The incidence of phosphatidyl inositol-3-kinase (PI3K) pathping in advanced breast cancer (ABC), which is positive for hormone-positive (HR-), human epithelial growth factor-negative (HER2-) by PIC3CA mutation, is about 28%-46%, which is related to poor prognostication in patients.
SOLAR-1 trials have shown that the addition of alpelisib (Apelis, PI3K inhibitors) to the treatment of fluorovis groups (targeted drugs for PIK3CA mutations) can provide statistically and clinically significant non-progressive survival (PFS) benefits for patients with PIK3CA mutations, HR-plus, AND2-ABC.
this study treated or treated aromatase inhibitors (AI) with progressions of HR-HER2-ABC male and post-menophageal female patients into two groups at a random 1:1 level, receiving aphedox (300 mg/day) and fluorovirs (500 mg, 1/28 days, 15th day with a placebo) or a placebo plus fluorovirs group.
end point is total lifetime (OS).
the prognostication of patients in the total population was 39.3 months in the PIC3CA mutation queue (n-341), the mid-OS of the Apellis-Fluvis group and the placebo-fluvis group were 39.3 months (95% CI 34.1-44.9) and 31.4 months (26.8-41.3) (risk ratio of 0.86, 95% CI 0.64-1.15;
OS results did not exceed the pre-specified efficacy threshold.
patients with pulmonary/liver metastasis had a prognosis of 37.2 months and 22.8 months (HR 0.68) in patients with pulmonary/liver metastasis, and 23.3 months and 14.8 months in the placebo group (HR 0.72).
no new security issues were observed during the long follow-up.
in summary, although the results did not exceed the intended limits, the median OS in patients was extended by 7.9 months when the patients with the PIC3CA mutation were fully treated with HR-HER2-ABC.
overall, the results of the study further supported the PFS benefits observed by the Abeles United Fluvis group in the population.