ADAURA QoL data support osimertinib use in resected, EGFR-mutated NSCLC
medwireNews: Health-related quality of life (HRQoL) is maintained during long-term treatment with adjuvant osimertinib in people with resected, EGFR-mutated non-small-cell lung cancer (NSCLC), research shows.
Speaking at the IASLC 2020 World Conference on Lung Cancer, Margarita Majem, from the Hospital de la Santa Creu i Sant Pau in Barcelona, Spain, explained that the phase 3 ADAURA study has already shown that adjuvant osimertinib reduced the risk for disease recurrence by a significant 80% versus placebo.
She said that the current analysis of patient-reported outcomes “further supports osimertinib as an effective new treatment strategy” among completely resected and disease-free patients with stage IB–IIIA EGFR-mutated NSCLC with or without prior adjuvant chemotherapy.
The study included 679 individuals who were randomly assigned to receive osimertinib 80 mg or placebo once daily for 3 years or until disease recurrence or treatment discontinuation.
Majem reported that physical component summary (PCS) and mental component summary (MCS) T-scores on the SF-36 HRQoL survey were similar between the two treatment arms at time of randomization (46–47 points) and were also comparable with those seen in the general population, at 0.3–0.4 standard deviations below the normative mean.
By week 96, the adjusted mean PCS score had increased by 1.13 and 2.31 points, respectively. The resulting mean difference of 1.18 points was below the cutoff for a clinically meaningful change, which was set at 2.00 points.
Similarly, the mean MCS score increased by 1.34 points with osimertinib and by 2.68 points with placebo, with the mean difference of 1.34 points again falling below the clinically meaningful cutoff of 3.00 points in this case.
When Majem looked at the eight individual components of the SF-36, they observed similar results and no clinically meaningful differences between osimertinib and placebo.
Majem noted that more than 80% of patients in both arms experienced no clinically meaningful deterioration in PCS or MCS while they remained disease-free.
However, among the patients who did have deterioration, there was no significant difference in the time to deterioration of either PCS or MCS between the osimertinib and placebo arms.
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