Abstract | PURPOSE: METHODS: The T-DM1 Patient Access Study was an expanded-access, multicenter study of T-DM1 in US patients with pretreated HER2-positive locally advanced breast cancer or MBC. The primary endpoint was safety. The secondary endpoint was investigator-assessed objective response rate among patients with measurable disease at baseline. Data are presented for the first 215 enrolled patients. RESULTS: The median number of prior systemic MBC agents was 8 (range, 3-23). At baseline, median left ventricular ejection fraction was 60%, and 52.6% of patients had nonclinically significant cardiovascular disease. Median T-DM1 treatment duration was 5.0 months (range, 0-29 months; median follow-up, 5.9 months), with 18.6% having received more than 18 cycles. The most common any-grade adverse events were fatigue (50.7%) and nausea (38.1%). Adverse events of grade 3 or greater were reported in 46.5%, most commonly thrombocytopenia and platelet count decrease (10.2%). Bleeding of grade 3 or greater was reported in 4 patients (1.9%). Cardiac dysfunction (primarily asymptomatic left ventricular ejection fraction decreases) was reported in 14 patients (6.5%). Among those with measurable disease at baseline (n = 172), objective response rate was 25.6% (95% confidence interval, 19.2%-32.8%). DISCUSSION: The safety profile of T-DM1 in this real-world setting of heterogeneous, HER2-positive, pretreated, locally advanced breast cancer or MBC was comparable with that reported in phases II and III studies of similar patient populations. T-DM1 was efficacious with no new safety signals.
|
Authors | Denise A Yardley, Ian E Krop, Patricia M LoRusso, Musa Mayer, Brian Barnett, Bongin Yoo, Edith A Perez |
Journal | Cancer journal (Sudbury, Mass.)
(Cancer J)
2015 Sep-Oct
Vol. 21
Issue 5
Pg. 357-64
ISSN: 1540-336X [Electronic] United States |
PMID | 26389758
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antibodies, Monoclonal, Humanized
- Antineoplastic Agents
- Biomarkers, Tumor
- Maytansine
- Receptor, ErbB-2
- Trastuzumab
- Ado-Trastuzumab Emtansine
|
Topics |
- Ado-Trastuzumab Emtansine
- Adult
- Aged
- Antibodies, Monoclonal, Humanized
(administration & dosage, adverse effects, therapeutic use)
- Antineoplastic Agents
(administration & dosage, adverse effects, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Biomarkers, Tumor
- Breast Neoplasms
(drug therapy, metabolism, pathology)
- Breast Neoplasms, Male
(drug therapy, pathology)
- Comorbidity
- Female
- Humans
- Male
- Maytansine
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Middle Aged
- Molecular Targeted Therapy
- Neoplasm Metastasis
- Neoplasm Recurrence, Local
- Neoplasm Staging
- Receptor, ErbB-2
(antagonists & inhibitors, metabolism)
- Retreatment
- Trastuzumab
- Treatment Outcome
|