Association of Residual Ductal Carcinoma In Situ With Breast Cancer Recurrence in the Neoadjuvant I-SPY2 Trial.
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Osdoit Marie, Yau Christina, Symmans W Fraser, Boughey Judy C, Ewing Cheryl A, Balassanian Ron, Chen Yunn-Yi, Krings Gregor, Wallace Anne M, Zare Somaye, Fadare Oluwole, Lancaster Rachael, Wei Shi, Godellas Constantine V, Tang Ping, Tuttle Todd M, Klein Molly, Sahoo Sunati, Hieken Tina J, Carter Jodi M, Chen Beiyun, Ahrendt Gretchen, Tchou Julia, Feldman Michael, Tousimis Eleni, Zeck Jay, Jaskowiak Nora, Sattar Husain, Naik Arpana M, Lee Marie Catherine, Rosa Marilin, Khazai Laila, Rendi Mara H, Lang Julie E, Lu Janice, Tawfik Ossama, Asare Smita M, Esserman Laura J, Mukhtar Rita A
Аннотация
OBJECTIVE: To examine the association of residual DCIS in surgical specimens after neoadjuvant chemotherapy for breast cancer with survival end points to inform standards for the assessment of pathologic complete response.
DESIGN, SETTING, AND PARTICIPANTS: The study team analyzed the association of residual DCIS after NAC with 3-year event-free survival (EFS), distant recurrence-free survival (DRFS), and local-regional recurrence (LRR) in the I-SPY2 trial, an adaptive neoadjuvant platform trial for patients with breast cancer at high risk of recurrence. This is a retrospective analysis of clinical specimens and data from the ongoing I-SPY2 adaptive platform trial of novel therapeutics on a background of standard of care for early breast cancer. I-SPY2 participants are adult women diagnosed with stage II/III breast cancer at high risk of recurrence.
INTERVENTIONS: Participants were randomized to receive taxane and anthracycline-based neoadjuvant therapy with or without 1 of 10 investigational agents, followed by definitive surgery.
MAIN OUTCOMES AND MEASURES: The presence of DCIS and EFS, DRFS, and LRR.
RESULTS: The study team identified 933 I-SPY2 participants (aged 24 to 77 years) with complete pathology and follow-up data. Median follow-up time was 3.9 years; 337 participants (36%) had no residual invasive disease (residual cancer burden 0, or pCR). Of the 337 participants with pCR, 70 (21%) had residual DCIS, which varied significantly by tumor-receptor subtype; residual DCIS was present in 8.5% of triple negative tumors, 15.6% of hormone-receptor positive tumors, and 36.6% of ERBB2-positive tumors. Among those participants with pCR, there was no significant difference in EFS, DRFS, or LRR based on presence or absence of residual DCIS.
CONCLUSIONS AND RELEVANCE: The analysis supports the definition of pCR as the absence of invasive disease after NAC regardless of the presence or absence of DCIS.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01042379.