PMID- 26123628
OWN - NLM
STAT- MEDLINE
DCOM- 20160822
LR  - 20191210
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 35
IP  - 8
DP  - 2015 Aug
TI  - Safety Profile and Costs of Related Adverse Events of Trastuzumab Emtansine for 
      the Treatment of HER2-Positive Locally Advanced or Metastatic Breast Cancer 
      Compared to Capecitabine Plus Lapatinib from the Perspective of the Canadian 
      Health-Care System.
PG  - 487-93
LID - 10.1007/s40261-015-0302-x [doi]
AB  - BACKGROUND AND OBJECTIVES: Trastuzumab emtansine (T-DM1, KADCYLA((R))) is an 
      antibody-drug conjugate comprised of the cytotoxic agent DM1 and trastuzumab 
      (HERCEPTIN((R))). The safety profile of T-DM1 in human epidermal growth factor 
      receptor 2 (HER2)-positive locally advanced or metastatic breast cancer 
      previously treated with trastuzumab and a taxane was investigated in the phase 
      III EMILIA trial. The trial demonstrated clinically and statistically meaningful 
      differences in the safety profile between T-DM1 and capecitabine plus lapatinib 
      (CAP + LAP). The objective of this study was to estimate the costs of managing 
      treatment-related grade >/= 3 adverse events (AEs) that occurred in >/= 2% of 
      patients and grade 2 AEs that occurred in >/= 5% of patients taking T-DM1 compared 
      with patients taking CAP + LAP based on the EMILIA trial, from the perspective of 
      Canadian public payers. METHODS: An Excel-based model was utilized to estimate 
      the relevant costs. Clinical data were obtained from the EMILIA trial. Cost 
      information was obtained from the literature, clinical experts, and standard cost 
      sources. The analysis was conducted from the Canadian public-payer perspective 
      and reported in 2014 Canadian dollars (CAD). RESULTS: The management of included 
      treatment-related AEs resulted in higher estimated per-patient costs of CAD6901 
      for CAP + LAP versus CAD3380 for T-DM1, resulting in savings of CAD3521. 
      CONCLUSIONS: From a Canadian perspective, this analysis demonstrated that 
      utilizing T-DM1 for the management of HER2-positive metastatic breast cancer 
      results in substantial savings to the public health-care system when considering 
      the costs of treatment-related AEs, due to fewer amount of toxicities compared 
      with CAP + LAP. Results of various sensitivity analyses investigating changes in 
      number and costs of AEs confirmed the findings; however, the magnitude of cost 
      savings varied. Further analyses are necessary to determine whether these cost 
      savings would occur in other countries and health-care systems.
FAU - Piwko, Charles
AU  - Piwko C
AD  - CHP Pharma Inc, 20 Maimonides Court, Thornhill, ON, L4J 4X8, Canada, 
      cpiwko@chppharma.com.
FAU - Prady, Catherine
AU  - Prady C
FAU - Yunger, Simon
AU  - Yunger S
FAU - Pollex, Erika
AU  - Pollex E
FAU - Moser, Aurelie
AU  - Moser A
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Quinazolines)
RN  - 0VUA21238F (Lapatinib)
RN  - 14083FR882 (Maytansine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
RN  - SE2KH7T06F (Ado-Trastuzumab Emtansine)
SB  - IM
MH  - Ado-Trastuzumab Emtansine
MH  - Antibodies, Monoclonal, Humanized/*adverse effects
MH  - Antineoplastic Agents/*adverse effects
MH  - Breast Neoplasms/chemistry/*drug therapy/pathology
MH  - Canada
MH  - Capecitabine/administration & dosage/*adverse effects
MH  - Delivery of Health Care
MH  - Female
MH  - Health Care Costs
MH  - Humans
MH  - Lapatinib
MH  - Maytansine/adverse effects/*analogs & derivatives
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Quinazolines/administration & dosage/*adverse effects
MH  - Receptor, ErbB-2/*analysis
MH  - Trastuzumab
EDAT- 2015/07/01 06:00
MHDA- 2016/08/23 06:00
CRDT- 2015/07/01 06:00
PHST- 2015/07/01 06:00 [entrez]
PHST- 2015/07/01 06:00 [pubmed]
PHST- 2016/08/23 06:00 [medline]
AID - 10.1007/s40261-015-0302-x [doi]
PST - ppublish
SO  - Clin Drug Investig. 2015 Aug;35(8):487-93. doi: 10.1007/s40261-015-0302-x.