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Poster Spotlight Session Abstracts

Abstract PD9-04: Breast cancer subtype specific association of pCR with MRI assessed tumor volume progression during NAC in the I-SPY 2 trial

Wen Li, Natsuko Onishi, David C Newitt, Jessica Gibbs, Lisa J Wilmes, Ella F Jones, Bonnie N Joe, Laura S Sit, Christina Yau, A. Jo Chien, Elissa Price, Kathy S Albain, Theresa Kuritza, Kevin Morley, Judy C Boughey, Kathy Brandt, Sadia Choudhery, Amy S Clark, Mark Rosen, Elizabeth S McDonald, Anthony D Elias, Dulcy Wolverton, Kelly Fountain, David M Euhus, Heather S Han, Bethany Niell, Jennifer Drukteinis, Julie E Lang, Janice Lu, Jane L Meisel, Zaha Mitri, Rita Nanda, Donald W Northfelt, Tara Sanft, Erica Stringer-Reasor, Rebecca K Viscusi, Anne M Wallace, Douglas Yee, Rachel Yung, Smita M Asare, Michelle E Melisko, Jane Perlmutter, Hope S Rugo, Richard Schwab, W. Fraser Symmans, Laura J van't Veer, Donald A Berry, Angela DeMichele, Hiroyuki Abe, Deepa Sheth, Kirsten K Edmiston, Erin D Ellis, Richard Ha, Ralph Wynn, Erin P Crane, Charlotte Dillis, Michael Nelson, An Church, Claudine Isaacs, Qamar J Khan, Karen Y Oh, Neda Jafarian, Dae Hee Bang, Christiane Mullins, Stefanie Woodard, Kathryn W Zamora, Haydee Ojeda-Fornier, Pulin Sheth, Linda Hovanessian-Larsen, Mohammad Eghtedari, Michael Spektor, Marina Giurescu, Mary S Newell, Michael A Cohen, Elise Berman, Constance Lehman, William Smith, Kim Fitzpatrick, Marisa H Borders, Wei Yang, Basak Dogan, Sally Goudreau, Thelma Brown, Laura J Esserman and Nola M Hylton
Wen Li
1University of California, San Francisco, San Francisco, CA;
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Natsuko Onishi
1University of California, San Francisco, San Francisco, CA;
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David C Newitt
1University of California, San Francisco, San Francisco, CA;
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Jessica Gibbs
1University of California, San Francisco, San Francisco, CA;
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Lisa J Wilmes
1University of California, San Francisco, San Francisco, CA;
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Ella F Jones
1University of California, San Francisco, San Francisco, CA;
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Bonnie N Joe
1University of California, San Francisco, San Francisco, CA;
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Laura S Sit
1University of California, San Francisco, San Francisco, CA;
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Christina Yau
1University of California, San Francisco, San Francisco, CA;
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A. Jo Chien
1University of California, San Francisco, San Francisco, CA;
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Elissa Price
1University of California, San Francisco, San Francisco, CA;
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Kathy S Albain
2Loyola University, Maywood, IL;
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Theresa Kuritza
2Loyola University, Maywood, IL;
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Kevin Morley
2Loyola University, Maywood, IL;
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Judy C Boughey
3Mayo Clinic, Rochester, MN;
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Kathy Brandt
3Mayo Clinic, Rochester, MN;
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Sadia Choudhery
3Mayo Clinic, Rochester, MN;
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Amy S Clark
4University of Pennsylvania, Philadelphia, PA;
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Mark Rosen
4University of Pennsylvania, Philadelphia, PA;
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Elizabeth S McDonald
4University of Pennsylvania, Philadelphia, PA;
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Anthony D Elias
5University of Colorado, Denver, Aurora, CO;
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Dulcy Wolverton
5University of Colorado, Denver, Aurora, CO;
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Kelly Fountain
5University of Colorado, Denver, Aurora, CO;
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David M Euhus
6Johns Hopkins Medicine, Dallas, TX;
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Heather S Han
7Moffitt Cancer Center, Tampa, FL;
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Bethany Niell
7Moffitt Cancer Center, Tampa, FL;
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Jennifer Drukteinis
7Moffitt Cancer Center, Tampa, FL;
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Julie E Lang
8University of Southern California, Los Angeles, CA;
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Janice Lu
8University of Southern California, Los Angeles, CA;
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Jane L Meisel
9Emory University, Atlanta, GA;
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Zaha Mitri
10Oregon Health & Science University, Portland, OR;
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Rita Nanda
11The University of Chicago Medical Center, Chicago, IL;
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Donald W Northfelt
12Mayo Clinic, Scottsdale, AZ;
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Tara Sanft
13Yale Cancer Center, New Haven, CT;
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Erica Stringer-Reasor
14University of Alabama at Birmingham, Birmingham, AL;
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Rebecca K Viscusi
15University of Arizona, Tucson, AZ;
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Anne M Wallace
16University of California, San Diego, La Jolla, CA;
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Douglas Yee
17University of Minnesota, Minneapolis, MN;
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Rachel Yung
18CTEP, National Cancer Institute, Rockville, MD;
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Smita M Asare
19Quantum Leap Healthcare Collaborative, San Francisco, CA;
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Michelle E Melisko
1University of California, San Francisco, San Francisco, CA;
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Jane Perlmutter
20Gemini Group, Bad Axe, MI;
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Hope S Rugo
1University of California, San Francisco, San Francisco, CA;
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Richard Schwab
16University of California, San Diego, La Jolla, CA;
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W. Fraser Symmans
21University of Texas, M.D. Anderson Cancer Center, Houston, TX;
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Laura J van't Veer
1University of California, San Francisco, San Francisco, CA;
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Donald A Berry
22Berry Consultants, LLC, Houston, TX;
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Angela DeMichele
4University of Pennsylvania, Philadelphia, PA;
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Hiroyuki Abe
11The University of Chicago Medical Center, Chicago, IL;
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Deepa Sheth
11The University of Chicago Medical Center, Chicago, IL;
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Kirsten K Edmiston
23Inova Health System, Fairfax, VA;
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Erin D Ellis
24Swedish Cancer Institute, Seattle, WA;
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Richard Ha
25Columbia University, New York City, NY;
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Ralph Wynn
25Columbia University, New York City, NY;
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Erin P Crane
26Georgetown University, Washington, DC;
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Charlotte Dillis
26Georgetown University, Washington, DC;
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Michael Nelson
17University of Minnesota, Minneapolis, MN;
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An Church
17University of Minnesota, Minneapolis, MN;
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Claudine Isaacs
26Georgetown University, Washington, DC;
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Qamar J Khan
27University of Kansas, Westwood, KS;
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Karen Y Oh
10Oregon Health & Science University, Portland, OR;
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Neda Jafarian
10Oregon Health & Science University, Portland, OR;
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Dae Hee Bang
24Swedish Cancer Institute, Seattle, WA;
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Christiane Mullins
24Swedish Cancer Institute, Seattle, WA;
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Stefanie Woodard
14University of Alabama at Birmingham, Birmingham, AL;
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Kathryn W Zamora
14University of Alabama at Birmingham, Birmingham, AL;
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Haydee Ojeda-Fornier
16University of California, San Diego, La Jolla, CA;
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Pulin Sheth
8University of Southern California, Los Angeles, CA;
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Linda Hovanessian-Larsen
8University of Southern California, Los Angeles, CA;
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Mohammad Eghtedari
16University of California, San Diego, La Jolla, CA;
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Michael Spektor
13Yale Cancer Center, New Haven, CT;
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Marina Giurescu
12Mayo Clinic, Scottsdale, AZ;
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Mary S Newell
9Emory University, Atlanta, GA;
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Michael A Cohen
9Emory University, Atlanta, GA;
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Elise Berman
23Inova Health System, Fairfax, VA;
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Constance Lehman
28University of Washington, Seattle, WA;
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William Smith
29University of Kansas, Lawrence, KS;
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15University of Arizona, Tucson, AZ;
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Marisa H Borders
15University of Arizona, Tucson, AZ;
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Wei Yang
21University of Texas, M.D. Anderson Cancer Center, Houston, TX;
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Basak Dogan
21University of Texas, M.D. Anderson Cancer Center, Houston, TX;
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Sally Goudreau
30University of Texas Southwestern Medical Center, Dallas, TX;
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Thelma Brown
31I-SPY 2 Advocacy Group, San Francisco, CA
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Laura J Esserman
1University of California, San Francisco, San Francisco, CA;
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Nola M Hylton
1University of California, San Francisco, San Francisco, CA;
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DOI: 10.1158/1538-7445.SABCS19-PD9-04 Published February 2020
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Abstracts: 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, Texas

Abstract

Background: In an adaptive randomized trial, when new treatment combinations are being tested, it is important to be able to identify patients who are progressing on treatment so that they can be changed to a different therapeutic regimen. We know that even within the molecularly high risk patients in I-SPY 2, there is considerable variation in biology. In this study, we will present results of using MRI-calculated functional tumor volume (FTV) to identify tumor progression for each breast cancer subtype.

Methods: Patients (n=990) enrolled in the I-SPY 2 TRIAL who were randomized to the graduated experimental drug arms or controls from 2010 to 2016 were analyzed. Four MRI exams were performed for each patient: pre-NAC (T0), after 3 weeks of NAC (T1), between regimens (T2), and post-NAC (T3). Functional tumor volume (FTV) was calculated at each exam by summing voxels meeting enhancement thresholds. Tumor progression at T1, T2 or T3 was identified by a positive FTV change relative to T0. Visual inspection was used to exclude false progression due to strong background parenchymal enhancement post-contrast, prominent vessels, motion, or insufficient image quality. pCR was defined as no invasive disease in the breast and lymph nodes. Negative predictive value for pCR was defined as:NPV=number of true non-pCRs / number of patients with MRI assessed tumor progressions, where “true non-pCRs” referred to patients who were non-pCRs at surgery and were assessed as progressors by MRI. The analysis was performed in the full cohort and in sub-cohorts defined by HR and HER2 statuses.

Results: Out of 990 patients, 878 had pCR outcome data (pCR or non-pCR, pCR rate = 35%). Total and non-pCR numbers for each subtype, number of patients with tumor progression assessed by MRI at T1, T2, and T3, and NPVs, are shown in Table 1. In the full cohort, the NPV increased consistently over treatment, from T1 (NPV=83%) to T2 (93%), and to T3 (100%). The HER2+ cancer subtypes showed fewer MRI-assessed tumor progressions than HER2- subtypes: e.g. 10/209 (5%) vs. 108/669 (16%) at T1. NPV was 100% for HER2+ subtypes at T1 and T2 except for a single misclassification of a HR- tumor at T1. Only 6 tumor progressors, all HER2- were identified at T3, and all were confirmed at surgery as non-pCRs (NPV=100%). For HR+/HER2-, the NPV increased slightly from 89% at T1 to 91% at T2, while triple negative subtype had a more substantial increase, from 78% to 92%.

Conclusions: Our study showed strong association between tumor progressors assessed by MRI with true non-pCRs after NAC. For HER2+ tumors, although MRI progressors are rare, they strongly indicate non-pCR at all treatment time points, while HER2- subtypes show more accurate results later in treatment. We are evaluating MRI change at 6 weeks to determine if that time point is sufficient to predict progressors.

N/non-pCRs/%non-pCRMRI assessed tumor progression
T1 (after 3 weeks)T2 (inter-regimen)T3 (post-NAC)
NNPV (%)NNPV (%)NNPV (%)
Full cohort878/572/65%11883.14192.76100%
HR+/HER2-344/280/81%4588.91190.93100%
HR+/HER2+134/85/63%610021000N/A
HR-/HER2+75/23/31%47521000N/A
triple negative325/184/57%6377.82692.33100%

Table 1 MRI assessed tumor progression at different treatment time point

Citation Format: Wen Li, Natsuko Onishi, David C Newitt, Jessica Gibbs, Lisa J Wilmes, Ella F Jones, Bonnie N Joe, Laura S Sit, Christina Yau, A. Jo Chien, Elissa Price, Kathy S Albain, Theresa Kuritza, Kevin Morley, Judy C Boughey, Kathy Brandt, Sadia Choudhery, Amy S Clark, Mark Rosen, Elizabeth S McDonald, Anthony D Elias, Dulcy Wolverton, Kelly Fountain, David M Euhus, Heather S Han, Bethany Niell, Jennifer Drukteinis, Julie E Lang, Janice Lu, Jane L Meisel, Zaha Mitri, Rita Nanda, Donald W Northfelt, Tara Sanft, Erica Stringer-Reasor, Rebecca K Viscusi, Anne M Wallace, Douglas Yee, Rachel Yung, Smita M Asare, Michelle E Melisko, Jane Perlmutter, Hope S Rugo, Richard Schwab, W. Fraser Symmans, Laura J van't Veer, Donald A Berry, Angela DeMichele, Hiroyuki Abe, Deepa Sheth, Kirsten K Edmiston, Erin D Ellis, Richard Ha, Ralph Wynn, Erin P Crane, Charlotte Dillis, Michael Nelson, An Church, Claudine Isaacs, Qamar J Khan, Karen Y Oh, Neda Jafarian, Dae Hee Bang, Christiane Mullins, Stefanie Woodard, Kathryn W Zamora, Haydee Ojeda-Fornier, Pulin Sheth, Linda Hovanessian-Larsen, Mohammad Eghtedari, Michael Spektor, Marina Giurescu, Mary S Newell, Michael A Cohen, Elise Berman, Constance Lehman, William Smith, Kim Fitzpatrick, Marisa H Borders, Wei Yang, Basak Dogan, Sally Goudreau, Thelma Brown, Laura J Esserman, Nola M Hylton. Breast cancer subtype specific association of pCR with MRI assessed tumor volume progression during NAC in the I-SPY 2 trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD9-04.

  • ©2020 American Association for Cancer Research.
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Cancer Research: 80 (4 Supplement)
February 2020
Volume 80, Issue 4 Supplement
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Abstract PD9-04: Breast cancer subtype specific association of pCR with MRI assessed tumor volume progression during NAC in the I-SPY 2 trial
Wen Li, Natsuko Onishi, David C Newitt, Jessica Gibbs, Lisa J Wilmes, Ella F Jones, Bonnie N Joe, Laura S Sit, Christina Yau, A. Jo Chien, Elissa Price, Kathy S Albain, Theresa Kuritza, Kevin Morley, Judy C Boughey, Kathy Brandt, Sadia Choudhery, Amy S Clark, Mark Rosen, Elizabeth S McDonald, Anthony D Elias, Dulcy Wolverton, Kelly Fountain, David M Euhus, Heather S Han, Bethany Niell, Jennifer Drukteinis, Julie E Lang, Janice Lu, Jane L Meisel, Zaha Mitri, Rita Nanda, Donald W Northfelt, Tara Sanft, Erica Stringer-Reasor, Rebecca K Viscusi, Anne M Wallace, Douglas Yee, Rachel Yung, Smita M Asare, Michelle E Melisko, Jane Perlmutter, Hope S Rugo, Richard Schwab, W. Fraser Symmans, Laura J van't Veer, Donald A Berry, Angela DeMichele, Hiroyuki Abe, Deepa Sheth, Kirsten K Edmiston, Erin D Ellis, Richard Ha, Ralph Wynn, Erin P Crane, Charlotte Dillis, Michael Nelson, An Church, Claudine Isaacs, Qamar J Khan, Karen Y Oh, Neda Jafarian, Dae Hee Bang, Christiane Mullins, Stefanie Woodard, Kathryn W Zamora, Haydee Ojeda-Fornier, Pulin Sheth, Linda Hovanessian-Larsen, Mohammad Eghtedari, Michael Spektor, Marina Giurescu, Mary S Newell, Michael A Cohen, Elise Berman, Constance Lehman, William Smith, Kim Fitzpatrick, Marisa H Borders, Wei Yang, Basak Dogan, Sally Goudreau, Thelma Brown, Laura J Esserman and Nola M Hylton
Cancer Res February 15 2020 (80) (4 Supplement) PD9-04; DOI: 10.1158/1538-7445.SABCS19-PD9-04

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Abstract PD9-04: Breast cancer subtype specific association of pCR with MRI assessed tumor volume progression during NAC in the I-SPY 2 trial
Wen Li, Natsuko Onishi, David C Newitt, Jessica Gibbs, Lisa J Wilmes, Ella F Jones, Bonnie N Joe, Laura S Sit, Christina Yau, A. Jo Chien, Elissa Price, Kathy S Albain, Theresa Kuritza, Kevin Morley, Judy C Boughey, Kathy Brandt, Sadia Choudhery, Amy S Clark, Mark Rosen, Elizabeth S McDonald, Anthony D Elias, Dulcy Wolverton, Kelly Fountain, David M Euhus, Heather S Han, Bethany Niell, Jennifer Drukteinis, Julie E Lang, Janice Lu, Jane L Meisel, Zaha Mitri, Rita Nanda, Donald W Northfelt, Tara Sanft, Erica Stringer-Reasor, Rebecca K Viscusi, Anne M Wallace, Douglas Yee, Rachel Yung, Smita M Asare, Michelle E Melisko, Jane Perlmutter, Hope S Rugo, Richard Schwab, W. Fraser Symmans, Laura J van't Veer, Donald A Berry, Angela DeMichele, Hiroyuki Abe, Deepa Sheth, Kirsten K Edmiston, Erin D Ellis, Richard Ha, Ralph Wynn, Erin P Crane, Charlotte Dillis, Michael Nelson, An Church, Claudine Isaacs, Qamar J Khan, Karen Y Oh, Neda Jafarian, Dae Hee Bang, Christiane Mullins, Stefanie Woodard, Kathryn W Zamora, Haydee Ojeda-Fornier, Pulin Sheth, Linda Hovanessian-Larsen, Mohammad Eghtedari, Michael Spektor, Marina Giurescu, Mary S Newell, Michael A Cohen, Elise Berman, Constance Lehman, William Smith, Kim Fitzpatrick, Marisa H Borders, Wei Yang, Basak Dogan, Sally Goudreau, Thelma Brown, Laura J Esserman and Nola M Hylton
Cancer Res February 15 2020 (80) (4 Supplement) PD9-04; DOI: 10.1158/1538-7445.SABCS19-PD9-04
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Cancer Research Online ISSN: 1538-7445
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