NEJM: Combination medication delays the progression of advanced breast cancer
Last Update: 2020-06-19
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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
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