Efficacy of Endocrine Therapy Plus Trastuzumab and Pertuzumab vs De-escalated Chemotherapy in Patients with Hormone Receptor–Positive/ ERBB2-Positive Early Breast Cancer ; The Neoadjuvant WSG-TP-II Randomized Clinical Trial
In: JAMA Oncology, Jg. 9 (2023), Heft 7, S. 946
Online
academicJournal
Zugriff:
Importance Combination of chemotherapy with (dual) ERBB2 blockade is considered standard in hormone receptor (HR)-positive/ ERBB2 -positive early breast cancer (EBC). Despite some promising data on endocrine therapy (ET) combination with dual ERBB2 blockade in HR-positive/ ERBB2 -positive BC, to our knowledge, no prospective comparison of neoadjuvant chemotherapy vs ET plus ERBB2 blockade in particular with focus on molecular markers has yet been performed. Objective To determine whether neoadjuvant de-escalated chemotherapy is superior to endocrine therapy, both in combination with pertuzumab and trastuzumab, in a highly heterogeneous HR-positive/ ERBB2 -positive EBC. Design, Setting, and Participants This prospective, multicenter, neoadjuvant randomized clinical trial allocated 207 patients with centrally confirmed estrogen receptor–positive and/or progesterone receptor–positive (>1%) HR-positive/ ERBB2 -positive EBC to 12 weeks of standard ET (n = 100) vs paclitaxel (n = 107) plus trastuzumab and pertuzumab. A total of 186 patients were required to detect a statistically significant difference in pathological complete response (pCR) (assumptions: 19% absolute difference in pCR; power, ≥80%; 1-sided Fisher exact test, 2.5% significance level). Interventions Standard ET (aromatase inhibitor or tamoxifen) or paclitaxel, 80 mg/m 2 , weekly plus trastuzumab and pertuzumab every 21 days. Main Outcomes and Measures The primary end point was pCR (ypT0/is, ypN0). Secondary end points included safety, translational research, and health-related quality of life. Omission of further chemotherapy was allowed in patients with pCR. PAM50 analysis was performed on baseline tumor biopsies. Results Of the 207 patients included (median [range] age, 53 [25-83] years), 121 (58%) had cT2 to cT4 tumors, and 58 (28%) had clinically node-positive EBC. The pCR rate in the ET plus trastuzumab and pertuzumab arm was 23.7% (95% CI, 15.7%-33.4%) vs 56.4% (95% CI, 46.2%-66.3%) in the paclitaxel plus trastuzumab and pertuzumab arm ...
Titel: |
Efficacy of Endocrine Therapy Plus Trastuzumab and Pertuzumab vs De-escalated Chemotherapy in Patients with Hormone Receptor–Positive/ ERBB2-Positive Early Breast Cancer ; The Neoadjuvant WSG-TP-II Randomized Clinical Trial
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Autor/in / Beteiligte Person: | Gluz, Oleg ; Nitz, Ulrike A. ; Christgen, Matthias ; Kuemmel, Sherko ; Holtschmidt, Johannes ; Schumacher, Johannes ; Hartkopf, Andreas ; Potenberg, Jochem ; Lüedtke-Heckenkamp, Kerstin ; Just, Marianne ; Schem, Christian ; von Schumann, Raquel ; Kolberg-Liedtke, Cornelia ; Eulenburg, Christine Zu ; Schinköthe, Timo ; Graeser, Monika ; Wuerstlein, Rachel ; Kates, Ronald E. ; Kreipe, Hans Heinrich ; Harbeck, Nadia |
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Zeitschrift: | JAMA Oncology, Jg. 9 (2023), Heft 7, S. 946 |
Veröffentlichung: | American Medical Association (AMA), 2023 |
Medientyp: | academicJournal |
ISSN: | 2374-2437 |
DOI: | 10.1001/jamaoncol.2023.0646 |
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