TY - JOUR
T1 - De Novo Versus Recurrent HER2-Positive Metastatic Breast Cancer
T2 - Patient Characteristics, Treatment, and Survival from the SystHERs Registry
AU - Tripathy, Debu
AU - Brufsky, Adam
AU - Cobleigh, Melody
AU - Jahanzeb, Mohammad
AU - Kaufman, Peter A.
AU - Mason, Ginny
AU - O'Shaughnessy, Joyce
AU - Rugo, Hope S.
AU - Swain, Sandra M.
AU - Yardley, Denise A.
AU - Chu, Laura
AU - Li, Haocheng
AU - Antao, Vincent
AU - Hurvitz, Sara A.
N1 - Funding Information:
The authors are grateful to the patients, families, and investigators who participated in SystHERs. We would also like to thank Musa Mayer (AdvancedBC.org) for her work as part of the SystHERs steering committee; the SystHERs team, including clinical operations leads Michelle Usher (F. Hoffmann-La Roche/Genentech, Inc.) and Sandy Lam (F. Hoffmann-La Roche/Genentech, Inc.); Bongin Yoo (F. Hoffmann-La Roche/Genentech, Inc.) for his contributions to the statistical analysis; Allen Lee (Everest Clinical Research Services, Inc.) for his assistance with the statistical analysis; and Bokai Xia (F. Hoffmann-La Roche/Genentech, Inc.) for his statistical programming expertise. Third-party writing assistance was provided by Sabrina Hom, Ph.D., of Ashfield Healthcare Communications (a UDG Healthcare plc company) and funded by F. Hoffmann-La Roche/Genentech, Inc. F. Hoffmann-La Roche/Genentech, Inc. funded the SystHERs study and participated in the study design, data collection, data analysis, data interpretation, and writing of this report. Results from a similar analysis of interim data were presented in part at the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium, December 9–13, 2014, in San Antonio, TX, as follows: Debu Tripathy, Adam Brufsky, Melody Cobleigh et al. Increasing proportion of de novo compared with recurrent HER2-positive metastatic breast cancer: Early results from the Systemic Therapies for HER2-Positive Metastatic Breast Cancer Registry study. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: December 9–13, 2014; San Antonio, TX. Cancer Res. 2015;75(suppl 9):P3-07-14A.
Publisher Copyright:
© 2019 The Authors. The Oncologist published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.
PY - 2020/2/1
Y1 - 2020/2/1
N2 - Background: Limited data exist describing real-world treatment of de novo and recurrent HER2-positive metastatic breast cancer (MBC). Materials and Methods: The Systemic Therapies for HER2-Positive Metastatic Breast Cancer Study (SystHERs) was a fully enrolled (2012–2016), observational, prospective registry of patients with HER2-positive MBC. Patients aged ≥18 years and ≤6 months from HER2-positive MBC diagnosis were treated and assessed per their physician's standard practice. The primary endpoint was to characterize treatment patterns by de novo versus recurrent MBC status, compared descriptively. Secondary endpoints included patient characteristics, progression-free and overall survival (PFS and OS, by Kaplan-Meier method; hazard ratio [HR] and 95% confidence interval [CI] by Cox regression), and patient-reported outcomes. Results: Among 977 eligible patients, 49.8% (n = 487) had de novo and 50.2% (n = 490) had recurrent disease. A higher proportion of de novo patients had hormone receptor–negative disease (34.9% vs. 24.9%), bone metastasis (57.1% vs. 45.9%), and/or liver metastasis (41.9% vs. 33.1%), and a lower proportion had central nervous system metastasis (4.3% vs. 13.5%). De novo patients received first-line regimens containing chemotherapy (89.7%), trastuzumab (95.7%), and pertuzumab (77.8%) more commonly than recurrent patients (80.0%, 85.9%, and 68.6%, respectively). De novo patients had longer median PFS (17.7 vs. 11.9 months; HR, 0.69; 95% CI, 0.59–0.80; p <.0001) and OS (not estimable vs. 44.5 months; HR, 0.55; 95% CI, 0.44–0.69; p <.0001). Conclusion: Patients with de novo versus recurrent HER2-positive MBC exhibit different disease characteristics and survival durations, suggesting these groups have distinct outcomes. These differences may affect future clinical trial design. Clinical trial identification number. NCT01615068 (clinicaltrials.gov). Implications for Practice: SystHERs was an observational registry of patients with HER2-positive metastatic breast cancer (MBC), which is a large, modern, real-world data set for this population and, thereby, provides a unique opportunity to study patients with de novo and recurrent HER2-positive MBC. In SystHERs, patients with de novo disease had different baseline demographics and disease characteristics, had superior clinical outcomes, and more commonly received first-line chemotherapy and/or trastuzumab versus those with recurrent disease. Data from this and other studies suggest that de novo and recurrent MBC have distinct outcomes, which may have implications for disease management strategies and future clinical study design.
AB - Background: Limited data exist describing real-world treatment of de novo and recurrent HER2-positive metastatic breast cancer (MBC). Materials and Methods: The Systemic Therapies for HER2-Positive Metastatic Breast Cancer Study (SystHERs) was a fully enrolled (2012–2016), observational, prospective registry of patients with HER2-positive MBC. Patients aged ≥18 years and ≤6 months from HER2-positive MBC diagnosis were treated and assessed per their physician's standard practice. The primary endpoint was to characterize treatment patterns by de novo versus recurrent MBC status, compared descriptively. Secondary endpoints included patient characteristics, progression-free and overall survival (PFS and OS, by Kaplan-Meier method; hazard ratio [HR] and 95% confidence interval [CI] by Cox regression), and patient-reported outcomes. Results: Among 977 eligible patients, 49.8% (n = 487) had de novo and 50.2% (n = 490) had recurrent disease. A higher proportion of de novo patients had hormone receptor–negative disease (34.9% vs. 24.9%), bone metastasis (57.1% vs. 45.9%), and/or liver metastasis (41.9% vs. 33.1%), and a lower proportion had central nervous system metastasis (4.3% vs. 13.5%). De novo patients received first-line regimens containing chemotherapy (89.7%), trastuzumab (95.7%), and pertuzumab (77.8%) more commonly than recurrent patients (80.0%, 85.9%, and 68.6%, respectively). De novo patients had longer median PFS (17.7 vs. 11.9 months; HR, 0.69; 95% CI, 0.59–0.80; p <.0001) and OS (not estimable vs. 44.5 months; HR, 0.55; 95% CI, 0.44–0.69; p <.0001). Conclusion: Patients with de novo versus recurrent HER2-positive MBC exhibit different disease characteristics and survival durations, suggesting these groups have distinct outcomes. These differences may affect future clinical trial design. Clinical trial identification number. NCT01615068 (clinicaltrials.gov). Implications for Practice: SystHERs was an observational registry of patients with HER2-positive metastatic breast cancer (MBC), which is a large, modern, real-world data set for this population and, thereby, provides a unique opportunity to study patients with de novo and recurrent HER2-positive MBC. In SystHERs, patients with de novo disease had different baseline demographics and disease characteristics, had superior clinical outcomes, and more commonly received first-line chemotherapy and/or trastuzumab versus those with recurrent disease. Data from this and other studies suggest that de novo and recurrent MBC have distinct outcomes, which may have implications for disease management strategies and future clinical study design.
KW - De novo
KW - HER2-positive metastatic breast cancer
KW - Recurrent
KW - Registry
KW - SystHERs
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UR - http://www.scopus.com/inward/citedby.url?scp=85074431803&partnerID=8YFLogxK
U2 - 10.1634/theoncologist.2019-0446
DO - 10.1634/theoncologist.2019-0446
M3 - Article
C2 - 32043771
AN - SCOPUS:85074431803
SN - 1083-7159
VL - 25
SP - e214-e222
JO - Oncologist
JF - Oncologist
IS - 2
ER -