Local Recurrence Rates are Low in High-Risk Neoadjuvant Breast Cancer in the I-SPY 1 Trial (CALGB 150007/150012; ACRIN 6657)
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Increasingly, women with stage 2 and 3 breast cancers receive neoadjuvant therapy, after which many are eligible for breast-conserving surgery (BCS). The question often arises as to whether BCS, if achievable, provides adequate local control. We report the results of local recurrence (LR) from the I-SPY 1 Trial in the setting of maximal multidisciplinary treatment where approximately 50 % of patients were treated with BCS.
We analyzed data from the I-SPY 1 Trial. Women with tumors ≥3 cm from nine clinical breast centers received neoadjuvant doxorubicin, cyclophosphamide and paclitaxel followed by definitive surgical therapy, and radiation at physician discretion. LR following mastectomy and BCS were analyzed in relation to clinical characteristics and response to therapy as measured by residual cancer burden.
Of the 237 patients enrolled in the I-SPY 1 Trial, 206 were available for analysis. Median tumor size was 6.0 cm, and median follow-up was 3.9 years. Fourteen patients (7 %) had LR and 45 (22 %) had distant recurrence (DR). Of the 14 patients with LR, nine had synchronous DR; one had DR > 2 years later. Only four (2 % of evaluable patients) had LR alone. The rate of LR was low after mastectomy and after BCS, even in the setting of significant residual disease.
Overall, these patients at high risk for early recurrence, treated with maximal multidisciplinary treatment, had low LR. Recurrence was associated with aggressive biological features such as more advanced stage at presentation, where LR occurs most frequently in the setting of DR.
KeywordsLocal Recurrence Distant Recurrence Ipsilateral Breast Tumor Recurrence Residual Cancer Burden Local Recurrence Risk
We wish to thank the study patients and patient advocates. There are also several people who were the champions of this I-SPY Trial, without whom the study would not have been initiated: Jorge Gomez from the National Cancer Institute (NCI); Larry Norton from CALGB; and Ken Buetow and Subha Madhavan for enabling the development of the data systems for the trial data. We also wish to thank Rachel Gomez for developing the training and systems to guarantee the quality of the pathologic data, and to Sarah Davis for her efforts to ensure the integrity of the entire data set, and to Meredith Buxton for coordinating the entire study. We would also like to thank Lisa Carey from the University of North Carolina for her valuable input. Funding was received from the NCI SPORE in Breast Cancer (CA58207), ACRIN (CA079778 and CA080098), CALGB (CA31964 & CA33601), NCI Center for Bioinformatics, The Breast Cancer Research Foundation, Bruce and Martha Atwater, The Terry Fox Foundation Postdoctoral Fellowship, and ‘Give Breast Cancer the Boot’.
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