NEJM: Combination medication delays the progression of advanced breast cancer

Fabrice Andr é, M.D., and colleagues randomly divided patients with advanced breast cancer who had previously received endocrine therapy into two groups, one taking alpelisib (300 mg / day) and fulvestrant (500 mg / 28 days, once on the fifteenth day), the other placebo and fulvestrantA total of 572 patients were involved, including 341 cases of tumor tissue PIK3CA mutation< br / > the median progression free survival was 11.0 months in the alpelisib fulvestrant group and 5.7 months in the placebo fulvestrant group (hazard ratio for progression or death, 0.65; 95% confidence interval, 0.50 to 0.85; P < 0.001) in patients with the PIK3CA mutationHowever, in cancer patients without a PIK3CA mutation, the hazard ratio was 0.85 (95% confidence interval, 0.58 to 1.25)However, for all cancer patients without PIK3CA mutation, the overall response to alpelisib fulvestrant was greater than that to placebo fulvestrant (26.6% vs12.8%)The most common level 3 or 4 adverse events were hyperglycemia (36.6% in the alpeliib fulvestrant group, 0.7% in the placebo fulvestrant group) and rash (9.9% vs 0.3%)In the alpelisib fulvestrant group, 6.7% of the patients had grade 3 diarrhea, compared with 0.3% in the placebo fulvestrant groupA quarter of patients stopped using alpelisib due to adverse events, compared with 4.2% in the placebo fulvestrant group< br / > "these results show that PIK3CA mutation, HR positive, HER2 negative patients with advanced breast cancer can improve the treatment prognosis by adding A-specific PI3K inhibitor to the standard therapyThese findings confirm that PIK3CA is an important treatment target for such patients"The author wrote< br / > several authors have disclosed their financial relationship with pharmaceutical companies, including NovartisNovartis, a manufacturer of alpelisib, funded the study< br / > reference materials: < br / > fabric Andr é et alAlpine for PIK3CA mutated, hormone receptor positive advanced breast cancerN Engl J Med 2019; 380:1929-1940 doi: 10.1056/nejmoa1813904