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Title: | Patient-reported outcomes from KATHERINE: A phase 3 study of adjuvant trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer |
Authors: | CONTE, PierFranco; SCHNEEWEISS, Andreas; LOIBL, Sibylle; MAMOUNAS, Eleftherios P.; MINCKWITZ, Gunter von; MANO, Max S.; UNTCH, Michael; HUANG, Chiun-Sheng; WOLMARK, Norman; RASTOGI, Priya; D'HONDT, Veronique; REDONDO, Andres; STAMATOVIC, Ljiljana; BONNEFOI, Herve; CASTRO-SALGUERO, Hugo; FISCHER, Hans H.; WAHL, Tanya; SONG, Chunyan; BOULET, Thomas; TRASK, Peter; GEYER JR., Charles E. |
Citation: | CANCER, v.126, n.13, p.3132-3139, 2020 |
Abstract: | Background The phase 3 KATHERINE trial demonstrated significantly improved invasive disease-free survival with adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy. Methods Patients who received taxane- and trastuzumab-containing neoadjuvant therapy (with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery were randomly assigned to 14 cycles of adjuvant T-DM1 (3.6 mg/kg intravenously every 3 weeks) or trastuzumab (6 mg/kg intravenously every 3 weeks). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23) were completed at screening, at day 1 of cycles 5 and 11, within 30 days after study drug completion, and at 6- and 12-month follow-up visits. Results Of patients who were randomly assigned to T-DM1 (n = 743) and trastuzumab (n = 743), 612 (82%) and 640 (86%), respectively, had valid baseline and >= 1 postbaseline assessments. No clinically meaningful changes (>= 10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm. More patients receiving T-DM1 reported clinically meaningful deterioration at any assessment point in role functioning (49% vs 41%), appetite loss (38% vs 28%), constipation (47% vs 38%), fatigue (66% vs 60%), nausea/vomiting (39% vs 30%), and systemic therapy side effects (49% vs 36%). These differences were no longer apparent at the 6-month follow-up assessment, except for role functioning (23% vs 16%). Conclusion These data suggest that health-related quality of life was generally maintained in both study arms over the course of treatment. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - FM/Outros Artigos e Materiais de Revistas Científicas - ODS/03 |
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