Abstract
BackgroundPrevious large trials of trastuzumab (TZM) demonstrated improved outcomes in patients with HER2-positive early breast cancer. However, its effectiveness and safety in Japanese patients is not yet clear. Recently, new anti-HER2 agents were developed to improve treatment outcomes, but the patient selection criteria remain controversial.PurposeThe aim of this study was to evaluate the long-term effectiveness of TZM therapy as perioperative therapy for HER2-positive operable breast cancer in daily clinical practice and to create a recurrence prediction model for therapeutic selection.MethodsAn observational study was conducted in Japan (UMIN000002737) to observe the prognosis of women (n = 2024) with HER2-positive invasive breast cancer who received TZM for stage I–III C disease between July 2009 and June 2011. Moreover, a recurrence-predicting model was designed to evaluate the risk factors for recurrence.ResultsThe 5- and 10-year disease-free survival (DFS) rates were 88.9 (95% CI 87.5–90.3%) and 82.4% (95% CI 79.2–85.6%), respectively. The 5- and 10-year overall survival (OS) rates were 96% (95% CI 95.1–96.9%) and 92.7% (95% CI 91.1–94.3%), respectively. Multivariate analysis revealed that the risk factors for recurrence were an age of ≥ 70 years, T2 or larger tumors, clinically detected lymph node metastasis, histological tumor diameter of > 1 cm, histologically detected lymph node metastasis (≥ n2), and the implementation of preoperative treatment. The 5-year recurrence rate under the standard treatment was estimated to be > 10% in patients with a score of 3 or greater on the recurrence-predicting model.ConclusionThe recurrence-predicting model designed in this study may improve treatment selection of patients with stage I–III C disease. However, further studies are needed to validate the scores generated by this model.
Highlights
Several randomized trials of trastuzumab (TZM) have demonstrated improved outcomes in patients with HER2positive early breast cancer (EBC) [1,2,3,4]
Perioperative therapy for HER2-positive EBC has been improved via attempts to eliminate anthracycline [1, 6, 7], the development of antiHER2 agents, such as neratinib [8] and pertuzumab [9], and shortening of the trastuzumab administration duration [10,11,12]
We directly investigated the interaction between the presence of preoperative treatment and lymph node metastasis or pathological tumor size by analysis involving an interaction item, but it was insignificant
Summary
Several randomized trials of trastuzumab (TZM) have demonstrated improved outcomes in patients with HER2positive early breast cancer (EBC) [1,2,3,4]. The effectiveness of TZM therapy as perioperative therapy for HER2-positive operable breast cancer in daily clinical. Previous large trials of trastuzumab (TZM) demonstrated improved outcomes in patients with HER2-positive early breast cancer. Purpose The aim of this study was to evaluate the long-term effectiveness of TZM therapy as perioperative therapy for HER2-positive operable breast cancer in daily clinical practice and to create a recurrence prediction model for therapeutic selection. Conclusion The recurrence-predicting model designed in this study may improve treatment selection of patients with stage I–III C disease. Further studies are needed to validate the scores generated by this model
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