medwireNews: Disease-free survival (DFS) benefit of osimertinib persists in patients with stage IB–IIIA EGFR-positive non-small-cell lung cancer (NSCLC) regardless of adjuvant chemotherapy use, suggest exploratory analyses of the phase 3 ADAURA trial.
The findings, reported in Journal of Thoracic Oncology, build on the preliminary analysis, which demonstrated a “highly statistically significant and clinically meaningful improvement” in DFS with osimertinib relative to placebo in this patient population, say Yi-Long Wu (Guangdong Lung Cancer Institute, Guangzhou, China) and team.
And it “further [supports] adjuvant osimertinib as a highly effective treatment for patients with stage IB–IIIA resected EGFR[-mutated] NSCLC, with or without adjuvant chemotherapy, as indicated,” report Wu et al.
A total of 682 patients (64% Asian; average age 63 years) with postsurgical pathologic stage IB, II, or IIIA NSCLC with an EGFR mutation were randomly assigned to receive osimertinib or placebo. Sixty percent of the study participants received adjuvant chemotherapy (median 4 cycles); 203 in the osimertinib group and 207 in the placebo group.
All but one patient (n=409) received platinum-based chemotherapy, predominantly cisplatin-based (n=275) or carboplatin-based (n=139).
Adjuvant chemotherapy use was most frequent in patients with stage II–IIIA disease (76%) and those younger than 70 years (66%).
Among patients who received adjuvant chemotherapy, DFS favored those taking osimertinib over placebo with corresponding median durations not yet reached versus 22.1 months, after a median follow-up of 22.1 and 16.6 months, respectively. This translated to a significant hazard ratio (HR) for disease recurrence or death of 0.16.
Similarly, osimertinib conferred a DFS advantage over placebo in those who did not receive adjuvant chemotherapy, the researchers note. The median DFS was not reached in the osimertinib group compared with 33.1 months in the placebo arm (HR=0.23) after a median follow-up of 22.1 versus 18.2 months, respectively.
The team also reports that the DFS benefit with osimertinib occurred “consistently” in patients with and without adjuvant chemotherapy, irrespective of disease stage, with HRs ranging from 0.10 to 0.38.
The authors highlight that the “data advocate the need for EGFR mutation testing across all NSCLC disease stages, not only advanced disease, to guide treatment decisions.”
Wu et al say that “[a]lthough the ADAURA study was not designed to assess the efficacy of adjuvant chemotherapy, the ADAURA results do not indicate that chemotherapy is harmful and should not displace the use of adjuvant chemotherapy in the resected NSCLC setting.”
They conclude: “To date, adjuvant chemotherapy is one of the only treatments that, even if modest, has shown an overall survival benefit in resected NSCLC. As such, physicians should continue to deliver adjuvant chemotherapy in accordance with guidelines and local practice.”
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J Thorac Oncol 2021; doi:10.1016/j.jtho.2021.10.014