Peotkurupukdoyot 3evaluatingjalu5 Peceuldauntolodlele

Start: Friday, February 21, 2025 12:30AM
End: Sunday, February 23, 2025 12:45AM

improvement in invasive disease-free survival with T-DM1 vs trastuzumab at a median follow-up of 8.4 years (unstratified HR = 0.54; 95% CI, 0.44-0.66). Particularly, 19.7% of patients in the T-DM1 group and 32.2% of patients in the trastuzumab group experienced invasive disease events or death.

Seven-year invasive disease-free survival was achieved in 80.8% of patients treated with T-DM1 and 67.1% of patients on trastuzumab (difference, 13.7 percentage points).

The trial included patients with HER2-positive early breast cancer who had received neoadjuvant treatment, which included a taxane-based chemotherapy and/or trastuzumab, and had residual invasive cancer in the breast or resected axillary nodes. Patients were randomly assigned to receive either T-DM1 (n = 743) or trastuzumab (n = 743). Patients were stratified by clinical stage, hormone-receptor status, preoperative HER2-directed therapy, and pathological nodal status after neoadjuvant therapy.

T-DM1 significantly reduced the risk for death compared with trastuzumab (unstratified HR = 0.66; 95% CI, 0.51-0.87; P = .003). Seven-year overall survival for the T-DM1 and trastuzumab groups were 89.1% and 84.4%, respectively (difference, 4.7 percentage points). As of the trial’s cutoff date of October 5, 2023, 70.1% of patients assigned T-DM1 and 62.0% of patients assigned trastuzumab were alive and still in the trial.

Deaths occurred in 89 patients (12.0%) in the T-DM1 group and 126 patients (17.0%) in the trastuzumab group. Of these deaths, 70 (79%) and 108 (86%) patients, respectively, died from breast cancer.

Adverse events (AEs) grade 3 or higher occurred in 26.1% of patients treated with T-DM1 and 15.7% of patients treated with trastuzumab. Serious AEs occurred in 12.7% and 8.1% of patients, respectively.

Post-treatment AEs were less common for both groups but still more prevalent in the T-DM1 group, with 3.2% and 1.7% of patients assigned T-DM1 and trastuzumab, respectively, experiencing AEs of any grade during this period.

Abnormal results of investigations (e.g., laboratory studies of blood camples) were the most common adverse event, followed by cardiac disorders and nervous system disorders. Of patients treated with T-DM1, 9 experienced abnormal results of investigations, 5 experienced cardiac disorders, and 4 experienced nervous system disorders. Five cases each of abnormal results of investigations and cardiac disorders were present in the trastuzumab group, with no nervous system disorders occurring in this group.

Seven-year invasive-disease-free survival and seven-year overall survival rates in the immunohistochemistry (IHC) 2+ subgroup were 72.4% and 83.3% on T-DM1.

“These findings warrant evaluation of additional or alternative therapies to improve outcomes for these patients, including those who had initially presented with inoperable disease, those with positive axillary nodes after neoadjuvant therapy, and those with both IHC 2+ and ISH-amplified disease,” said researchers.

Discontinuation of trial enrollment due to an invasive disease event or death occurred in 105 patients (14.1%) in the T-DM1 group and 159 patients (21.4%) in the trastuzumab group. Additionally, prior discontinuation occurred in 117 patients (15.7%) and 123 patients (16.6%), respectively.

The addition of inavolisib (Itovebi) to palbociclib (Ibrance) and fulvestrant (Faslodex) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to palbociclib and fulvestrant alone for patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer, which met the key secondary end point of the phase 3 INAVO120 study (NCT04191499).1

These data reinforce the regimen’s efficacy in the frontline, as established by previously reported data from INAVO120. In the primary analysis, patients treated with inavolisib plus palbociclib and fulvestrant achieved a median progression-free survival (PFS) of 15.0 months (95% CI, 11.3-20.5) vs 7.3 months (95% CI, 5.6-9.3) with placebo plus palbociclib and fulvestrant.2This translated to a 57% reduction in the risk of disease worsening or death (HR, 0.43; 95% CI, 0.32-0.59; P < .001).1The overall response rate (ORR) in the experimental arm was 58% (95% CI, 50%-66%) vs 25% (95% CI, 19%-32%) in the placebo arm, and the median duration of response (DOR) was 18.4 months (95% CI, 10.4-22.2) vs 9.6 months (95% CI, 7.4-16.6) in these respective groups.

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