The investigators concluded: “Giredestrant offers encouraging antiproliferative and antitumor activity and was well tolerated, both as a single agent and in combination with palbociclib. No treatment-related deaths were reported. Serious adverse events occurred in 4% vs 2% of patients. The most common grade 3 or 4 adverse events were neutropenia (26% vs 27%) and decreased neutrophil count (15% vs 15%).
Pathologic complete response and objective response rates were similar with palbociclib/giredestrant and palbociclib/anastrozole.Īmong 112 and 109 patients in the safety population, respectively, the most common adverse events of any grade in the palbociclib/giredestrant group were neutropenia (41% vs 40% in the palbociclib/anastrozole group), asthenia (22% vs 25%), decreased neutrophil count (23% vs 22%), arthralgia (11% vs 19%), and hot flush (14% vs 15%). Giredestrant was associated with a greater reduction in Ki67 score vs anastrozole after 2 weeks. 043), meeting the study’s primary endpoint.Īmong 112 evaluable patients in the palbociclib/giredestrant group vs 108 in the palbociclib/anastrozole group, pathologic complete response was achieved in 4.5% (95% CI = 1.5%–10.1%) among the former vs 4.6% (95% CI = 1.5%–10.5%) among the latter. The geometric mean relative reduction of Ki67 from baseline to week 2 was –75% (95% confidence interval = –80% to –70%) with giredestrant and –67% (95% CI = –73% to –59%) with anastrozole ( P =. The primary endpoint was geometric mean relative Ki67 score change from baseline to week 2. 
Patients had to have a baseline Ki67 score of at least 5%. Patients initially received giredestrant at 30 mg daily or anastrozole at 1 mg daily on days 1 to 14 and then entered a 16-week phase in which palbociclib at 125 mg daily was added on days 1 to 21 of 28-day cycles for four cycles. In the open-label trial, 221 patients from sites in 11 countries were randomly assigned between September 2020 and June 2021 to receive palbociclib with giredestrant (n = 112) or anastrozole (n = 109).
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