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5. Radiotherapy to regional nodes in early breast cancer: an individual patient data meta-analysis of 14 324 women in 16 trials

Author

Taylor, Carolyn, Dodwell, David, McGale, Paul, Hills, Robert K, Berry, Richard, Bradley, Rosie, Braybrooke, Jeremy, Clarke, Mike, Gray, Richard, Holt, Francesca, Liu, Zulian, Pan, Hongchao, Peto, Richard, Straiton, Ewan, Coles, Charlotte, Duane, Fran, Hennequin, Christophe, Jones, Glenn, Kühn, Thorsten, Oliveros, Sileida, Overgaard, Jens, Pritchard, Kathy I, Suh, Chang-Ok, Beake, Graham, Boddington, Clare, Davies, Christina, Davies, Lucy, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Kerr, Amanda, Liu, Hui, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Nakahara, Mariko, Read, Simon, Taylor, Hannah, Ferguson, John, Scheurlen, Hans, Zurrida, Stefano, Galimberti, Viviana, Ingle, James, Valagussa, Pinuccia, Veronesi, Umberto, Anderson, Stewart, Tang, Gong, Fisher, Bernard, Fossa, Sophie, Valborg Reinertsen, Kristin, Host, Herman, Muss, Hyman, Holli, Kaija, Albain, Kathy, Arriagada, Rodrigo, Bartlett, John, Bergsten-Nordström, Elizabeth, Bliss, Judith, Brain, Etienne, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Del Mastro, Lucia, Di Leo, Angelo, Dignam, James, Dowsett, Mitch, Ejlertsen, Bent, Francis, Prue, García-Sáenz, José Angel, Gelber, Rich, Gnant, Michael, Goetz, Matthew, Goodwin, Pam, Halpin-Murphy, Pat, Hayes, Dan, Hill, Catherine, Jagsi, Reshma, Janni, Wolfgang, Loibl, Sibylle, Mamounas, Eleftherios, Martín, Miguel, McIntosh, Stuart, Mukai, Hirofumi, Nekljudova, Valentina, Norton, Larry, Ohashi, Yasuo, Piccart, Martine, Pierce, Lori, Raina, Vinod, Rea, Daniel, Regan, Meredith, Robertson, John, Rutgers, Emiel, Salgado, Roberto, Slamon, Dennis, Spanic, Tanja, Sparano, Joseph, Steger, Guenther, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Wilcken, Nicholas, Wolmark, Norman, Yu, Ke-Da, Cameron, David, Bergh, Jonas, Swain, Sandra, Whelan, Tim, and Poortmans, Philip

Published
2023
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7. Anthracycline-containing and taxane-containing chemotherapy for early-stage operable breast cancer: a patient-level meta-analysis of 100 000 women from 86 randomised trials

Author

Braybrooke, Jeremy, Bradley, Rosie, Gray, Richard, Hills, Robert K, Pan, Hongchao, Peto, Richard, Dodwell, David, McGale, Paul, Taylor, Carolyn, Aihara, Tomohiko, Anderson, Stewart, Blum, Joanne, Cardoso, Fatima, Chen, Xiaosong, Crown, John P, Ejlertsen, Bent, Friedl, Thomas W P, Harbeck, Nadia, Janni, Wolfgang, Jensen, Maj-Britt, Mamounas, Eleftherios, Narui, Kazutaka, Nitz, Ulrike, Norton, Larry, O'Shaughnessy, Joyce, Piccart, Martine, Robert, Nicholas, Shao, Zhi-Ming, Slamon, Dennis, Sparano, Joseph, Watanabe, Toru, Yothers, Greg, Yu, Ke-Da, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Davies, Lucy, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Lui, Hui, Lui, Zulian, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Buzdar, Aman, Suman, Vera J, Hunt, Kelly K, Leonard, Robert C F, Mansi, Janine, Delbaldo, Catherine, Piedbois, Pascal, Quinaux, Emmanuel, Fesl, Christian, Gnant, Michael, Sölkner, Lidija, Steger, Guenther, Eikesdal, Hans Petter, Lønning, Per Eystein, Bee, Valerie, Fung, Helena, Mackey, John, Martin, Miguel, Press, Michael, De Azambuja, Evandro, Gelber, Richard, Regan, Meredith, Di Leo, Angelo, Van Dooren, Veerle, Nogaret, Jean Marie, Bartlett, John, Chen, Bingshu E, Gelmon, Karen, Goss, Paul E, Levine, Mark N, Parulekar, Wendy, Pritchard, Kathleen I, Shepherd, Lois, Berry, Donald, Cirrincione, Constance, Shulman, Lawrence N, Winer, Eric, Gelman, Rebecca S, Harris, Jay R, Henderson, Craig, Shapiro, Charles L, Christiansen, Peer, Ewertz, Marianne, Mouridsen, Henning T, Van Leeuwen, Elise, Linn, Sabine, Van Rossum, Annelot G J, Van Tinteren, Harm, Van Werkhoven, Erik, Goldstein, Lori, Gray, Robert, Eiermann, Wolfgang, Gianni, Luca, Valagussa, Pinuccia, Bogaerts, Jan, Bonnefoi, Herve, Poncet, Coralie, Huovinen, Riikka, Joensuu, Heikki, Bonneterre, Jacques, Fargeot, Pierre, Fumoleau, Pierre, Kerbrat, Pierre, Luporsi, Elisabeth, Namer, Moïse, Carrasco, Eva M, Segui, Miguel Angel, Meisner, Christoph, Loibl, Sibylle, Nekljudova, Valentina, Thomssen, Christoph, Von Minckwitz, Gunter, Kümmel, Sherko, Lopez, Massimo, Vici, Patrizia, Fountzilas, George, Koliou, Georgia, Mavroudis, Dimitrios, Saloustros, Emmanouil, Brain, Etienne, Delaloge, Suzette, Michiels, Stefan, Mathoulin-Pelissier, Simone, Bines, Jose, Sarmento, Roberta M B, Bonadonna, Gianni, Brambilla, Cristina, Rossi, Anna, Bliss, Judith, Coombes, Raoul Charles, Kilburn, Lucy, Marty, Michel, Amadori, Dino, Boccardo, Francesco, Nanni, Oriana, Rubagotti, Alessandra, Scarpi, Emanuela, Masuda, Norikazu, Toi, Masakazu, Ueno, Takayuki, Ishikawa, Takashi, Matsumoto, Koji, Takao, Shintaro, Sommer, Harald, Foroglou, Pericles, Giokas, George, Kondylis, D, Lissaios, Byron, Reinisch, Mattea, Lee, Keun Seok, Nam, Byung-Ho, Ro, Jung Sil, De Matteis, Andrea, Perrone, Francesco, Tang, Gong, Wolmark, Norman, Hozumi, Yasuo, Nomura, Yasuo, Earl, Helena, Hiller, Louise, Vallier, Anne-Laure, De Mastro, Lucia, Venturini, Macro, Delozier, Thierry, Lemonnier, Jerome, Martin, Anne-Laure, Roché, Henri, Spielmann, Marc, Chen, Xiasong, Shen, Kunwei, Albain, Kathy, Barlow, William, Budd, George T, Gralow, Julie, Hayes, Dan, Bartlett-Lee, Peter, Ellis, Paul, Bianco, Angelo Raffaele, De Laurentiis, Michelino, De Placido, Sabino, Wildiers, Hans, Hsu, Limin, Eremin, Oleg, Walker, Leslie G, Ahlgren, Johan, Blomqvist, Carl, Holmberg, Lars, Lindman, Henrik, Asmar, Lina, Jones, Stephen E, Gluz, Oleg, Liedtke, Cornelia, Arriagada, Rodrigo, Bergsten-Nordström, Elizabeth, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Dignam, James, Dowsett, Mitch, Francis, Prudence A, Goetz, Matthew P, Goodwin, Pam, Halpin-Murphy, Pat, Hill, Catherine, Jagsi, Reshma, Mukai, Hirofumi, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Raina, Vinod, Rea, Daniel, Robertson, John, Rutgers, Emiel, Salgado, Roberto, Spanic, Tanja, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Cameron, David, Bergh, Jonas, and Swain, Sandra M

Published
2023
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9. Neoadjuvant clinical trials provide a window of opportunity for cancer drug discovery

Author

Marron, Thomas U., Galsky, Matthew D., Taouli, Bachir, Fiel, Maria Isabel, Ward, Stephen, Kim, Edward, Yankelevitz, David, Doroshow, Deborah, Guttman-Yassky, Emma, Ungar, Benjamin, Mehandru, Saurabh, Golas, Benjamin J., Labow, Daniel, Sfakianos, John, Nair, Sujit S., Chakravarty, Dimple, Buckstein, Michael, Song, Xiaoyu, Kenigsberg, Effi, Gnjatic, Sacha, Brown, Brian D., Sparano, Joseph, Tewari, Ashutosh, Schwartz, Myron, Bhardwaj, Nina, and Merad, Miriam

Published
2022
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10. Systematically higher Ki67 scores on core biopsy samples compared to corresponding resection specimen in breast cancer: a multi-operator and multi-institutional study

Author

Acs, Balazs, Leung, Samuel C.Y., Kidwell, Kelley M., Arun, Indu, Augulis, Renaldas, Badve, Sunil S., Bai, Yalai, Bane, Anita L., Bartlett, John M.S., Bayani, Jane, Bigras, Gilbert, Blank, Annika, Buikema, Henk, Chang, Martin C., Dietz, Robin L., Dodson, Andrew, Fineberg, Susan, Focke, Cornelia M., Gao, Dongxia, Gown, Allen M., Gutierrez, Carolina, Hartman, Johan, Kos, Zuzana, Lænkholm, Anne-Vibeke, Laurinavicius, Arvydas, Levenson, Richard M., Mahboubi-Ardakani, Rustin, Mastropasqua, Mauro G., Nofech-Mozes, Sharon, Osborne, C. Kent, Penault-Llorca, Frédérique M., Piper, Tammy, Quintayo, Mary Anne, Rau, Tilman T., Reinhard, Stefan, Robertson, Stephanie, Salgado, Roberto, Sugie, Tomoharu, van der Vegt, Bert, Viale, Giuseppe, Zabaglo, Lila A., Hayes, Daniel F., Dowsett, Mitch, Nielsen, Torsten O., Rimm, David L., McShane, Lisa M., Nielsen, Torsten, Leung, Samuel, Borgquist, Signe, Chan, Angela, Denkert, Carsten, Ehinger, Anna, Ellis, Matthew, Flowers, Margaret, Galderisi, Chad, Gholap, Abhi, Hartman, Douglas J., Hugh, Judith C., Jadhav, Anagha, Kornaga, Elizabeth N., Kreipe, Hans, Levenson, Richard, Mastropasqua, Mauro, Moriya, Takuya, Pan, Hongchao, Pantanowitz, Liron, Neri, Ernesta Paola, Polley, Mei-Yin, Ruan, Jason, Sakatani, Takashi, Shepherd, Lois, Smith, Ian, Sparano, Joseph, Spears, Melanie, Srinivasan, Malini, Starczynski, Jane, Todd, Austin, Virk, Shakeel, Wang, Yihong, Yang, Hua, Zhang, Zhiwei, and Zlobec, Inti

Published
2022
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11. Assessment of MRI to estimate metastatic dissemination risk and prometastatic effects of chemotherapy

Author

Karagiannis, George S., Bianchi, Anthony, Sanchez, Luis Rivera, Ambadipudi, Kamal, Cui, Min-Hui, Anampa, Jesus M., Asiry, Saeed, Wang, Yarong, Harney, Allison S., Pastoriza, Jessica M., Lin, Yu, Chen, Xiaoming, Jones, Joan G., Entenberg, David, Haddad, Dana, Hodges, Laura J., Duong, Timothy Q., Sparano, Joseph A., Oktay, Maja H., Branch, Craig A., and Condeelis, John S.

Published
2022
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16. Aromatase inhibitors versus tamoxifen in premenopausal women with oestrogen receptor-positive early-stage breast cancer treated with ovarian suppression: a patient-level meta-analysis of 7030 women from four randomised trials

Author

Bradley, Rosie, Braybrooke, Jeremy, Gray, Richard, Hills, Robert K, Liu, Zulian, Pan, Hongchao, Peto, Richard, Dodwell, David, McGale, Paul, Taylor, Carolyn, Francis, Prudence A, Gnant, Michael, Perrone, Francesco, Regan, Meredith M, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Davies, Lucy, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Liu, Hui, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Jakesz, Raimund, Fesl, Christian, Pagani, Olivia, Gelber, Richard, De Laurentiis, Michelino, De Placido, Sabino, Gallo, Ciro, Albain, Kathy, Anderson, Stewart, Arriagada, Rodrigo, Bartlett, John, Bergsten-Nordström, Elizabeth, Bliss, Judith, Brain, Etienne, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Del Mastro, Lucia, Di Leo, Angelo, Dignam, James, Dowsett, Mitch, Ejlertsen, Bent, Goetz, Matthew, Goodwin, Pam, Halpin-Murphy, Pat, Hayes, Dan, Hill, Catherine, Jagsi, Reshma, Janni, Wolfgang, Loibl, Sibylle, Mamounas, Eleftherios P, Martín, Miguel, Mukai, Hirofumi, Nekljudova, Valentina, Norton, Larry, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Pritchard, Kathleen I, Raina, Vinod, Rea, Daniel, Robertson, John, Rutgers, Emiel, Spanic, Tanja, Sparano, Joseph, Steger, Guenther, Tang, Gong, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Wolmark, Norman, Cameron, David, Bergh, Jonas, and Swain, Sandra M

Published
2022
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17. Clinical and Genomic Risk for Late Breast Cancer Recurrence and Survival.

Author

Sparano, Joseph A., Crager, Michael, Gray, Robert J., Tang, Gong, Hoag, Jess, Baehner, Frederick L., Shak, Steven, Makower, Della F., Albain, Kathy S., Hayes, Daniel F., Geyer Jr., Charles E., Dees, Elizabeth C., Goetz, Matthew P., Olson Jr., John A., Lively, Tracy, Badve, Sunil S., Saphner, Thomas J., Whelan, Timothy J., Kaklamani, Virginia G., and Wolmark, Norman

Subjects
BREAST cancer prognosis, RISK assessment, BIOLOGICAL models, CANCER relapse, GENOMICS, BREAST tumors, CHI-squared test, DESCRIPTIVE statistics, LONGITUDINAL method, SURVIVAL analysis (Biometry), TUMOR classification, COMPARATIVE studies, CONFIDENCE intervals, PROPORTIONAL hazards models, OVERALL survival, DISEASE risk factors
Abstract

Background: The 21-gene recurrence score (RS) assay (Oncotype DX) is used to guide adjuvant chemotherapy use for patients with hormone receptor-positive, HER2 (human epidermal growth factor receptor 2)-negative, axillary node-negative breast cancer. Its role, however, in providing prognostic information for late distant recurrence when added to clinicopathologic prognostic factors is unknown. Methods: A patient-specific meta-analysis including 10,004 women enrolled in three trials was updated using extended follow-up data from TAILORx, integrating the RS with histologic grade, tumor size, and age at surgery for the RSClin tool. Cox models integrating clinicopathologic factors and the RS were compared by using likelihood ratio (LR) tests. External validation of prognosis for distant recurrence in years 0 to 10 and 5 to 10 was performed in an independent cohort of 1098 women in a real-world registry. Results: RSClin provided significantly more prognostic information than either the clinicopathologic factors (ΔLR chi-square, 86.2; P<0.001) or RS alone (ΔLR chi-square, 131.0; P<0.001). The model was prognostic in an independent cohort for distant recurrence by 10 years after diagnosis (standardized hazard ratio, 1.56; 95% confidence interval, 1.25 to 1.94), was associated with late distant recurrence risk between 5 and 10 years after diagnosis (standardized hazard ratio, 1.78; 95% confidence interval, 1.25 to 2.55), and approximated the observed 10-year distant recurrence risk (Lin concordance, 0.87) and 5- to 10-year distant recurrence risk (Lin concordance, 0.92). Conclusions: The 21-gene RS is prognostic for distant recurrence and overall survival in early breast cancer. A model integrating the 21-gene RS and clinicopathologic factors improved estimates of distant recurrence risk compared with either used individually and stratified late distant recurrence risk. (Funded by the National Cancer Institute, National Institutes of Health [U10CA180820, U10CA180794, UG1CA189859, U10CA180868, and U10CA180822] and others.) [ABSTRACT FROM AUTHOR]

Published
2024
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18. Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials

Author

Bradley, Rosie, Braybrooke, Jeremy, Gray, Richard, Hills, Robert, Liu, Zulian, Peto, Richard, Davies, Lucy, Dodwell, David, McGale, Paul, Pan, Hongchao, Taylor, Carolyn, Anderson, Stewart, Gelber, Richard, Gianni, Luca, Jacot, William, Joensuu, Heikki, Moreno-Aspitia, Alvaro, Piccart, Martine, Press, Michael, Romond, Edward, Slamon, Dennis, Suman, Vera, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Liu, Hui, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Wang, Yaochen, Crown, John, de Azambuja, Evandro, Delaloge, Suzette, Fung, Helena, Geyer, Charles, Spielmann, Marc, Valagussa, Pinuccia, Albain, Kathy, Arriagada, Rodrigo, Bartlett, John, Bergsten-Nordström, Elizabeth, Bliss, Judith, Brain, Etienne, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Del Mastro, Lucia, Di Leo, Angelo, Dignam, James, Dowsett, Mitch, Ejlertsen, Bent, Francis, Prue, Gnant, Michael, Goetz, Matthew, Goodwin, Pam, Halpin-Murphy, Pat, Hayes, Dan, Hill, Catherine, Jagsi, Reshma, Janni, Wolfgang, Loibl, Sibylle, Mamounas, Eleftherios P, Martín, Miguel, Mukai, Hirofumi, Nekljudova, Valentina, Norton, Larry, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Raina, Vinod, Rea, Daniel, Regan, Meredith, Robertson, John, Rutgers, Emiel, Spanic, Tanja, Sparano, Joseph, Steger, Guenther, Tang, Gong, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Wolmark, Norman, Cameron, David, Bergh, Jonas, Pritchard, Kathleen I, and Swain, Sandra M

Published
2021
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20. Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 (Cituxumumab) in Patients with HER2-Positive Advanced Breast Cancer Previously Treated with Trastuzumab and Chemotherapy: NCCTG N0733 (Alliance)

Author

Haddad, Tufia C., He, Jun, O’Sullivan, Ciara C., Chen, Beiyun, Northfelt, Donald, Dueck, Amylou C., Ballman, Karla V., Tenner, Kathleen S., Linden, Hannah, Sparano, Joseph A., Hopkins, Judith O., De Silva, Chamath, Perez, Edith A., Haluska, Paul, and Goetz, Matthew P.

Published
2021
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23. ECOG-ACRIN EAZ171: Prospective validation trial of germline variants and taxane type in association with taxane-induced peripheral neuropathy (TIPN) in Black women with early-stage breast cancer.

Author

Ballinger, Tarah Jean, Zhao, Fengmin, Sparano, Joseph A., Garcia, Sofia F., Shen, Fei, Virani, Shamsuddin, Srinivasiah, Jayanthi, Stringer-Reasor, Erica Michelle, Chitalia, Ami, Davis, Andrew A., Makower, Della F., Incorvati, Jason, Simon, Melissa A., Mitchell, Edith P., DeMichele, Angela, Miller, Kathy, Wagner, Lynne I., Wolff, Antonio C., and Schneider, Bryan P.

Published
2024
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25. Author Correction: Neoadjuvant clinical trials provide a window of opportunity for cancer drug discovery

Author

Marron, Thomas U., Galsky, Matthew D., Taouli, Bachir, Fiel, Maria Isabel, Ward, Stephen, Kim, Edward, Yankelevitz, David, Doroshow, Deborah, Guttman-Yassky, Emma, Ungar, Benjamin, Mehandru, Saurabh, Golas, Benjamin J., Labow, Daniel, Sfakianos, John, Nair, Sujit S., Chakravarty, Dimple, Buckstein, Michael, Song, Xiaoyu, Kenigsberg, Effi, Gnjatic, Sacha, Brown, Brian D., Sparano, Joseph, Tewari, Ashutosh, Schwartz, Myron, Bhardwaj, Nina, and Merad, Miriam

Published
2022
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27. Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study

Author

Yardley, Denise A., Hart, Lowell, Favret, Anne, Blau, Sibel, Diab, Sami, Richards, Donald, Sparano, Joseph, Beck, J. Thad, Richards, Paul, Ward, Patrick, Ramaswamy, Bhuvaneswari, Tsai, Michaela, Blackwell, Kimberly, Pluard, Timothy, Tolaney, Sara M., Esteva, Francisco J., Truica, Cristina I., Alemany, Carlos, Volas-Redd, Gena, Shtivelband, Mikhail, Purkayastha, Das, Dalal, Anand A., Miller, Michelle, and Hortobagyi, Gabriel N.

Published
2019
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28. Assessment of the safety of nivolumab in people living with HIV with advanced cancer on antiretroviral therapy: the AIDS Malignancy Consortium 095 Study.

Author

Rajdev, Lakshmi, Jackie Wang, Chia‐Ching, Joshi, Himanshu, Lensing, Shelly, Lee, Jeannette, Ramos, Juan Carlos, Baiocchi, Robert, Ratner, Lee, Rubinstein, Paul G., Ambinder, Richard, Henry, David, Streicher, Howard, Little, Richard F., Chiao, Elizabeth, Dittmer, Dirk P., Einstein, Mark H., Cesarman, Ethel, Mitsuyasu, Ronald, and Sparano, Joseph A.

Subjects
HIV-positive persons, ANTIRETROVIRAL agents, NIVOLUMAB, CANCER treatment, IMMUNE reconstitution inflammatory syndrome, CD4 lymphocyte count
Abstract

Background: Although immunotherapy has emerged as a therapeutic strategy for many cancers, there are limited studies establishing the safety and efficacy in people living with HIV (PLWH) and cancer. Methods: PLWH and solid tumors or Kaposi sarcoma (KS) receiving antiretroviral therapy and a suppressed HIV viral load received nivolumab at 3 mg/kg every 2 weeks, in two dose deescalation cohorts stratified by CD4 count (stratum 1: CD4 count > 200/µL and stratum 2: CD4 count 100–199/µL). An expansion cohort of 24 participants with a CD4 count > 200/µL was then enrolled. Results: A total of 36 PLWH received nivolumab, including 15 with KS and 21 with a variety of other solid tumors. None of the first 12 participants had dose‐limiting toxicity in both CD4 strata, and five patients (14%) overall had grade 3 or higher immune related adverse events. Objective partial response occurred in nine PLWH and cancer (25%), including in six of 15 with KS (40%; 95% CI, 16.3–64.7). The median duration of response was 9.0 months overall and 12.5 months in KS. Responses were observed regardless of PDL1 expression. There were no significant changes in CD4 count or HIV viral load. Conclusions: Nivolumab has a safety profile in PLWH similar to HIV‐negative subjects with cancer, and also efficacy in KS. Plasma HIV remained suppressed and CD4 counts remained stable during treatment and antiretroviral therapy, indicating no adverse impact on immune function. Trial Registration: ClinicalTrials.gov Identifier: NCT02408861. The anti‐PD1 inhibitor nivolumab may be used safely for treatment of cancer, and has activity in Kaposi sarcoma, in people living with HIV receiving antiretroviral therapy, a suppressed HIV viral load, and CD4 lymphocyte count of at least 100/µL. [ABSTRACT FROM AUTHOR]

Published
2024
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35. Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer

Author

Kos, Zuzana, Roblin, Elvire, Kim, Rim S., Michiels, Stefan, Gallas, Brandon D., Chen, Weijie, van de Vijver, Koen K., Goel, Shom, Adams, Sylvia, Demaria, Sandra, Viale, Giuseppe, Nielsen, Torsten O., Badve, Sunil S., Symmans, W. Fraser, Sotiriou, Christos, Rimm, David L., Hewitt, Stephen, Denkert, Carsten, Loibl, Sibylle, Luen, Stephen J., Bartlett, John M. S., Savas, Peter, Pruneri, Giancarlo, Dillon, Deborah A., Cheang, Maggie Chon U., Tutt, Andrew, Hall, Jacqueline A., Kok, Marleen, Horlings, Hugo M., Madabhushi, Anant, van der Laak, Jeroen, Ciompi, Francesco, Laenkholm, Anne-Vibeke, Bellolio, Enrique, Gruosso, Tina, Fox, Stephen B., Araya, Juan Carlos, Floris, Giuseppe, Hudeček, Jan, Voorwerk, Leonie, Beck, Andrew H., Kerner, Jen, Larsimont, Denis, Declercq, Sabine, Van den Eynden, Gert, Pusztai, Lajos, Ehinger, Anna, Yang, Wentao, AbdulJabbar, Khalid, Yuan, Yinyin, Singh, Rajendra, Hiley, Crispin, Bakir, Maise al, Lazar, Alexander J., Naber, Stephen, Wienert, Stephan, Castillo, Miluska, Curigliano, Giuseppe, Dieci, Maria-Vittoria, André, Fabrice, Swanton, Charles, Reis-Filho, Jorge, Sparano, Joseph, Balslev, Eva, Chen, I-Chun, Stovgaard, Elisabeth Ida Specht, Pogue-Geile, Katherine, Blenman, Kim R. M., Penault-Llorca, Frédérique, Schnitt, Stuart, Lakhani, Sunil R., Vincent-Salomon, Anne, Rojo, Federico, Braybrooke, Jeremy P., Hanna, Matthew G., Soler-Monsó, M. Teresa, Bethmann, Daniel, Castaneda, Carlos A., Willard-Gallo, Karen, Sharma, Ashish, Lien, Huang-Chun, Fineberg, Susan, Thagaard, Jeppe, Comerma, Laura, Gonzalez-Ericsson, Paula, Brogi, Edi, Loi, Sherene, Saltz, Joel, Klaushen, Frederick, Cooper, Lee, Amgad, Mohamed, Moore, David A., and Salgado, Roberto

Published
2020
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38. Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer

Author

Page, David B., Bear, Harry, Prabhakaran, Sangeetha, Gatti-Mays, Margaret E., Thomas, Alexandra, Cobain, Erin, McArthur, Heather, Balko, Justin M., Gameiro, Sofia R., Nanda, Rita, Gulley, James L., Kalinsky, Kevin, White, Julia, Litton, Jennifer, Chmura, Steven J., Polley, Mei-Yin, Vincent, Benjamin, Cescon, David W., Disis, Mary L., Sparano, Joseph A., Mittendorf, Elizabeth A., and Adams, Sylvia

Published
2019
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39. A Phase I/II study of suberoylanilide hydroxamic acid (SAHA) in combination with trastuzumab (Herceptin) in patients with advanced metastatic and/or local chest wall recurrent HER2-amplified breast cancer: a trial of the ECOG-ACRIN Cancer Research Group (E1104)

Author

Goldstein, Lori J., Zhao, Fengmin, Wang, Molin, Swaby, Ramona F., Sparano, Joseph A., Meropol, Neal J., Bhalla, Kapil N., Pellegrino, Christine M., Katherine Alpaugh, R., Falkson, Carla I., Klein, Paula, and Sledge, George W.

Published
2017
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42. Assessing Tumor-Infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method from the International Immuno-Oncology Biomarkers Working Group: Part 2: TILs in Melanoma, Gastrointestinal Tract Carcinomas, Non–Small Cell Lung Carcinoma and Mesothelioma, Endometrial and Ovarian Carcinomas, Squamous Cell Carcinoma of the Head and Neck, Genitourinary Carcinomas, and Primary Brain Tumors

Author

Hendry, Shona, Salgado, Roberto, Gevaert, Thomas, Russell, Prudence A., John, Tom, Thapa, Bibhusal, Christie, Michael, van de Vijver, Koen, Estrada, M.V., Gonzalez-Ericsson, Paula I., Sanders, Melinda, Solomon, Benjamin, Solinas, Cinzia, Van den Eynden, Gert G.G.M., Allory, Yves, Preusser, Matthias, Hainfellner, Johannes, Pruneri, Giancarlo, Vingiani, Andrea, Demaria, Sandra, Symmans, Fraser, Nuciforo, Paolo, Comerma, Laura, Thompson, E.A., Lakhani, Sunil, Kim, Seong-Rim, Schnitt, Stuart, Colpaert, Cecile, Sotiriou, Christos, Scherer, Stefan J., Ignatiadis, Michail, Badve, Sunil, Pierce, Robert H., Viale, Giuseppe, Sirtaine, Nicolas, Penault-Llorca, Frederique, Sugie, Tomohagu, Fineberg, Susan, Paik, Soonmyung, Srinivasan, Ashok, Richardson, Andrea, Wang, Yihong, Chmielik, Ewa, Brock, Jane, Johnson, Douglas B., Balko, Justin, Wienert, Stephan, Bossuyt, Veerle, Michiels, Stefan, Ternes, Nils, Burchardi, Nicole, Luen, Stephen J., Savas, Peter, Klauschen, Frederick, Watson, Peter H., Nelson, Brad H., Criscitiello, Carmen, O’Toole, Sandra, Larsimont, Denis, de Wind, Roland, Curigliano, Giuseppe, André, Fabrice, Lacroix-Triki, Magali, van de Vijver, Mark, Rojo, Federico, Floris, Giuseppe, Bedri, Shahinaz, Sparano, Joseph, Rimm, David, Nielsen, Torsten, Kos, Zuzana, Hewitt, Stephen, Singh, Baljit, Farshid, Gelareh, Loibl, Sibylle, Allison, Kimberly H., Tung, Nadine, Adams, Sylvia, Willard-Gallo, Karen, Horlings, Hugo M., Gandhi, Leena, Moreira, Andre, Hirsch, Fred, Dieci, Maria V., Urbanowicz, Maria, Brcic, Iva, Korski, Konstanty, Gaire, Fabien, Koeppen, Hartmut, Lo, Amy, Giltnane, Jennifer, Rebelatto, Marlon C., Steele, Keith E., Zha, Jiping, Emancipator, Kenneth, Juco, Jonathan W., Denkert, Carsten, Reis-Filho, Jorge, Loi, Sherene, and Fox, Stephen B.

Published
2017
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44. Gene Expression Assays in Early-Stage Breast Cancer: Dr. Sparano discusses the implications of TAILORx, the first trial to use Oncotype DX in clinical decision making

Author

Sparano, Joseph A.

Subjects
Adjuvant chemotherapy -- Usage, Breast cancer -- Genetic aspects -- Care and treatment -- Risk factors, Decision making -- Analysis, Gene expression -- Research, Women's health -- Analysis, Cancer genetics, Cancer treatment, Periodicals, Estrogens, Phenols (Class of compounds), Genes, Epidermal growth factors, Clinical trials, Genetic research, Biochemistry, Health
Abstract

Results from the first clinical trial to incorporate a gene expression assay--which may potentially facilitate clinical decisions in women with early-stage breast cancer--were recently published in the New England Journal [...]

Published
2018

47. Treatment factors affecting outcomes in HIV-associated non-Hodgkin lymphomas: a pooled analysis of 1546 patients

Author

Barta, Stefan K., Xue, Xiaonan, Wang, Dan, Tamari, Roni, Lee, Jeannette Y., Mounier, Nicolas, Kaplan, Lawrence D., Ribera, Josep-Maria, Spina, Michele, Tirelli, Umberto, Weiss, Rudolf, Galicier, Lionel, Boue, Francois, Wilson, Wyndham H., Wyen, Christoph, Oriol, Albert, Navarro, José-Tomás, Dunleavy, Kieron, Little, Richard F., Ratner, Lee, Garcia, Olga, Morgades, Mireia, Remick, Scot C., Noy, Ariela, and Sparano, Joseph A.

Published
2013
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49. Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer

Author

Palefsky, Joel M, Lee, Jeannette Y, Jay, Naomi, Goldstone, Stephen E, Darragh, Teresa M, Dunlevy, Hillary A, Rosa-Cunha, Isabella, Arons, Abigail, Pugliese, Julia C, Vena, Don, Sparano, Joseph A, Wilkin, Timothy J, Bucher, Gary, Stier, Elizabeth A, Tirado Gomez, Maribel, Flowers, Lisa, Barroso, Luis F, Mitsuyasu, Ronald T, Lensing, Shelly Y, Logan, Jeffrey, Aboulafia, David M, Schouten, Jeffrey T, de la Ossa, Juan, Levine, Rebecca, Korman, Jessica D, Hagensee, Michael, Atkinson, Thomas M, Einstein, Mark H, Cracchiolo, Bernadette M, Wiley, Dorothy, Ellsworth, Grant B, Brickman, Cristina, Berry-Lawhorn, J Michael, and ANCHOR Investigators Group

Subjects
Male, Adult, Biopsy, Squamous Intraepithelial Lesions, Clinical Trials and Supportive Activities, ANCHOR Investigators Group, HIV Infections, Medical and Health Sciences, Article, Clinical Research, General & Internal Medicine, Humans, Prospective Studies, Homosexuality, Male, Watchful Waiting, Cancer, Prevention, Papillomavirus Infections, General Medicine, Homosexuality, Anus Neoplasms, HIV/AIDS, Female, Digestive Diseases, Precancerous Conditions
Abstract

BACKGROUND: The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking. METHODS: We conducted a phase 3 trial at 25 U.S. sites. Persons living with HIV who were 35 years of age or older and who had biopsy-proven anal HSIL were randomly assigned, in a 1:1 ratio, to receive either HSIL treatment or active monitoring without treatment. Treatment included office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod. The primary outcome was progression to anal cancer in a time-to-event analysis. Participants in the treatment group were treated until HSIL was completely resolved. All the participants underwent high-resolution anoscopy at least every 6 months; biopsy was also performed for suspected ongoing HSIL in the treatment group, annually in the active-monitoring group, or any time there was concern for cancer. RESULTS: Of 4459 participants who underwent randomization, 4446 (99.7%) were included in the analysis of the time to progression to cancer. With a median follow-up of 25.8 months, 9 cases were diagnosed in the treatment group (173 per 100,000 person-years; 95% confidence interval [CI], 90 to 332) and 21 cases in the active-monitoring group (402 per 100,000 person-years; 95% CI, 262 to 616). The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test). CONCLUSIONS: Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02135419.)

Published
2022

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