KEY TAKEAWAYS
- The phase 3 trial BYLieve aimed to evaluate the efficacy of alpelisib in combination with fulvestrant for treating hormone receptor-positive, human epidermal growth factor receptor-2-negative, and PIK3CA-mutant advanced breast cancer.
- The method used in the trial involved comparing the efficacy of BYLieve with the effectiveness of standard treatment in a real-world setting using a deidentified clinico-genomics database.
- The trial outcome demonstrated that administering alpelisib in combination with fulvestrant was more efficacious than standard treatments.
- The median progression-free survival for patients administered with alpelisib in the BYLieve study was 7.3 months, while it was 3.7 months in the real-world cohort.
- The clinical trial BYLieve has established the effectiveness and safety of alpelisib in combination with fulvestrant for treating hormone receptor-positive.
The clinical trial known as BYLieve (NCT03056755) has established the effectiveness and safety of alpelisib in combination with fulvestrant for the treatment of advanced breast cancer (ABC) that is hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-). It has a mutation in the PIK3CA gene. This treatment is recommended for patients who have previously received a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with an aromatase inhibitor (AI). Further analyses were performed to compare the efficacy of BYLieve with the effectiveness of standard treatment in a real-world setting. The study evaluated patients who exhibited progression while on a CDK4/6 inhibitor in combination with an aromatase inhibitor and subsequently underwent treatment with alpelisib and fulvestrant in the BYLieve trial. These patients were compared to a real-world cohort who received standard-of-care treatment, as documented in a deidentified clinico-genomics database (CGDB). The primary and secondary endpoints of the study were to evaluate the progression-free survival (PFS) using the Kaplan-Meier method and to compare the proportion of patients who remained progression-free at 6 months between the two cohorts.
A cohort comprising 855 individuals diagnosed with PIK3CA-mutant ailment, who had previously undergone CDK4/6i therapy in conjunction with hormone therapy, was identified from the CGDB. Subsequently, 120 patients from BYLieve were matched, and 95 were selected after excluding those exposed to HER2-targeting agents, clinical study drugs, or alpelisib. The outcomes of both primary and secondary endpoints in the BYLieve study demonstrated that the administration of alpelisib combined with fulvestrant was more efficacious than standard treatments in the real-world cohort, as evidenced by both unadjusted and post-matching analyses. Following the post-adjustment investigation, the median progression-free survival (PFS) for patients administered with alpelisib in the BYLieve study was 7.3 months. In contrast, it was 3.7 months in the real-world cohort. Additionally, the 6-month PFS rate was 54.6% for patients in the BYLieve study and 40.1% for those in the real-world cohort. Matched/weighted analysis comparing BYLieve with the real-world setting further supports the clinical benefit of alpelisib with fulvestrant for treating HR+, HER2-, and PIK3CA-mutant ABC after CDK4/6i treatment.
Source:https://pubmed.ncbi.nlm.nih.gov/33909934/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03056755
Turner S, Chia S, Kanakamedala H, Hsu WC, Park J, Chandiwana D, Ridolfi A, Yu CL, Zarate JP, Rugo HS. Effectiveness of Alpelisib + Fulvestrant Compared with Real-World Standard Treatment Among Patients with HR+, HER2-, PIK3CA-Mutated Breast Cancer. Oncologist. 2021 Jul;26(7):e1133-e1142. doi: 10.1002/onco.13804. Epub 2021 May 13. PMID: 33909934; PMCID: PMC8265362.
