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BREAST CANCER

AKT inhibition associated with improved OS

Nature Reviews Clinical Oncology volume 19, page 568 (2022)Cite this article

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A primary analysis of the randomized, placebo-controlled, phase II FAKTION trial indicated that addition of the AKT inhibitor capivasertib to fulvestrant improves progression-free survival (PFS) in post-menopausal women with advanced-stage, aromatase inhibitor-resistant ER+HER2− breast cancer. New data from this trial clarify the benefit of capivasertib in this setting.

In the updated analysis performed at 5 years, the median PFS durations remained unchanged at 10.3 months in the 69 women who received fulvestrant plus capivasertib and 4.8 months in the 71 women who received fulvestrant plus placebo (HR 0.56, 95% CI 0.38–0.81; P = 0.0023), confirming the improvement in the primary end point. In addition, overall survival (OS) was improved with capivasertib: median 29.3 months versus 23.4 months in the placebo group (HR 0.66, 95% CI 0.45–0.97; P = 0.035). However, extended biomarker testing, encompassing a broader range of PIK3CA, AKT1 and PTEN alterations than the primary analysis, revealed that benefit from capivasertib was predominantly restricted to the 54% of patients with PI3K-pathway-altered tumours. The relative gains in median PFS and OS were 8.2 months (HR 0.44; P = 0.001) and 18.9 months (HR 0.46; P = 0.005), respectively, in this subgroup as compared with 2.8 months (HR 0.70; P = 0.23) and 0.8 months (HR 0.86; P = 0.60) in those without PI3K-pathway alterations.

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References

Original article

  • Howell, S. J. et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive, HER2-negative breast cancer (FAKTION): overall survival, updated progression-free survival, and expanded biomarker analysis from a randomised, phase 2 trial. Lancet Oncol. https://doi.org/10.1016/S1470-2045(22)00284-4 (2022)

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  1. Nature Reviews Clinical Oncology http://www.nature.com/nrclinonc

    David Killock

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  1. David Killock
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Correspondence to David Killock.

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Killock, D. AKT inhibition associated with improved OS. Nat Rev Clin Oncol 19, 568 (2022). https://doi.org/10.1038/s41571-022-00662-w

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  • DOI: https://doi.org/10.1038/s41571-022-00662-w

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