NEJM: Oghidini as an EGFR mutation-positive NSCLC postoperative auxiliary therapy, patients significantly benefit.

The topic of ADAURA research and postoperative auxiliary treatment for lung cancer patients has been the subject of much attention and discussion by experts and scholars at home and abroad recently.
The third generation EGFR-TKI Oghithini is a first-line treatment for patients with EGFR mutation-positive advanced NSCLC in clinical practice, and the ADAURA study shifted the role of Oghidini to postoperative complementary therapy, adding more clinical roles to Oghidini and benefiting more patients.
ADAURA study is a global multi-center, randomized, double-blind, placebo-controlled Phase III. clinical study designed to compare the efficacy and safety of esotinib and placebo for complementary therapy after complete tumor removal in patients with EGFR gene mutation-positive I.B.III.A. phase A NSCLC.
group will be treated with oxytinib or placebo for 3 years or until the disease returns.
of the study was the disease-free survival (DFS) of patients assessed by the researchers in stage II.III.A.
secondary study endpoints include total lifetime (OS) and security.
ADAURA study was first published at the 2020 annual meeting of the American Society of Clinical Oncology (ASCO) and showed that DFS rates were 97%, 90%, 80% in the 1, 2 and 3 years of the Ohithinib group in patients with stage II.III.A, compared with 61%, 44% and 28% in the placebo group.
83% lower risk of recurrence or death (HR=0.17, P.0001).
in all populations (I.B.-III.A), the DFS rates in the Otini group of 1, 2 and 3 years were 97%, 89% and 79%, respectively, compared with 69%, 53% and 41% in the placebo group.
79% lower risk of recurrence or death (HR=0.21, P.0001).
ADAURA Research DFS Data This ESMO Virtual Annual Meeting, ADAURA Research CNS Disease Recurrence Data was published.
17 January 2020, 11 per cent of patients in the Oghitini and 46 per cent of the placebo group had a recurrence of the disease, respectively.
in patients with a recurrence of the disease, the Oxitinib group was mainly locally relapsed (62%), while the placebo group was mainly distant (61%).
only 1% of patients in the Oxitinib group had a recurrence of CNS, up from 10% in the placebo group.
45 patients in all populations had CNS DFS events, including 6 cases in the Oghithini group: 4 cases (1%) with CNS recurrence and 2 deaths (1%), and 39 cases in the placebo group: 33 cases (10%) cnS recurrence and 6 deaths (2%).
the CNS DFS event in all populations, the mid-level CNS DFS in the Oghithini group had not yet been achieved, while in the placebo group it was 48.2 months, and the risk of CNS recurrence or death was reduced by 82% (HR=0.18, P.0001);
the 18-month relapse of CNS disease estimated by the ADAURA study of CNS DFS data for all populations, the Oghithini group was 1 percent, compared with 9 percent in the placebo group.
the cumulative rate of CNS recurrence at the same time, the Oghitini group was consistently lower than the placebo group. Data updated by
's hypothetical CNS and non-CNS recurrence rates ADAURA studies show that reduced risk of local and distant recurrence, as well as improvements in CNS DFS, further support for Oghidini-assisted therapy as an efficient, practice-changing treatment strategy for EGFR gene mutation-positive I.B.III.A NSCLC patients after tumor complete removal.
chinese experts and scholars have made great contributions to the exploration of postoperative-assisted targeted therapy of EGFR gene mutation-positive NSCLC, and both ADJUVANT and EVAN studies have been published before the ADAURA study was published.
At the same time in the ADAURA research, from a number of hospitals in China are involved, in the New England Journal of Medicine published in the ADAURA researchers list, Guangdong Provincial People's Hospital Professor Wu Yilong, the National Cancer Center / Chinese Academy of Medical Sciences Cancer Hospital Hejie academician, Shanghai Jiaoda University affiliated chest hospital Professor Lu Yan in the column, in addition to the research behind, there are many Chinese experts and scholars silently pay.
the joint efforts of Chinese oncologists and scholars in the future, we can make more Chinese voices on the world stage.
fact, the ADAURA study is different from previous designs.
further research is carried out on the basis of ADJUVANT research.
based on the ADJUVANT study, the design of the ADAURA study has been improved.
First, the ADAURA study extended the targeting period from 2 to 3 years, and previous evidence suggests that osexitini is high in brain concentration, and brain metastasis is a common postoperative relapse site, so osexitini is used for postoperative assistance to benefit patients even more.
, the ADJUVANT study was a head-to-head study of targeted therapy and chemotherapy, with the group at higher risk of recurrence.
ADAURA study group covers phase I.B-III.A, according to current clinical practice standards, patients with stage I.B do not receive complementary chemotherapy, and patients with lymph node metastasis in stage II.-III.A complete standard complementary chemotherapy before being given targeted treatment.
this research design will provide a deeper exploration of the benefits of complementary targeted therapy, and whether there is a difference in treatment benefits between patients with phase I.B and phase II./III is a highly anticipated subgroup analysis.
addition, whether the benefits of giving or not giving complementary chemotherapy after surgery differ from the benefits of subsequent use of targeted treatment options are equally expected in the references Tsuboi M, Wu YL, He J, et al. Osimertinib adjuvant therapy in patients (pts) with resected EGFR muted (EGFRm) NSCLC (ADAURA): Central nervous system (CNS) reseed disease (EB/OL). ESMO 2020, abstract LBA1. Wu YL, Tsuboi M, He J, et al. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Cancer (EB/OL) . N Engl J Med, 2020 Sep 19.DOI:10.1056/NEJMoa2027071.AZ Source: AZ Copyright Notice: All Noted on this website Source: May The text, images and audio-visual materials of SMM or Source: MedSci Originals are owned by Mace Medical and may not be reproduced by any media, website or individual without authorization, and shall be reproduced with the words "Source: Metz Medicine".
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