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Editor: Xiaoyuan
Medical pulse through the collation, unauthorized please do not reprint
.
The European Society for Internal Oncology (ESMO) Annual Meeting is the most prestigious and influential oncology conference
in Europe.
The oral presentation on the morning of the 11th local time, ADAURA research announced the updated results
.
1 Background
Third-generation EGFR TKI
.
2 Methods
Eligible patients (18 years of age [20 years in Japan/Taiwan], WHO PS 0/1, complete resection of EGFR-sensitive mutations, IB-IIIA staging [AJCC 7th edition] NSCLC, adjuvant chemotherapy allowed) were randomized to receive ositinib (80 mg once daily) or placebo (3 years)
in a 1:1 ratio.
3 Results
Globally, 682 patients were randomized, with 339 in the ositinib group and 343 in the placebo group
, respectively.
Update DFS results
DFS HR for total population (IB-IIIA phase) was 0.
Total population DFS updated results
DFS HR for patients with stage IB, stage II, and stage IIIA (AJCC version 7) was 0.
41, 0.
34, and 0.
20
, respectively.
DFS for patients with each stage (AJCC seventh edition).
DFS for patients with various stages (AJCC 8th edition).
There were fewer
patients with local/regional and distant recurrence in the ositinib group compared to the placebo group.
The most common recurrence sites in the ositinib group were the lungs (12%), lymph nodes (6%), and CNS (6%), while the most common recurrence sites in the placebo group were the lungs (26%), lymph nodes (17%), and CNS (11%)
.
Relapse patterns in the general population
The CNS DFS HR in patients with stage II-IIIA was 0.
24 (95% CI 0.
14, 0.
42; 63/470).
CNS DFS in patients with stage II-IIIA
The safety results are similar
to known security events for oxitinib.
Security analysis
4 Conclusion
Additional 2-year follow-up results showed that adjuvant oshitinib was associated with a sustained DFS benefit
compared with placebo.
Overall, adjuvant oxitinib reduced the risk of disease progression in patients with stage II-IIIA by up to 77% compared with placebo (DFS HR = 0.
23).
Benefit from DFS was observed regardless of previous adjuvant chemotherapy, and ositinib also significantly improved CNS DFS
in patients with stage II-IIIA.
This analysis is similar
to previous results.
More mature data further validate that aushitinib adjuvant therapy ±adjuvant chemotherapy is the standard of care for
patients with EGFR-sensitive stage IB-IIIA NSCLC after complete resection, adjuvant chemotherapy 。 Reference: LBA47-Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC): Updated results from ADAURA.
2022 ESMO.