(Breast Cancer) Neoadjuvant Chemotherapy: Ipatasertib + Paclitaxel?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On May 30, 2019, the medical journal "Annals of Oncology" published the results of a Phase 2 clinical trial evaluating the effectiveness and safety of AKT inhibitor Ipatasertib + Paclitaxel as neoadjuvant chemotherapy in patients with early-stage triple-negative breast cancer. The trial (FAIRLANE) was a double-blind, placebo-controlled study divided into an Ipatasertib + Paclitaxel group and a Placebo + Paclitaxel group. The primary endpoint was the pathological complete response (pCR) rate in all patients; secondary endpoints included verification of pCR rates in patients with PIK3CA/AKT1/PTEN gene alterations.
In the trial results, the primary endpoint showed pCR rates in all patients (N=151) were 16% for the Ipatasertib group and 13% for the placebo group. For patients with PIK3CA/AKT1/PTEN gene alterations (N=62), pCR rates were 18% for the Ipatasertib group and 12% for the placebo group.
Regarding safety, the incidence of adverse events was 32% in the Ipatasertib group and 16% in the placebo group. Among these, diarrhea occurred in 17% of the Ipatasertib group and 1% of the placebo group.
Based on these results, M. Oliveira concluded that in early-stage triple-negative breast cancer patients using AKT inhibitor Ipatasertib + Paclitaxel as neoadjuvant chemotherapy, the pathological complete response rate did not differ significantly from the placebo control group.
Source: FAIRLANE, a double-blind placebo-controlled randomized phase II trial of neoadjuvant ipatasertib plus paclitaxel for early triple-negative breast cancer (Ann Oncol. 2019 May 30. pii: mdz177. doi: 10.1093/annonc/mdz177.)
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