Back to Authors

King, Tari A.

https://orcid.org/0000-0003-3602-2351

Mayo Clinic

Brigham and Women's Hospital

Citations 27

Cluster randomized controlled trial of decision support for breast cancer chemoprevention, MiCHOICE
Crew, Katherine D. , Arnold, Kathryn B. , Dzingle, Sam, Michel, Alissa, DeLucie, Michael, Law, Cynthia W., Pruthi, Sandhya , Leon, Ana C Sandoval, Shirley, Rachel, Perdekamp, Maria T Grosse, Colonna, Sarah V, Krisher, Stacy L, King, Tari A. , Yee, Lisa D. , Braun-Inglis, Christa, Mangino, Debra A. , Wisinski, Kari B. , DeYoung, Claudia A, Ross, Masey, Floyd, Justin D., Kaster, Andrea, VanderWalde, Lindi, Saphner, Thomas J. , Zarwan, Corrine, Lo, Shelly, Graham, Cathy, Conlin, Alison, Yost, K. , Agnese, Doreen M, Jernigan, Cheryl, Neuhouser, Marian L, Arun, Banu, Pruthi, Sandhya , Anderson, Garnet L. , Michel, Alissa , DeLucie, M. T., Sandoval-Leon, Ana Cristina , Shirley, Rachel, Perdekamp, Maria T. Grosse, Colonna, Sarah V. , Krisher, Stacy, Ballinger, Tarah Jean , Braun‐Inglis, Christa , Ross, Masey, Graham, Cathy Lynne , Yost, Kathleen J. , Agnese, Doreen Marie , Hershman, Dawn L. , Zell, Jason A. , Kukafka, Rita

JNCI: Journal of the National Cancer Institute | June 30, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1093/jnci/djag216 Get It

Abstract Background Breast cancer chemoprevention is underutilized among high-risk women. We examined whether decision support could increase informed decision making. Methods We conducted a cluster randomized controlled trial to evaluate the effect of a patient-facing decision aid (RealRisks) and provider tool (BNAV) compared with standard education on the number of women with high-risk breast lesions making informed choices. Questionnaires were administered at baseline and 6 and 12 months. The primary outcome was chemoprevention informed choice (defined as adequate knowledge and attitudes congruent with decision) at 6 months. Secondary endpoints included breast cancer risk perceptions, worry, chemoprevention knowledge, decision conflict, and chemoprevention decision. Results Across 31 randomized sites, we enrolled 210 providers, who were primarily breast health specialists. Of these, 24 sites (14 intervention, 10 control) enrolled 412 patients. Among 287 patients evaluable for the primary outcome, there were no statistically significant differences in informed choice between the intervention and control arms at 6 months (35% vs 27%, respectively; P = .20) and 12 months (37% vs 25%, respectively; P = .05). At 6 months, women in the intervention compared with control arm were more likely to have accurate breast cancer risk perceptions (31% vs 21%, respectively; P = .03) and adequate chemoprevention knowledge (33% vs 23%, respectively; P = .04). At 12 months, 52% of women in the control and 50% in the intervention arm self-reported initiating chemoprevention. Conclusion Decision support led to modest improvements in accurate risk perceptions and chemoprevention knowledge but not informed choice. Relatively high chemoprevention uptake was achieved among women with high-risk breast lesions managed mainly by breast health specialists. Trial Registration NCT04496739, https://clinicaltrials.gov/study/NCT04496739?cond=NCT04496739&viewType=Card&rank=1
Outcomes and treatment patterns in germline BRCA1/2 carriers from two matched cohort studies
Morganti, Stefania , Kim, Se Eun , Jin, Qingchun , Cha, Jaeyoon , Zeigler, Jacqueline E, Newman, Alexandra Bili, Kirkner, Gregory J. , Snow, Craig , Zheng, Yue, Vincuilla, Julie, Parker, Tonia , Buehler, Ryan M. , Bychkovsky, Brittany L , Dibble, Kate E. , Sella, Tal , Ruddy, Kathryn J, Rosenberg, Shoshana M, Collins, Laura C. , Peppercorn, Jeffrey, Schapira, Lidia, Guzman-Arocho, Yaileen D, Come, Steven E. , Warner, Ellen, Poorvu, Philip D. , Lambertini, Matteo, Curigliano, G, Hughes, Melissa E. , Mittendorf, Elizabeth A, King, Tari A, Lin, Nancy U, Garber, Judy E, Tayob, Nabihah, Tolaney, S M, Partridge, Ann H, Zheng, Yue , Newman, Alexandra B , Zheng, Yue , Ruddy, Kathryn J , Peppercorn, Jeffrey M , Borges, Virginia F , Guzman-Arocho, Yaileen D , Come, Steven , Poorvu, Philip D , Lambertini, Matteo , Curigliano, Giuseppe , Mittendorf, EA , King, Tari A , Lin, Nancy U , Garber, J. E. , Tayob, Nabihah , Tolaney, Sara , Partridge, Ann H , Lynce, Filipa , Kirkner, Gregory , Snow, Craig , Vincuilla, Julie, Ruddy, Kathryn J. , Rosenberg, Shoshana M. , Peppercorn, Jeffrey , Schapira, Lidia , Borges, Virginia F. , Guzmán‐Arocho, Yaileen D. , Warner, Ellen , Lambertini, Matteo , Curigliano, Giuseppe , King, Tari A. , Lin, Nancy U. , Garber, Judy E. , Partridge, Ann H.

JNCI Cancer Spectrum | May 23, 2026 | Volume: 10 | Issue: 4 | Pages: No page available

10.1093/jncics/pkag055 Get It

Abstract Background Whether outcomes of germline BRCA1/2 (gBRCA1/2)-associated breast cancer differ compared with sporadic tumors is controversial. We explored the impact of gBRCA1/2 pathogenic variant (PV) status beyond established prognostic features. Methods We conducted 2 retrospective, matched cohort studies comparing gBRCA1/2 PV carriers and noncarriers with HER2-negative, stage I-III breast cancer (Clinical Outcomes Quality Database [COQD] cohort: 185 carriers, 555 noncarriers; Young Women’s Breast Cancer Study [YWS] cohort: 113 carriers, 226 noncarriers). Matching factors were age, stage, hormone receptor status, and year of diagnosis. Clinicopathological features, treatments, and survival outcomes were compared between carriers and noncarriers. Results Most patients in COQD had stage I-II disease (87.2%), and more carriers than noncarriers had genetic testing before diagnosis (33% vs 5.6%, P < .001). In YWS, 22.7% of patients had stage III tumors, and few were tested before diagnosis (14.8% of carriers vs 1.7% of noncarriers; P < .001). Carriers in COQD received chemotherapy more often than noncarriers (81.1 vs 67.0%, P < .001), including platinum (P = .010); the proportion was similar for carriers and noncarriers in YWS. After adjusting for chemotherapy, relapse-free survival was longer in carriers than noncarriers in COQD (adjusted hazard ratio = 0.48 [95% CI = 0.26 to 0.87], P = .016), and a favorable trend was observed for other survival outcomes in both cohorts. Triple-negative tumors appeared to drive the differences. Conclusions We observed a trend toward improved outcomes in gBRCA1/2 PV carriers compared with noncarriers. These findings suggest that carriers should not receive more aggressive treatment solely based on their germline mutation status. Prospective clinical trials in this population are warranted.
Long-Term Locoregional Outcomes in a Contemporary Cohort of Young Women With Breast Cancer
Dominici, Laura S. , King, Tari A. , Wong, Julia S., Ruddy, Kathryn J. , Peppercorn, Jeffrey , Schapira, Lidia , Come, Steven E. , Collins, Laura C. , Rosenberg, Shoshana M. , Zheng, Yue , Tamimi, Rulla M. , Borges, Virginia F. , Warner, Ellen , Partridge, Ann H.

JAMA Surgery | July 23, 2025 | Volume: 160 | Issue: 9 | Pages: 964

10.1001/jamasurg.2025.2324 Get It

Importance Women diagnosed with breast cancer at a young age are felt to have a higher risk for locoregional recurrence (LRR) regardless of type of local therapy. Objective To assess the long-term incidence of isolated LRR by molecular subtype in a modern multicenter cohort of young women. Design, Setting, and Participants This cohort study, a multicenter prospective study named the Young Women’s Breast Cancer Study, enrolled 1302 women diagnosed with breast cancer at 40 years or younger from 2006 to 2016. Treatment information and incident LRR (ipsilateral breast/chest or lymph node recurrence) were self-reported on study surveys and confirmed with medical record review; molecular subtype was determined by record review. Analysis was reported from February 2023 to May 2025. Main Outcomes and Measures Cumulative incidence of isolated LRR was calculated using the Kaplan-Meier method; hazard ratios were estimated by Cox proportional hazards regression. Results The cohort included 1135 women with stage I through III breast cancer who had a median follow-up of 10.1 years (range, 0.4-16.3 years). The age at diagnosis was younger than 30 years for 145 patients (12.8%), 31 to 35 years for 318 patients (28.0%), and 36 to 40 years for 672 patients (59.2%). There were 59 isolated local recurrences (5.2%) and 4 isolated regional recurrences (0.4%). Among patients with local therapy and subtype data available (n = 1128), 366 (32%) had luminal A–like tumors; 240 (21%), luminal B–like tumors; 231 (20%) luminal ERBB2 positive (+)–like (formerly HER2 positive); 90 (8%) ERBB2 +-like; and 201 (18%) triple negative. A total of 346 women (30%) had breast-conserving therapy (BCT) (98% of whom had radiation), 296 (26%) unilateral mastectomy, and 487 (43%) bilateral mastectomy. Of women who had mastectomy, 425 (54%) had radiation. The cumulative incidence of LRR at 10.1 years by subtype was as follows: luminal A, 4.4% (range, 1.0%-6.9%); luminal B, 4.7% (range 1.8%-7.7%); luminal ERBB2 +, 6.1% (range, 3.1%-8.3%); ERBB2 +, 2.2% (range, 0%-6.3%); and triple negative, 6.5% (range, 4.2%-10.1%). The cumulative incidence of LRR by locoregional treatment type at 10.1 years was 6.7% after BCT (range, 4.3%-10.1%), 6.5% after mastectomy without radiation (range, 0%-7.7%), and 2.4% after mastectomy with radiation (range, 1%-4.2%). Although mastectomy with radiation was associated with the lowest risk of LRR on multivariable analysis, when examined within molecular subtype, there were no differences seen. Conclusions and Relevance In this contemporary cohort of women diagnosed with breast cancer at age 40 years or younger, risk of isolated LRR was relatively low (5.6%) at a median follow-up of 10.1 years, and significant differences were not seen by tumor subtype. Concerns for long-term risk of LRR should not influence surgical decision-making with young women, irrespective of molecular subtype.
Financial Difficulty Over Time in Young Adults With Breast Cancer
Myers, Sara P. , Dibble, Kate E. , King, Tari A. , Ruddy, Kathryn J. , Peppercorn, Jeffrey , Schapira, Lidia , Come, Steven E. , Rosenberg, Shoshana M. , Zheng, Yue , Mittendorf, EA , Borges, Virginia F. , Partridge, Ann H.

JAMA Network Open | November 13, 2024 | Volume: 7 | Issue: 11 | Pages: e2446091

10.1001/jamanetworkopen.2024.46091 Get It

IMPORTANCEYoung adults aged 18 to 39 years represent the minority of breast cancer diagnoses but are particularly vulnerable to financial hardship. Factors contributing to sustained financial hardship are unknown.OBJECTIVESTo identify financial hardship patterns over time and characterize factors associated with discrete trajectories; it was hypothesized that treatment-related arm morbidity, a key source of expense, would be associated with long-term financial difficulty.DESIGN, SETTING, AND PARTICIPANTSThis cohort study included US young adults aged 40 years or younger treated between 2006 and 2016. Eligible patients were treated for stage 0 to stage III breast cancer at institutions participating in the Young Women’s Breast Cancer Study, which included a specialized cancer institute and 12 other academic and community hospitals. Patients who responded at baseline and returned a 1-year survey were included in analysis. Data were analyzed in March 2024.MAIN OUTCOMES AND MEASURESTrajectory modeling classified patterns of financial difficulty from baseline through 10 years postdiagnosis using the Cancer Rehabilitation Evaluation System (CARES) scale. Multinomial regression examined characteristics, including treatment-related arm morbidity, associated with each trajectory.RESULTSA total 1008 patients were included (median [IQR] age at diagnosis, 36 [33-39] years; 60 Asian [6.0%], 35 Black [3.5%], 47 Hispanic [4.7%], 884 White [87.7%]); 840 patients were college graduates (83.3%), 764 were partnered at baseline (75.8%), 649 were nulliparous (64.4%), and 908 were without comorbidities at enrollment (90.1%). Patients’ tumors were primarily stage I-II (778 [77.2%]), estrogen receptor/progesterone receptor–positive (754 [74.8%]), and ERBB2-negative (formerly HER2) (686 [68.1%]). Patients were more frequently treated with mastectomy than breast conservation (771 [76.5%] vs 297 [29.5%]; P < .001). A majority of patients received radiation therapy (627 [62.2%]), chemotherapy (760 [75.4%]), and endocrine therapy (610 [60.6%]). A total of 727 patients (72.1%) reported arm symptoms within 2 years of surgery. Three distinct trajectories of experiences with finances emerged: 551 patients (54.7%) had low financial difficulty (trajectory 1), 293 (29.1%) had mild difficulty that improved (trajectory 2), and 164 (16.3%) had moderate to severe difficulty peaking several years after diagnosis before improving (trajectory 3). Hispanic ethnicity (OR, 3.71; 95% CI, 1.47-9.36), unemployment at baseline and 1 year (OR, 2.66; 95% CI, 1.63-4.33), and arm symptoms (OR, 1.77; 95% CI, 1.06-2.96) were associated with increased odds of experiencing trajectory 3. Having a college degree (OR, 0.20; 95% CI, 0.12-0.34) or being partnered (OR, 0.24; 95% CI, 0.15-0.38) were associated with increased odds of experiencing trajectory 1.CONCLUSIONIn this cohort study of young adults with breast cancer, we identified a subset of patients who experienced a high degree of financial difficulty persisting into early survivorship. Targeted interventions to mitigate financial toxicity—modifiable factors that include support for the employability or return to work support for those experiencing arm symptoms after treatment—are needed.
Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+): The OPBC-05/ICARO Study
Montagna, Giacomo , Laws, Alison , Ferrucci, Massimo , Mrdutt, Mary M., Sun, Susie X. , Bademler, Süleyman , Balbaloĝlu, Hakan , Balint‐Lahat, Nora, Banys-Paluchowski, Maggie, Barrio, Andrea V. , Benson, John R. , Beşe, Nuran , Boyle, Marissa K. , Diego, Emilia J. , Eden, Claire , Eller, Ruth S. , Goldschmidt, Maite, Hlavin, Callie , Heidinger, Martin , Jelinska, Justyna, Çakmak, Güldeniz Karadeniz , King, Tari A. , Kuerer, Henry M. , Loesch, Julie M, Milardi, Francesco , Murawa, Dawid , Moo, Tracy‐Ann , Menes, Tehillah S. , Passeri, Daniele , Pastoriza, Jessica , Perhavec, Andraž , Pislar, Nina , Polidorio, Natália , Rami, Avina , Ryu, Jai Min , Schulz, Alexandra , Sevilimedu, Varadan , Uğurlu, Mustafa Ümit , Uras, Cihan, Hemert, Annemiek K. E. van , Wong, Stephanie M. , Yoo, Tae-Kyung , Zhang, Jennifer Q. , Cabıoğlu, Neslihan , Peeters, Marie-Jeanne T. F. D. Vrancken , Morrow, Monica , Weber, William P. , Group, on behalf of the ICARO Study, Andreozzi, Mariacarla, Barbalho, Daniel Meirelles , Boileau, J.-F., Brogi, Edi , Cabero, Flávia Vidal, Cocco, Daniela , Bree, Eelco de , Vernet-Tomás, M. , Deutschmann, Christine , Ditsch, Nina, Fick, Franziska, Fitzal, Florian , Flanagan, Meghan R. , Gentile, Damiano , Grabenstetter, Anne , Heil, Jörg, Holtschmidt, Johannes , Krawczyk, Natalia , Kühn, Thorsten, Kümmel, Sherko, Muslumanoglu, Mahmut , Nekljudova, Valentina , Newman, Lisa A. , Poulakaki, Fiorita , Schwartz, Christopher J. , Siegel, Emily , Simonson, Colin , Tampaki, Ekaterini Christina , Tampakis, Athanasios , Tausch, Christoph, Bruele, Astrid Botty van den , Vorburger, Denise , Weiss, Anna, Wimmer, Kerstin , Woodward, Steven G. , Ziauddin, Firdos M., Boughey, JC , Boyle, Marissa K , Eller, Ruth , Heidinger, Martin , Karadeniz Cakmak, Güldeniz , Kesmodel, Susan B , King, Tari A , Milardi, Francesco , Murawa, Dawid , Menes, Tehillah S , Passeri, Daniele , Pastoriza, Jessica M , Perhavec, Andraz , Polidorio, Natália , Rami, Avina , Ugurlu, M Umit , van Hemert, Annemiek , Yoo, Tae-Kyung Robyn , Zhang, Jennifer Q , Peeters, Marie-Jeanne Vrancken , Morrow, Monica , Weber, Walter P , Wong, Stephanie M , Mrdutt, Mary M , Banys‐Paluchowski, Maggie , Boughey, Judy C. , Uras, Cihan , Karanlık, Hasan , Group, on behalf of the ICARO Study, Ahn, Sung Gwe , Corsi, Fabio , Crown, Angelena , Esposito, Emanuela , Fayanju, Oluwadamilola M. , Gentilini, Oreste D , Gülçelik, Mehmet Ali , Heil, Joerg , Leo, Cornelia , Pilewskie, Melissa , Riedel, Fabian , Rocco, Nicola , Schnabel, Freya Ruth , Singer, Christian F. , Soares, Leonardo Ribeiro , Tasoulis, Marios Konstantinos , Urban, Cicero A. , Vergauwen, Glenn , Wärnberg, Fredrik , Williams, Austin David

Journal of Clinical Oncology | November 7, 2024 | Volume: 43 | Issue: 7 | Pages: 810-820

10.1200/jco.24.01052 Get It

PURPOSE The nodal burden of patients with residual isolated tumor cells (ITCs) in the sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) (ypN0i+) is unknown, and axillary management is not standardized. We investigated rates of additional positive lymph nodes (LNs) at axillary lymph node dissection (ALND) and oncologic outcomes in patients with ypN0i+ treated with and without ALND. METHODS The Oncoplastic Breast Consortium-05/ICARO cohort study (ClinicalTrials.gov identifier: NCT06464341 ) retrospectively analyzed data from patients with stage I to III breast cancer with ITCs in SLNs after NAC from 62 centers in 18 countries. The primary end point was the 3-year rate of any axillary recurrence. The rate of any invasive recurrence was the secondary end point. RESULTS In total, 583 patients were included, of whom 182 (31%) had completion ALND and 401 (69%) did not. The median age was 48 years. Most patients (74%) were clinically node-positive at diagnosis and 41% had hormone receptor–positive/human epidermal growth factor receptor 2–negative tumors. The mean number of SLNs with ITCs was 1.2. Patients treated with ALND were more likely to present with cN2/3 disease (17% v 7%, P < .001), have ITCs detected on frozen section (62% v 8%, P < .001), have lymphovascular invasion (38% v 24%, P < .001), and receive adjuvant chest wall (89% v 78%, P = .024) and nodal radiation (82% v 75%, P = .038). Additional positive nodes were found at ALND in 30% of patients, but only 5% had macrometastases. The 3-year rates of any axillary and any invasive recurrence were 2% (95% CI, 0.95 to 3.6) and 11% (95% CI, 8 to 14), respectively, with no statistical difference by type of axillary surgery. CONCLUSION The nodal burden in patients with ypN0(i+) was low, and axillary recurrence after ALND omission was rare in patients selected for this approach. These results do not support routine ALND in all patients with ypN0(i+).
Abstract GS02-02: Are nodal ITCs after neoadjuvant chemotherapy an indication for axillary dissection? The OPBC05/EUBREAST-14R/ICARO study
Laws, Alison , Ferrucci, Massimo , Mrdutt, Mary M., Moo, Tracy‐Ann , Boyle, Marissa K., Cabero, Flávia Vidal, Cocco, Daniela , Flanagan, Meghan R. , Hlavin, Callie , Jelinska, Justyna, Kuerer, Henry M. , Küemmel, Sherko , Menes, Tehillah S. , Pislar, Nina , Ryu, Jai Min , Tausch, Christoph, Uğurlu, Mustafa Ümit , Bruele, Astrid Botty van den , Vorburger, Denise , Weiss, Anna, Wong, Stephanie M. , Woodward, Steven G. , Zhang, Jennifer Q. , Ziauddin, M. Firdos, Çakmak, Güldeniz Karadeniz , Beşe, Nuran , Kühn, Thorsten, King, Tari A. , Ditsch, Nina , Banys‐Paluchowski, Maggie , Morrow, Monica , Wong, Stephanie M , Montagna, Giacomo , Polidorio, Natália , Sevilimedu, Varadan , Barrio, Andrea V. , Boyle, Marissa K., Corsi, Fabio , Crown, Angelena , Gülçelik, Mehmet Ali , Karanlık, Hasan , Kesmodel, Susan B , Leo, Cornelia , Pilewskie, Melissa , Rocco, Nicola , Soares, Leonardo Ribeiro , Urban, Cicero A. , Wärnberg, Fredrik , Williams, Austin David , Sun, Susie X. , Boughey, Judy C. , Weber, William P.

Cancer Research | May 2, 2024 | Volume: 84 | Issue: 9_Supplement | Pages: GS02-02-GS02-02

10.1158/1538-7445.sabcs23-gs02-02 Get It

Abstract Background: In patients with micro- and macrometastases in the sentinel lymph node (SLN) after neoadjuvant chemotherapy (NAC), additional positive nodes are found in &gt;60% of cases and axillary lymph node dissection (ALND) is currently considered standard of care. The likelihood of finding additional positive lymph nodes in patients with residual isolated tumor cells (ITCs) is unknown, and the benefit of ALND is unclear. As a consequence, surgical management of the axilla in these patients is not standardized. We sought to evaluate how often additional positive lymph nodes are found, to determine factors associated with ALND, and to compare oncological outcomes in patients treated with and without ALND after identification of residual ITCs in the SLN. Methods: Data were collected from 42 centers: 20 in the Oncoplastic Breast Consortium (OPBC) and EUBREAST networks, and 22 in North and South America. We included patients with cT1-4 N0-3 breast cancer at diagnosis who underwent NAC followed by axillary staging with either SLN biopsy (SLNB) or targeted axillary dissection (TAD) and were found to have residual ITCs [ypN0(i+)]. Single-tracer mapping was allowed for cN0 patients, while dual mapping or TAD was required for cN+ cases. Axillary treatment included completion ALND and/or nodal radiotherapy (RT). Competing risk analysis was performed to assess the cumulative incidence rates of any axillary recurrence (AR), locoregional recurrence (LRR), and any invasive (locoregional or distant) recurrence. Five-year cumulative incidence rates were compared between patients who underwent ALND and those who did not using the Gray’s test. Type I error rate was set to 0.05 (α). Results: We included 412 patients treated with NAC followed by surgery from 01/2009-05/2022. 146 (35.4%) had completion ALND and 266 (64.6%%) did not. Median patient age was 48 years. The majority (57%) of patients had clinical T2 tumors, and 68% had biopsy-proven N1 disease. Most were HR+/HER2- (41%) or HER2+ (39%). Most patients (80%) received anthracycline and taxane-based chemotherapy regimens. Nodal RT was administered to 83% of patients. The median number of SLNs with ITCs was 1. Patients treated with ALND were more likely to have ITCs detected on frozen section (61% v 6.7%, p&lt; 0.001), to have N2/3 disease at presentation (15.1% v 5.6%, p=0.001) and to have LVI (40% v 26%, p=0.004) (Table 1). There was no significant trend over time in the proportion of patients undergoing completion ALND during the study period (p=0.5). In the ALND group, additional positive nodes were found in 43/146 (29.5%) of cases, and consisted of macrometastases in 11/146 (7.5%), micrometastases in 9/146 (6.2%), and ITCs in 23/146 (15.8%). 5-year rates of any AR, LRR, and any invasive recurrence in the entire cohort were 2.7% (95% CI 1.2-5.4), 2.8% (95% CI 1.2-5.4) and 16% (95% CI 11-21), respectively. There was no statistical difference between patients who underwent ALND and those who did not in any of the 3 endpoints (2.2% v 3.1%, p=0.6), (2.6% v 3.0%, p=0.4) and (14% v 18%, p=0.12), respectively. Conclusion: The likelihood of finding additional positive lymph nodes in patients with ITCs after NAC is lower than in patients with residual micro- and macrometastases, and in the majority of cases, they contain ITCs. Nodal recurrence after omission of ALND is rare in this population. Overall, these results do not support routine ALND in patients with residual ITCs. Table 1. Clinicopathological Features of the Study Cohort, Stratified by Type of Axillary Surgery Frequency (row percent) reported for categorical variables, and median (IQR) reported for continuous variables. SLNB sentinel lymph node biopsy; TAD targeted axillary dissection; SLNs sentinel lymph nodes; LNs lymph nodes; pCR pathologic complete response; ACT anthracycline and taxane; AC anthracycline; H Herceptin, HP, Herceptin and Perjeta; TC taxol (or Taxotere) and carboplatinum; LVI lymphovascular invasion; BCS breast-conserving surgery. ^ Applied to HER2- tumors only (n=252). ^^ Applies to HER2+ tumors only (n=160). # LVI was present on core biopsy or final pathology. * Applies to BCS patients only (n=175). ** Applies to mastectomy patients only (n=237). Citation Format: Giacomo Montagna, Alison Laws, Massimo Ferrucci, Mary Mrdutt, Natália Polidorio, Varadan Sevilimedu, Tracy-Ann Moo, Andrea Barrio, Marissa K. Boyle, Flavia Vidal Cabero, Daniela Cocco, Fabio Corsi, Angelena Crown, Meghan R. Flanagan, Mehmet Ali Gulcelik, Callie Hlavin, Justyna Jelinska, Hasan Karanlik, Susan Kesmodel, Henry Kuerer, Sherko Küemmel, Cornelia Leo, Tehillah Menes, Melissa Pilewskie, Nina Pislar, Nicola Rocco, Jai Min Ryu, Leonardo Soares, Christoph Tausch, M. Umit Ugurlu, CICERO URBAN, Astrid Botty van de Bruele, Denise Vorburger, Fredrik Wärnberg, Anna Weiss, Austin Williams, Stephanie Wong, Steven G. Woodward, Susie X. Sun, Jennifer Q. Zhang, M. Firdos Ziauddin, Guldeniz Karadeniz Cakmak, Nuran Bese, Thorsten Kühn, Judy Boughey, Tari King, Nina Ditsch, Maggie Banys-Paluchowski, Monica Morrow, Walter Weber. Are nodal ITCs after neoadjuvant chemotherapy an indication for axillary dissection? The OPBC05/EUBREAST-14R/ICARO study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr GS02-02.
Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP
Litton, Jennifer K. , Regan, Meredith M. , Pusztai, Lajos , Tolaney, Sara M. , Garrett‐Mayer, Elizabeth , Amiri‐Kordestani, Laleh , Basho, Reva , Boileau, Jean-François , Foster, Jared C. , Jacene, Heather A. , King, Tari A. , Mason, Ginny, O’Sullivan, Ciara C. , Prowell, Tatiana M. , Richardson, Andrea L. , Sepulveda, Karla A., Smith, Mary Lou , Tjoe, Judy A., Turashvili, Gulisa , Butler, Lynn Pearson, Schwartz, Elena I., Korde, Larissa A. , Rugo, Hope S , Tolaney, Sara , Garrett-Mayer, Elizabeth , Amiri-Kordestani, Laleh , Basho, Reva K , Best, Ana F , Boileau, Jean-Francois , Denkert, Carsten , Foster, Jared C , Harbeck, Nadia , Jacene, Heather A , O'Sullivan, Ciara Catherine , Prowell, Tatiana M , Turashvili, Gulisa , Woodward, Wendy A , Pusztai, Lajos , Rugo, Hope S.

Journal of Clinical Oncology | July 11, 2023 | Volume: 41 | Issue: 27 | Pages: 4433-4442

10.1200/jco.23.00435 Get It

PURPOSE The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007 and updated in 2021 (STEEP 2.0), provide standardized definitions of adjuvant breast cancer (BC) end points. STEEP 2.0 identified a need to separately address end points for neoadjuvant clinical trials. The multidisciplinary NeoSTEEP working group of experts was convened to critically evaluate and align neoadjuvant BC trial end points. METHODS The NeoSTEEP working group concentrated on neoadjuvant systemic therapy end points in clinical trials with efficacy outcomes—both pathologic and time-to-event survival end points—particularly for registrational intent. Special considerations for subtypes and therapeutic approaches, imaging, nodal staging at surgery, bilateral and multifocal diseases, correlative tissue collection, and US Food and Drug Administration regulatory considerations were contemplated. RESULTS The working group recommends a preferred definition of pathologic complete response (pCR) as the absence of residual invasive cancer in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0 per AJCC staging). Residual cancer burden should be a secondary end point to facilitate future assessment of its utility. Alternative end points are needed for hormone receptor–positive disease. Time-to-event survival end point definitions should pay particular attention to the measurement starting point. Trials should include end points originating at random assignment (event-free survival and overall survival) to capture presurgery progression and deaths as events. Secondary end points adapted from STEEP 2.0, which are defined from starting at curative-intent surgery, may also be appropriate. Specification and standardization of biopsy protocols, imaging, and pathologic nodal evaluation are also crucial. CONCLUSION End points in addition to pCR should be selected on the basis of clinical and biologic aspects of the tumor and the therapeutic agent investigated. Consistent prespecified definitions and interventions are paramount for clinically meaningful trial results and cross-trial comparison.
Abstract P1-07-02: Using clinical characteristics and molecular markers to predict the risk of subsequent ipsilateral breast events after excision of DCIS
King, Lorraine , Harmon, Bryan, Gallagher, Kristalyn K. , Kilgore, Mark , Wei, Shi, King, Tari A. , McAuliffe, Priscilla F. , Hwang, Esther , Liu, Ying , Strand, Siri H. , Couch, Fergus J. , DeMichele, Angela , Marks, Jeffrey R. , Maley, Carlo C. , West, Robert B. , Colditz, Graham A.

Cancer Research | March 2, 2023 | Volume: 83 | Issue: 5_Supplement | Pages: P1-07-02-P1-07-02

10.1158/1538-7445.sabcs22-p1-07-02 Get It

Abstract PURPOSE To examine incremental values of estrogen receptor (ER) status, body mass index (BMI), menopausal status, and a previously reported multi-gene classifier over commonly used clinical factors (i.e. age, tumor grade, comedonecrosis, surgical margins, and treatment) in predicting risk of any ipsilateral recurrence (IR) event within five years after DCIS diagnosis. METHODS A derivation cohort consisted of participants in the Translational Breast Cancer Research Consortium (TBCRC) 038, a retrospective multicenter cohort study in women undergoing surgical resection for DCIS between 01/01/1998 and 02/29/2016 (n=216). The validation cohort, the Repository of Archival Human Breast Tissue (RAHBT) at Washington University School of Medicine, provided cases meeting the same eligibility criteria as TBCRC038 (n=97). Participants in both cohorts had RNA-seq data and either developed IR 1-5y after initial DCIS diagnosis or were free from subsequent breast events for at least five years. The previously reported 812-gene classifier had been developed from a subset of the TBCRC038 samples using a negative-binomial regression model to identify differentially expressed genes in the primary tumor associated with subsequent recurrence events. This classifier has been shown to be highly correlated with 5-year invasive, DCIS, and all breast cancer events, and validated in the RAHBT cohort. Cox proportional hazards regression was used to estimate hazard ratios (HRs) of IR in the TBCRC038 cohort (76 with IR). The clinical score was developed using clinical predictors (aforementioned clinical factors and ER) and their regression coefficients from the model with the maximum predictive accuracy (e.g. c-index) and the minimum number of predictors; the summary score integrated the clinical score and multi-gene classifier. Predictive performance of both clinical and summary scores was validated in the RAHBT cohort (20 with IR). RESULTS In the TBCRC cohort derivation set, we used a multivariable model based on clinical factors alone (clinical score) and found that ER status, but not BMI or menopausal status, was independently associated with a higher IR risk (HR=2.06, 95% CI 1.18-3.58). Adding the multi-gene classifier to the clinical factors-based model (summary score) in the TBCRC038 test set increased predictive accuracy (c-index 0.68 to 0.70), with the genomic classifier-adjusted HR of 14.96 (95% CI 8.64-25.91). The summary score had higher predictive performance for IR risk than clinical score alone (c-index 0.82 vs. 0.70). In the RAHBT validation samples, model performance was similarly improved using summary scores clinical factors-based model plus multigene classifier as compared to clinical scores along (c-index 0.74 vs. 0.58). CONCLUSION Combining clinical factors and a multigene classifier provided more accurate risk estimates of IR within five years after excision of DCIS than clinical factors alone. Figure 1. Observed and predicted recurrence-free survival in the first five years after initial DCIS diagnosis in the RAHBT validation cohort, by risk groups defined by clinical scores (left) and clinical score plus multigene classifier (right). Citation Format: Ying Liu, Siri H. Strand, Lorraine King, Bryan Harmon, Fergus J. Couch, Kristalyn Gallagher, Mark Kilgore, Shi Wei, Angela DeMichele, Tari King, Priscilla F. McAuliffe, Jeffrey Marks, Carlo Maley, Robert West, E Shelley Hwang, Graham A. Colditz. Using clinical characteristics and molecular markers to predict the risk of subsequent ipsilateral breast events after excision of DCIS [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-07-02.
Abstract OT1-15-01: SWOG 1904: Cluster-randomized controlled trial of patient and provider decision support to increase chemoprevention informed choice among women with atypical hyperplasia or lobular carcinoma in situ (MiCHOICE)
Arnold, Kathryn B. , Stieb, Andrew, Amenta, Jacquelyn , Law, Cynthia, Sandoval-Leon, Ana, King, Tari A. , Mangino, Debra A. , Pruthi, Sandhya , Perdekamp, Maria Grosse , Braun‐Inglis, Christa , Krisher, Stacy, Yee, Lisa, Bertoni, Danielle M., Seaward, Samantha A. , Wisinski, Kari B. , Floyd, Justin D., Zarwan, Corrine, VanderWalde, Lindi, Ross, Masey M., Steen, Preston D. , Lo, Shelly S. , Conlin, Alison, Yost, Kathleen J. , Ellerton, John , Lin, Erin, Sardesai, Sagar , Jernigan, Cheryl, Arun, Banu, Sardesai, Sagar , Seaward, Samantha A , Crew, Katherine D. , Anderson, Garnet L. , Sandoval-Leon, Ana Cristina , Colonna, Sarah V. , Yee, Lisa, Ballinger, Tarah Jean , Ross, Masey, Pederson, Holly J. , Hershman, Dawn L. , Neuhouser, Marian L. , Kukafka, Rita

Cancer Research | March 2, 2023 | Volume: 83 | Issue: 5_Supplement | Pages: OT1-15-01-OT1-15-01

10.1158/1538-7445.sabcs22-ot1-15-01 Get It

Abstract Background: Despite evidence of substantial breast cancer risk reduction, few high-risk women adopt chemopreventive medications such as selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs). Women with benign breast disease, such as atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), have an increased risk of developing breast cancer and derive a greater benefit from antiestrogens compared to other high-risk women. Reasons for low uptake of chemoprevention include insufficient patient and clinician knowledge about antiestrogens, time constraints during the clinical encounter, and concerns about side effects. To address these barriers, we have developed patient and provider web-based decision support tools to improve informed choice about breast cancer chemoprevention among women with AH or LCIS. Study design: We are conducting a cluster-randomized controlled trial of clinical decision support to improve chemoprevention informed choice among women with AH or LCIS and their treating providers. Twenty-six U.S. sites through the SWOG Cancer Research Network were randomly assigned 1:1 to standard educational materials alone or in combination with the patient-centered decision aid (RealRisks) and provider decision support tool (BNAV). A total of 415 patients and 200 healthcare providers will be recruited from these sites. RealRisks consists of interactive modules to calculate personalized breast cancer risk and elicit preferences on chemoprevention. The modules are available in English and Spanish. BNAV is comprised of self-directed case-based learning modules on breast cancer risk assessment and chemoprevention. Patients complete questionnaires at baseline, 6 and 12 months. Providers complete surveys at baseline and after their enrolled patient’s 6-month clinical encounter. The primary endpoint is chemoprevention informed choice at 6 months, using a measure combining knowledge, attitude, and intention scales. Secondary endpoints include perceived breast cancer risk/worry, chemoprevention knowledge/intention, decision conflict/regret, shared decision-making, and chemoprevention uptake. For patients who begin chemoprevention, adherence and reasons for discontinuation are assessed annually for up to 5 years. Barriers and facilitators to implementing RealRisks and BNAV into clinic workflow will be assessed by conducting patient and provider interviews at baseline and mid-implementation. Eligibility criteria: Eligible patients include women, age 35-74 years, with AH or LCIS, no history of breast cancer, no prior use of SERMs or AIs, no bilateral mastectomies, English or Spanish-speaking, and access to the internet. Eligible providers include breast surgeons, medical oncologists, primary care providers, and physician extenders who see patients with AH or LCIS. Statistical methods: We have 90% power to detect a 15% increase in the frequency of chemoprevention informed choice with a 1-sided 0.025 level test, assuming an intraclass correlation (ICC) of 0.02 to account for clustering, roughly equal accrual at each site, 10% loss to follow-up, and ≤10% event rate in the control arm. Current/target accrual: The trial was activated on 9/1/2020. As of 7/7/2022, all 26 sites have been randomized, 157/200 providers and 184/415 patients have been enrolled. Discussion: Our hybrid effectiveness/implementation study seeks to evaluate the effectiveness of a multi-level intervention in promoting informed decision-making about breast cancer chemoprevention. Study results will provide valuable insights on how the decision support tools are integrated in diverse clinical settings. Citation Format: Katherine D. Crew, Garnet Anderson, Kathryn Arnold, Andrew Stieb, Jacquelyn N. Amenta, Cynthia Law, Ana Sandoval-Leon, Sarah Colonna, Tari King, Debra Mangino, Sandhya Pruthi, Maria Grosse Perdekamp, Christa Braun-Inglis, Stacy Krisher, Lisa Yee, Danielle Bertoni, Samantha Seaward, Kari B. Wisinski, Justin Floyd, Corrine Zarwan, Tarah J. Ballinger, Lindi VanderWalde, Masey M. Ross, Preston Steen, Shelly Lo, Alison Conlin, Kathleen Yost, John Ellerton, Erin Lin, Holly J. Pederson, Sagar Sardesai, Cheryl Jernigan, Dawn Hershman, Marian L. Neuhouser, Banu K. Arun, Rita Kukafka. SWOG 1904: Cluster-randomized controlled trial of patient and provider decision support to increase chemoprevention informed choice among women with atypical hyperplasia or lobular carcinoma in situ (MiCHOICE) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-15-01.
Racial‐ethnic variations in phyllodes tumors among a multicenter United States cohort
Nash, Amanda L. , Nimbkar, Suniti, Hieken, Tina J. , Ludwig, Kandice K. , Jacobs, Lisa K. , Gallagher, Kristalyn K. , Wong, Jasmine , Neuman, Heather B. , Tseng, Jennifer , Hassinger, Taryn E. , King, Tari A. , Hwang, E. Shelley , Jakub, James W. , Hwang, E. Shelley , Hieken, Tina J , Neuman, Heather B , Jakub, James W , Thomas, Samantha Marie , Miller, Megan E. , Rosenberger, Laura H.

Journal of Surgical Oncology | October 7, 2022 | Volume: 127 | Issue: 3 | Pages: 369-373

10.1002/jso.27117 Get It

AbstractBackground and objectivesPrevious studies have identified racial‐ethnic differences in the diagnostic patterns and recurrence outcomes of women with phyllodes tumors (PT). However, these studies are generally limited in size and generalizability. We therefore sought to explore racial‐ethnic differences in age, tumor size, subtype, and recurrence in a large US cohort of women with PT.MethodsWe performed an 11‐institution retrospective review of women with PT from 2007 to 2017. Differences in age at diagnosis, tumor size and subtype, and recurrence‐free survival according to race‐ethnicity.ResultsWomen of non‐White race or Hispanic ethnicity were younger at the time of diagnosis with phyllodes tumor. Non‐Hispanic Other women had a larger proportion of malignant PT. There were no differences in recurrence‐free survival in our cohort.ConclusionsDifferences in age, tumor size, and subtype were small. Therefore, the workup of young women with breast masses and the treatment of women with PT should not differ according to race‐ethnicity. These conclusions are supported by our finding that there were no differences in recurrence‐free survival.