Survival Outcomes, Digital TILs, and On-treatment PET/CT During Neoadjuvant Therapy for HER2-positive Breast Cancer: Results from the Randomized PREDIX HER2 Trial
| العنوان: | Survival Outcomes, Digital TILs, and On-treatment PET/CT During Neoadjuvant Therapy for HER2-positive Breast Cancer: Results from the Randomized PREDIX HER2 Trial |
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| المؤلفون: | Alexios Matikas, Hemming Johansson, Per Grybäck, Judith Bjöhle, Balazs Acs, Ceren Boyaci, Tobias Lekberg, Hanna Fredholm, Ellinor Elinder, Sara Margolin, Erika Isaksson-Friman, Ana Bosch, Henrik Lindman, Jamila Adra, Anne Andersson, Susanne Agartz, Mats Hellström, Ioannis Zerdes, Johan Hartman, Jonas Bergh, Thomas Hatschek, Theodoros Foukakis |
| المصدر: | Clinical Cancer Research. 29:532-540 |
| بيانات النشر: | American Association for Cancer Research (AACR), 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Cancer Research, Oncology |
| الوصف: | Purpose: PREDIX HER2 is a randomized Phase II trial that compared neoadjuvant docetaxel, trastuzumab, and pertuzumab (THP) with trastuzumab emtansine (T-DM1) for HER2-positive breast cancer. Rates of pathologic complete response (pCR) did not differ between the two groups. Here, we present the survival outcomes from PREDIX HER2 and investigate metabolic response and tumor-infiltrating lymphocytes (TIL) as prognostic factors. Patients and Methods: In total, 202 patients with HER2-positive breast cancer were enrolled and 197 patients received six cycles of either THP or T-DM1. Secondary endpoints included event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Assessment with PET/CT was performed at baseline, after two and six treatment cycles. TILs were assessed manually at baseline biopsies, while image-based evaluation of TILs [digital TILs (DTIL)] was performed in digitized full-face sections. Results: After a median follow-up of 5.21 years, there was no difference between the two treatment groups in terms of EFS [HR = 1.26; 95% confidence interval (CI), 0.54–2.91], RFS (HR = 0.69; 95% CI, 0.24–1.93), or OS (HR = 0.52; 95% CI, 0.09–2.82). Higher SUVmax at cycle 2 (C2) predicted lower pCR (ORadj = 0.65; 95% CI, 0.48–0.87; P = 0.005) and worse EFS (HRadj = 1.27; 95% CI, 1.12–1.41; P < 0.001). Baseline TILs and DTILs provided additional prognostic information to clinical parameters and C2 SUVmax. Conclusions: Long-term outcomes following neoadjuvant T-DM1 were similar to neoadjuvant THP. SUVmax after two cycles of neoadjuvant therapy for HER2-positive breast cancer may be an independent predictor of both short- and long-term outcomes. Combined assessment with TILs may facilitate early selection of poor responders for alternative treatment strategies. |
| تدمد: | 1557-3265 1078-0432 |
| DOI: | 10.1158/1078-0432.ccr-22-2829 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9cdd62bb9a3e1dea28fdf78f52cde05 https://doi.org/10.1158/1078-0432.ccr-22-2829 |
| رقم الانضمام: | edsair.doi.dedup.....d9cdd62bb9a3e1dea28fdf78f52cde05 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15573265 10780432 |
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| DOI: | 10.1158/1078-0432.ccr-22-2829 |