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2. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression.

Author

Tolaney, Sara, Loirat, Delphine, Punie, Kevin, Oliveira, Mafalda, Brufsky, Adam, Kalinsky, Kevin, Cortés, Javier, Shaughnessy, Joyce, Diéras, Véronique, Carey, Lisa, Gianni, Luca, Piccart-Gebhart, Martine, Loibl, Sibylle, Yoon, Oh, Pan, Yang, Hofsess, Scott, Phan, See-Chun, Hurvitz, Sara, Bardia, Aditya, and Rugo, Hope

Subjects
Humans, Triple Negative Breast Neoplasms, Female, Middle Aged, Antigens, Neoplasm, Adult, Receptor, ErbB-2, Antibodies, Monoclonal, Humanized, Cell Adhesion Molecules, Aged, Immunoconjugates, Camptothecin, Progression-Free Survival, Neoplasm Metastasis
Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Sacituzumab govitecan (SG), a first-in-class anti-trophoblast cell surface antigen 2 (Trop-2) antibody-drug conjugate, demonstrated superior efficacy over single-agent chemotherapy (treatment of physicians choice [TPC]) in patients with metastatic triple-negative breast cancer (mTNBC) in the international, multicenter, phase III ASCENT study.Patients were randomly assigned 1:1 to receive SG or TPC until unacceptable toxicity/progression. Final efficacy secondary end point analyses and post hoc analyses of outcomes stratified by Trop-2 expression and human epidermal growth factor receptor 2 status are reported. Updated safety analyses are provided.In this final analysis, SG (n = 267) improved median progression-free survival (PFS; 4.8 v 1.7 months; hazard ratio (HR), 0.41 [95% CI, 0.33 to 0.52]) and median overall survival (OS; 11.8 v 6.9 months; HR, 0.51 [95% CI, 0.42 to 0.63]) over TPC (n = 262). SG improved PFS over TPC in each Trop-2 expression quartile (n = 168); a trend was observed for improved OS across quartiles. Overall, SG had a manageable safety profile, with ≤5% of treatment-related discontinuations because of adverse events and no treatment-related deaths. The safety profile was consistent across all subgroups.These data confirm the clinical benefit of SG over chemotherapy, reinforcing SG as an effective treatment option in patients with mTNBC in the second line or later.

Published
2024

4. Author Correction: Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer

Author

Rugo, Hope S., Tolaney, Sara M., Loirat, Delphine, Punie, Kevin, Bardia, Aditya, Hurvitz, Sara A., O’Shaughnessy, Joyce, Cortés, Javier, Diéras, Véronique, Carey, Lisa A., Gianni, Luca, Piccart, Martine J., Loibl, Sibylle, Goldenberg, David M., Hong, Quan, Olivo, Martin, Itri, Loretta M., and Kalinsky, Kevin

Published
2024
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6. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, Zurawski, Bogdan, Spicer, Jonathan D, Garassino, Marina C, Majem, Margarita, Martinengo, Gastón L, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, and Samkari, Ayman

Published
2024
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7. Spatial predictors of immunotherapy response in triple-negative breast cancer

Author

Wang, Xiao Qian, Danenberg, Esther, Huang, Chiun-Sheng, Egle, Daniel, Callari, Maurizio, Bermejo, Begoña, Dugo, Matteo, Zamagni, Claudio, Thill, Marc, Anton, Anton, Zambelli, Stefania, Russo, Stefania, Ciruelos, Eva Maria, Greil, Richard, Győrffy, Balázs, Semiglazov, Vladimir, Colleoni, Marco, Kelly, Catherine M., Mariani, Gabriella, Del Mastro, Lucia, Biasi, Olivia, Seitz, Robert S., Valagussa, Pinuccia, Viale, Giuseppe, Gianni, Luca, Bianchini, Giampaolo, and Ali, H. Raza

Published
2023
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8. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Azevedo, Sergio, Braghiroli, Maria Ignez, Girotto, Gustavo, Bragagnoli, Arinilda, Branco, Ricardo, Faccio, Adilson, Moretto, Andrea, Skare, Nils, Dutra, Jamille, Viola, Luciana, Vianna, Karina, Meton, Fernando, Sette, Claudia, Faulhaber, Amanda, Tam, Vincent C., Couture, Felix, Biagi, Jim, Castel, Helene, Mulder, Karen, Ko, Yoo-Joung, Zbuk, Kevin, Welch, Stephen, Beaudoin, Annie, Heurgué, Alexandra, Assenat, Eric, Archambeaud, Isabelle, Tougeron, David, Peron, Jean-Marie, Gilabert, Marine, Bronowicki, Jean-Pierre, Cattan, Stephane, Blanc, Jean-Frederic, Bouattour, Mohamed, Phelip, Jean-Marc, Boige, Valerie, Michel, Pierre, Frin, Anne-Claire, De Toni, Enrico N., Berres, Marie-Luise, Vogel, Arndt, Berg, Thomas, Ettrich, Thomas, Waldschmidt, Dirk, Wedemeyer, Hans Heinrich, Worns, Marcus-Alexander, Bitzer, Michael, Weiss, Karl-Heinz, Lau, George, Chan, Stephen L., Yau, Thomas, Tai, Yin Ping, Lee, Ann Shing, Thungappa, Satheesh Chiradoni, N, Lokesh K., Sureshchand Ostwal, Vikas, Ashok, Kattimani Kiran, Mittal, Sushant, Goyal, Hari, Srinivasan, Sankar, Biswas, Ghanashyam, Mohan, Mallavarapu, Limaye, Sewanti, Asarawala, Nirav, Rimassa, Lorenza, Falcone, Alfredo, Gianni, Luca, Gasbarrini, Antonio, Daniele, Bruno, Avallone, Antonio, Paolo Frassineti, Giovanni Luca, Roila, Fausto, Kudo, Masatoshi, Kawaoka, Tomokazu, Morimoto, Manabu, Takikawa, Yasuhiro, Kato, Naoya, Yamashita, Tatsuya, Osaki, Yukio, Motomura, Kenta, Tateishi, Ryosuke, Ohkawa, Kazuyoshi, Wada, Yoshiyuki, Onishi, Hideki, Sasahira, Naoki, Inaba, Yoshitaka, Kurosaki, Masayuki, Tsuji, Kunihiko, Takei, Yoshiyuki, Aramaki, Takeshi, Hagihara, Atsushi, Furuse, Junji, Kioka, Kiyohide, Koga, Hironori, Sasaki, Yutaka, Numata, Kazushi, Tada, Toshifumi, Kawaguchi, Yasunori, Nadano, Seijin, Vasilyev, Alexander, Breder, Valery, Lipatov, Oleg, Dvorkin, Mikhail, Zarubenkov, Oleg, Kutukova, Svetlana, Ponomarev, Roman, Shostka, Kirill, Alyasova, Anna, Topuzov, Eldar, Severtsev, Alexey, Petrov, Yuryi, Erygin, Dmitriy, Berdov, Boris, Kang, Yoon-Koo, Tak, Won-Young, Park, Joong-Won, Lim, Ho Yeong, Heo, Jeong, Kim, Jee Hyun, Kim, Tae-You, Choi, Hye Jin, Varela, María, Reig Monzon, María Elisa, Sangro, Bruno, Martin, Carlos Gómez, Ponce, Carmen Guillén, López, Carlos, Cheng, Ann-Lii, Chao, Yee, Feng, Yin-Hsun, Jeng, Long-Bin, Hung, Chao-Hung, Hou, Ming-Mo, Wang Tsang-En Wang, Jing-Houng, Yen, Chia-Jui, Sukeepaisarnjaroen, Wattana, Sunpaweravong, Patrapim, Charoentum, Chaiyut, Tanasanvimon, Suebpong, Sirachainan, Ekaphop, Ungtrakul, Teerapat, Prasongsook, Naiyarat, Maneenil, Kunlatida, Jitpewngarm, Wittawat, Ostapenko, Yurii, Skoryi, Denys, Bondarenko, Igor, Shparyk, Yaroslav, Trukhin, Dmytro, Hotko, Yevhen, Ursol, Grygorii, Kryzhanivska, Anna, Abou-Alfa, Ghassan K., Mody, Kabir, Dayyani, Farshid, Al-Rajabi, Raed, Yarchoan, Mark, Gandhi, Sunil, Crysler, Oxana, He, Aiwu Ruth, Reeves, James, Bahary, Nathan, Mahipal, Amit, Kelley, Robin Kate, Dasgupta, Anirudha, Rowe, Julie, Thota, Ramya, Beg, Muhammad, Morse, Michael, Choi, Sung-hee, Crocenzi, Todd, Somer, Bradley, Abrams, Thomas, Denlinger, Crystal, Zhang, Yue, Sharma, Nisha, Dao, Tu V., Thinh, Nguyen Tien, Tuyet Phuong, Le Thi, Sangro, B., Chan, S.L., Kelley, R.K., Lau, G., Kudo, M., Sukeepaisarnjaroen, W., Yarchoan, M., De Toni, E.N., Furuse, J., Kang, Y.K., Galle, P.R., Rimassa, L., Heurgué, A., Tam, V.C., Van Dao, T., Thungappa, S.C., Breder, V., Ostapenko, Y., Reig, M., Makowsky, M., Paskow, M.J., Gupta, C., Kurland, J.F., Negro, A., and Abou-Alfa, G.K.

Published
2024
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9. Event-Free Survival in Patients with Early HER2-Positive Breast Cancer with a Pathological Complete Response after HER2-Targeted Therapy: A Pooled Analysis

Author

Swain, Sandra M, Macharia, Harrison, Cortes, Javier, Dang, Chau, Gianni, Luca, Hurvitz, Sara A, Jackisch, Christian, Schneeweiss, Andreas, Slamon, Dennis, Valagussa, Pinuccia, du Toit, Yolande, Heinzmann, Dominik, Knott, Adam, Song, Chunyan, and Cortazar, Patricia

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Breast Cancer, Clinical Trials and Supportive Activities, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, dual HER2 targeting, early breast cancer, event-free survival, HER2, pathologic complete response, pertuzumab, trastuzumab, Oncology and carcinogenesis
Abstract

The standard-of-care for patients with pathological complete response (pCR) after neoadjuvant human epidermal growth factor receptor 2 (HER2)-targeted therapy plus chemotherapy is continuation of HER2-targeted therapy in the adjuvant setting. Our objective was to evaluate risk of recurrence or death in these patients and determine if outcomes differed by the HER2-targeted regimen received in each setting. We analyzed patient-level data from five randomized trials evaluating trastuzumab, pertuzumab, or both as part of systemic neoadjuvant and adjuvant therapy for HER2-positive early breast cancer, and assessed event-free survival (EFS) in 1763 patients. Patients with pCR had decreased risk of an EFS event versus those with residual disease (unadjusted hazard ratio [HR] = 0.35; 95% confidence interval [CI]: 0.27-0.46). Regardless of pCR status, after adjusting for baseline factors, reduction in EFS event risk was greater in patients administered pertuzumab/trastuzumab in both settings versus those administered only trastuzumab in both settings (HR = 0.36; 95% CI: 0.26-0.49), or pertuzumab/trastuzumab in the neoadjuvant setting and only trastuzumab in the adjuvant setting (HR = 0.67; 95% CI: 0.47-0.96). Patients with pCR had longer EFS than those with residual disease. Patients treated with pertuzumab/trastuzumab in both the neoadjuvant and adjuvant settings had the lowest risk of breast cancer recurrence.

Published
2022

10. Sacituzumab govitecan as second-line treatment for metastatic triple-negative breast cancer—phase 3 ASCENT study subanalysis

Author

Carey, Lisa A, Loirat, Delphine, Punie, Kevin, Bardia, Aditya, Diéras, Véronique, Dalenc, Florence, Diamond, Jennifer R, Fontaine, Christel, Wang, Grace, Rugo, Hope S, Hurvitz, Sara A, Kalinsky, Kevin, O’Shaughnessy, Joyce, Loibl, Sibylle, Gianni, Luca, Piccart, Martine, Zhu, Yanni, Delaney, Rosemary, Phan, See, and Cortés, Javier

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Trials and Supportive Activities, Breast Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Clinical sciences, Oncology and carcinogenesis, Epidemiology
Abstract

Patients with triple-negative breast cancer (TNBC) who relapse early after (neo)adjuvant chemotherapy have more aggressive disease. In the ASCENT trial, sacituzumab govitecan (SG), an antibody-drug conjugate composed of an anti-Trop-2 antibody coupled to SN-38 via a hydrolyzable linker, improved outcomes over single-agent chemotherapy of physician's choice (TPC) in metastatic TNBC (mTNBC). Of 468 patients without known baseline brain metastases, 33/235 vs 32/233 patients (both 14%) in the SG vs TPC arms, respectively, received one line of therapy in the metastatic setting and experienced disease recurrence ≤12 months after (neo)adjuvant chemotherapy. SG prolonged progression-free survival (median 5.7 vs 1.5 months [HR, 0.41; 95% CI, 0.22-0.76]) and overall survival (median 10.9 vs 4.9 months [HR, 0.51; 95% CI, 0.28-0.91]) vs TPC, with a manageable safety profile in this subgroup consistent with the overall population. In this second-line setting, as with later-line therapy, SG improved survival over conventional chemotherapy for patients with mTNBC.

Published
2022

11. Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer

Author

Rugo, Hope S, Tolaney, Sara M, Loirat, Delphine, Punie, Kevin, Bardia, Aditya, Hurvitz, Sara A, O’Shaughnessy, Joyce, Cortés, Javier, Diéras, Véronique, Carey, Lisa A, Gianni, Luca, Piccart, Martine J, Loibl, Sibylle, Goldenberg, David M, Hong, Quan, Olivo, Martin, Itri, Loretta M, and Kalinsky, Kevin

Subjects
Genetics, Breast Cancer, Clinical Trials and Supportive Activities, Patient Safety, Clinical Research, Cancer
Abstract

Sacituzumab govitecan (SG) is an anti-Trop-2 antibody-drug conjugate with an SN-38 payload. In the ASCENT study, patients with metastatic triple-negative breast cancer (mTNBC) relapsed/refractory to ≥2 prior chemotherapy regimens (≥1 in the metastatic setting), received SG or single-agent treatment of physician's choice (eribulin, vinorelbine, capecitabine, or gemcitabine). This ASCENT safety analysis includes the impact of age and UGT1A1 polymorphisms, which hinder SN-38 detoxification. SG demonstrated a manageable safety profile in patients with mTNBC, including those ≥65 years; neutropenia/diarrhea are key adverse events (AE). Patients with UGT1A1 *28/*28 genotype versus those with 1/*28 and *1/*1 genotypes had higher rates of grade ≥3 SG-related neutropenia (59% vs 47% and 53%), febrile neutropenia (18% vs 5% and 3%), anemia (15% vs 6% and 4%), and diarrhea (15% vs 9% and 10%), respectively. Individuals with UGT1A1 *28/*28 genotype should be monitored closely; active monitoring and routine AE management allow optimal therapeutic exposure of SG.

Published
2022

12. 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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13. Health-related quality of life in the phase III ASCENT trial of sacituzumab govitecan versus standard chemotherapy in metastatic triple-negative breast cancer

Author

Loibl, Sibylle, Loirat, Delphine, Tolaney, Sara M., Punie, Kevin, Oliveira, Mafalda, Rugo, Hope S., Bardia, Aditya, Hurvitz, Sara A., Brufsky, Adam M., Kalinsky, Kevin, Cortés, Javier, O'Shaughnessy, Joyce A., Dieras, Véronique, Carey, Lisa A., Gianni, Luca, Gharaibeh, Mahdi, Preger, Luciana, Phan, See, Chang, Lawrence, Shi, Ling, and Piccart, Martine J.

Published
2023
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14. Incidence and severity of anaphylaxis and hypersensitivity in trials of intravenous pertuzumab plus trastuzumab or the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection for HER2-positive breast cancer

Author

Swain, Sandra M., Tan, Antoinette R., Gianni, Luca, Kuemmel, Sherko, Dang, Chau T., Schneeweiss, Andreas, O'Shaughnessy, Joyce, Liu, Haiying, Aguila, Christian, Heeson, Sarah, Macharia, Harrison, Yang, Ke, Restuccia, Eleonora, and Loibl, Sibylle

Published
2023
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16. Summary of quality of life in the ASCENT phase 3 clinical trial for people with metastatic triple-negative breast cancer.

Author

Loibl, Sibylle, Loirat, Delphine, Tolaney, Sara M., Punie, Kevin, Dieras, Véronique, Carey, Lisa A., Gianni, Luca, Shah, Anuj, Phan, See, Shi, Ling, Spears, Patricia A., and Piccart, Martine J.

Abstract

What is this summary about? A medicine called sacituzumab govitecan (brand name TRODELVY®) has been proven to be an effective treatment for metastatic triple-negative breast cancer (mTNBC for short). Metastatic breast cancer is cancer that has spread to other parts of the body. In mTNBC, the breast cancer cells do not have 3 common proteins on the cell surface, called receptors. mTNBC is more difficult to treat and more likely to come back than other types of breast cancer. The ASCENT study showed that participants with mTNBC treated with sacituzumab govitecan had a higher likelihood of living longer and delayed progression (worsening) of their cancer than those treated with standard chemotherapy. Here, we summarize the quality of life of participants with mTNBC in the ASCENT study. We compared quality of life between 236 participants treated with sacituzumab govitecan and 183 participants treated with standard chemotherapy. All participants previously received 2 or more chemotherapies that no longer controlled their cancer. What are the key takeaways? This analysis showed that participants treated with sacituzumab govitecan had better overall quality of life than participants treated with standard chemotherapy. They also had better "physical functioning", which is the ability to walk and do physical activities. Participants treated with sacituzumab govitecan maintained their overall quality of life for a longer time than those treated with standard chemotherapy. Participants treated with sacituzumab govitecan had less pain and were less tired than those treated with standard chemotherapy. On the other hand, participants treated with sacituzumab govitecan had worse diarrhea (loose or watery stools) and were more likely to have nausea/vomiting (feel sick or throw up) than participants treated with standard chemotherapy. What were the main conclusions reported by the researchers? Participants treated with sacituzumab govitecan had a higher likelihood of living longer and delayed progression (worsening) of their cancer. Participants also had a better overall quality of life, which was maintained (did not get worse) for a longer time. However, they experienced worsening of diarrhea and/or nausea/vomiting. Clinical Trial Registration:NCT02574455 (ASCENT) (ClinicalTrials.gov) [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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19. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Spicer, Jonathan D, Garassino, Marina C, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, Samkari, Ayman, Gao, Shugeng, Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, and Zurawski, Bogdan

Abstract

At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis.

Published
2024
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21. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

Author

Park, Se Hoon, van der Heijden, Michiel S., Necchi, Andrea, Castellano, Daniel, Bamias, Aristotelis, Lee, Jae Lyun, De Giorgi, Ugo, Bögemann, Martin, Eigl, Bernhard J., Tsiatas, Marinos, Powles, Thomas, Novikov, Andrey, Skoneczna, Iwona, Mukherjee, Som D., Suarez, Cristina, Westgeest, Hans, Fradet, Yves, Flechon, Aude, Ou, Yen-Chuan, Park, Inkeun, Matveev, Vsevolod, Pérez-Valderrama, Begoña, Cheng, Susanna, Frank, Stephen, Gurney, Howard, Anido, Urbano, Hamzaj, Alketa, Retz, Margitta, Sridhar, Srikala, Scagliotti, Giorgio Vittorio, Voortman, Jens, Alekseev, Boris, Alyasova, Anna, Komyakov, Boris, Dumez, Herlinde, Pavic, Michel, Kimura, Go, Mizokami, Atsushi, Osanto, Susanne, Arranz, Jose Angel, Piersma, Djura, Shin, Sang Joon, Karyakin, Oleg, Delgado, Ignacio, Gonzalez, Jose Luis, Pang, See-Tong, Tran, Anna, Lipatov, Oleg, Su, Wen-Pin, Flaig, Thomas, Alva, Ajjai, Park Kyong, Hwa, Kopyltsov, Evgeny, Almagro, Elena, Domenech, Monserrat, Chang, Yen-Hwa, Sautois, Brieuc, Ravaux, Andre, Aravantinos, Gerasimos, Georgoulias, Vasileios, Mulder, Sasja, Kim, Yu Jung, Kater, Fabio, Chevreau, Christine, Tagawa, Scott, Zalewski, Pawel, Joly, Florence, Loriot, Yohann, Hatiboglu, Gencay, Gianni, Luca, Morelli, Franco, Tambaro, Rosa, Hashimoto, Yasuhiro, Nosov, Alexander, Font, Albert, Rodriguez-Vida, Alejo M., Jones, Robert, Vasudev, Naveen, Srinivas, Sandhya, Zhang, Jingsong, Gil, Thierry, Finch, Daygen, Grimm, Marc-Oliver, Su, Yu-Li, Chowdhury, Simon, Hocking, Christopher, Plas, Eugen, North, Scott, Jensen, Niels Viggo, Theodore, Christine, Imkamp, Florian, Peer, Avivit, Kobayashi, Takashi, Sakai, Hideki, Sassa, Naoto, Yoshimura, Kazuhiro, Aarts, Maureen, Ferreira Castro, Ana, Topuzov, Marlen, Rodriguez, Juan Francisco, Vazquez, Federico Jose, Tsai, Yu-Chieh, Crabb, Simon, Hussain, Syed, Bendell, Johanna, Gross-Goupil, Marine, Gwenaelle, Gravis, Berger, Raanan, Statsenko, Galina, Evans, Linda, Drakaki, Alexandra, Somer, Bradley, Davis, Ian, Lynam, James, Borges, Giuliano, Dettino, Aldo, Fay, André P., Martins, Graziella, Zucca, Luis Eduardo, Agerbaek, Mads, Kalofonos, Haralambos, Rosenbaum, Eli, Enokida, Hideki, Kikukawa, Hiroaki, Nishimura, Kazuo, Tamada, Satoshi, Uemura, Motohide, Lopez, Yamil, Gietema, Jourik, Slojewski, Marcin, Fernandes, Isabel, Smolin, Alexey, Mazhar, Danish, Kalebasty, Arash Rezazadeh, Carthon, Bradley, Loidl, Wolfgang, Franke, Fabio, Girotto, Gustavo, Alimohamed, Nimira, Macfarlane, Robyn, Pappot, Helle, Niegisch, Guenter, Mavroudis, Dimitrios, Sella, Avishay, Porta, Camillo, Ebara, Shin, Nakamura, Motonobu, Obara, Wataru, Okuno, Norihiko, Shinohara, Nobuo, Sugimoto, Mikio, Suzuki, Akitaka, Tokuda, Noriaki, Uemura, Hiroji, Yamaguchi, Akito, Ramirez, Francisco, Rozanowski, Pawel, Wiechno, Pawel, Keam, Bhumsuk, Kislov, Nikolay, Plaksin, Denis, Cicin, Irfan, Kumar, Satish, Galsky, Matthew D., Petrylak, Daniel P., Rosales, Joseph, Vaishampayan, Ulka, Culine, Stephane, Papandreou, Christos, Nara, Taketoshi, Erman, Mustafa, Kreiger, Laurence, Janoski, Juliana, Rosa, Diogo, Siqueira, Mariana, Canil, Christina, Sengelov, Lisa, Tourani, Jean-Marc, Arai, Gaku, Hashine, Katsuyoshi, Kawakita, Mutsushi, Nakaigawa, Noboru, Nomi, Hayahito, Shiina, Hiroaki, Suzuki, Hiroyoshi, Yonese, Junji, Kuri, Roberto, Macedo, Eleazar, Rivera, Samuel, Villalobos Prieto, Alberto, Polakiewicz-Gilowska, Anna, Zaucha, Renata, Lopes, Fabio, Ponomarev, Roman, Pomerantz, Mark, Shariat, Shahrokh, Luk, Cynthia, Lesniewski-Kmak, Krzysztof, van der Heijden, Michiel S, Galsky, Matthew D, Petrylak, Daniel P, Ogawa, Osamu, Lee, Jae-Lyun, Eigl, Bernhard J, Mukherjee, Som D, Suárez, Cristina, Fay, André P, Duran, Ignacio, Wildsmith, Sophie, He, Philip, Angra, Natasha, Gupta, Ashok K, Levin, Wendy, and Bellmunt, Joaquim

Published
2020
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22. Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial

Author

Falcone, Alfredo, Lonardi, Sara, De Braud, Filippo Guglielmo Maria, Bordonaro, Roberto, Maiello, Evaristo, Tamburini, Emiliano, Santini, Daniele, Frassineti, Giovanni Luca, Gamucci, Teresa, Aprile, Giuseppe, Zaniboni, Alberto, Granetto, Cristina, Buonadonna, Angela, Di Costanzo, Francesco, Tomasello, Gianluca, Gianni, Luca, Di Donato, Samantha, Carlomagno, Chiara, Clavarezza, Matteo, Racca, Patrizia, Mambrini, Andrea, Roselli, Mario, Allegrini, Giacomo, Sobrero, Alberto, Aglietta, Massimo, Corgna, Enrichetta, Cortesi, Enrico, Corsi, Domenico Cristiano, Ballestrero, Alberto, Bonetti, Andrea, Di Clemente, Francesco, Ruggeri, Enzo, Ciardiello, Fortunato, Benasso, Marco, Vitello, Stefano, Cinieri, Saverio, Mosconi, Stefania, Silvestris, Nicola, Frassoldati, Antonio, Cupini, Samantha, Bertolini, Alessandro, Tortora, Giampaolo, Bengala, Carmelo, Ferrari, Daris, Ardizzoia, Antonia, Milandri, Carlo, Chiara, Silvana, Romano, Gianpiero, Miraglia, Stefania, Scaltriti, Laura, Pucci, Francesca, Blasi, Livio, Brugnatelli, Silvia, Fioretto, Luisa, Ribecco, Angela Stefania, Longarini, Raffaella, Frisinghelli, Michela, Banzi, Maria, Cremolini, Chiara, Antoniotti, Carlotta, Rossini, Daniele, Loupakis, Fotios, Pietrantonio, Filippo, Latiano, Tiziana Pia, Passardi, Alessandro, Marmorino, Federica, Grande, Roberta, Murgioni, Sabina, Moretto, Roberto, Corallo, Salvatore, Cordio, Stefano, Antonuzzo, Lorenzo, Masi, Gianluca, Ronzoni, Monica, Ritorto, Giuliana, Cupini, Samanta, Mammoliti, Serafina, Fenocchio, Elisabetta, Zagonel, Vittorina, Fontanini, Gabriella, Ugolini, Clara, and Boni, Luca

Published
2020
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23. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression

Author

Bardia, Aditya, primary, Rugo, Hope S., additional, Tolaney, Sara M., additional, Loirat, Delphine, additional, Punie, Kevin, additional, Oliveira, Mafalda, additional, Brufsky, Adam, additional, Kalinsky, Kevin, additional, Cortés, Javier, additional, Shaughnessy, Joyce O', additional, Diéras, Véronique, additional, Carey, Lisa A., additional, Gianni, Luca, additional, Piccart-Gebhart, Martine, additional, Loibl, Sibylle, additional, Yoon, Oh Kyu, additional, Pan, Yang, additional, Hofsess, Scott, additional, Phan, See-Chun, additional, and Hurvitz, Sara A., additional

Published
2024
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24. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Sangro, B., primary, Chan, S.L., additional, Kelley, R.K., additional, Lau, G., additional, Kudo, M., additional, Sukeepaisarnjaroen, W., additional, Yarchoan, M., additional, De Toni, E.N., additional, Furuse, J., additional, Kang, Y.K., additional, Galle, P.R., additional, Rimassa, L., additional, Heurgué, A., additional, Tam, V.C., additional, Van Dao, T., additional, Thungappa, S.C., additional, Breder, V., additional, Ostapenko, Y., additional, Reig, M., additional, Makowsky, M., additional, Paskow, M.J., additional, Gupta, C., additional, Kurland, J.F., additional, Negro, A., additional, Abou-Alfa, G.K., additional, Azevedo, Sergio, additional, Braghiroli, Maria Ignez, additional, Girotto, Gustavo, additional, Bragagnoli, Arinilda, additional, Branco, Ricardo, additional, Faccio, Adilson, additional, Moretto, Andrea, additional, Skare, Nils, additional, Dutra, Jamille, additional, Viola, Luciana, additional, Vianna, Karina, additional, Meton, Fernando, additional, Sette, Claudia, additional, Faulhaber, Amanda, additional, Tam, Vincent C., additional, Couture, Felix, additional, Biagi, Jim, additional, Castel, Helene, additional, Mulder, Karen, additional, Ko, Yoo-Joung, additional, Zbuk, Kevin, additional, Welch, Stephen, additional, Beaudoin, Annie, additional, Heurgué, Alexandra, additional, Assenat, Eric, additional, Archambeaud, Isabelle, additional, Tougeron, David, additional, Peron, Jean-Marie, additional, Gilabert, Marine, additional, Bronowicki, Jean-Pierre, additional, Cattan, Stephane, additional, Blanc, Jean-Frederic, additional, Bouattour, Mohamed, additional, Phelip, Jean-Marc, additional, Boige, Valerie, additional, Michel, Pierre, additional, Frin, Anne-Claire, additional, Enrico N De Toni, Germany, additional, Berres, Marie-Luise, additional, Vogel, Arndt, additional, Berg, Thomas, additional, Ettrich, Thomas, additional, Waldschmidt, Dirk, additional, Wedemeyer, Hans Heinrich, additional, Worns, Marcus-Alexander, additional, Bitzer, Michael, additional, Weiss, Karl-Heinz, additional, Lau, George, additional, Chan, Stephen L., additional, Yau, Thomas, additional, Tai, Yin Ping, additional, Lee, Ann Shing, additional, Thungappa, Satheesh Chiradoni, additional, N, Lokesh K., additional, Ostwal, Vikas Sureshchand, additional, Ashok, Kattimani Kiran, additional, Mittal, Sushant, additional, Goyal, Hari, additional, Srinivasan, Sankar, additional, Biswas, Ghanashyam, additional, Mohan, Mallavarapu, additional, Limaye, Sewanti, additional, Asarawala, Nirav, additional, Rimassa, Lorenza, additional, Falcone, Alfredo, additional, Gianni, Luca, additional, Gasbarrini, Antonio, additional, Daniele, Bruno, additional, Avallone, Antonio, additional, Paolo Frassineti, Giovanni Luca, additional, Roila, Fausto, additional, Kudo, Masatoshi, additional, Kawaoka, Tomokazu, additional, Morimoto, Manabu, additional, Takikawa, Yasuhiro, additional, Kato, Naoya, additional, Yamashita, Tatsuya, additional, Osaki, Yukio, additional, Motomura, Kenta, additional, Tateishi, Ryosuke, additional, Ohkawa, Kazuyoshi, additional, Wada, Yoshiyuki, additional, Onishi, Hideki, additional, Sasahira, Naoki, additional, Inaba, Yoshitaka, additional, Kurosaki, Masayuki, additional, Tsuji, Kunihiko, additional, Takei, Yoshiyuki, additional, Aramaki, Takeshi, additional, Hagihara, Atsushi, additional, Furuse, Junji, additional, Kioka, Kiyohide, additional, Koga, Hironori, additional, Sasaki, Yutaka, additional, Numata, Kazushi, additional, Tada, Toshifumi, additional, Kawaguchi, Yasunori, additional, Nadano, Seijin, additional, Alexander Vasilyev, Russian Federation, additional, Breder, Valery, additional, Lipatov, Oleg, additional, Dvorkin, Mikhail, additional, Zarubenkov, Oleg, additional, Kutukova, Svetlana, additional, Ponomarev, Roman, additional, Shostka, Kirill, additional, Alyasova, Anna, additional, Topuzov, Eldar, additional, Severtsev, Alexey, additional, Petrov, Yuryi, additional, Erygin, Dmitriy, additional, Berdov, Boris, additional, Kang, Yoon-Koo, additional, Tak, Won-Young, additional, Park, Joong-Won, additional, Lim, Ho Yeong, additional, Heo, Jeong, additional, Kim, Jee Hyun, additional, Kim, Tae-You, additional, Choi, Hye Jin, additional, Varela, María, additional, Reig Monzon, María Elisa, additional, Sangro, Bruno, additional, Martin, Carlos Gómez, additional, Ponce, Carmen Guillén, additional, López, Carlos, additional, Cheng, Ann-Lii, additional, Chao, Yee, additional, Feng, Yin-Hsun, additional, Jeng, Long-Bin, additional, Hung, Chao-Hung, additional, Hou, Ming-Mo, additional, Wang Tsang-En Wang, Jing-Houng, additional, Yen, Chia-Jui, additional, Sukeepaisarnjaroen, Wattana, additional, Sunpaweravong, Patrapim, additional, Charoentum, Chaiyut, additional, Tanasanvimon, Suebpong, additional, Sirachainan, Ekaphop, additional, Ungtrakul, Teerapat, additional, Prasongsook, Naiyarat, additional, Maneenil, Kunlatida, additional, Jitpewngarm, Wittawat, additional, Ostapenko, Yurii, additional, Skoryi, Denys, additional, Bondarenko, Igor, additional, Shparyk, Yaroslav, additional, Trukhin, Dmytro, additional, Hotko, Yevhen, additional, Ursol, Grygorii, additional, Kryzhanivska, Anna, additional, Abou-Alfa, Ghassan K., additional, Mody, Kabir, additional, Dayyani, Farshid, additional, Al-Rajabi, Raed, additional, Yarchoan, Mark, additional, Gandhi, Sunil, additional, Crysler, Oxana, additional, He, Aiwu Ruth, additional, Reeves, James, additional, Bahary, Nathan, additional, Mahipal, Amit, additional, Kelley, Robin Kate, additional, Dasgupta, Anirudha, additional, Rowe, Julie, additional, Thota, Ramya, additional, Beg, Muhammad, additional, Morse, Michael, additional, Choi, Sung-hee, additional, Crocenzi, Todd, additional, Somer, Bradley, additional, Abrams, Thomas, additional, Denlinger, Crystal, additional, Zhang, Yue, additional, Sharma, Nisha, additional, Dao, Tu V., additional, Thinh, Nguyen Tien, additional, and Tuyet Phuong, Le Thi, additional

Published
2024
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27. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Author

Bouzid, Kamel, Campone, Mario, Coudert, Bruno, Nowecki, Zbigniew, Errihani, Hassan, Dalenc, Florence, Ferreira, Ana, Mano, Max, Ricci, Francesco, Kalofonos, Haralabos, Andreetta, Claudia, Montemurro, Filippo, Barrett, Sophie, Zhang, Qingyuan, Mavroudis, Dimitris, Matus, Juan, Beato, Carlos, Hu, Xichun, Gaafar, Rabab, Abdel Azeem, Hamdy, Perrin, Christophe, Ettl, Johannes, Lang, Istvan, Verma, Sunil, Li, Huiping, Brain, Etienne, Hoffmann, Oliver, Cariello, Anna, Tondini, Carlo, Altwegeiri, Taher, Loman, Niklas, Lux, Michael, Frassoldati, Antonio, Aziz, Zeba, Salas, Fernando, Streb, Joanna, Wronski, Andrzej, Menjón Beltrán, Salomón, Cicin, Irfan, Schmid, Peter, Laing, Robert, Tong, Zhongsheng, Boer, Katalin, Juhasz, Balazs, Gianni, Luca, Curigliano, Giuseppe, Juarez, Alejandro, Susnjar, Snezana, Matos, Erika, Uslu, Ruchan, Wildiers, Hans, Cruz, Marcelo, Bourgeois, Hugues, von Schumann, Raquel, Stemmer, Salomón, Vásquez, Flavia Morales, Dominguez, Adriana, Wojtukiewicz, Marek, Trifunovic, Jasna, Illarramendi, Jose Juan, Garcia, Laura, Peron, Yann Izarzugaza, Echarri, Maria Jose, Voitko, Natliia, Wheatley, Duncan, Waters, Simon, De Boer, Richard, Jerusalem, Guy, Cocquyt, Véronique, Barrios, Carlos, Panasci, Lawrence, Mattson, Johanna, Tanner, Minna, Gozy, Michel, Vasilopoulos, Georgios, Revesz, Janos, Latini, Luciano, Gridelli, Cesare, Lazaro, Jesus, Gonzalez, Antonio, Barnadas Molins, Agusti, Martinez, Eduardo, Alarcón, Jesús, Arance, Ana, Klint, Leif, Kovalyov, Oleksiy, Baird, Richard, Yeo, Belinda, McCarthy, Nicole, Greil, Richard, Wang, Shusen, Artignan, Xavier, Augereau, Paule, Juhasz-Boess, Ingolf, Ngan, Roger, Goldberg, Hadassah, Di Costanzo, Francesco, Ferraù, Francesco, Aleknavicius, Eduardas, Rashid, Kamran, Costa, Luís, Angel Garcia, Jose, de la Cruz, Luis Ruiz, López López, Rafael, Del Val, Olga, Ozyilkan, Ozgur, Azribi, Fathi, Verrill, Mark, Turner, Nicholas, Beith, Jane, Petzer, Andreas, Andrade, Jurandyr, Bernstein, Vanessa, Rayson, Daniel, Saad Eldin, Ibtessam, Achille, Mihaëla, Mueller, Volkmar, Gennari, Alessandra, Cascinu, Stefano, Ghosn, Marwan, El-Saghir, Nagi, Van den Bosch, Joan, Oosterkamp, Rianne, Kukulska, Monika, Pelaez, Ignacio, Hernandez, Carolina, del Mar Gordon, Maria, Dalmau, Elsa, Alonso, Jose Luis, Aksoy, Sercan, Coskun, Hasan Senol, Shparyk, Yaroslav, Varughese, Mohini, Panwar, Udaiveer, Barraclough, Lisa, Levitt, Nicola, Hicks, Jonathan, Rigg, Anna, Allen, Mark, Castillo, Cecila, Fein, Luis Enrique, Stuart-Harris, Robin, Singer, Christian, Stoeger, Herbert, Smiljanic, Sasha, Feng, Jifeng, Cedeño, Miguel, Berdah, Jean Francois, Orfeuvre, Hubert, Goncalves, Anthony, Grischke, Eva-Maria, Simon, Eike, Wagner, Steffen, Efremidou, Anna, Papazisis, Konstantinos, Evron, Ella, Inbar, Moshe, Baruch, Noa Ben, Geffen, David, Karminsky, Natalya, Ruggeri, Enzo Maria, Luigi, Cavanna, Grasso, Donatella, Juozaityte, Elona, Rafael Rodriguez Cid, Jeronimo, Roerdink, Henk, Siddiqi, Neelum, Passos Coelho, José Luís, Garre, Elisa Garcia, Garcia, Andres, Martínez Jañez, Noelia, Lopez Ceballos, Maria Helena, Mele, Mireia, García, María, Arcediano, Alberto, McAdam, Karen, Perren, Timothy, Taylor, Wendy, Humphreys, Alison, Vera, Raul, Kaen, Luis Alberto, Steger, Günther, Andel, Johannes, de Grève, Jacques, Huizing, Manon, Hegg, Roberto, Joy, Anil, Sehdev, Sandeep, Kütner, Riina, Ruohola, Johanna, Dohollou, Nadine, Grosjean, Jessica, Laplaige, Philippe, Largillier, Rémy, Martin, Philippe, Pottier, Virginie, Alexandre, Jerome, Christensen, Bernd, Zahm, Dirk-Michael, Khandan, Fariba, Lueck, Hans-Joachim, Fountzilas, Georgios, Fried, Georgeta, Giacobino, Alice, Bonetti, Andrea, Guerra, Yanin Chavarri, Van Warmerdam, Laurens, Van der Velden, Annette, Vrijaldenhoven, Suzan, de Jongh, Felix, Cavero, Milagros, Andres Conejero, Raquel, Murias, Adolfo, Saura, Salvador, Oltra, Amparo, Redondo, Andres, Ribelles, Nuria, Bachmeier, Kilian, Joffe, Johnathan, Chakraborti, Prabir, Beresford, Mark, Butt, Mohammad, Poole, Christopher, Yordi, Gassan, Woodward, Natasha, Amorim, Gilberto, Califaretti, Nadia, Fox, Susan, Robidoux, Andre, Li, NanLi, Li, Nenxiao, Jiang, Jun, Soria, Tannia, Padrik, Peeter, Saarni, Outi, Genet, Dominique, Catala, Stéphanie, Barletta, Hugues, Teixeira, Luis, Facchini, Thomas, Hesse, Tobias, Kühn, Thorsten, Ober, Angelika, Repp, Roland, Schroeder, Willibald, Pectasides, Dimitrios, Bodoky, Gyorgy, Kahan, Zsuzsanna, Jiveliouk, Irina, Rosengarten, Ora, Alabiso, Oscar, Perez, Mario, Van de Wouw, Yes, Smok-Kalwat, Jolanta, Damasceno, Margarida, Sousa, Gabriela, Abulkhair, Omalkhair, Antón Torres, Antonio, Martinez, Maria Purificación, Garcia Mata, Jesús, Jesús Florián Jerico, Marta Santisteban, Llombart, Antonio, Sanchez, Rosa, Torrego, Juan Carlos, Garate, Clara Olier, Rodriguez, Cesar, Llorente, Rosa, de Prado, Diego Soto, Cortés, Javier, Llorca, Cristina, Galán, Antonio, Viñas Villaro, Gemma, Narbe, Ulrik, Bjömeklett, Helena Granstam, Westwell, Sarah, Newby, Jackie, Jafri, Mariam, Rodríguez, Robinson, Alonso, Isabel, Bachelot, T., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Bondarenko, I., Paluch-Shimon, S., Wardley, A., Merot, J.-L., du Toit, Y., Easton, V., Lindegger, N., and Miles, D.

Published
2019
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29. Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer

Author

Blumenthal, Gideon M., Bunn, Paul A., Jr., Chaft, Jamie E., McCoach, Caroline E., Perez, Edith A., Scagliotti, Giorgio V., Carbone, David P., Aerts, Hugo J.W.L., Aisner, Dara L., Bergh, Jonas, Berry, Donald A., Jarkowski, Anthony, Botwood, Nicholas, Cross, Darren A.E., Diehn, Max, Drezner, Nicole L., Doebele, Robert C., Blakely, Collin M., Eberhardt, Wilfried E.E., Felip, Enriqueta, Gianni, Luca, Keller, Steven P., Leavey, Patrick J., Malik, Shakun, Pignatti, Francesco, Prowell, Tatiana M., Redman, Mary W., Rizvi, Naiyer A., Rosell, Rafael, Rusch, Valerie, de Ruysscher, Dirk, Schwartz, Lawrence H., Sridhara, Rajeshwari, Stahel, Rolf A., Swisher, Stephen, Taube, Janis M., Travis, William D., Keegan, Patricia, Wiens, Jacinta R., Wistuba, Ignacio I., Wynes, Murry W., Hirsch, Fred R., and Kris, Mark G.

Published
2018
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30. Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: a randomized phase II study of patients with previously untreated HER2-positive metastatic breast cancer

Author

Perez, Edith A, Hurvitz, Sara A, Amler, Lukas C, Mundt, Kirsten E, Ng, Vivian, Guardino, Ellie, and Gianni, Luca

Subjects
Genetics, Clinical Trials and Supportive Activities, Clinical Research, Cancer, Breast Cancer, Ado-Trastuzumab Emtansine, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Disease-Free Survival, Docetaxel, Female, Humans, Maytansine, Middle Aged, RNA, Messenger, Receptor, ErbB-2, Retrospective Studies, Taxoids, Trastuzumab, Treatment Outcome, Receptor, erbB-2, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

IntroductionThe purpose of this study was to retrospectively explore the relationship between human epidermal growth factor receptor 2 (HER2) messenger RNA (mRNA) expression and efficacy in patients receiving trastuzumab plus docetaxel (HT) or trastuzumab emtansine (T-DM1).MethodsPatients with HER2-positive, locally advanced or metastatic breast cancer (MBC) were randomly assigned to HT (n=70) or T-DM1 (n=67). HER2 status was assessed locally using immunohistochemistry or fluorescence in situ hybridization and confirmed retrospectively by central testing. HER2 mRNA expression was assessed using quantitative reverse transcriptase polymerase chain reaction.ResultsHER2 mRNA levels were obtained for 116/137 patients (HT=61; T-DM1=55). Median pretreatment HER2 mRNA was 8.9. The risk of disease progression in the overall population was lower with T-DM1 than with HT (hazard ratio (HR)=0.59; 95% confidence interval (CI) 0.36 to 0.97). This effect was more pronounced in patients with HER2 mRNA≥median (HR=0.39; 95% CI 0.18 to 0.85) versus ConclusionsThis exploratory analysis suggests that while overall, patients with HER2-positive MBC show improved PFS with T-DM1 relative to HT, the effect is enhanced in patients with tumor HER2 mRNA ≥ median.Trial registrationClinicalTrials.gov NCT00679341.

Published
2014

31. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma

Author

Reni, Michele, Zanon, Silvia, Balzano, Gianpaolo, Passoni, Paolo, Pircher, Chiara, Chiaravalli, Marta, Fugazza, Clara, Ceraulo, Domenica, Nicoletti, Roberto, Arcidiacono, Paolo Giorgio, Macchini, Marina, Peretti, Umberto, Castoldi, Renato, Doglioni, Claudio, Falconi, Massimo, Partelli, Stefano, and Gianni, Luca

Published
2018
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33. Safety and efficacy of preoperative or postoperative chemotherapy for resectable pancreatic adenocarcinoma (PACT-15): a randomised, open-label, phase 2–3 trial

Author

Reni, Michele, Balzano, Gianpaolo, Zanon, Silvia, Zerbi, Alessandro, Rimassa, Lorenza, Castoldi, Renato, Pinelli, Domenico, Mosconi, Stefania, Doglioni, Claudio, Chiaravalli, Marta, Pircher, Chiara, Arcidiacono, Paolo Giorgio, Torri, Valter, Maggiora, Paola, Ceraulo, Domenica, Falconi, Massimo, and Gianni, Luca

Published
2018
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36. Immunotherapy Bridge 2017 and Melanoma Bridge 2017: meeting abstracts

Author

David Carbone, Michael Sharpnack, Kai He, Lisa H. Butterfield, Alexander M. M. Eggermont, Maria Gonzalez-Cao, Niki Karachaliou, Guillermo Crespo, Erika Aldeguer, Ana Drozdowskyj, Ana Giménez-Capitán, Cristina Teixidó, Miguel Angel Molina-Vila, Santiago Viteri Ramírez, Salvador Martin Algarra, Elisabeth Pérez-Ruiz, Iván Márquez-Rodas, Delvys Rodriguez-Abreu, Remei Blanco, Teresa Puértolas, Maria Angeles Royo, Rafael Rosell, Maria Libera Ascierto, Svetlana Hamm, Tanja Wulff, Kerstin Kronthaler, Sabine Schrepfer, Ulrike Parnitzke, Anne Catherine Bretz, Roland Baumgartner, Veronica Ferrucci, Francesco Paolo Pennino, Luisa Dassi, Fatemeh Asadzadeh, Roberto Siciliano, Marianeve Carotenuto, Daniela Spano, Cristina Maria Chiarolla, Adelaide Greco, Monica Cantile, Maurizio Di Bonito, Gerardo Botti, Vandenbussche Jonathan, Gevaert Kris, Massimo Zollo, Teresa Amaral, Ioanna Tampouri, Ulrike Keim, Thomas Eigentler, Claus Garbe, Andrea Forschner, Alessandra Cesano, Sarah Warren, Duane Moogk, Kaitao Li, Zhou Yuan, Shi Zhong, Zhiya Yu, Ivan Liadi, William Rittase, Victoria Fang, Janna Dougherty, Arianne Perez-Garcia, Iman Osman, Navin Varadarajan, Nicholas P. Restifo, Alan Frey, Cheng Zhu, Michelle Krogsgaard, Claire Vanpouille-Box, Silvia C. Formenti, Sandra Demaria, Cristiana Lo Nigro, Alexander Renziehausen, Andreas G. Tzakos, Hexiao Wang, Bhavya Rao, Rubeta Matin, Catherine Harwood, Daniela Vivenza, Federica Tonissi, Marcella Occelli, Lynda Weir, Su Li, Van Ren Sim, Kevin O’Neill, Alan Evans, Alastair Thompson, Peter Szlosarek, Colin Fleming, Charlotte Proby, Nelofer Syed, Marco Merlano, Tim Crook, Robert Ferguson, Danny Simpson, Carlos Martinez, Matjaz Vogelsang, Esther Kazlow, Melissa Wilson, Anna Pavlick, Jeffrey Weber, Ryan Sullivan, Keith Flaherty, Antoni Ribas, Tomas Kirchhoff, Antonio D’Avino, Licia Guida, Augusto Cosacco, Roberta D’Aniello, Piera Maiolino, Teresa Tramontano, Maria R. Sarno, Ida Palazzo, Angela Di Napoli, Gianclaudio Acunzo, Mariarosanna De Fina, Antonia Silvestri, Monica Specchia, Michela Musacchio, Gianfranco Giglio, Francesco Carrozza, Liberato Di Lullo, Gian Marco De Maddi, Adele Venturelli, Elisabetta Gambale, Alessia Gatta, Davide Brocco, Consiglia Carella, Michele De Tursi, Thomas F. Gajewski, Costanza M. Cristiani, Rossana Tallerico, Valeria Ventura, Mariaelena Capone, Gabriele Madonna, Domenico Mallardo, Eliska Selinger, Cinzia Garofalo, Elina Staaf, Ester Simeone, Antonio M. Grimaldi, Genny del Zotto, Elio Gulletta, Gennaro Ciliberto, Alessandro Moretta, Paolo A. Ascierto, Ennio Carbone, Susan Costantini, Angela Sorice, Francesca Capone, Alfredo Budillon, Carolina Cauchi, Grazia Sciancalepore, Michela Rovera, Chiara Varamo, Zelda Seia, Stefania Palazzini, Fabiana Errico, Davide Basso, Laura Quaranta, Giuseppe Forte, Fulvio Lavagna, Silvia Violante, Paolo Bosio, Laura Lattanzio, Marco C Merlano, Mike Gowen, Jeremy Tchack, Hua Zhou, Keith Giles, Scott Paschke, Una Moran, David Fenyo, Aris Tsirigos, Michael Pacold, Silvana Morello, Claudia Sorrentino, Diana Giannarelli, Aldo Pinto, Federica Fratangelo, Rosaria Falcone, Vito Vanella, Dirk Schadendorf, Karl Lewis, Michele Maio, Lev Demidov, Mario Mandalà, Igor Bondarenko, Christopher Herbert, Andrzej Mackiewicz, Piotr Rutkowski, Alexander Guminski, Grant Goodman, Brian Simmons, Chenglin Ye, Gregory Hooper, Matthew J. Wongchenko, Yibing Yan, Frank Hermann, Astrid Ammendola, René Bartz, Bulotta Alessandra, Colombo Letizia, Mirabile Aurora, Lazzari Chiara, Mercuri Santo Raffaele, Parolini Danilo, Rizzo Nathalie, Martella Stefano, Modorati Giulio, Brianti Pina, Cestone Enza, Bellinzona Federica, Miserocchi Elisabetta, Gianni Luca, Gregorc Vanesa, Sanjiv Agarwala, B. Mark Smithers, Axel Haushild, Eric Watcher, Luigi Fattore, Ciro Francesco Ruggiero, Domenico Liguoro, Andrea Cerri, Maria Elena Pisanu, and Rita Mancini

Subjects
Medicine
Published
2018
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37. Treatment sequence with either irinotecan/cetuximab followed by FOLFOX-4 or the reverse strategy in metastatic colorectal cancer patients progressing after first-line FOLFIRI/bevacizumab: An Italian Group for the Study of Gastrointestinal Cancer phase III, randomised trial comparing two sequences of therapy in colorectal metastatic patients

Author

Cascinu, Stefano, Rosati, Gerardo, Bilancia, Domenico, Nasti, Guglielmo, Iaffaioli, Rosario Vincenzo, Lonardi, Sara, Zagonel, Vittorina, Zaniboni, Alberto, Marchetti, Paolo, Romiti, Adriana, Leone, Francesco, Aglietta, Massimo, Giordano, Monica, Corsi, Domenico C., Ferraú, Francesco, Labianca, Roberto, Mosconi, Stefania, Ronzoni, Monica, Gianni, Luca, Rulli, Eliana, Poli, Davide, Galli, Francesca, Torri, Valter, De Simone, Irene, Galli, Fabio, Pasini, Felice, Rangoni, Giovanni, Venezia, Raffaele, Sozzi, Pietro, Nuzzo, Antonio, Berardi, Rossana, Frontini, Luciano, Rota, Silvia, Cozzi, Lorena, and Scartozzi, Mario

Published
2017
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40. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial

Author

Cameron, David, Piccart-Gebhart, Martine J, Gelber, Richard D, Procter, Marion, Goldhirsch, Aron, de Azambuja, Evandro, Castro, Gilberto, Jr, Untch, Michael, Smith, Ian, Gianni, Luca, Baselga, Jose, Al-Sakaff, Nedal, Lauer, Sabine, McFadden, Eleanor, Leyland-Jones, Brian, Bell, Richard, Dowsett, Mitch, and Jackisch, Christian

Published
2017
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41. Phase II study (KAMELEON) of single-agent T-DM1 in patients with HER2-positive advanced urothelial bladder cancer or pancreatic cancer/cholangiocarcinoma

Author

Rüschoff, Josef, Lolkema, Martijn, GIANNI, LUCA, Voest, Emile, de Vries, Elisabeth, Tabernero, Josep, Institut Català de la Salut, [de Vries EGE] Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. [Rüschoff J] Targos Molecular Pathology GmbH, Kassel, Germany. [Lolkema M] Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. [Tabernero J] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVicUCC, IOB-Quiron, Barcelona, Spain. [Gianni L] Michelangelo Foundation, Milan, Italy. [Voest E] Netherlands Cancer Institute, Amsterdam, The Netherlands. Oncode Institute, Amsterdam, The Netherlands, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::adenocarcinoma::colangiocarcinoma [ENFERMEDADES], Anticossos monoclonals - Ús terapèutic, Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Adenocarcinoma::Cholangiocarcinoma [DISEASES], neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias de la vejiga [ENFERMEDADES], Pàncrees - Càncer - Tractament, Bufeta - Càncer - Tractament, Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal [CHEMICALS AND DRUGS], Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Urinary Bladder Neoplasms [DISEASES], neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales [COMPUESTOS QUÍMICOS Y DROGAS]
Abstract

HER2-positive; Pancreatic cancer; Urothelial bladder cancer HER2 positivo; Cáncer de páncreas; Cáncer de vejiga urotelial HER2-positiu; Càncer de pàncrees; Càncer de bufeta urotelial The antibody-drug conjugate trastuzumab emtansine (T-DM1) is approved for human epidermal growth factor receptor 2 (HER2/ERBB2)–positive breast cancer. We aimed to study tumor HER2 expression and its effects on T-DM1 responses in patients with HER2-positive urothelial bladder cancer (UBC) or pancreatic cancer (PC)/cholangiocarcinoma (CC). In the phase II KAMELEON study (NCT02999672), HER2 status was centrally assessed by immunohistochemistry, with positivity defined as non-focal homogeneous or heterogeneous overexpression of HER2 in ≥30% of stained cells. We also performed exploratory biomarker analyses (e.g., gene-protein assay) on tissue samples collected from study participants and consenting patients who failed screening. Of the 284 patients successfully screened for HER2 status (UBC, n = 69; PC/CC, n = 215), 13 with UBC, four with PC, and three with CC fulfilled eligibility criteria. Due to recruitment difficulty, the sponsor terminated KAMELEON prematurely. Of the five responders in the UBC cohort (overall response rate, 38.5%), HER2 expression was heterogeneous in two and homogeneous in three. The one responder in the PC/CC cohort had PC, and the tumor displayed homogeneous expression. In the biomarker-evaluable population, composed of screen-failed and enrolled patients, 24.3% (9/37), 1.5% (1/66), and 8.2% (4/49) of those with UBC, PC, or CC, respectively, had HER2-positive tumors. In a gene-protein assay combining in situ hybridization with immunohistochemistry, greater HER2 homogeneity was associated with increased ERBB2 amplification ratio. In conclusion, KAMELEON showed that some patients with HER2-positive UBC or PC can respond to T-DM1 and provided insight into the prevalence of HER2 positivity and expression patterns in three non-breast tumor types.

Published
2023

42. Introduction and Background Biology

Author

Fasolo, Angelica, Zambelli, Stefania, Gianni, Luca, Alvarez, Ricardo H, Cortés, Javier, De Mattos-Arruda, Leticia, Falzon, Mary, Fasolo, Angelica, Gandy, Michael, Gianni, Luca, Harbeck, Nadia, Piccart, Martine, Zambelli, Stefania, and Zardavas, Dimitrios

Published
2013
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44. Phase II study ( KAMELEON ) of single‐agent T‐DM1 in patients with HER2 ‐positive advanced urothelial bladder cancer or pancreatic cancer/cholangiocarcinoma

Author

de Vries, Elisabeth G. E., primary, Rüschoff, Josef, additional, Lolkema, Martijn, additional, Tabernero, Josep, additional, Gianni, Luca, additional, Voest, Emile, additional, de Groot, Derk Jan A., additional, Castellano, Daniel, additional, Erb, Gilles, additional, Naab, Julia, additional, Donica, Margarita, additional, Deurloo, Regula, additional, van der Heijden, Michiel S., additional, and Viale, Giuseppe, additional

Published
2023
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45. Pathologic Complete Response and Individual Patient Prognosis After Neoadjuvant Chemotherapy Plus Anti–Human Epidermal Growth Factor Receptor 2 Therapy of Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer

Author

van Mackelenbergh, Marion T., primary, Loibl, Sibylle, additional, Untch, Michael, additional, Buyse, Marc, additional, Geyer, Charles E., additional, Gianni, Luca, additional, Schneeweiss, Andreas, additional, Conte, Pierfranco, additional, Piccart, Martine, additional, Bonnefoi, Herve, additional, Jackisch, Christian, additional, Nekljudova, Valentina, additional, Tang, Gong, additional, Valagussa, Pinuccia, additional, Neate, Colin, additional, Gelber, Richard, additional, Poncet, Coralie, additional, Squifflet, Pierre, additional, Saad, Everardo D., additional, Heinzmann, Dominik, additional, Denkert, Carsten, additional, Rastogi, Priya, additional, Cortes, Javier, additional, Guarneri, Valentina, additional, de Azambuja, Evandro, additional, Cameron, David, additional, Ismael, Gustavo, additional, Wolmark, Norman, additional, and Cortazar, Patricia, additional

Published
2023
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46. Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial

Author

Tempero, Margaret A., primary, Pelzer, Uwe, additional, O'Reilly, Eileen M., additional, Winter, Jordan, additional, Oh, Do-Youn, additional, Li, Chung-Pin, additional, Tortora, Giampaolo, additional, Chang, Heung-Moon, additional, Lopez, Charles D., additional, Bekaii-Saab, Tanios, additional, Ko, Andrew H., additional, Santoro, Armando, additional, Park, Joon Oh, additional, Noel, Marcus S., additional, Frassineti, Giovanni Luca, additional, Shan, Yan-Shen, additional, Dean, Andrew, additional, Riess, Hanno, additional, Van Cutsem, Eric, additional, Berlin, Jordan, additional, Philip, Philip, additional, Moore, Malcolm, additional, Goldstein, David, additional, Tabernero, Josep, additional, Li, Mingyu, additional, Ferrara, Stefano, additional, Le Bruchec, Yvan, additional, Zhang, George, additional, Lu, Brian, additional, Biankin, Andrew V., additional, Reni, Michele, additional, Epstein, Richard, additional, Vasey, Paul, additional, Shapiro, Jeremy, additional, Burge, Matthew, additional, Chua, Yu Jo, additional, Harris, Marion, additional, Pavlakis, Nick, additional, Tebbutt, Niall, additional, Prager, Gerald, additional, Dittrich, Christian, additional, Längle, Friedrich, additional, Philipp-Abbrederis, Kathrin, additional, Greil, Richard, additional, Stöger, Herbert, additional, Girschikofsky, Michael, additional, Kuehr, Thomas, additional, Van Laethem, Jean-Luc, additional, Laurent, Stéphanie, additional, Dhani, Neesha, additional, Ko, Yoo Joung, additional, Dowden, Scot, additional, Kavan, Petr, additional, Tehfe, Mustapha Édouard, additional, Kubala, Eugen, additional, Kohoutek, Milan, additional, Pfeiffer, Per, additional, Yilmaz, Mette, additional, Parner, Vibeke, additional, Salminen, Tapio, additional, Soveri, Leena-Maija, additional, Korkeila, Eija, additional, Osterlund, Pia, additional, Taieb, Julien, additional, Tougeron, David, additional, Artru, Pascal, additional, Caroli-Bosc, François Xavier, additional, Guimbaud, Rosine, additional, Turpin, Antony, additional, Walter, Thomas, additional, Bachet, Jean Baptiste, additional, Kunzmann, Volker, additional, Kreth, Florian, additional, Block, Andreas, additional, Venerito, Marino, additional, Oettle, Helmut, additional, Karthaus, Meinolf, additional, Trojan, Jörg, additional, Folprecht, Gunnar, additional, Lerch, Markus, additional, Kullmann, Frank, additional, Reiser, Marcel, additional, Heinemann, Volker, additional, Wörns, Marcus-Alexander, additional, Schulz, Holger, additional, Garlipp, Benjamin, additional, Yau, Thomas, additional, Chan, Lam Stephen, additional, Juhasz, Balazs, additional, Landherr, László, additional, Pinter, Tamas, additional, Bodoky, György, additional, Kahán, Zsuzsanna, additional, McDermott, Raymond, additional, Power, Derek, additional, Gianni, Luca, additional, Siena, Salvatore, additional, Milella, Michele, additional, Falcone, Alfredo, additional, Berardi, Rossana, additional, Bagalà, Cinzia, additional, Di Costanzo, Francesco, additional, Roila, Fausto, additional, Ardizzoni, Andrea, additional, Maiello, Evaristo, additional, Fanello, Silvia, additional, Wilmink, Johanna, additional, Willem de Groot, Jan, additional, Creemers, Geert, additional, Barroso, Eduardo, additional, Rodrigues, Tânia, additional, Sarmento, Cristina, additional, Chee, Cheng Ean, additional, Tai, David, additional, Mercade, Teresa Macarulla, additional, Medina, Manuel Hidalgo, additional, Mena, Alfredo Carrato, additional, Santasusana, Joan Maurel, additional, Flor Oncala, Maria Jose, additional, Martin, Carlos Gomez, additional, Lopez, Rafael, additional, Muñoz, Andres, additional, Garcia, Ruth Vera, additional, Ales, Inmaculada, additional, Sáez, Berta Laquente, additional, Rivera, Fernando, additional, Sastre, Javier, additional, Wu, Cheng-Chung, additional, Tien, Yu-Wen, additional, Chan, De-Chuan, additional, Hwang, Tsann-Long, additional, Evans, Jeffry, additional, Wadsley, Jonathan, additional, Corrie, Pippa, additional, Biankin, Andrew, additional, Ko, Andrew, additional, Cardin, Dana, additional, Chiorean, Elena, additional, Bendell, Johanna, additional, Noonan, Anne, additional, Kindler, Hedy, additional, Fernando, Nishan, additional, Beg, Muhammad, additional, George, Thomas, additional, Noel, Marcus, additional, LoConte, Noelle, additional, Arena, Francis, additional, Posey, James, additional, Malhotra, Rajat, additional, Lopez, Charles, additional, Sohal, Davendra, additional, McWilliams, Robert, additional, Brenner, Warren, additional, Womack, Mark, additional, Seth, Rahul, additional, lyer, Renuka, additional, Bahary, Nathan, additional, Marsh, Robert, additional, Ramirez, Robert, additional, Chua, Cynthia, additional, Reeves, James, additional, Manji, Gulam, additional, El-Khoueiry, Anthony, additional, Weaver, Robert, additional, Sahai, Vaibhav, additional, Messersmith, Wells, additional, Dreicer, Robert, additional, Zakari, Ahmed, additional, Bullock, Andrea, additional, Musher, Benjamin, additional, Borad, Mitesh, additional, Kim, Edward, additional, Bajor, David, additional, Huyck, Tim, additional, Hatoum, Hassan, additional, Xiong, Henry, additional, Pasche, Boris, additional, Lacy, Jill, additional, Olowokure, Olugbenga, additional, Cohn, Allen, additional, Richards, Donald, additional, Martin, Robert, additional, Paulson, Andrew, additional, Fanta, Paul, additional, Krishnamurthi, Smitha, additional, Oberstein, Paul, additional, and Fuloria, Jyotsna, additional

Published
2023
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47. Supplementary Figure 1 from Bevacizumab Prevents Brain Metastases Formation in Lung Adenocarcinoma

Author

Ilhan-Mutlu, Aysegül, primary, Osswald, Matthias, primary, Liao, Yunxiang, primary, Gömmel, Miriam, primary, Reck, Martin, primary, Miles, David, primary, Mariani, Paola, primary, Gianni, Luca, primary, Lutiger, Beatrix, primary, Nendel, Viktor, primary, Srock, Stefanie, primary, Perez-Moreno, Pablo, primary, Thorsen, Frits, primary, von Baumgarten, Louisa, primary, Preusser, Matthias, primary, Wick, Wolfgang, primary, and Winkler, Frank, primary

Published
2023
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48. Data from Bevacizumab Prevents Brain Metastases Formation in Lung Adenocarcinoma

Author

Ilhan-Mutlu, Aysegül, primary, Osswald, Matthias, primary, Liao, Yunxiang, primary, Gömmel, Miriam, primary, Reck, Martin, primary, Miles, David, primary, Mariani, Paola, primary, Gianni, Luca, primary, Lutiger, Beatrix, primary, Nendel, Viktor, primary, Srock, Stefanie, primary, Perez-Moreno, Pablo, primary, Thorsen, Frits, primary, von Baumgarten, Louisa, primary, Preusser, Matthias, primary, Wick, Wolfgang, primary, and Winkler, Frank, primary

Published
2023
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49. Supplementary Figure 2 from Bevacizumab Prevents Brain Metastases Formation in Lung Adenocarcinoma

Author

Ilhan-Mutlu, Aysegül, primary, Osswald, Matthias, primary, Liao, Yunxiang, primary, Gömmel, Miriam, primary, Reck, Martin, primary, Miles, David, primary, Mariani, Paola, primary, Gianni, Luca, primary, Lutiger, Beatrix, primary, Nendel, Viktor, primary, Srock, Stefanie, primary, Perez-Moreno, Pablo, primary, Thorsen, Frits, primary, von Baumgarten, Louisa, primary, Preusser, Matthias, primary, Wick, Wolfgang, primary, and Winkler, Frank, primary

Published
2023
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50. Supplementary Data - Figure Legends from Bevacizumab Prevents Brain Metastases Formation in Lung Adenocarcinoma

Author

Ilhan-Mutlu, Aysegül, primary, Osswald, Matthias, primary, Liao, Yunxiang, primary, Gömmel, Miriam, primary, Reck, Martin, primary, Miles, David, primary, Mariani, Paola, primary, Gianni, Luca, primary, Lutiger, Beatrix, primary, Nendel, Viktor, primary, Srock, Stefanie, primary, Perez-Moreno, Pablo, primary, Thorsen, Frits, primary, von Baumgarten, Louisa, primary, Preusser, Matthias, primary, Wick, Wolfgang, primary, and Winkler, Frank, primary

Published
2023
Full Text
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