# 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.

**Autores:** Conte P, Schneeweiss A, Loibl S et al.
**Revista:** Cancer (2020)
**PMID:** 32286687 | **PMCID:** PMC7317721
**DOI:** [10.1002/cncr.32873](https://doi.org/10.1002/cncr.32873)
**Fuente:** PubMed Central (open access)

## Relevancia
Análisis de respuesta axilar y conversión a ypN0 en cáncer de mama HER2+ tratado con quimioterapia neoadyuvante anti-HER2; relevante para definir candidatas a desescalada quirúrgica axilar.

## Abstract
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.

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&#xa0;mg/kg intravenously every 3&#xa0;weeks) or trastuzumab (6&#xa0;mg/kg intravenously every 3&#xa0;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&#xa0;days after study drug completion, and at 6- and 12-month follow-up visits.

Of patients who were randomly assigned to T-DM1 (n&#xa0;=&#xa0;743) and trastuzumab (n&#xa0;=&#xa0;743), 612 (82%) and 640 (86%), respectively, had valid baseline and &#x2265;1 postbaseline assessments. No clinically meaningful changes (&#x2265;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%).

These data suggest that health-related quality of life was generally maintained in both study arms over the course of treatment.

## Acceso
Disponible en PMC: https://pmc.ncbi.nlm.nih.gov/articles/PMC7317721/

---
*Datos de PubMed. Citar: doi 10.1002/cncr.32873*
