| Added by | pcoopman |
|---|---|
| Last modified by | standudu |
| Group name | EquipePC |
| Item Type | Journal Article |
| 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 |
| Creator | Conte et al. |
| Author | PierFranco Conte |
| Author | Andreas Schneeweiss |
| Author | Sibylle Loibl |
| Author | Eleftherios P. Mamounas |
| Author | Gunter von Minckwitz |
| Author | Max S. Mano |
| Author | Michael Untch |
| Author | Chiun-Sheng Huang |
| Author | Norman Wolmark |
| Author | Priya Rastogi |
| Author | Ljiljana Stamatovic |
| Author | Hervé Bonnefoi |
| Author | Hugo Castro-Salguero |
| Author | Hans H. Fischer |
| Author | Tanya Wahl |
| Author | Chunyan Song |
| Author | Thomas Boulet |
| Author | Peter Trask |
| Author | Charles E. Geyer |
| 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. |
| Publication | Cancer |
| Volume | 126 |
| Issue | 13 |
| Pages | 3132-3139 |
| Date | Jul 01, 2020 |
| Journal Abbr | Cancer |
| Language | eng |
| DOI | 10.1002/cncr.32873 |
| ISSN | 1097-0142 |
| Short Title | Patient-reported outcomes from KATHERINE |
| Library Catalog | PubMed |
| Extra | 00000 PMID: 32286687 PMCID: PMC7317721 |
| Tags | ado-trastuzumab emtansine, antibody-drug conjugate, clinic, patient-reported outcome, T-DM1 |
| Date Added | 2020/07/17 - 17:58:23 |
| Date Modified | 2020/10/04 - 14:01:57 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) |
Institut de Recherche en Cancérologie de
