NEJM Heavyweight: 2 years in advance! Wu Yilong, in a team of 284 centers around the world and in China, found that surgery and precision-type targeted therapy reduced the risk of recurrence of early and mid-stage lung cancer by 83%.

In China, the annual incidence of lung cancer is as high as 784,000, and the morbidity and mortality rate of lung cancer account for 20.03% and 26.99% of all malignant tumors, respectively, ranking first in malignant tumors.
this makes the research results of lung cancer treatment all the attention.
is the standard treatment for advanced non-small cell lung cancer (NSCLC), which is positive for the skin growth factor subject (EGFR) mutation, and the efficacy and safety of oxytinib as an auxiliary treatment is not clear.
September 19, 2020, Wu Yilong, Life Director of Guangdong Provincial People's Hospital and Guangdong Lung Cancer Research Institute, joined forces with a global and domestic team of 284 centers to publish online the title "Osimertinib in Resected EGFR-Small-Cell Lung Cancer" in the new England Journal of Medicine, a leading medical journal. In this double-blind Phase 3 clinical trial, a completely removed EGFR mutation-positive NSCLC patient (NSCLC patient with EGFR mutation-positive phase IB to IIIA) was randomly assigned a 1:1 ratio to receive ocythioninib (80 mg per day) or a placebo treatment for 3 years.
end of the disease is disease-free survival in patients with stage II to IIIA disease (according to the researchers' assessment).
secondary endpoints include overall disease-free survival, overall survival and safety in patients with IB to IIIA diseases.
a total of 682 patients in the study were randomly grouped (339 in the Ositeni group and 343 in the placebo group).
At 24 months, 90 percent of patients in the 20 to IIIA group and 44 percent of the placebo group survived without disease (the overall risk ratio of recurrence or death was 0.17).
89% of patients in the esotinib group and 52% of patients in the placebo group survived without disease for 24 months (the overall risk of recurrence or death was 0.20).
at 24 months, 98 percent of patients in the Ossiny group and 85 percent of the placebo group survived without central nervous system disease (the overall risk of recurrence or death was 0.18).
In summary, the study found that in NSCLC patients who were positive for EGFR mutations in periods IB to IIIA, patients who received oxytinib had significantly longer disease-free survival than those who received placebo (for patients with early and mid-stage lung cancer from IB to IIIA with a drive gene mutation, their risk of tumor recurrence decreased by 83 percentage points after pre-surgical removal with the help of third-generation targeted drugs).
about 30% of patients with non-small cell lung cancer (NSCLC) have removable diseases.
for patients with a fully removed phase II to IIIA, complementary chemotherapy based on cisplatin is recommended after surgery.
, however, reduced the risk of recurrence or death by only 16 per cent.
5 years, the risk of death was reduced by 5%.
the proportion of patients who returned from the disease or died after surgery remained high during a medium follow-up of about five years.
skin growth factor (EGFR) mutations, such as exon 19 missing (Ex19del) and exon 21 colist p. Leu858Arg (L858R) point mutation is a common cancer-driven mutation in NSCLC.
EGFR Tyrosine Kinase Inhibitor (EGFR-TKIs) is a recommended first-line treatment for late NSCLC positive for EGFR mutations.
the efficacy of EGFR-TKIs in patients with advanced diseases has led to research on its use as an auxiliary treatment for excisionable diseases.
studies have shown that patients who received the first generation of EGFR-TKI-assisted treatment with EGFR mutation-positive NSCLC excision may have a longer disease-free life than patients who received complementary chemotherapy or placebo.
Osimertinib is a third-generation oral EGFR-TKI that effectively and selectively inhibits EGFR-TKI sensitivity and EGFR p.Thr790Met resistance mutations and is effective for NSCLC central nervous system (CNS) transfer.
in phase 3 FLAURA trials, Ositeni was superior to Giftoninib or Erotini in terms of progress-free survival and overall survival.
these findings support Ositinib as a standard treatment for late NSCLC in the previously untreated EGFR mutation-positive (Ex19del or L858R).
, the risk of level 3 or higher adverse events in patients receiving oxytinib was similar to that in patients receiving gyfeitinib or erlotinib, although the duration of treatment was longer.
efficacy and safety in patients with advanced EGFR mutation-positive NSCLC support the drug as an auxiliary treatment for excision disease.
ADAURA Phase 3 randomized trial assessed the efficacy and safety of oxytosinib in patients with a fully removed IB to IIIA phase compared to placebo, and, depending on the doctor's and patient's choice, the EGFR mutation-positive (Ex19del or L858R) NSCLC after complementary chemotherapy was selected.
an independent data monitoring committee's planned review in April 2020, the committee recommended that the trial be published two years ahead of schedule because of evidence of efficacy (clinical data originally scheduled for publication in 2022).
in this double-blind Phase 3 clinical trial, patients with a completely removed EGFR mutation-positive NSCLC were randomly assigned a 1:1 ratio and were treated with oxytosinib (80 mg once a day) or a placebo for 3 years.
end of the disease is disease-free survival in patients with stage II to IIIA disease (according to the researchers' assessment).
secondary endpoints include overall disease-free survival, overall survival and safety in patients with IB to IIIA diseases.
a total of 682 patients in the study were randomly grouped (339 in the Ositeni group and 343 in the placebo group).
At 24 months, 90 percent of patients in the 20 to IIIA group and 44 percent of the placebo group survived without disease (the overall risk ratio of recurrence or death was 0.17).
89% of patients in the esotinib group and 52% of patients in the placebo group survived without disease for 24 months (the overall risk of recurrence or death was 0.20).
at 24 months, 98 percent of patients in the Ossiny group and 85 percent of the placebo group survived without central nervous system disease (the overall risk of recurrence or death was 0.18).
In summary, the study found that in NSCLC patients who were positive for EGFR mutations in periods IB to IIIA, patients who received oxytinib had significantly longer disease-free survival than those who received placebo (for patients with early and mid-stage lung cancer from IB to IIIA with a drive gene mutation, their risk of tumor recurrence decreased by 83 percentage points after pre-surgical removal with the help of third-generation targeted drugs).
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