ArticleMedicine2020
A phase I study of pharmacokinetics of trastuzumab emtansine in Chinese patients with locally advanced inoperable or metastatic human epidermal growth factor receptor 2-positive breast cancer who have received prior trastuzumab-based therapy.
Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03153163 (A Phase I Study of Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Patients With Logically Advanced Inoperable or Metastatic HER2-Positive Breast Cancer Who Have Received Prior Trastuzumab Based Therapy), which is not on this map. Cited by 2 papers.
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A Phase I Study of Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Patients With Logically Advanced Inoperable or Metastatic HER2-Positive Breast Cancer Who Have Received Prior Trastuzumab Based Therapy
Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Anthracyclines induce cardiotoxicity through a shared gene expression response signature.PLoS genetics · 2024Article
- Strategies for Mitigating Antibody-Drug Conjugate Related Adverse Events for Precision Therapy.Cancer journal (Sudbury, Mass.)Review
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTrastuzumab emtansine (T-DM1) is an antibody-drug conjugate that retains the antitumor effects of trastuzumab while also delivering the cytotoxic antimicrotubule agent, DM1, directly to tumor cells that overexpress human epidermal growth factor receptor 2. The pharmacokinetic (PK) profile of T-DM1 has been well characterized in Western, Asian, and Japanese patients; this single-center, phase I study (NCT03153163) examined the PK of T-DM1 and safety specifically in Chinese patients.
methodsPatients with locally advanced or metastatic breast cancer, previously treated with trastuzumab and a taxane, received open-label T-DM1 at 3.6 mg/kg every 3 weeks. Serum T-DM1 and total trastuzumab, and plasma DM1 were evaluated, and PK parameters were calculated using standard noncompartmental approaches. Adverse events (AEs) were assessed, and immunogenicity was evaluated by measuring antidrug antibodies to T-DM1.
resultsAmong 11 Chinese patients, mean (±standard deviation) PK parameters (maximum serum concentration, 77.6 ± 17.4 μg/mL; clearance 11.0 ± 2.6 mL/d/kg; terminal half-life 3.8 ± 1.0 days) were similar to those previously reported in Western and Japanese patients. One patient transiently developed antidrug antibodies, which did not appear to influence safety or PK. T-DM1 was generally well tolerated. Grade 3-4 AEs occurred in 7 patients (63.6%) and serious AEs occurred in 4 patients (36.4%). Platelet count decrease was the most common all-grade AE (10/11; 90.9%), grade 3-4 AE (5/11; 45.5%), and serious AE (3/11; 27.3%), but did not appear to be associated with any clinically significant bleeding events.
conclusionsT-DM1 PK in Chinese patients was consistent with those in global and Asian populations, supporting its use in patients with advanced human epidermal growth factor receptor 2-positive breast cancer following progression on trastuzumab and a taxane. The safety profile of T-DM1 was consistent with prior experience.
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