Results From CONTESSA: A Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2-, Hormone Receptor+ Metastatic Breast Cancer Who Have Previously Received a Taxane

O'Shaughnessy, Joyce; Schwartzberg, Lee; Piccart, Martine; Rugo, Hope S.; Yardley, Denise A.; Cortes, Javier; Untch, Michael; Harbeck, Nadia; Wright, Gail S.; Bondarenko, Igor; Glaspy, John; Nowecki, Zbigniew; Kayali, Fadi; Chan, Arlene; Levy, Christelle; Liu, Mei-Ching; Kim, Sung-Bae; Lemieux, Julie; Manikhas, Alexey; Tolaney, Sara; Lim, Elaine; Gombos, Andrea; Stradella, Agostina; Pegram, Mark; Fasching, Peter; Mangel, Laszlo; Semiglazov, Vladimir; Dieras, Veronique; Gianni, Luca; Danso, Michael A.; Vacirca, Jeff; Kroll, Stew; O'Connell, Joseph; Tang, Kevin; Wei, Thomas und Seidman, Andrew (2021): Results From CONTESSA: A Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2-, Hormone Receptor+ Metastatic Breast Cancer Who Have Previously Received a Taxane. In: Clinical Advances in Hematology & Oncology, Bd. 19, Nr. 2: S. 12-13

Abstract

A SUMMARY PRIME 2 Randomised Trial (Postoperative Radiotherapy in Minimum-Risk Elderly): Wide Local Excision and Adjuvant Hormonal Therapy +/- Whole Breast Irradiation in Women >= 65 Years With Early Invasive Breast Cancer: 10-Year Results The PRIME 2 phase 3 trial enrolled 1326 women ages 65 years or older with hormone receptor-positive, unilateral invasive breast cancer with a tumor size of 3 cm or less and no regional lymph node involvement (Abstract GS2-03). Patients underwent breast-conserving surgery and received neoadjuvant endocrine therapy. They were randomly assigned to receive whole breast radiotherapy (n=658) or not to receive radiotherapy (n=668). The mean age was approximately 71 years. Ipsilateral breast tumor recurrence was the primary endpoint. The 10-year ipsilateral breast tumor recurrence rate was 9.8% without radiotherapy and 0.9% with radiotherapy (HR, 0.12;95% CI, 0.05-0.31;P<.0001). Regional recurrence was reported in 2.3% vs 0.5%, respectively (P=.014). No differences were seen for subgroups such as patients with contralateral breast cancer (1% vs 2.2%;P=.20), distant metastases (1.4% vs 3.6%;P=.07), or new cancers (excluding breast cancer;10.2% vs 8.7%;P=.41). Metastasis-free survival was 98.1% without radiotherapy and 96.4% with radiotherapy (P=.28). OS at 10 years was 80.4% vs 81.0%, respectively (P=.68). Most deaths were not attributable to breast cancer recurrence.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1543-0790
• Sprache: Englisch