Survival in patients with non-metastatic breast cancer treated with adjuvant trastuzumab in clinical practice

Abstract

PurposeThe NSABP Trial B-31 and NCCTG Trial N9831 (B-31/N9831 trials, Romond et al. in N Engl J Med 353:1673–84, 2005. doi:10.1056/NEJMoa052122; Perez et al. in J Clin Oncol 32:3744–52, 2014. doi:10.1200/JCO.2014.55.5730) established the efficacy of adjuvant trastuzumab for patients with HER2-positive early stage breast cancer. We aimed to estimate the overall survival (OS) and relapse-free survival (RFS) of HER2-positive non-metastatic breast cancer patients treated with adjuvant trastuzumab in a clinical practice setting in the United States.MethodsAdult women initiating adjuvant trastuzumab within 1 year of breast cancer surgery were identified in the health claims database of the US Department of Defense (01/2003–12/2012). OS and RFS unadjusted rates at 4 and 6 years after the first trastuzumab treatment following the breast cancer diagnosis were estimated from Kaplan–Meier analyses.ResultsThe study sample included 3188 women followed for a median of 3.3 years after trastuzumab initiation and treated continuously with trastuzumab for a median of 12 months. The OS rates (95 % confidence intervals) at 4 and 6 years were 90.0 % (88.6–91.2) and 87.1 (85.3–88.6), respectively. The corresponding RFS rates were 75.8 % (74.0–77.5) and 72.7 (70.7–74.7), respectively. The OS and RFS rates at 6 years reported in the B-31/N9831 trials were 89.8 and 81.4 %, respectively.ConclusionsOS rates estimated in this study were in range with those estimated in the B-31/N9831 trials, while RFS rates were lower. However, patients in the B-31/N9831 trials were younger and possibly had fewer comorbidities than patients in the current study; these differences were not adjusted for in the crude OS and RFS analyses.Electronic supplementary materialThe online version of this article (doi:10.1186/s40064-016-2008-9) contains supplementary material, which is available to authorized users.

Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort

“… 43 The 4-year relapse-free survival rate in MBC was 76%. 50 An Italian study found no difference in OS (HR 0.79 (95% CI 0.50 to 1.26)) between metastatic patients previously treated with trastuzumab for EBC who are subsequently treated with trastuzumab for MBC and patients first diagnosed with MBC receiving trastuzumab for MBC. 42 An Australian study of patients with HER2-positive MBC estimated a median OS of 29.9 months.…”

“…Population-based study estimates of survival outcomes for women receiving HER2-targeted therapies are within the range of pivotal clinical trial estimates. Several studies reported 4-year survival rates in patients with early BC (EBC) at ∼90% 41 50 and in patients with MBC at 41%. 43 The 4-year relapse-free survival rate in MBC was 76%.…”

Translating the ABC-02 trial into daily practice: outcome of palliative treatment in patients with unresectable biliary tract cancer treated with gemcitabine and cisplatin

“…No difference in median overall survival (OS) between trial and non-trial patients was observed in similar retrospective studies in colorectal and breast cancer [7,8]. In a study performed in men with metastatic castration resistant prostate cancer, it has been demonstrated that treatment in daily practice is associated with a shorter survival and more toxicity compared with men treated in a clinical trial [9].…”

Atypical breast adenosquamous carcinoma following acute myeloid leukemia in a middle-aged woman: A case report

“…According to previous studies, mastectomy is an effective treatment for breast cancer, and it has been demonstrated that a bilateral risk-reducing mastectomy decreases the risk of invasion and metastases in patients with breast cancer by up to 90% (19,20). Based on a review of the literature, almost 20% of all breast cancers are HER2-positive, and one of the monoclonal antibodies against the HER2 receptor is trastuzumab, which has been used for HER2-positive breast cancers as an adjuvant treatment and target therapy (21,22). SCC may present with smooth or hyperkeratotic lesions, abscesses, nodules and ulceration of the skin, although nipple discharge is uncommon (23,24), and the symptoms of invasive ductal carcinoma are lumps, itching, burning and pain (25).…”