In 2020, the researchers presented the first effectiveness results from the HR+/HER2 study of phase 3 WSG adapt in patients with luminal breast cancer.1
In patients with up to 2 affected axillary nodes, the endocrine therapy (ET) solely led excellent long-term results for patients with medium genomic risk (21-gene recurrence score of 12-25) and a decrease in tumor cell proliferation (from the initial basis Ki-67 of> 10%) after 2-4 weeks from et.
At the time of the presentation, the investigators were asked about results for patients with similar recurrences who had no early decrease in AI-67 from preliminary operational ET and in patients with a higher clinical or genomic relapse risk.
At the annual conference of the American Society of Clinical Oncology (ASCO) 2021, Oleg Gluz, MD, from Bethesda Evangelical Hospital in Duisburg, Germany, answered.2
Protocol for high -risk patients
The WSG-Adapt-HR+/HER2 study, a wear and tear of the adaptation study (Clinicalaltrials.gov Identifier: NCT01779206), actually consists of 2 treatment studies-an ET study. Dr. Gluz together presented results from high-risk patients in the ET and chemotherapy studies.
In the patients, clinically risky breast cancer was defined if their tumors were 2 cm or larger, clinically involved axillary nodes, were assessed as a histological degree 3 during the central review or assessed centrally, AI 67 proliferation values of more than 15%.
How the patients with low and medium risk presented in 2020,1 The high-risk patients were initially treated with 2-4 weeks of standard ET before the operation or the sequential core biopsy.
High-risk patients with up to 3 positive lymph nodes and recurrences from 0-11 required no assessment of KI-67 according to the ET. They received et.
Et alone was also administered to patients with up to 3 positive lymph nodes and recurrences of 12-25 who were ki-67 responders on Neoadjuvant et.
Patients who met one of the following criteria were assigned to chemotherapy plus ET: recurrence score of more than 25, recurrence score of 12-25 without AI 67 reaction, more than 4 positive lymph nodes or a diseases defined by additional clinical and pathological criteria.
Patients who were assigned to chemotherapy were assigned according to the random principle 1 of 2 dose of dose of dense taxan/anthracycline regime, followed by Standard ET.
There were a total of 2335 patients who were assigned to the chemotherapy ET and 2356 patients alone. Among the patients who were assigned to chemotherapy had about 50% axillary nodes, tumor size of 2 cm or larger, high -grade histology and/or repetition of more than 25.
The primary endpoint was invasive disease -free survival (IDFS), and the secondary endpoints were far away disease -free survival (DDFS) and overall survival.
This article originally appeared in the Cancer Therapy Advisor