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5. Spatial Attention-Based Deep Learning System for Breast Cancer Pathological Complete Response Prediction with Serial Histopathology Images in Multiple Stains

Author

Duanmu, Hongyi, Bhattarai, Shristi, Li, Hongxiao, Cheng, Chia Cheng, Wang, Fusheng, Teodoro, George, Janssen, Emiel A. M., Gogineni, Keerthi, Subhedar, Preeti, Aneja, Ritu, Kong, Jun, Goos, Gerhard, Founding Editor, Hartmanis, Juris, Founding Editor, Bertino, Elisa, Editorial Board Member, Gao, Wen, Editorial Board Member, Steffen, Bernhard, Editorial Board Member, Woeginger, Gerhard, Editorial Board Member, Yung, Moti, Editorial Board Member, de Bruijne, Marleen, editor, Cattin, Philippe C., editor, Cotin, Stéphane, editor, Padoy, Nicolas, editor, Speidel, Stefanie, editor, Zheng, Yefeng, editor, and Essert, Caroline, editor

Published
2021
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8. Spatial Attention-Based Deep Learning System for Breast Cancer Pathological Complete Response Prediction with Serial Histopathology Images in Multiple Stains

Author

Duanmu, Hongyi, primary, Bhattarai, Shristi, additional, Li, Hongxiao, additional, Cheng, Chia Cheng, additional, Wang, Fusheng, additional, Teodoro, George, additional, Janssen, Emiel A. M., additional, Gogineni, Keerthi, additional, Subhedar, Preeti, additional, Aneja, Ritu, additional, and Kong, Jun, additional

Published
2021
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10. Sunitinib in Patients With Breast Cancer With FGFR1 or FGFR2 Amplifications or Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Calfa, Carmen J., Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Ahn, Eugene R., Burness, Monika L., Gogineni, Keerthi, Rohatgi, Nitin, Al Baghdadi, Tareq, Conlin, Alison, Gaba, Anu, Hamid, Omid, Krishnamurthy, Jairam, Gavini, Naga Jyothi, Gold, Philip J., Rodon, Jordi, Rueter, Jens, Thota, Ramya, Grantham, Gina N., and Hinshaw, Dominique C.

Subjects
SUNITINIB, CANCER patients, BREAST cancer, METASTATIC breast cancer, DRUG target
Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results from cohorts of patients with metastatic breast cancer (BC) with FGFR1 and FGFR2 alterations treated with sunitinib are reported. METHODS: Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) or stable disease of at least 16 weeks duration (SD16+) according to RECIST v1.1. Secondary end points included OR, progression-free survival, overall survival, duration of response, duration of stable disease, and safety. RESULTS: Forty patients with BC with FGFR1 (N = 30; amplification only n = 26, mutation only n = 1, both n = 3) or FGFR2 (N = 10; amplification only n = 2, mutation only n = 6, both n = 2) alterations were enrolled. Three patients in the FGFR1 cohort were not evaluable for efficacy; all patients in the FGFR2 cohort were evaluable. For the FGFR1 cohort, two patients with partial response and four with SD16+ were observed for DC and OR rates of 27% (90% CI, 13 to 100) and 7% (95% CI, 1 to 24), respectively. The null hypothesis of 15% DC rate was not rejected (P =.169). No patients achieved DC in the FGFR2 cohort (P = 1.00). Thirteen of the 40 total patients across both cohorts had at least one grade 3-4 adverse event or serious adverse event at least possibly related to sunitinib. CONCLUSION: Sunitinib did not meet prespecified criteria to declare a signal of antitumor activity in patients with BC with either FGFR1 or FGFR2 alterations. Other treatments and clinical trials should be considered for these patient populations. Sunitinib did not demonstrate antitumor activity in patients with FGFR1-/2-amplified or -mutated breast cancer. @ASCO #TAPUR [ABSTRACT FROM AUTHOR]

Published
2024
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11. Redlining−associated methylation in breast tumors: the impact of contemporary structural racism on the tumor epigenome

Author

Miller-Kleinhenz, Jasmine M., primary, Moubadder, Leah, additional, Beyer, Kirsten M., additional, Zhou, Yuhong, additional, Gaglioti, Anne H., additional, Collin, Lindsay J., additional, Gohar, Jazib, additional, Do, Whitney, additional, Conneely, Karen, additional, Krishnamurti, Uma, additional, Gogineni, Keerthi, additional, Gabram-Mendola, Sheryl, additional, D’Angelo, Olivia, additional, Henry, Kashari, additional, Torres, Mylin, additional, and McCullough, Lauren E., additional

Published
2023
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15. Data from CDK 4/6 Inhibitor Palbociclib (PD0332991) in Rb+ Advanced Breast Cancer: Phase II Activity, Safety, and Predictive Biomarker Assessment

Author

DeMichele, Angela, primary, Clark, Amy S., primary, Tan, Kay See, primary, Heitjan, Daniel F., primary, Gramlich, Kristi, primary, Gallagher, Maryann, primary, Lal, Priti, primary, Feldman, Michael, primary, Zhang, Paul, primary, Colameco, Christopher, primary, Lewis, David, primary, Langer, Melissa, primary, Goodman, Noah, primary, Domchek, Susan, primary, Gogineni, Keerthi, primary, Rosen, Mark, primary, Fox, Kevin, primary, and O'Dwyer, Peter, primary

Published
2023
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16. Supplementary Figure Legend from CDK 4/6 Inhibitor Palbociclib (PD0332991) in Rb+ Advanced Breast Cancer: Phase II Activity, Safety, and Predictive Biomarker Assessment

Author

DeMichele, Angela, primary, Clark, Amy S., primary, Tan, Kay See, primary, Heitjan, Daniel F., primary, Gramlich, Kristi, primary, Gallagher, Maryann, primary, Lal, Priti, primary, Feldman, Michael, primary, Zhang, Paul, primary, Colameco, Christopher, primary, Lewis, David, primary, Langer, Melissa, primary, Goodman, Noah, primary, Domchek, Susan, primary, Gogineni, Keerthi, primary, Rosen, Mark, primary, Fox, Kevin, primary, and O'Dwyer, Peter, primary

Published
2023
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17. Supplemental Table 1 from CDK 4/6 Inhibitor Palbociclib (PD0332991) in Rb+ Advanced Breast Cancer: Phase II Activity, Safety, and Predictive Biomarker Assessment

Author

DeMichele, Angela, primary, Clark, Amy S., primary, Tan, Kay See, primary, Heitjan, Daniel F., primary, Gramlich, Kristi, primary, Gallagher, Maryann, primary, Lal, Priti, primary, Feldman, Michael, primary, Zhang, Paul, primary, Colameco, Christopher, primary, Lewis, David, primary, Langer, Melissa, primary, Goodman, Noah, primary, Domchek, Susan, primary, Gogineni, Keerthi, primary, Rosen, Mark, primary, Fox, Kevin, primary, and O'Dwyer, Peter, primary

Published
2023
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18. Supplemental Figure 1 from CDK 4/6 Inhibitor Palbociclib (PD0332991) in Rb+ Advanced Breast Cancer: Phase II Activity, Safety, and Predictive Biomarker Assessment

Author

DeMichele, Angela, primary, Clark, Amy S., primary, Tan, Kay See, primary, Heitjan, Daniel F., primary, Gramlich, Kristi, primary, Gallagher, Maryann, primary, Lal, Priti, primary, Feldman, Michael, primary, Zhang, Paul, primary, Colameco, Christopher, primary, Lewis, David, primary, Langer, Melissa, primary, Goodman, Noah, primary, Domchek, Susan, primary, Gogineni, Keerthi, primary, Rosen, Mark, primary, Fox, Kevin, primary, and O'Dwyer, Peter, primary

Published
2023
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19. Supplemental Figure 2 from CDK 4/6 Inhibitor Palbociclib (PD0332991) in Rb+ Advanced Breast Cancer: Phase II Activity, Safety, and Predictive Biomarker Assessment

Author

DeMichele, Angela, primary, Clark, Amy S., primary, Tan, Kay See, primary, Heitjan, Daniel F., primary, Gramlich, Kristi, primary, Gallagher, Maryann, primary, Lal, Priti, primary, Feldman, Michael, primary, Zhang, Paul, primary, Colameco, Christopher, primary, Lewis, David, primary, Langer, Melissa, primary, Goodman, Noah, primary, Domchek, Susan, primary, Gogineni, Keerthi, primary, Rosen, Mark, primary, Fox, Kevin, primary, and O'Dwyer, Peter, primary

Published
2023
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20. Abstract PD13-05: PD13-05 Updated results of a Phase 1b study of gedatolisib plus palbociclib and endocrine therapy in women with hormone receptor positive advanced breast cancer: Subgroup analysis by PIK3CA mutation status

Author

Wesolowski, Robert, primary, Rugo, Hope, additional, Stringer-Reasor, Erica, additional, Han, Hyo S., additional, Specht, Jennifer M., additional, Dees, E. Claire, additional, Kabos, Peter, additional, Vaishampayan, Ulka, additional, Wander, Seth A., additional, Lu, Janice, additional, Gogineni, Keerthi, additional, Spira, Alexander I., additional, Schott, Anne F., additional, Abu-Khalaf, Maysa, additional, Nayak, Pratima, additional, Sullivan, Brian F., additional, Gorbatchevsky, Igor, additional, and Layman, AND Rachel M., additional

Published
2023
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22. Redlining-associated methylation in breast tumors: the impact of contemporary structural racism on the tumor epigenome.

Author

Miller-Kleinhenz, Jasmine M., Moubadder, Leah, Beyer, Kirsten M., Yuhong Zhou, Gaglioti, Anne H., Collin, Lindsay J., Gohar, Jazib, Do, Whitney, Conneely, Karen, Krishnamurti, Uma, Gogineni, Keerthi, Gabram-Mendola, Sheryl, D'Angelo, Olivia, Henry, Kashari, Torres, Mylin, and McCullough, Lauren E.

Subjects
INSTITUTIONAL racism, BREAST tumors, METHYLATION, DNA methylation, ENVIRONMENTAL exposure
Abstract

Purpose: Place-based measures of structural racism have been associated with breast cancer mortality, which may be driven, in part, by epigenetic perturbations. We examined the association between contemporary redlining, a measure of structural racism at the neighborhood level, and DNA methylation in breast tumor tissue. Methods: We identified 80 Black and White women diagnosed and treated for a first-primary breast cancer at Emory University Hospitals (2008-2017). Contemporary redlining was derived for census tracts using the Home Mortgage Disclosure Act database. Linear regression models were used to calculate the association between contemporary redlining and methylation in breast tumor tissue. We also examined epigenetic age acceleration for two different metrics, regressing b values for each cytosine-phosphate-guanine dinucleotide (CpG) site on redlining while adjusting for covariates. We employed multivariable Coxproportional hazards models and 95% confidence intervals (CI) to estimate the association between aberrant methylation and mortality. Results: Contemporary redlining was associated with 5 CpG sites after adjustment for multiple comparisons (FDR<0.10). All genes were implicated in breast carcinogenesis, including genes related to inflammation, immune function and stress response (ANGPT1, PRG4 and PRG4). Further exploration of the top 25 CpG sites, identified interaction of 2 sites (MRPS28 and cg11092048) by ER status and 1 site (GDP1) was associated with all-cause mortality. Contemporary redlining was associated with epigenetic age acceleration by the Hannum metric (b=5.35; CI 95%=0.30,10.4) and showed positive but non-significant correlation with the other clock. Conclusion: We identified novel associations between neighborhood contemporary redlining and the breast tumor DNA methylome, suggesting that racist policies leading to inequitable social and environmental exposures, may impact the breast tumor epigenome. Additional research on the potential implications for prognosis is needed. [ABSTRACT FROM AUTHOR]

Published
2023
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23. Association of Race and Area Deprivation With Breast Cancer Survival Among Black and White Women in the State of Georgia

Author

Luningham, Justin M., primary, Seth, Gaurav, additional, Saini, Geetanjali, additional, Bhattarai, Shristi, additional, Awan, Sofia, additional, Collin, Lindsay J., additional, Swahn, Monica H., additional, Dai, Dajun, additional, Gogineni, Keerthi, additional, Subhedar, Preeti, additional, Mishra, Pooja, additional, and Aneja, Ritu, additional

Published
2022
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24. A spatial attention guided deep learning system for prediction of pathological complete response using breast cancer histopathology images

Author

Duanmu, Hongyi, primary, Bhattarai, Shristi, additional, Li, Hongxiao, additional, Shi, Zhan, additional, Wang, Fusheng, additional, Teodoro, George, additional, Gogineni, Keerthi, additional, Subhedar, Preeti, additional, Kiraz, Umay, additional, Janssen, Emiel A M, additional, Aneja, Ritu, additional, and Kong, Jun, additional

Published
2022
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29. Abstract PD13-02: Phase Ib expansion study of gedatolisib in combination with palbociclib and endocrine therapy in women with ER+ metastatic breast cancer

Author

Layman, Rachel, primary, Wesolowski, Robert, additional, Han, Hyo, additional, Specht, Jennifer M, additional, Stringer-Reasor, Erica M, additional, Dees, E. Claire, additional, Kabos, Peter, additional, Mayer, Ingrid A, additional, Vaishampayan, Ulka, additional, Lu, Janice, additional, Gogineni, Keerthi, additional, Bardia, Aditya, additional, Schott, Anne F, additional, Abu-Khalaf, Maysa, additional, Howkins, Doug, additional, Sullivan, Brian, additional, Gorbatchevsky, Igor, additional, and Rugo, Hope, additional

Published
2022
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30. Abstract OT1-16-01: A multicenter phase II study of vaccines to prevent recurrence in patients with HER-2 positive breast cancer

Author

Han, Hyo S, primary, Disis, Mary, additional, Wesolowski, Robert, additional, Fisher, Carla, additional, Gandhi, Shipra, additional, Chan, Nancy, additional, Gwin, William, additional, Gogineni, Keerthi, additional, Mick, Rosemarie, additional, Rodriguez, Christina Sierra, additional, Hogue, Deanna, additional, Liu, Hien, additional, Costa, Ricardo, additional, and Czerniecki, Brian, additional

Published
2022
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31. Abstract PR-03: Neighborhood-level redlining-associated methylation in breast tumors: The impact of structural racism on the tumor epigenome

Author

Miller-Kleinhenz, Jasmine M, primary, Moubadder, Leah, additional, Beyer, Kirsten M., additional, Zhou, Yuhong, additional, Gaglioti, Anne H., additional, Gohar, Jazib, additional, Collin, Lindsay J., additional, Henry, Kashari, additional, Conneely, Karen M., additional, Krishnamurti, Uma, additional, D'Angelo, Olivia, additional, Gogineni, Keerthi, additional, Torres, Mylin, additional, Gabram-Mendola, Sheryl, additional, and McCullough, Lauren E., additional

Published
2022
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32. Receipt of Guideline-Concordant Care Does Not Explain Breast Cancer Mortality Disparities by Race in Metropolitan Atlanta

Author

Collin, Lindsay J., primary, Yan, Ming, additional, Jiang, Renjian, additional, Gogineni, Keerthi, additional, Subhedar, Preeti, additional, Ward, Kevin C., additional, Switchenko, Jeffrey M., additional, Lipscomb, Joseph, additional, Miller-Kleinhenz, Jasmine, additional, Torres, Mylin A., additional, Lin, Jolinta, additional, and McCullough, Lauren E., additional

Published
2021
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35. spatial attention guided deep learning system for prediction of pathological complete response using breast cancer histopathology images.

Author

Duanmu, Hongyi, Bhattarai, Shristi, Li, Hongxiao, Shi, Zhan, Wang, Fusheng, Teodoro, George, Gogineni, Keerthi, Subhedar, Preeti, Kiraz, Umay, Janssen, Emiel A M, Aneja, Ritu, and Kong, Jun

Subjects
INTERNET servers, DEEP learning, BREAST cancer, TRIPLE-negative breast cancer, INSTRUCTIONAL systems, HISTOPATHOLOGY, DECISION making
Abstract

Motivation Predicting pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in triple-negative breast cancer (TNBC) patients accurately is direly needed for clinical decision making. pCR is also regarded as a strong predictor of overall survival. In this work, we propose a deep learning system to predict pCR to NAC based on serial pathology images stained with hematoxylin and eosin and two immunohistochemical biomarkers (Ki67 and PHH3). To support human prior domain knowledge-based guidance and enhance interpretability of the deep learning system, we introduce a human knowledge-derived spatial attention mechanism to inform deep learning models of informative tissue areas of interest. For each patient, three serial breast tumor tissue sections from biopsy blocks were sectioned, stained in three different stains and integrated. The resulting comprehensive attention information from the image triplets is used to guide our prediction system for prognostic tissue regions. Results The experimental dataset consists of 26 419 pathology image patches of 1000 × 1000 pixels from 73 TNBC patients treated with NAC. Image patches from randomly selected 43 patients are used as a training dataset and images patches from the rest 30 are used as a testing dataset. By the maximum voting from patch-level results, our proposed model achieves a 93% patient-level accuracy, outperforming baselines and other state-of-the-art systems, suggesting its high potential for clinical decision making. Availability and implementation The codes, the documentation and example data are available on an open source at: https://github.com/jkonglab/PCR%5fPrediction%5fSerial%5fWSIs%5fbiomarkers Supplementary information Supplementary data are available at Bioinformatics online. [ABSTRACT FROM AUTHOR]

Published
2022
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36. Abstract CT173: Sunitinib (S) in patients (pts) with metastatic breast cancer (mBC) withFGFR1mutations or amplifications: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Calfa, Carmen, primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Ahn, Eugene, additional, Gogineni, Keerthi, additional, Rohatgi, Nitin, additional, Burness, Monika L., additional, Gaba, Anu, additional, Hamid, Omid, additional, Albaghdadi, Tareq, additional, Conlin, Alison, additional, Gold, Philip, additional, Rodon, Jordi, additional, Thota, Ramya, additional, and Schilsky, Richard L., additional

Published
2021
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37. Saci-IO HR+: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1+ hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC).

Author

Garrido-Castro, Ana Christina, primary, Keenan, Tanya Elizabeth, additional, Li, Tianyu, additional, Lange, Paulina, additional, Callahan, Catherine, additional, Guerriero, Jennifer, additional, Tayob, Nabihah, additional, Anderson, Leilani, additional, Stover, Daniel G., additional, Gogineni, Keerthi, additional, Carey, Lisa A., additional, Nanda, Rita, additional, Winer, Eric P., additional, Mittendorf, Elizabeth A., additional, and Tolaney, Sara M., additional

Published
2021
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43. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial

Author

Vassiliki Karantza, Shparyk Yaroslav, Sumrall Bradley, Javier Cortes, Iwata Hiroji, Kolesnik Oleksii, Ahn Jin Hee, Harbeck Nadia, Prausova Jana, Song Xinni, Berzoy Oleksandr, Mena Raul, Osaki Akihiko, Kahan Zsuzsanna, Simon Michael, Ozguroglu Mustafa, Chmielowska Ewa, Tsugawa Koichiro, Tsao Chao-Jung, Ozyilkan Ozgur, Nowecki Zbigniew, Fadeeva Natalia, Kaen Diego, Garcia Saenz Jose, Porter David, Ngan Kai Cheong Roger, Sherene Loi, Bermejo de las Heras Begona, Turner Nicholas, David W. Cescon, Hope S. Rugo, Oliff Ira, Kelly Catherine, Barrios Carlos, Cole Scott, Shevnya Sergii, Seock-Ah Im, Hoskins Kent, Komisarenko Hanna, Yavuz Sinan, Chaudhry Madhu, Sagara Yasuaki, Brust Leandro, Chan Steve, Gomez Villanueva Angel, Gallardo Carlos, Watanabe Junichiro, Ishikawa Takashi, Schleider Michael, Salas Claudio, Hardy-Bessard Anne-Claire, Erhan Gokmen, Adamchuk Hryhoriy, Beelen Karin, Holeckova Petra, Szczylik Cezary, Fujii Takaaki, Nakamura Seigo, Aruga Tomoyuki, Gokmen Erhan, Jing Zhao, Hiroji Iwata, Molinas Mandel Nil, Gogineni Keerthi, Im Seock-Ah, Zifang Guo, Loi Sherene, Costa Fabiano, Forstmeyer Dirk, Kosaka Yoshimasa, Gomez Diaz Alvaro, Ponomarova Olga, Wimberger Pauline, DAlessio Antonietta, Suzuki Eiji, Blohmer Jens-Uwe, Kowalwszyn Ruben, Molina Matias, Clingan Philip, Yamamoto Yutaka, Sabanathan Dhanusha, Gursel Aktan, Vynnychenko Ihor, Ferrario Cristiano, Schumann Raquel Von, Trukhin Dmytro, Arkosy Peter, Tseng Ling-Ming, Moore Susan, Gunduz Seyda, Stampleman Laura, de Freitas Junior Ruffo, Acevedo Alejandro, Lipatov Oleg, Niikura Naoki, Norikazu Masuda, Rusyn Andrii, Kral Zdenek, Crown John, Yamamoto Naohito, Jakobsen Erik, Blau Sibel, Bustam Anita, Zamora Adelantado Esther, Nanda Rita, Omene Coral, Arslan Cagatay, Kwong Ava, Teixeira Luis, Jensen Jeanette, Ito Yoshinori, Siegel Robert, Mastura Md Yusof, Nowakowska-Zajdel Ewa, Miyoshi Yasuo, Yu Joanne, Tuthill Mark, Mukhametshina Guzel, Matsumoto Koji, Gion Maria, Melichar Bohuslav, Desmoulins Isabelle, Moiseyenko Vladimir, Zurawski Bogdan, Carlos Gallardo, Lorincz Tamas, Cruz Jurado Josefina, Bondarenko Igor, Kaczerowsky Flores de Sousa Anna, Yamauchi Teruo, Loutfi Randa, Esther Holgado, Holgado Esther, Twelves Christopher, Streb Joanna, Tanabe Yuko, Tarnawski Rafal, Morales-Vasquez Flavia, Park Kwong Hwa, Csoszi Tibor, Meshcheryakov Andrey, Scalabrini Neto Antonio Orlando, Oleg Lipatov, Iwasa Tsutomu, Ricevuto Enrico, Tamura Kenji, Patson Brian, Liu Mei-Ching, Cinieri Saverio, Loibl Sibylle, Tjan-Heijnen Vivianne, Glavicic Vesna, Panwalkar Amit, Hargis Jeffrey, Kryzhanivska Anna, Yusof Mastura, O'Reilly Seamus, Rubovszky Gabor, Irvin William, Takahashi Masato, Ohtani Shoichiro, Peter Schmid, Carlos H. Barrios, Sanchez Cesar, Zbigniew Nowecki, Arkhipov Alexander, Chung Michael, Liu Chien-Ting, Mukai Hirofumi, Marco Torregroza Otero, Charpentier Danielle, Park-Simon Tjoung-Won, Lee Keun Seok, Leshchenko Iurii, Huang Chiun-Sheng, Tsai Michaela, Panella Timothy, Petrakova Katarina, MacPherson Iain, Schmid Peter, Baron-Hay Sally, Ursol Grygorii, Lacerda Domicio Carvalho, Cobb Patrick, Sanchez Jesus, Park Yeon Hee, Reyes Contreras Jessica, Fein Luis, Hegg Roberto, Diamond Jennifer, Huober Jens, Rugo Hope, Rybalova Irina, de la Cruz Merino Luis, Linnet Soren, Inoue Kenichi, Wheatley Duncan, Cescon David, Cicin Irfan, Gombos Andrea, Bonnefoi Herve, Nasonova Alla, Taylor Donatienne, Martinez Rodriguez Jorge, Valdes-Albini Frances, Juarez Ramiro Alejandro, Cortes Javier, Lu Janice, Silva Felipe, Lueftner Diana, Landherr Laszlo, Gomez Abuin Gonzalo, Yanez Eduardo, Rocha Roberto Odebrecht, Chow Louis, Otchenash Natalya, Radecka Barbara, Kolesnik Olena, Basaran Gul, Kurbacher Christian, Mahr Karoly, Goncalves Anthony, Begbie Stephen, Graham Janine, Fasching Peter, Varela Mirta, and Lissa Fernando Cezar Toniazzi

Subjects
Oncology, double blind procedure, pharmacist, CD274 protein, human, hazard ratio, 0302 clinical medicine, middle aged, Antineoplastic Combined Chemotherapy Protocols, cancer survival, comparative study, education.field_of_study, progression free survival, adult, drug effect, gemcitabine, clinical trial, General Medicine, nausea, anemia, Progression-Free Survival, priority journal, immunological antineoplastic agent, thyroiditis, pembrolizumab, metastatic breast cancer, neoadjuvant chemotherapy, medicine.medical_specialty, Antineoplastic Agents, intention to treat analysis, Article, skin manifestation, 03 medical and health sciences, Breast cancer, cancer combination chemotherapy, neutropenia, Humans, Progression-free survival, human, education, protein expression, cancer immunotherapy, treatment response, Interim analysis, medicine.disease, major clinical study, tumor recurrence, Carboplatin, programmed death 1 ligand 1, drug efficacy, multicenter study, chemistry, monoclonal antibody, randomized controlled trial, fatigue, drug tolerability, cancer patient, age distribution, drug safety, colitis, clinical outcome, Triple Negative Breast Neoplasms, Pembrolizumab, 030204 cardiovascular system & hematology, B7-H1 Antigen, Placebos, chemistry.chemical_compound, paclitaxel, Antineoplastic Agents, Immunological, Outcome Assessment, Health Care, 030212 general & internal medicine, antineoplastic agent, cancer adjuvant therapy, Eastern Cooperative Oncology Group performance status, female, carboplatin, sodium chloride, immunohistochemistry, medicine.drug, interactive voice response system, alanine aminotransferase, overall survival, Population, Antibodies, Monoclonal, Humanized, Double-Blind Method, Internal medicine, medicine, follow up, hyperthyroidism, pneumonia, controlled study, Taxane, phase 3 clinical trial, business.industry, hypertransaminasemia, alopecia, Gemcitabine, human tissue, cancer recurrence, functional status assessment, triple negative breast cancer, placebo, inoperable cancer, pathology, hypothyroidism, Neoplasm Recurrence, Local, business, metabolism, Follow-Up Studies
Abstract

Background: Pembrolizumab monotherapy showed durable antitumour activity and manageable safety in patients with metastatic triple-negative breast cancer. We aimed to examine whether the addition of pembrolizumab would enhance the antitumour activity of chemotherapy in patients with metastatic triple-negative breast cancer. Methods: In this randomised, placebo-controlled, double-blind, phase 3 trial, done in 209 sites in 29 countries, we randomly assigned patients 2:1 with untreated locally recurrent inoperable or metastatic triple-negative breast cancer using a block method (block size of six) and an interactive voice-response system with integrated web-response to pembrolizumab (200 mg) every 3 weeks plus chemotherapy (nab-paclitaxel; paclitaxel; or gemcitabine plus carboplatin) or placebo plus chemotherapy. Randomisation was stratified by type of on-study chemotherapy (taxane or gemcitabine–carboplatin), PD-L1 expression at baseline (combined positive score [CPS] ?1 or, Breast Cancer Research Foundation, BCRF; Pfizer; AstraZeneca; Merck; Roche; Samsung; Merck Sharp and Dohme, MSD; Eisai, JC reports personal fees and research funding paid to his institution from Roche, AstraZeneca, Merck Sharp & Dohme, and Eisai; personal fees from Celgene, Cellestia, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, GlaxoSmithKline, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Kyowa Kirin, Novartis, Pfizer, Samsung Bioepis; research funding paid to his institution from Ariad Pharmaceuticals, Bayer Healthcare, F Hoffman-La Roche, Guardanth Health, Piqur Therapeutics, Puma C, and Queen Mary University of London, outside the submitted work. In addition, JC has a MedSIR patent pending. DWC reports research support from Merck during the conduct of the study; research support paid to his institution from Merck, Pfizer, and GlaxoSmithKline; personal fees from Merck, Roche–Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Puma, Agenda, Exact Sciences, and Dynamo Therapeutics, outside the submitted work. In addition, DWC has a Biomarkers of TTK inhibitors patent pending. HSR reports funding for sponsored studies paid to the University of California San Francisco from Pfizer, Novartis, Lilly, Roche–Genentech, Macrogenics, OBI, Merck, Eisai, Immunomedics, Daiichi Sankyo, Seattle Genetics, and Odonate; travel support for educational meetings from Daiichi Sankyo, Mylan, Pfizer, Merck, AstraZeneca, Novartis, and Macrogenics; and consulting fees from Samsung and Puma, outside the submitted work. S-AI reports grants from AstraZeneca, Eisai, Pfizer, Roche, and Daewoong; an advisory role for AstraZeneca, Amgen, Eisai, Hanmi, Novartis, Lily, MedPacto, Pfizer, and Roche; and travel expenses for presentation from Novartis, outside the submitted work. CG reports Advisory Board fees from Merck Sharp & Dohme and Roche; and speaker's bureau fees from Bristol Myers Squibb and AstraZeneca, outside the submitted work. CHB reports grants and fees from Merck Sharp & Dohme for clinical research consulting during the conduct of the study; consulting–advisory role fees from Boehringer Ingelheim, GlaxoSmithKline, and Bayer; consulting–advisory role fees and grants for clinical research from Novartis, Pfizer, Roche–Genentech, Eisai, Merck Sharp & Dohme, and AstraZeneca; grants for clinical research from Abbvie, Amgen, Astellas Pharma, Bristol Myers Squibb, Celgene, Covance, Lilly, Medication, Merck Serono, and PharmaMar; grants for academic research projects from CPO, Pontificia Universidade Católica do Rio Grande do Sul, Latin American Cooperative Oncology Group, Grupo Brasileiro Estudos Câncer Mama, and Instituto Nacional de Câncer-Brazil, outside the submitted work. HI reports a grant from Merck Sharp & Dohme during the conduct of the study; honoraria and consulting fees from Novartis, AstraZeneca, Pfizer, Lilly, Daiichi Sankyo, Eisai, and Chugai; and a grant from Chugai, outside the submitted work. NM reports honoraria and research funding paid to his institution from Chugai, AstraZeneca, Pfizer, Eli-Lilly, Eisai, Takeda, Kyowa-Kirin, Merck Sharp & Dohme, Novartis, and Daiichi Sankyo, outside the submitted work. EG reports non-financial support from Merck Sharp & Dohme during the conduct of the study; honoraria, consulting–advisory fees and meeting support from Novartis, Roche, Bristol Myers Squibb, and Pfizer; and honoraria from AstraZeneca and Astellas, outside the submitted work. SL reports research funding or consulting fees paid to her institution from Bristol Myers Squibb, Roche–Genentech, Puma Biotechnology, Pfizer, Seattle Genetics, Novartis, Merck Sharp & Dohme, Eli Lilly, Aduro Biotech, GI Therapeutics, AstraZeneca, and GlaxoSmithKline; and non-remunerated consultancy for Bristol Myers Squibb, Roche–Genentech, Pfizer, Seattle Genetics, Novartis, Merck Sharp & Dohme, and AstraZeneca, outside the submitted work. In addition, SL is supported by the National Breast Cancer Foundation of Australia Endowed Chair and the Breast Cancer Research Foundation, New York. ZG, JZ, GA, and VK are employees of Merck Sharp & Dohme and own stock or stock options in Merck. PS reports consultancy fees from Pfizer, AstraZeneca, Novartis, Roche, Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Eisai, Celgene, and Puma; consultancy fees to his spouse from Genentech and Roche; and grants or funding to his institution from Roche, Genentech, Oncogenex, Novartis, Astellas, and AstraZeneca, outside the submitted work. All other authors declare no competing interests., The authors thank the patients, their families and caregivers for participating in this trial, all of the investigators and site personnel, and the following employees of Merck Sharp & Dohme: Wilbur Pan, Deborah Card, Eleanor Readinger, Shana Hamm, Roger Maxwell, and Krystal Bourdon, for collection of data, supervision of research, provision of study materials or patients or administrative or logistical support; Aline Galvao, for collection of data, supervision of research, administrative or logistical support, and review of imaging data related to the primary end point; Donna Letizia, for collection of data and imaging expertise; Jennifer Kimmel, for study management; Mercedes Bustamante, for data collection and management; Xuan Zhou and Madhusudhan Reddy Papasani, for statistical expertise; Christine McCrary Sisk, for medical writing and editorial assistance; and Joseph C Naggar and Michele McColgan, for administrative or logistical support.

Published
2020

46. A Quantitative Centrosomal Amplification Score Predicts Local Recurrence of Ductal Carcinoma In Situ

Author

Mittal, Karuna, primary, Toss, Michael S., additional, Wei, Guanhao, additional, Kaur, Jaspreet, additional, Choi, Da Hoon, additional, Melton, Brian D., additional, Osan, Remus M., additional, Miligy, Islam M., additional, Green, Andrew R., additional, Janssen, Emiel A.M., additional, Søiland, Håvard, additional, Gogineni, Keerthi, additional, Manne, Upender, additional, Rida, Padmashree, additional, Rakha, Emad A., additional, and Aneja, Ritu, additional

Published
2020
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47. Abstract C074: Presence of crown-like structures in breast adipose tissue and clinical outcomes among African-American and White breast cancer patients

Author

Cheriyan, Aswathy M, primary, Sherman, Mark E, additional, Liu, Yuan, additional, Gogineni, Keerthi, additional, Liu, Jiaqi, additional, He, Jiabei, additional, Krishnamurti, Uma, additional, Ashiqueali, Ryan, additional, He, Jinjing, additional, Yacoub, Rami, additional, Miller-Kleinhenz, Jasmine, additional, McCullough, Lauren E, additional, and Maliniak, Maret L, additional

Published
2020
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48. Abstract C053: Identification of factors contributing to breast cancer mortality disparities in the metropolitan Atlanta area

Author

Collin, Lindsay J., primary, Jiang, Renjian, additional, Ward, Kevin C., additional, Gogineni, Keerthi, additional, Subhedar, Preeti D., additional, Sherman, Mark, additional, Gaudet, Mia M., additional, Breitkopf, Carmen Radecki, additional, D'Angelo, Olivia, additional, Gabram-Mendola, Sheryl, additional, Siegel, Jolie, additional, Aneja, Rana, additional, Gaglioti, Anne, additional, and McCullough, Lauren E., additional

Published
2020
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49. Molecular profiling and quantitative image analysis reveal spatial intratumor heterogeneity in TNBC.

Author

Mittal, Karuna, primary, Li, Hongxiao, additional, Wylie, Dennis, additional, Kaur, Jaspreet, additional, Kolachina, Rishab, additional, Sahoo, Bikram, additional, Wei, Guanhao, additional, Toss, Michael S, additional, Green, Andrew R., additional, Arasappan, Dhivya, additional, Yang, Jianchen, additional, Yankeelov, Thomas, additional, Bhattarai, Shristi, additional, Rakha, Emad A., additional, Gogineni, Keerthi, additional, Kong, Jun, additional, Kowalski, Jeanne, additional, and Aneja, Ritu, additional

Published
2020
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