# Source screening: PMID 33647599

**Catalogue:** Muse Solves Cancer papers page 002 (HER2 residual disease / toxicity / access mission).
**Decision:** INCLUDE — adjuvant T-DM1 after neoadjuvant therapy with invasive residual disease is core residual-disease scope; abstract also reports comparative toxicity.

## Bibliographic identity (PubMed EFetch)
- PMID: 33647599
- Title: The EMA review of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer.
- Journal: ESMO open (2021)
- DOI: 10.1016/j.esmoop.2021.100074
- PubMed: https://pubmed.ncbi.nlm.nih.gov/33647599/
- contentHash SHA-256(TITLE+PMID+ABSTRACT): `fc86d2d0da8406c872201a7cec36541ece0a0073c624f1919ef63febb04e5964`

## What the abstract states (no full-text review)
- Regulatory note summarizing the EMA scientific review that extended T-DM1 marketing authorisation (18 Dec 2019) to adjuvant therapy in adults with HER2-positive early breast cancer who have residual invasive disease in breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy.
- Underlying evidence: phase III randomised open-label trial of adjuvant T-DM1 vs trastuzumab after preoperative chemo + HER2-targeted therapy and surgery with residual invasive disease.
- Primary endpoint (abstract): 3-year invasive DFS 88.3% (T-DM1) vs 77.0% (trastuzumab); unstratified HR 0.50 (95% CI 0.39–0.64).
- Toxicity (abstract rates, T-DM1 vs control): hepatotoxicity 37.3% vs 10.6%; thrombocytopenia 28.5% vs 2.4%; peripheral neuropathy 32.3% vs 16.9%; haemorrhage 29.2% vs 9.6%; pulmonary toxicity 2.8% vs 0.8%.

## Screening notes
- INCLUDE for residual-disease and safety sections. This is a secondary regulatory summary of the KATHERINE-class residual-disease indication, not a new primary RCT extract.
- Catalogue metadata alone is not evidence; figures above are taken only from the PubMed abstract.
- Not patient advice; not a treatment recommendation.

## Catalogue metadata cross-check
- Catalogue title match: The EMA review of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer.
- Catalogue DOI: 10.1016/j.esmoop.2021.100074
- Catalogue screeningStatus before this agent screen: not_screened