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2. 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, and Berry-Lawhorn, J Michael

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

BackgroundThe 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.MethodsWe 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.ResultsOf 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).ConclusionsAmong 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

5. Plasma extracellular vesicles bearing PD-L1, CD40, CD40L or TNF-RII are significantly reduced after treatment of AIDS-NHL

Author

Martínez, Laura E, Lensing, Shelly, Chang, Di, Magpantay, Larry I, Mitsuyasu, Ronald, Ambinder, Richard F, Sparano, Joseph A, Martínez-Maza, Otoniel, and Epeldegui, Marta

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Hematology, Rare Diseases, Lymphoma, Clinical Research, Clinical Trials and Supportive Activities, Cancer, 2.1 Biological and endogenous factors, Aetiology, Acquired Immunodeficiency Syndrome, B7-H1 Antigen, CD40 Antigens, CD40 Ligand, Extracellular Vesicles, Humans, Lymphoma, AIDS-Related, Receptors, Tumor Necrosis Factor, Type II
Abstract

Emerging evidence shows that tumor cells secrete extracellular vesicles (EVs) that carry bioactive cell surface markers, such as programmed death-ligand 1 (PD-L1), which can modulate immune responses and inhibit anti-tumor responses, potentially playing a role in lymphomagenesis and in promoting the growth of these cancers. In this study, we investigated the role of EVs expressing cell surface molecules associated with B cell activation and immune regulation. We measured levels of EVs derived from plasma from 57 subjects with AIDS-related non-Hodgkin lymphoma (AIDS-NHL) enrolled in the AIDS Malignancies Consortium (AMC) 034 clinical trial at baseline and post-treatment with rituximab plus concurrent infusional EPOCH chemotherapy. We found that plasma levels of EVs expressing PD-L1, CD40, CD40L or TNF-RII were significantly reduced after cancer treatment. AIDS-NHL patients with the diffuse large B cell lymphoma (DLBCL) tumor subtype had decreased plasma levels of EVs bearing PD-L1, compared to those with Burkitt's lymphoma. CD40, CD40L and TNF-RII-expressing EVs showed a significant positive correlation with plasma levels of IL-10, CXCL13, sCD25, sTNF-RII and IL-18. Our results suggest that patients with AIDS-NHL have higher levels of EVs expressing PD-L1, CD40, CD40L or TNF-RII in circulation before cancer treatment and that levels of these EVs are associated with levels of biomarkers of microbial translocation and inflammation.

Published
2022

6. Immune Activation and Microbial Translocation as Prognostic Biomarkers for AIDS-Related Non-Hodgkin Lymphoma in the AMC-034 Study

Author

Martínez, Laura E, Lensing, Shelly, Chang, Di, Magpantay, Larry I, Mitsuyasu, Ronald, Ambinder, Richard F, Sparano, Joseph A, Martínez-Maza, Otoniel, and Epeldegui, Marta

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Infectious Diseases, Lymphoma, HIV/AIDS, Rare Diseases, Hematology, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Bacterial Translocation, Biomarkers, Humans, Lymphoma, AIDS-Related, Lymphoma, Non-Hodgkin, Prognosis, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeAIDS-related non-Hodgkin lymphoma (ARL) is the most common cancer in HIV-infected individuals in the United States and other countries in which HIV-positive persons have access to effective combination antiretroviral therapy (cART). Our prior work showed that pretreatment/postdiagnosis plasma levels of some cytokines, such as IL6, IL10, and CXCL13, have the potential to serve as indicators of clinical response to treatment and survival in ARL. The aims of this study were to identify novel prognostic biomarkers for response to treatment and/or survival in persons with ARL, including biomarkers of microbial translocation and inflammation.Experimental designWe quantified plasma levels of several biomarkers (sCD14, LBP, FABP2, EndoCab IgM, IL18, CCL2/MCP-1, sCD163, IP-10/CXCL10, TARC/CCL17, TNFα, BAFF/BLyS, sTNFRII, sCD44, and sIL2Rα/sCD25) by multiplexed immunometric assays (Luminex) or ELISA in plasma specimens obtained from ARL patients enrolled in the AMC-034 trial, which compared infusional combination chemotherapy (EPOCH: etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone) with concurrent or sequential rituximab. Plasma was collected prior to the initiation of therapy (n = 57) and after treatment initiation (n = 55).ResultsWe found that several biomarkers decreased significantly after treatment, including TNFα, sCD25, LBP, and TARC (CCL17). Moreover, pretreatment plasma levels of BAFF, sCD14, sTNFRII, and CCL2/MCP-1 were univariately associated with overall survival, and pretreatment levels of BAFF, sTNFRII, and CCL2/MCP-1 were also associated with progression-free survival.ConclusionsOur results suggest that patients with ARL who responded to therapy had lower pretreatment levels of inflammation and microbial translocation as compared with those who did not respond optimally.

Published
2021

7. 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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9. 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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11. 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, primary, Zhao, Fengmin, additional, Sparano, Joseph A., additional, Garcia, Sofia F., additional, Shen, Fei, additional, Virani, Shamsuddin, additional, Srinivasiah, Jayanthi, additional, Stringer-Reasor, Erica Michelle, additional, Chitalia, Ami, additional, Davis, Andrew A., additional, Makower, Della F., additional, Incorvati, Jason, additional, Simon, Melissa A., additional, Mitchell, Edith P., additional, DeMichele, Angela, additional, Miller, Kathy, additional, Wagner, Lynne I., additional, Wolff, Antonio C., additional, and Schneider, Bryan P., additional

Published
2024
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12. Phase II study of a PARP inhibitor, talazoparib, in HER2- metastatic breast cancer (MBC) with a somatic BRCA1/2mutation identified in a cell-free DNA or tumor tissue genotyping assay.

Author

Vidula, Neelima, primary, Damodaran, Senthil, additional, Bhave, Manali A., additional, Blouch, Erica, additional, Ogbenna, Ogadinma, additional, Flaum, Lisa E., additional, Shah, Ami N., additional, Abramson, Vandana G, additional, Cristofanilli, Massimo, additional, Sparano, Joseph A., additional, Ostrer, Harry, additional, Horick, Nora K., additional, Rugo, Hope S., additional, and Bardia, Aditya, additional

Published
2024
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14. 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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15. 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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16. Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study

Author

Hurvitz, Sara A, Martin, Miguel, Jung, Kyung Hae, Huang, Chiun-Sheng, Harbeck, Nadia, Valero, Vicente, Stroyakovskiy, Daniil, Wildiers, Hans, Campone, Mario, Boileau, Jean-François, Fasching, Peter A, Afenjar, Karen, Spera, Gonzalo, Lopez-Valverde, Vanesa, Song, Chunyan, Trask, Peter, Boulet, Thomas, Sparano, Joseph A, Symmans, W Fraser, Thompson, Alastair M, and Slamon, Dennis

Subjects
Clinical Trials and Supportive Activities, Patient Safety, Breast Cancer, Cancer, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Carboplatin, Chemotherapy, Adjuvant, Disease-Free Survival, Docetaxel, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Neoadjuvant Therapy, Receptor, ErbB-2, Trastuzumab, Receptor, erbB-2, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe KRISTINE study compared neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P) for the treatment human epidermal growth factor receptor 2-positive stage II to III breast cancer. T-DM1+P led to a lower pathologic complete response rate (44.4% v 55.7%; P = .016), but fewer grade 3 or greater and serious adverse events (AEs). Here, we present 3-year outcomes from KRISTINE.MethodsPatients were randomly assigned to neoadjuvant T-DM1+P or TCH+P every 3 weeks for six cycles. Patients who received T-DM1+P continued adjuvant T-DM1+P, and patients who received TCH+P received adjuvant trastuzumab plus pertuzumab. Secondary end points included event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS; measured from surgery).ResultsOf patients, 444 were randomly assigned (T-DM1+P, n = 223; TCH+P, n = 221). Median follow-up was 37 months. Risk of an EFS event was higher with TDM-1+P (hazard ratio [HR], 2.61 [95% CI, 1.36 to 4.98]) with more locoregional progression events before surgery (15 [6.7%] v 0). Risk of an IDFS event after surgery was similar between arms (HR, 1.11 [95% CI, 0.52 to 2.40]). Pathologic complete response was associated with a reduced risk of an IDFS event (HR, 0.24 [95% CI, 0.09 to 0.60]) regardless of treatment arm. Overall, grade 3 or greater AEs (31.8% v 67.7%) were less common with T-DM1+P. During adjuvant treatment, grade 3 or greater AEs (24.5% v 9.9%) and AEs leading to treatment discontinuation (18.4% v 3.8%) were more common with T-DM1+P. Patient-reported outcomes favored T-DM1+P during neoadjuvant treatment and were similar to trastuzumab plus pertuzumab during adjuvant treatment.ConclusionCompared with TCH+P, T-DM1+P resulted in a higher risk of an EFS event owing to locoregional progression events before surgery, a similar risk of an IDFS event, fewer grade 3 or greater AEs during neoadjuvant treatment, and more AEs leading to treatment discontinuation during adjuvant treatment.

Published
2019

17. 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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21. 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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22. 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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25. Adjuvant platinum versus capecitabine for residual, invasive, triple‐negative breast cancer: Patient‐reported outcomes in ECOG‐ACRIN EA1131

Author

Smith, Karen L., primary, Zhao, Fengmin, additional, Mayer, Ingrid A., additional, Tevaarwerk, Amye J., additional, Garcia, Sofia F., additional, Arteaga, Carlos L., additional, Symmans, William F., additional, Park, Ben H., additional, Burnette, Brian L., additional, Makower, Della F., additional, Block, Margaret, additional, Morley, Kimberly A., additional, Jani, Chirag R., additional, Mescher, Craig, additional, Dewani, Shabana J., additional, Brown‐Glaberman, Ursa, additional, Flaum, Lisa E., additional, Mayer, Erica L., additional, Sikov, William M., additional, Rodler, Eve T., additional, DeMichele, Angela M., additional, Sparano, Joseph A., additional, Wolff, Antonio C., additional, Miller, Kathy D., additional, and Wagner, Lynne I., additional

Published
2024
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26. Data from A Phase I/II Study of GSK525762 Combined with Fulvestrant in Patients with Hormone Receptor–positive/HER2-negative Advanced or Metastatic Breast Cancer

Author

Cescon, David W., primary, Hilton, John, primary, Morales Murilo, Serafin, primary, Layman, Rachel M., primary, Pluard, Timothy, primary, Yeo, Belinda, primary, Park, In Hae, primary, Provencher, Louise, primary, Kim, Sung-Bae, primary, Im, Young-Hyuck, primary, Wyce, Anastasia, primary, Krishnatry, Anu Shilpa, primary, Hicks, Kirsty, primary, Zhang, Qu, primary, Barbash, Olena, primary, Khaled, Ahmed, primary, Horner, Thierry, primary, Dhar, Arindam, primary, Oliveira, Mafalda, primary, and Sparano, Joseph A., primary

Published
2024
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27. Supplementary Data1 from A Phase I/II Study of GSK525762 Combined with Fulvestrant in Patients with Hormone Receptor–positive/HER2-negative Advanced or Metastatic Breast Cancer

Author

Cescon, David W., primary, Hilton, John, primary, Morales Murilo, Serafin, primary, Layman, Rachel M., primary, Pluard, Timothy, primary, Yeo, Belinda, primary, Park, In Hae, primary, Provencher, Louise, primary, Kim, Sung-Bae, primary, Im, Young-Hyuck, primary, Wyce, Anastasia, primary, Krishnatry, Anu Shilpa, primary, Hicks, Kirsty, primary, Zhang, Qu, primary, Barbash, Olena, primary, Khaled, Ahmed, primary, Horner, Thierry, primary, Dhar, Arindam, primary, Oliveira, Mafalda, primary, and Sparano, Joseph A., primary

Published
2024
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28. 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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30. 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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32. Cetuximab Plus Chemoradiotherapy in Immunocompetent Patients With Anal Carcinoma: A Phase II Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group Trial (E3205)

Author

Garg, Madhur K, Zhao, Fengmin, Sparano, Joseph A, Palefsky, Joel, Whittington, Richard, Mitchell, Edith P, Mulcahy, Mary F, Armstrong, Karin I, Nabbout, Nassim H, Kalnicki, Shalom, El-Rayes, Bassel F, Onitilo, Adedayo A, Moriarty, Daniel J, Fitzgerald, Thomas J, and Benson, Al B

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Clinical Trials and Supportive Activities, Clinical Research, Cancer, Digestive Diseases, Evaluation of treatments and therapeutic interventions, 6.5 Radiotherapy and other non-invasive therapies, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Anus Neoplasms, Carcinoma, Squamous Cell, Cetuximab, Chemoradiotherapy, Cisplatin, Disease-Free Survival, Female, Fluorouracil, Humans, Immunocompetence, Male, Middle Aged, Neoplasm Staging, Survival Rate, Clinical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Purpose Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after sphincter-preserving definitive chemoradiation (CRT) and is typically associated with anogenital human papilloma virus infection. Because cetuximab enhances the effect of radiation therapy in human papilloma virus-associated oropharyngeal squamous cell carcinoma, we hypothesized that adding cetuximab to CRT would reduce LRF in SCCAC. Methods Sixty-one patients with stage I to III SCCAC received CRT including cisplatin, fluorouracil, and radiation therapy to the primary tumor and regional lymph nodes (45 to 54 Gy) plus eight once-weekly doses of concurrent cetuximab. The study was designed to detect at least a 50% reduction in 3-year LRF rate (one-sided α, 0.10; power 90%), assuming a 35% LRF rate from historical data. Results Poor risk features included stage III disease in 64% and male sex in 20%. The 3-year LRF rate was 23% (95% CI, 13% to 36%; one-sided P = .03) by binomial proportional estimate using the prespecified end point and 21% (95% CI, 7% to 26%) by Kaplan-Meier estimate in a post hoc analysis using methods consistent with historical data. Three-year rates were 68% (95% CI, 55% to 79%) for progression-free survival and 83% (95% CI, 71% to 91%) for overall survival. Grade 4 toxicity occurred in 32%, and 5% had treatment-associated deaths. Conclusion Although the addition of cetuximab to chemoradiation for SCCAC was associated with lower LRF rates than historical data with CRT alone, toxicity was substantial, and LRF still occurs in approximately 20%, indicating the continued need for more effective and less toxic therapies.

Published
2017

33. Cetuximab Plus Chemoradiotherapy for HIV-Associated Anal Carcinoma: A Phase II AIDS Malignancy Consortium Trial.

Author

Sparano, Joseph A, Lee, Jeannette Y, Palefsky, Joel, Henry, David H, Wachsman, William, Rajdev, Lakshmi, Aboulafia, David, Ratner, Lee, Fitzgerald, Thomas J, Kachnic, Lisa, and Mitsuyasu, Ronald

Subjects
Humans, HIV Infections, Carcinoma, Squamous Cell, Anus Neoplasms, Cisplatin, Fluorouracil, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Treatment Outcome, Prospective Studies, Adult, Aged, Middle Aged, Female, Male, Chemoradiotherapy, Cetuximab, Clinical Research, Digestive Diseases, Cancer, Infectious Diseases, Clinical Trials and Supportive Activities, HIV/AIDS, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Purpose Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after definitive chemoradiation (CRT), associated with anogenital human papilloma virus, and often appears in HIV infection. Because cetuximab enhances the effect of radiation therapy in human papilloma virus-associated oropharyngeal SCC, we hypothesized that adding cetuximab to CRT would reduce LRF in SCCAC. Methods Forty-five patients with stage I to III SCCAC and HIV infection received CRT: 45 to 54 Gy radiation therapy to the primary tumor and regional lymph nodes plus eight once-weekly doses of concurrent cetuximab and two cycles of cisplatin and fluorouracil. The study was designed to detect at least a 50% reduction in 3-year LRF rate (one-sided α, 0.10; power, 90%), assuming a 35% LRF rate from historical data. Results The 3-year LRF rate was 42% (95% CI, 28% to 56%; one-sided P = .9) by binomial proportional estimate using the prespecified end point (LRF or alive without LRF and followed < 3 years), and 20% (95% CI, 10% to 37%) by Kaplan-Meier estimate in post hoc analysis using definitions and methods consistent with historical data. Three-year rates by Kaplan-Meier estimate were 72% (95% CI, 56% to 84%) for progression-free survival and 79% (95% CI, 63% to 89%) for overall survival. Grade 4 toxicity occurred in 26%, and 4% had treatment-associated deaths. Conclusion HIV-associated SCCAC is potentially curable with definitive CRT. Although addition of cetuximab may result in less LRF, the 20% recurrence and 26% grade 4 toxicity rates indicate the continued need for more-effective and less-toxic therapies.

Published
2017

34. Genome-Wide Association Study for Anthracycline-Induced Congestive Heart Failure

Author

Schneider, Bryan P, Shen, Fei, Gardner, Laura, Radovich, Milan, Li, Lang, Miller, Kathy D, Jiang, Guanglong, Lai, Dongbing, O'Neill, Anne, Sparano, Joseph A, Davidson, Nancy E, Cameron, David, Gradus-Pizlo, Irmina, Mastouri, Ronald A, Suter, Thomas M, Foroud, Tatiana, and Sledge, George W

Subjects
Clinical Research, Cancer, Breast Cancer, Clinical Trials and Supportive Activities, Genetics, Heart Disease, Cardiovascular, Patient Safety, Prevention, Human Genome, Aging, Anthracyclines, Antibiotics, Antineoplastic, Breast Neoplasms, Case-Control Studies, Clinical Trials, Phase III as Topic, Female, Genetic Predisposition to Disease, Genome-Wide Association Study, Genotype, Heart Failure, Humans, Phenotype, Polymorphism, Single Nucleotide, Prognosis, Reproducibility of Results, Risk Assessment, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeAnthracycline-induced congestive heart failure (CHF) is a rare but serious toxicity associated with this commonly employed anticancer therapy. The ability to predict which patients might be at increased risk prior to exposure would be valuable to optimally counsel risk-to-benefit ratio for each patient. Herein, we present a genome-wide approach for biomarker discovery with two validation cohorts to predict CHF from adult patients planning to receive anthracycline.Experimental designWe performed a genome-wide association study in 3,431 patients from the randomized phase III adjuvant breast cancer trial E5103 to identify single nucleotide polymorphism (SNP) genotypes associated with an increased risk of anthracycline-induced CHF. We further attempted candidate validation in two independent phase III adjuvant trials, E1199 and BEATRICE.ResultsWhen evaluating for cardiologist-adjudicated CHF, 11 SNPs had a P value

Published
2017

35. Human Immunodeficiency Virus/AIDS, Human Papillomavirus, and Anal Cancer

Author

Wang, Chia-ching J, Sparano, Joseph, and Palefsky, Joel M

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Vaccine Related, Digestive Diseases, Infectious Diseases, Cancer, Immunization, Cervical Cancer, HIV/AIDS, Sexually Transmitted Infections, Aetiology, 2.1 Biological and endogenous factors, 2.2 Factors relating to the physical environment, Infection, Good Health and Well Being, Acquired Immunodeficiency Syndrome, Anal Canal, Anus Neoplasms, HIV, HIV Seropositivity, Humans, Immunocompromised Host, Immunosuppression Therapy, Papillomaviridae, Papillomavirus Infections, Papillomavirus Vaccines, HPV, HPV vaccination, Anal cancer, Immunosuppression, Oncology and Carcinogenesis, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Anal cancer is an increasingly common non-AIDS-defining cancer among individuals infected with the human immunodeficiency virus (HIV). It is associated with human papillomavirus (HPV). HPV16 is the most common genotype detected in anal cancers. The HPV types detected in anal cancer are included in the 9-valent vaccine. HPV vaccines have demonstrated efficacy in reducing anal precancerous lesions in HIV-infected individuals. Standard treatment has been fluorouracil and mitomycin (or cisplatin) plus radiation. Continued studies are needed to test new treatment strategies in HIV-infected patients with anal cancer to determine which treatment protocols provide the best therapeutic index.

Published
2017

37. Predictive Value of Cytokines and Immune Activation Biomarkers in AIDS-Related Non-Hodgkin Lymphoma Treated with Rituximab plus Infusional EPOCH (AMC-034 trial)

Author

Epeldegui, Marta, Lee, Jeannette Y, Martínez, Anna C, Widney, Daniel P, Magpantay, Larry I, Regidor, Deborah, Mitsuyasu, Ronald, Sparano, Joseph A, Ambinder, Richard F, and Martínez-Maza, Otoniel

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Rare Diseases, Cancer, Lymphoma, Hematology, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Acquired Immunodeficiency Syndrome, Adult, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Cyclophosphamide, Cytokines, Disease-Free Survival, Doxorubicin, Etoposide, Humans, Lymphocyte Activation, Lymphoma, AIDS-Related, Lymphoma, Non-Hodgkin, Prednisone, Rituximab, Vincristine, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeThe aims of this study were to determine whether pretreatment plasma levels of cytokines and immune activation-associated molecules changed following treatment for AIDS-NHL with rituximab plus infusional EPOCH, and to determine whether pretreatment levels of these molecules were associated with response to treatment and/or survival.Experimental designWe quantified plasma levels of B-cell activation-associated molecules (sCD27, sCD30, and sCD23) and cytokines (IL6, IL10, and CXCL13) before and after the initiation of treatment in persons with AIDS-NHL (n = 69) in the AIDS Malignancies Consortium (AMC) 034 study, which evaluated treatment of AIDS-NHL with EPOCH chemotherapy and rituximab.ResultsTreatment resulted in decreased plasma levels of some of these molecules (CXCL13, sCD27, and sCD30), with decreased levels persisting for one year following the completion of treatment. Lower levels of CXCL13 before treatment were associated with complete responses following lymphoma therapy. Elevated levels of IL6 pretreatment were associated with decreased overall survival, whereas higher IL10 levels were associated with shorter progression-free survival (PFS), in multivariate analyses. Furthermore, patients with CXCL13 or IL6 levels higher than the median levels for the NHL group, as well as those who had detectable IL10, had lower overall survival and PFS, in Kaplan-Meier analyses.ConclusionsThese results indicate that CXCL13, IL6, and IL10 have significant potential as prognostic biomarkers for AIDS-NHL.

Published
2016

38. Supplementary Table 1 from Phase I Trial of the Multi-kinase Inhibitor Cabozantinib, a CYP3A4 Substrate, plus CYP3A4-Interacting Antiretroviral Therapy in People Living with HIV and Cancer (AMC-087)

Author

Haigentz, Missak, primary, Lee, Jeannette Y., primary, Chiao, Elizabeth Y., primary, Aboulafia, David M., primary, Ratner, Lee, primary, Ambinder, Richard F., primary, Baiocchi, Robert A., primary, Mitsuyasu, Ronald T., primary, Wachsman, William, primary, Sparano, Joseph A., primary, and Rudek, Michelle A., primary

Published
2023
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39. Supplementary Figure 1 from Phase I Trial of the Multi-kinase Inhibitor Cabozantinib, a CYP3A4 Substrate, plus CYP3A4-Interacting Antiretroviral Therapy in People Living with HIV and Cancer (AMC-087)

Author

Haigentz, Missak, primary, Lee, Jeannette Y., primary, Chiao, Elizabeth Y., primary, Aboulafia, David M., primary, Ratner, Lee, primary, Ambinder, Richard F., primary, Baiocchi, Robert A., primary, Mitsuyasu, Ronald T., primary, Wachsman, William, primary, Sparano, Joseph A., primary, and Rudek, Michelle A., primary

Published
2023
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40. A Phase I/II Study of GSK525762 Combined With Fulvestrant in Patients With Hormone Receptor-Positive/HER2-Negative (HR+/HER2−) Advanced or Metastatic Breast Cancer

Author

Cescon, David W., primary, Hilton, John, additional, Morales Murilo, Serafín, additional, Layman, Rachel M., additional, Pluard, Timothy, additional, Yeo, Belinda, additional, Park, In Hae, additional, Provencher, Louise, additional, Kim, Sung-Bae, additional, Im, Young-Hyuck, additional, Wyce, Anastasia, additional, Krishnatry, Anu Shilpa, additional, Hicks, Kirsty, additional, Zhang, Qu, additional, Barbash, Olena, additional, Khaled, Ahmed, additional, Horner, Thierry, additional, Dhar, Arindam, additional, Oliveira, Mafalda, additional, and Sparano, Joseph A., additional

Published
2023
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42. 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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45. 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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46. 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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49. Data from Phase I Trial of the Multi-kinase Inhibitor Cabozantinib, a CYP3A4 Substrate, plus CYP3A4-Interacting Antiretroviral Therapy in People Living with HIV and Cancer (AMC-087)

Author

Haigentz, Missak, primary, Lee, Jeannette Y., primary, Chiao, Elizabeth Y., primary, Aboulafia, David M., primary, Ratner, Lee, primary, Ambinder, Richard F., primary, Baiocchi, Robert A., primary, Mitsuyasu, Ronald T., primary, Wachsman, William, primary, Sparano, Joseph A., primary, and Rudek, Michelle A., primary

Published
2023
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50. Phase I Trial of the Multi-kinase Inhibitor Cabozantinib, a CYP3A4 Substrate, plus CYP3A4-Interacting Antiretroviral Therapy in People Living with HIV and Cancer (AMC-087)

Author

Haigentz, Missak, primary, Lee, Jeannette Y., additional, Chiao, Elizabeth Y., additional, Aboulafia, David M., additional, Ratner, Lee, additional, Ambinder, Richard F., additional, Baiocchi, Robert A., additional, Mitsuyasu, Ronald T., additional, Wachsman, William, additional, Sparano, Joseph A., additional, and Rudek, Michelle A., additional

Published
2023
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