[t]he use of EGFR TKIs in the adjuvant setting remains an investigational approach.”
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