OVERALL SURVIVAL IN PATIENTS WITH HER2+ EARLY STAGE BREAST CANCER PATIENTS TREATED WITH TRASTUZUMAB IN THE US DEPARTMENT OF DEFENSE PRACTICE SETTING
Author(s)
Gallagher CM1, More K2, Masaquel AS3, Kamath T3, Guerin A4, Ionescu-Ittu R4, Gauthier-Loiselle M4, Nitulescu R4, Sicignano N5, Barnett B3, Wu EQ6
1Walter Reed National Military Medical Center, Bethesda, MD, USA, 2Naval Medical Center Portsmouth, Portsmouth, VA, USA, 3Genentech, South San Francisco, CA, USA, 4Analysis Group, Inc., Montréal, QC, Canada, 5Health ResearchTx, Trevose, VA, USA, 6Analysis Group, Inc., Boston, MA, USA
OBJECTIVES: The NSABP/NCCTG trial (Romond et al. NEJM 2005;353:1673-1684) established the efficacy of trastuzumab in the adjuvant treatment of HER2+ early stage breast cancer (HER2+BC). Yet, little is known about the patterns of use and outcomes of adjuvant trastuzumab in clinical practice. The study aimed to estimate the overall survival (OS) and relapse-free survival (RFS) of HER2+BC patients treated with adjuvant trastuzumab in the US Department of Defense (DOD) practice setting. METHODS: Adult women initiating adjuvant trastuzumab within 1 year of BC surgery were identified in the DOD health claims database (01/2003-12/2012). An algorithm based on secondary neoplasm ICD9 codes and treatment gaps and initiations was used to identify relapses. OS and RFS unadjusted rates at 3 and 4 years after the initiation of the adjuvant trastuzumab treatment were estimated from Kaplan-Meier plots. RESULTS: The study sample included 3,188 women (median age 63 years), followed for a median of 3.3 years after the initiation of trastuzumab and treated continuously with trastuzumab for a median of 12 months. Of these 3,188 women, 13.8% received neo-adjuvant therapy prior to the surgery, 17.7% relapsed, and 7.9% died during the follow-up. The OS rates at 3 and 4 years were 93.2% (95% CI 92.1%-94.2%) and 90.0% (88.6%-91.2%), respectively. The corresponding RFS rates were 78.8% (77.1%-80.3%) and 75.8% (74.0%-77.5%), respectively. CONCLUSIONS: The findings suggest that most HER2+BC patients in the DOD practice setting received per-label trastuzumab treatment (for 52 weeks) and had OS rates that are similar to the OS rates that were previously observed in the NSABP/NCCTG clinical trial (90.0% vs. 93% at four years). The lower RFS rates observed in this study versus the NSABP/NCCTG trial (75.8% vs. 85.7% at 4 years), may be partially explained by differences in the characteristics of the patients, including age.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PCN6
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology