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3. What is the gender representation in authorship in later phase systemic clinical trials in biliary tract cancer (BTC)? - a retrospective review of the published literature.

Author

McNamara, Mairéad, Bridgewater, John, Goyal, Lipika, Jacobs, Timothy, Wagner, Anna, Goldstein, David, Shroff, Rachna, Moehler, Markus, Lowery, Maeve, Bekaii-Saab, Tanios, Kelley, Robin, Furuse, Junji, Rimassa, Lorenza, Morizane, Chigusa, Lamarca, Angela, Hubner, Richard, Knox, Jennifer, and Valle, Juan

Subjects
adult oncology, chemotherapy, hepatobiliary tumours, Humans, Authorship, Biliary Tract Neoplasms, Europe, Physicians, Women, Retrospective Studies, Clinical Trials as Topic, Male, Female
Abstract

OBJECTIVES: Female physicians in medicine are increasing, but disparities in female authorship exist. The aim of this study was to characterise factors associated with female first (FF) and female senior (SF) authorship in later phase systemic oncological clinical trials in biliary tract cancer (BTC) and identify any changes over time. SETTING: Embase/Medline identified trial publications in BTC (2000-2020) were included. χ2 tests and log regression were used (assessed factors associated with FF and SF authorship, including changes over time (STATA V.16)). PRIMARY OUTCOME MEASURE: FF and SF authorship in later phase systemic oncological clinical trials in BTC. SECONDARY OUTCOME MEASURE: Any changes over time? RESULTS: Of 501 publications, 163 met inclusion criteria. The median percentage of female author representation in publications was 25%; there were no female authors in 13% of publications. Geographic location of the home institution of the first and senior authors was Asia (42%/42%), Europe (29%/29%), USA (24%/22%) and other (4%/6%), respectively. Overall, FF and SF author representation was 20% and 10%, respectively. The median position of the first female author was second in all the publication author lists. The phase of trial, journal-impact factor, industry funding or whether the study met its primary endpoint did not impact FF/SF author representation. More SF authors had home institutions in other geographic locations (40% in 10 trials) (p=0.02) versus Asia (6%), Europe (8%) and USA (14%). There were no significant changes in FF/SF representation over time (p=0.61 and p=0.33 respectively). CONCLUSIONS: FF and SF author representation in later phase systemic clinical trial publications in BTC is low and has not changed significantly over time. The underlying reasons for this imbalance need to be better understood and addressed.

Published
2022

4. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

Author

Mendez, Guillermo, O'Connor, Juan Manuel, Yanzi Castilla, Alvaro, Cundom, Juan, Kaen, Diego, Wong, Rachel, Ng, Weng, Aghmesheh, Morteza, Peressoni, Mauricio, Andrade, Carlos, Franke, Fabio, Alves, Gustavo, Cruz, Felipe Jose, Vianna, Karina, Monteiro, Maria Marcela, Raphael, Michael, Berry, Scott, Jang, Raymond, Tan, Ann, Asselah, Jamil, Yanez Weber, Patricio, Mahave, Mauricio, Sanchez, Cesar, Salman, Pamela, Bai, Yuxian, Li, Jin, Zhang, Xiaochun, Liu, Tianshu, Lin, Xiaoyan, Qin, Shukui, Yang, Jianwei, Luo, Suxia, Li, Wei, Ying, Jieer, Chen, Xi, Zeng, Shan, Qu, Yanli, Yang, Lin, Zhao, Lin, Chen, Ping, Pan, Hongming, Li, Enxiao, Ye, Feng, Lu, Jianwei, Liang, Xinjun, Zhao, Qun, Yin, Xianli, Li, Junhe, Ling, Yang, Lv, Guoqing, Li, Shouguo, Guerrero, Alvaro, Rubiano, Juan, Gonzalez Fernandez, Manuel, Manneh Kopp, Ray, Guzman Ramirez, Adrian, Corrales, Luis, Gonzalez Herrera, Ileana, Melichar, Bohuslav, Buchler, Tomas, Svoboda, Tomas, Obermannova, Radka, Vrana, David, Cvek, Jakub, Pfeiffer, Per, Baeksgaard, Lene, Yilmaz, Mette, Boige, Valerie, Lopez-Trabada, Daniel, Borg, Christophe, Pannier, Diane, Hiret, Sandrine, Di Fiore, Frederic, Metges, Jean-Philippe, Arnold, Dirk, Martens, Uwe, Lordick, Florian, Stein, Alexander, Castro, Hugo, Lopez, Karla, Ramirez, Julio, Aguilar, Mynor, Chivalan, Marco, Chan, Wendy, Cheng, Ashley, Yeo, Winnie, Arkosy, Peter, Csoszi, Tibor, Hitre, Erika, Horvath, Zsolt, Lowery, Maeve, McDermott, Ray, Morris, Patrick, Hubert, Ayala, Brenner, Baruch, Ben-Aharon, Irit, Shacham-Shmueli, Einat, Man, Sofia, Pelles Avraham, Sharon, Brenner, Ronen, Mishaeli, Moshe, Di Bartolomeo, Maria, Fazio, Nicola, Lonardi, Sara, Garufi, Carlo, Satoh, Taroh, Hara, Hiroki, Iwagami, Shiro, Yasui, Hisateru, Tsuda, Masahiro, Shimoyama, Tatsu, Shoji, Hirokazu, Sugimoto, Naotoshi, Shibata, Nobuhiro, Yamaguchi, Kensei, Amagai, Kenji, Choda, Yasuhiro, Esaki, Taito, Yabusaki, Hiroshi, Oshima, Takashi, Tsuji, Akihito, Kawakami, Hisato, Kawazoe, Akihito, Ishido, Kenji, Kadowaki, Shigenori, Martinez Rodriguez, Jorge, Herrera Martinez, Marytere, Huitzil Melendez, Fidel, Ramirez Godinez, Francisco, Balancan, Paola, Damianovich, Dragan, Castro Oliden, Victor, Grados, Julio, Torres, Cesar, Wyrwicz, Lucjan, Wysocki, Piotr, Hajac, Lukasz, Zolnierek, Jakub, Karaszewska, Boguslawa, Rha, Sun Young, Lee, Jeeyun, Ryu, Min-Hee, Oh, Do-Youn, Orlova, Rashida, Tjulandin, Sergey, Fadeeva, Natalia, Makarycheva, Yulia, Nosov, Dmitry, Smagina, Maria, Chan, Sze, Jacobs, Conrad, Kraus, Peter, Landers, Gregory, Robertson, Barbara, Ruff, Paul, Schoeman, Elizabeth, Maurel, Jean-Marc, Diez Garcia, Marc, Jimenez Fonseca, Paula, Gallego Plazas, Javier, Rivera Herrero, Fernando, Miranda Poma, Jesus, Layos Romero, Laura, Fritsch, Ralph, Bastian, Sara, Winterhalder, Ralph, Dosso, Sara De, Kossler, Thibaud, Yeh, Kun-Huei, Yen, Chia-Jui, Chen, Yen-Yang, Lin, Johnson, Bilici, Mehmet, Ozguroglu, Mustafa, Cil, Timucin, Oksuzoglu, Berna, Harputluoglu, Hakan, Karaoglu, Aziz, Hacibekiroglu, Ilhan, Erdogan, Bulent, Yalcin, Suayib, Adamchuk, Hryhoriy, Bondarenko, Igor, Kolesnik, Oleksii, Ostapenko, Yuriy, Kryzhanivska, Anna, Leshchenko, Lurii, Ilin, Ievgen, Shparyk, Yaroslav, Trukhin, Dmytro, Voitko, Nataliia, Roy, Rajarshi, Young, Anna-Mary, Medley, Louise, Shiu, Kai-Keen, Celano, Paul, Overton, Lindsay, Raj, Moses, Dunne, Richard, Wainberg, Zev, Dayyani, Farshid, Larson, Timothy, Kochenderfer, Mark, Yañez, Patricio, Rivera, Fernando, Alves, Gustavo Vasconcelos, Garrido, Marcelo, Fernández, Manuel González, Lowery, Maeve A, Çil, Timuçin, Cruz, Felipe Melo, Wainberg, Zev A, Yin, Lina, Bordia, Sonal, Bhagia, Pooja, and Wyrwicz, Lucjan S

Published
2023
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5. Visceral adipose tissue secretome from early and late-stage oesophageal cancer patients differentially affects effector and regulatory T cells

Author

Davern, Maria, Bracken-Clarke, Dara, Donlon, Noel E., Sheppard, Andrew D., Connell, Fiona O’, Heeran, Aisling B., Majcher, Klaudia, Conroy, Melissa J., Mylod, Eimear, Butler, Christine, Donohoe, Claire, Donnell, Dearbhaile O’, Lowery, Maeve, Bhardwaj, Anshul, Ravi, Narayanasamy, Melo, Ashanty A., Sullivan, Jacintha O’, Reynolds, John V., and Lysaght, Joanne

Published
2023
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8. Health diplomacy in action: The cancer legacy of the Good Friday Agreement

Author

Lawler, Mark, Sullivan, Richard, Abou-Alfa, Ghassan K., McCloskey, Karen, Keatley, Debbie, Feighan, Jennifer, Dahut, William, Mulroe, Eibhlin, Ladner, Robert, Genead, Mohamed, Lowery, Maeve, Gulley, James L., Scott, Christopher J., Longley, Daniel B., Culhane, Aedin, Gallagher, William M., Orr, Nick, Chanock, Stephen J., and Gopal, Satish

Published
2023
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10. Trimodality therapy versus perioperative chemotherapy in the management of locally advanced adenocarcinoma of the oesophagus and oesophagogastric junction (Neo-AEGIS): an open-label, randomised, phase 3 trial

Author

Mukherjee, Somnath, Morgan, Carys, Parsons, Simon L, Bhuva, Neel, Campbell, Sorcha, Grogan, Liam, Leonard, Greg, Bateman, Andrew R, Mitchell, Catherine, O'Reilly, Seamus, Mulroe, Eibhlin, McLoughlin, Olivia, Shevlin, Anna, Shannon, Aoife M, Marron, Jacinta, Nolan, Marc, Burch, Grace, Costello, Michelle, Griffiths, Daniel, Cozens, Kelly, Foley, Emma, Donohoe, Claire L, O'Farrell, Catherine, Moore, Jennifer, O'Sullivan, Jacintha, Reynolds, John V, Preston, Shaun R, O'Neill, Brian, Lowery, Maeve A, Baeksgaard, Lene, Crosby, Thomas, Cunningham, Moya, Cuffe, Sinead, Griffiths, Gareth O, Parker, Imelda, Risumlund, Signe Lenora, Roy, Rajarshi, Falk, Stephen, Hanna, George B, Bartlett, Frederick R, Alvarez-Iglesias, Alberto, Achiam, Michael P, Nilsson, Magnus, Piessen, Guillaume, Ravi, Narayanasamy, O'Toole, Dermot, Johnston, Ciaran, McDermott, Raymond S, Turkington, Richard C, Wahed, Shajahan, Sothi, Sharmila, Ford, Hugo, Wadley, Martin S, and Power, Derek

Published
2023
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11. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study

Author

Abou-Alfa, Ghassan K, Macarulla, Teresa, Javle, Milind M, Kelley, Robin K, Lubner, Sam J, Adeva, Jorge, Cleary, James M, Catenacci, Daniel V, Borad, Mitesh J, Bridgewater, John, Harris, William P, Murphy, Adrian G, Oh, Do-Youn, Whisenant, Jonathan, Lowery, Maeve A, Goyal, Lipika, Shroff, Rachna T, El-Khoueiry, Anthony B, Fan, Bin, Wu, Bin, Chamberlain, Christina X, Jiang, Liewen, Gliser, Camelia, Pandya, Shuchi S, Valle, Juan W, and Zhu, Andrew X

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Brain Disorders, Clinical Trials and Supportive Activities, Digestive Diseases, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Bile Duct Neoplasms, Cholangiocarcinoma, Disease Progression, Double-Blind Method, Drug Resistance, Neoplasm, Enzyme Inhibitors, Europe, Female, Glycine, Humans, Isocitrate Dehydrogenase, Male, Middle Aged, Mutation, Progression-Free Survival, Pyridines, Republic of Korea, Time Factors, United States, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundIsocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma.MethodsThis multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857.FindingsBetween Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p

Published
2020

12. Second‐line chemotherapy in advanced biliary cancers: A retrospective, multicenter analysis of outcomes

Author

Lowery, Maeve A, Goff, Laura W, Keenan, Bridget P, Jordan, Emmet, Wang, Rui, Bocobo, Andrea G, Chou, Joanne F, O’Reilly, Eileen M, Harding, James J, Kemeny, Nancy, Capanu, Marianela, Griffin, Ann C, McGuire, Joseph, Venook, Alan P, Abou‐Alfa, Ghassan K, and Kelley, Robin K

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Digestive Diseases, Digestive Diseases - (Gallbladder), Liver Disease, Clinical Trials and Supportive Activities, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Biliary Tract Neoplasms, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Retreatment, Retrospective Studies, Treatment Failure, Treatment Outcome, Young Adult, biliary cancer, bile duct cancer, chemotherapy, cholangiocarcinoma, gallbladder cancer, second line, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundAlthough gemcitabine plus platinum chemotherapy is the established first-line regimen for advanced biliary cancer (ABC), there is no standard second-line therapy. This study evaluated current practice and outcomes for second-line chemotherapy in patients with ABC across 3 US academic medical centers.MethodsInstitutional registries were reviewed to identify patients who had received second-line chemotherapy for ABC from April 2010 to March 2015 along with their demographics, diagnoses and staging, treatment histories, and clinical outcomes. Overall survival from the initiation of second-line chemotherapy (OS2) was estimated with Kaplan-Meier methods.ResultsThis study identified 198 patients with cholangiocarcinoma (intrahepatic [61.1%] or extrahepatic [14.1%]) or gallbladder carcinoma (24.8%); 52% received at least 3 lines of systemic chemotherapy. The median OS2 was 11 months (95% confidence interval [CI], 8.8-13.1 months). The median OS2 for patients with intrahepatic cholangiocarcinoma was 13.4 months (95% CI, 10.7-17.8 months), which was longer than that for patients with extrahepatic cholangiocarcinoma (6.8 months; 95% CI, 5-10.6 months) or gallbladder carcinoma (9.4 months; 95% CI, 7.2-12.3 months; P = .018). The median time to second-line treatment failure was 2.2 months (95% CI, 1.8-2.7 months), and it was similar across tumor locations (P = .60).ConclusionsIn this large cohort of patients with ABC treated across 3 academic medical centers after the failure of first-line chemotherapy, the time to treatment failure on standard therapies was short, although the median OS2 was longer than has been reported previously, and more than half of the patients received additional lines of treatment. This multicenter collaboration represents the largest cohort studied to date of second-line chemotherapy for ABC and provides a contemporary benchmark for future clinical trials.

Published
2019

14. Evidence for the Positive Impact of Centralization in Esophageal Cancer Surgery.

Author

Donlon, Noel E., Moran, Brendan, Davern, Maria, Davey, Matthew G., Kennedy, Czara, Leahy, Roisin, Moore, Jenny, King, Sinead, Lowery, Maeve, Cunningham, Moya, Donohoe, Claire L., O'Toole, Dermot, Ravi, Narayanasamy, and Reynolds, John V.

Abstract

Objective: To analyze the impact of centralization on key metrics, outcomes, and patterns of care at the Irish National Center. Background: Overall survival rates for esophageal cancer in the West have doubled in the last 25 years. An international trend towards centralization may be relevant; however, this model remains controversial, with Ireland centralizing esophageal cancer surgery in 2011. Methods: All patients (n=1245) with adenocarcinoma of the esophagus or junction treated with curative intent involving surgery, including endoscopic surgery, were included (n=461 from 2000 2011, and 784 from 2012 to 2022). All data entry was prospectively recorded. Overall survival was measured (1) for the entire cohort, (2) for patients with locally advanced disease (cT2-3N0-3), and (3) for patients undergoing neoadjuvant therapy. All complications were recorded as per Esophageal Complication Consensus Group definitions, and the Clavien-Dindo severity classification. Data were analyzed using GraphPad Prism (v.6.0) for Windows and SPSS (v.23.0) software (SPSS) R Studio (R version 4.2.2). Survival times were calculated using a log-rank test and Cox regression analysis, and Kaplan-Meier curves were generated. Results: Endotherapy for cT1a/intramucosal cancer adenocarcinoma increased from 40 (9% total) to 245 (31% total) procedures between the pre-centralization and post-centralization (post-C) periods. significantly (P < 0.001) higher proportion of patients with cT2-3N0- disease in the post-C period underwent neoadjuvant therapy (66% 53%). Operative mortality was lower (P=0.02) post-C, at 2% versus 4.5%, and ZIIIa Clavien-Dindo major complications decreased from 33% to 25% (P < 0.01). Recurrence rates were lower post- (38% vs 53%, P < 0.01). Median overall survival was 73.83 versus 47.23 months in the 2012 to 2022 and 2000 to 2011 cohorts, respectively (P < 0.001). For those who received neoadjuvant therapy, the median survival was 28.5 months pre-centralization and 42.5 months post-C (P < 0.001). Conclusions: These data highlight improvements in both operative outcomes and survival from the time of centralization, and a major expansion of endoscopic surgery. Although not providing proof, the study suggests a positive impact of formal centralization with governance on key quality metrics and an evolution in patterns of care. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma

Author

Javle, Milind, Lowery, Maeve, Shroff, Rachna T, Weiss, Karl Heinz, Springfeld, Christoph, Borad, Mitesh J, Ramanathan, Ramesh K, Goyal, Lipika, Sadeghi, Saeed, Macarulla, Teresa, El-Khoueiry, Anthony, Kelley, Robin Kate, Borbath, Ivan, Choo, Su Pin, Oh, Do-Youn, Philip, Philip A, Chen, Li-Tzong, Reungwetwattana, Thanyanan, Van Cutsem, Eric, Yeh, Kun-Huei, Ciombor, Kristen, Finn, Richard S, Patel, Anuradha, Sen, Suman, Porter, Dale, Isaacs, Randi, Zhu, Andrew X, Abou-Alfa, Ghassan K, and Bekaii-Saab, Tanios

Subjects
Orphan Drug, Rare Diseases, Clinical Research, Digestive Diseases, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Administration, Oral, Adult, Aged, Antineoplastic Agents, Bile Duct Neoplasms, Biomarkers, Tumor, Cholangiocarcinoma, Disease Progression, Drug Administration Schedule, Gene Amplification, Gene Fusion, Genetic Predisposition to Disease, Humans, Middle Aged, Mutation, Phenotype, Phenylurea Compounds, Progression-Free Survival, Prospective Studies, Protein Kinase Inhibitors, Pyrimidines, Receptor, Fibroblast Growth Factor, Type 2, Time Factors, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Purpose No standard treatment exists for patients with cholangiocarcinoma for whom first-line gemcitabine-based therapy fails. Fibroblast growth factor receptor 2 ( FGFR2) fusions/translocations are present in 13% to 17% of intrahepatic cholangiocarcinomas. BGJ398, an orally bioavailable, selective pan-FGFR kinase inhibitor, has shown preliminary clinical activity against tumors with FGFR alterations. Methods A multicenter, open-label, phase II study ( ClinicalTrials.gov identifier: NCT02150967) evaluated BGJ398 antitumor activity in patients age ≥ 18 years with advanced or metastatic cholangiocarcinoma containing FGFR2 fusions or other FGFR alterations whose disease had progressed while receiving prior therapy. Patients received BGJ398 125 mg once daily for 21 days, then 7 days off (28-day cycles). The primary end point was investigator-assessed overall response rate. Results Sixty-one patients (35 women; median age, 57 years) with FGFR2 fusion (n = 48), mutation (n = 8), or amplification (n = 3) participated. At the prespecified data cutoff (June 30, 2016), 50 patients had discontinued treatment. All responsive tumors contained FGFR2 fusions. The overall response rate was 14.8% (18.8% FGFR2 fusions only), disease control rate was 75.4% (83.3% FGFR2 fusions only), and estimated median progression-free survival was 5.8 months (95% CI, 4.3 to 7.6 months). Adverse events included hyperphosphatemia (72.1% all grade), fatigue (36.1%), stomatitis (29.5%), and alopecia (26.2%). Grade 3 or 4 treatment-related adverse events occurred in 25 patients (41%) and included hyperphosphatemia (16.4%), stomatitis (6.6%), and palmar-plantar erythrodysesthesia (4.9%). Conclusion BGJ398 is a first-in-class FGFR kinase inhibitor with manageable toxicities that shows meaningful clinical activity against chemotherapy-refractory cholangiocarcinoma containing FGFR2 fusions. This promising antitumor activity supports continued development of BGJ398 in this highly selected patient population.

Published
2018

16. PCM4EU and PRIME-ROSE: Collaboration for implementation of precision cancer medicine in Europe

Author

Taskén, Kjetil, primary, F. Haj Mohammad, Soemeya, additional, Fagereng, Gro Live, additional, Sørum Falk, Ragnhild, additional, Helland, Åslaug, additional, Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar, additional, Steen Carlsson, Katarina, additional, Ryll, Bettina, additional, Jalkanen, Katriina, additional, Edsjö, Anders, additional, Russnes, Hege G., additional, Lassen, Ulrik, additional, Hallersjö Hult, Ebba, additional, Lugowska, Iwona, additional, Blay, Jean-Yves, additional, Verlingue, Loic, additional, Abel, Edvard, additional, Lowery, Maeve A., additional, Krebs, Matthew G., additional, Staal Rohrberg, Kristoffer, additional, Ojamaa, Kristiina, additional, Oliveira, Julio, additional, Verheul, Henk M.W., additional, Voest, Emile E., additional, and Gelderblom, Hans, additional

Published
2024
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18. PCM4EU and PRIME-ROSE:Collaboration for implementation of precision cancer medicine in Europe

Author

Taskén, Kjetil, F Haj Mohammad, Soemeya, Fagereng, Gro Live, Sørum Falk, Ragnhild, Helland, Åslaug, Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar, Steen Carlsson, Katarina, Ryll, Bettina, Jalkanen, Katriina, Edsjö, Anders, Russnes, Hege G., Lassen, Ulrik, Hallersjö Hult, Ebba, Lugowska, Iwona, Blay, Jean Yves, Verlingue, Loic, Abel, Edvard, Lowery, Maeve A., Krebs, Matthew G., Staal Rohrberg, Kristoffer, Ojamaa, Kristiina, Oliveira, Julio, Verheul, Henk M.W., Voest, Emile E., Gelderblom, Hans, Taskén, Kjetil, F Haj Mohammad, Soemeya, Fagereng, Gro Live, Sørum Falk, Ragnhild, Helland, Åslaug, Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar, Steen Carlsson, Katarina, Ryll, Bettina, Jalkanen, Katriina, Edsjö, Anders, Russnes, Hege G., Lassen, Ulrik, Hallersjö Hult, Ebba, Lugowska, Iwona, Blay, Jean Yves, Verlingue, Loic, Abel, Edvard, Lowery, Maeve A., Krebs, Matthew G., Staal Rohrberg, Kristoffer, Ojamaa, Kristiina, Oliveira, Julio, Verheul, Henk M.W., Voest, Emile E., and Gelderblom, Hans

Abstract

Background: In the two European Union (EU)-funded projects, PCM4EU (Personalized Cancer Medicine for all EU citizens) and PRIME-ROSE (Precision Cancer Medicine Repurposing System Using Pragmatic Clinical Trials), we aim to facilitate implementation of precision cancer medicine (PCM) in Europe by leveraging the experience from ongoing national initiatives that have already been particularly successful. Patients and methods: PCM4EU and PRIME-ROSE gather 17 and 24 partners, respectively, from 19 European countries. The projects are based on a network of Drug Rediscovery Protocol (DRUP)-like clinical trials that are currently ongoing or soon to start in 11 different countries, and with more trials expected to be established soon. The main aims of both the projects are to improve implementation pathways from molecular diagnostics to treatment, and reimbursement of diagnostics and tumour-tailored therapies to provide examples of best practices for PCM in Europe. Results: PCM4EU and PRIME-ROSE were launched in January and July 2023, respectively. Educational materials, including a podcast series, are already available from the PCM4EU website (http://www.pcm4eu. eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. Conclusion: European collaboration can facilitate the implementation of PCM and thereby provide affordable and equitable access to precision diagnostics and matched therapies for more patients.

Published
2024

21. Health-related quality of life (HRQOL) with pembrolizumab (pembro) plus trastuzumab (tras) and chemotherapy (chemo) in first-line HER2-positive (HER2+) advanced gastric cancer: KEYNOTE-811 trial results.

Author

Janjigian, Yelena Y., primary, Kawazoe, Akihito, additional, Xu, Jianming, additional, Lonardi, Sara, additional, Metges, Jean-Philippe, additional, Wyrwicz, Lucjan S., additional, Shen, Lin, additional, Ostapenko, Yuriy, additional, Bilici, Mehmet, additional, Lowery, Maeve Aine, additional, Valderrama, Adriana, additional, Guan, Yanfen, additional, Li, Kan, additional, Shih, Chie-Schin, additional, and Rha, Sun Young, additional

Published
2024
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22. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

Author

Rha, Sun Young, primary, Oh, Do-Youn, additional, Yañez, Patricio, additional, Bai, Yuxian, additional, Ryu, Min-Hee, additional, Lee, Jeeyun, additional, Rivera, Fernando, additional, Alves, Gustavo Vasconcelos, additional, Garrido, Marcelo, additional, Shiu, Kai-Keen, additional, Fernández, Manuel González, additional, Li, Jin, additional, Lowery, Maeve A, additional, Çil, Timuçin, additional, Cruz, Felipe Melo, additional, Qin, Shukui, additional, Luo, Suxia, additional, Pan, Hongming, additional, Wainberg, Zev A, additional, Yin, Lina, additional, Bordia, Sonal, additional, Bhagia, Pooja, additional, Wyrwicz, Lucjan S, additional, Mendez, Guillermo, additional, O'Connor, Juan Manuel, additional, Yanzi Castilla, Alvaro, additional, Cundom, Juan, additional, Kaen, Diego, additional, Wong, Rachel, additional, Ng, Weng, additional, Aghmesheh, Morteza, additional, Peressoni, Mauricio, additional, Andrade, Carlos, additional, Franke, Fabio, additional, Alves, Gustavo, additional, Cruz, Felipe Jose, additional, Vianna, Karina, additional, Monteiro, Maria Marcela, additional, Raphael, Michael, additional, Berry, Scott, additional, Jang, Raymond, additional, Tan, Ann, additional, Asselah, Jamil, additional, Yanez Weber, Patricio, additional, Mahave, Mauricio, additional, Sanchez, Cesar, additional, Salman, Pamela, additional, Zhang, Xiaochun, additional, Liu, Tianshu, additional, Lin, Xiaoyan, additional, Yang, Jianwei, additional, Li, Wei, additional, Ying, Jieer, additional, Chen, Xi, additional, Zeng, Shan, additional, Qu, Yanli, additional, Yang, Lin, additional, Zhao, Lin, additional, Chen, Ping, additional, Li, Enxiao, additional, Ye, Feng, additional, Lu, Jianwei, additional, Liang, Xinjun, additional, Zhao, Qun, additional, Yin, Xianli, additional, Li, Junhe, additional, Ling, Yang, additional, Lv, Guoqing, additional, Li, Shouguo, additional, Guerrero, Alvaro, additional, Rubiano, Juan, additional, Gonzalez Fernandez, Manuel, additional, Manneh Kopp, Ray, additional, Guzman Ramirez, Adrian, additional, Corrales, Luis, additional, Gonzalez Herrera, Ileana, additional, Melichar, Bohuslav, additional, Buchler, Tomas, additional, Svoboda, Tomas, additional, Obermannova, Radka, additional, Vrana, David, additional, Cvek, Jakub, additional, Pfeiffer, Per, additional, Baeksgaard, Lene, additional, Yilmaz, Mette, additional, Boige, Valerie, additional, Lopez-Trabada, Daniel, additional, Borg, Christophe, additional, Pannier, Diane, additional, Hiret, Sandrine, additional, Di Fiore, Frederic, additional, Metges, Jean-Philippe, additional, Arnold, Dirk, additional, Martens, Uwe, additional, Lordick, Florian, additional, Stein, Alexander, additional, Castro, Hugo, additional, Lopez, Karla, additional, Ramirez, Julio, additional, Aguilar, Mynor, additional, Chivalan, Marco, additional, Chan, Wendy, additional, Cheng, Ashley, additional, Yeo, Winnie, additional, Arkosy, Peter, additional, Csoszi, Tibor, additional, Hitre, Erika, additional, Horvath, Zsolt, additional, Lowery, Maeve, additional, McDermott, Ray, additional, Morris, Patrick, additional, Hubert, Ayala, additional, Brenner, Baruch, additional, Ben-Aharon, Irit, additional, Shacham-Shmueli, Einat, additional, Man, Sofia, additional, Pelles Avraham, Sharon, additional, Brenner, Ronen, additional, Mishaeli, Moshe, additional, Di Bartolomeo, Maria, additional, Fazio, Nicola, additional, Lonardi, Sara, additional, Garufi, Carlo, additional, Satoh, Taroh, additional, Hara, Hiroki, additional, Iwagami, Shiro, additional, Yasui, Hisateru, additional, Tsuda, Masahiro, additional, Shimoyama, Tatsu, additional, Shoji, Hirokazu, additional, Sugimoto, Naotoshi, additional, Shibata, Nobuhiro, additional, Yamaguchi, Kensei, additional, Amagai, Kenji, additional, Choda, Yasuhiro, additional, Esaki, Taito, additional, Yabusaki, Hiroshi, additional, Oshima, Takashi, additional, Tsuji, Akihito, additional, Kawakami, Hisato, additional, Kawazoe, Akihito, additional, Ishido, Kenji, additional, Kadowaki, Shigenori, additional, Martinez Rodriguez, Jorge, additional, Herrera Martinez, Marytere, additional, Huitzil Melendez, Fidel, additional, Ramirez Godinez, Francisco, additional, Balancan, Paola, additional, Damianovich, Dragan, additional, Castro Oliden, Victor, additional, Grados, Julio, additional, Torres, Cesar, additional, Wyrwicz, Lucjan, additional, Wysocki, Piotr, additional, Hajac, Lukasz, additional, Zolnierek, Jakub, additional, Karaszewska, Boguslawa, additional, Rha, Sun Young, additional, Orlova, Rashida, additional, Tjulandin, Sergey, additional, Fadeeva, Natalia, additional, Makarycheva, Yulia, additional, Nosov, Dmitry, additional, Smagina, Maria, additional, Chan, Sze, additional, Jacobs, Conrad, additional, Kraus, Peter, additional, Landers, Gregory, additional, Robertson, Barbara, additional, Ruff, Paul, additional, Schoeman, Elizabeth, additional, Maurel, Jean-Marc, additional, Diez Garcia, Marc, additional, Jimenez Fonseca, Paula, additional, Gallego Plazas, Javier, additional, Rivera Herrero, Fernando, additional, Miranda Poma, Jesus, additional, Layos Romero, Laura, additional, Fritsch, Ralph, additional, Bastian, Sara, additional, Winterhalder, Ralph, additional, Dosso, Sara De, additional, Kossler, Thibaud, additional, Yeh, Kun-Huei, additional, Yen, Chia-Jui, additional, Chen, Yen-Yang, additional, Lin, Johnson, additional, Bilici, Mehmet, additional, Ozguroglu, Mustafa, additional, Cil, Timucin, additional, Oksuzoglu, Berna, additional, Harputluoglu, Hakan, additional, Karaoglu, Aziz, additional, Hacibekiroglu, Ilhan, additional, Erdogan, Bulent, additional, Yalcin, Suayib, additional, Adamchuk, Hryhoriy, additional, Bondarenko, Igor, additional, Kolesnik, Oleksii, additional, Ostapenko, Yuriy, additional, Kryzhanivska, Anna, additional, Leshchenko, Lurii, additional, Ilin, Ievgen, additional, Shparyk, Yaroslav, additional, Trukhin, Dmytro, additional, Voitko, Nataliia, additional, Roy, Rajarshi, additional, Young, Anna-Mary, additional, Medley, Louise, additional, Celano, Paul, additional, Overton, Lindsay, additional, Raj, Moses, additional, Dunne, Richard, additional, Wainberg, Zev, additional, Dayyani, Farshid, additional, Larson, Timothy, additional, and Kochenderfer, Mark, additional

Published
2023
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24. Pharmacologically controlling protein-protein interactions through epichaperomes for therapeutic vulnerability in cancer

Author

Joshi, Suhasini, Gomes, Erica DaGama, Wang, Tai, Corben, Adriana, Taldone, Tony, Gandu, Srinivasa, Xu, Chao, Sharma, Sahil, Buddaseth, Salma, Yan, Pengrong, Chan, Lon Yin L., Gokce, Askan, Rajasekhar, Vinagolu K., Shrestha, Lisa, Panchal, Palak, Almodovar, Justina, Digwal, Chander S., Rodina, Anna, Merugu, Swathi, Pillarsetty, NagaVaraKishore, Miclea, Vlad, Peter, Radu I., Wang, Wanyan, Ginsberg, Stephen D., Tang, Laura, Mattar, Marissa, de Stanchina, Elisa, Yu, Kenneth H., Lowery, Maeve, Grbovic-Huezo, Olivera, O’Reilly, Eileen M., Janjigian, Yelena, Healey, John H., Jarnagin, William R., Allen, Peter J., Sander, Chris, Erdjument-Bromage, Hediye, Neubert, Thomas A., Leach, Steven D., and Chiosis, Gabriela

Published
2021
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25. Phase 1b study of a small molecule antagonist of human chemokine (C-C motif) receptor 2 (PF-04136309) in combination with nab-paclitaxel/gemcitabine in first-line treatment of metastatic pancreatic ductal adenocarcinoma

Author

Noel, Marcus, O’Reilly, Eileen M., Wolpin, Brian M., Ryan, David P., Bullock, Andrea J., Britten, Carolyn D., Linehan, David C., Belt, Brian A., Gamelin, Eric C., Ganguly, Bishu, Yin, Donghua, Joh, Tenshang, Jacobs, Ira A., Taylor, Carrie T., and Lowery, Maeve A.

Published
2020
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27. Safety and activity of ivosidenib in patients with IDH1-mutant advanced cholangiocarcinoma: a phase 1 study

Author

Lowery, Maeve A, Burris, Howard A, III, Janku, Filip, Shroff, Rachna T, Cleary, James M, Azad, Nilofer S, Goyal, Lipika, Maher, Elizabeth A, Gore, Lia, Hollebecque, Antoine, Beeram, Muralidhar, Trent, Jonathan C, Jiang, Liewen, Fan, Bin, Aguado-Fraile, Elia, Choe, Sung, Wu, Bin, Gliser, Camelia, Agresta, Samuel V, Pandya, Shuchi S, Zhu, Andrew X, and Abou-Alfa, Ghassan K

Published
2019
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28. Trimodality therapy versus perioperative chemotherapy in the management of locally advanced adenocarcinoma of the oesophagus and oesophagogastric junction (Neo-AEGIS): an open-label, randomised, phase 3 trial

Author

Reynolds, John V, primary, Preston, Shaun R, additional, O'Neill, Brian, additional, Lowery, Maeve A, additional, Baeksgaard, Lene, additional, Crosby, Thomas, additional, Cunningham, Moya, additional, Cuffe, Sinead, additional, Griffiths, Gareth O, additional, Parker, Imelda, additional, Risumlund, Signe Lenora, additional, Roy, Rajarshi, additional, Falk, Stephen, additional, Hanna, George B, additional, Bartlett, Frederick R, additional, Alvarez-Iglesias, Alberto, additional, Achiam, Michael P, additional, Nilsson, Magnus, additional, Piessen, Guillaume, additional, Ravi, Narayanasamy, additional, O'Toole, Dermot, additional, Johnston, Ciaran, additional, McDermott, Raymond S, additional, Turkington, Richard C, additional, Wahed, Shajahan, additional, Sothi, Sharmila, additional, Ford, Hugo, additional, Wadley, Martin S, additional, Power, Derek, additional, Mukherjee, Somnath, additional, Morgan, Carys, additional, Parsons, Simon L, additional, Bhuva, Neel, additional, Campbell, Sorcha, additional, Grogan, Liam, additional, Leonard, Greg, additional, Bateman, Andrew R, additional, Mitchell, Catherine, additional, O'Reilly, Seamus, additional, Mulroe, Eibhlin, additional, McLoughlin, Olivia, additional, Shevlin, Anna, additional, Shannon, Aoife M, additional, Marron, Jacinta, additional, Nolan, Marc, additional, Burch, Grace, additional, Costello, Michelle, additional, Griffiths, Daniel, additional, Cozens, Kelly, additional, Foley, Emma, additional, Donohoe, Claire L, additional, O'Farrell, Catherine, additional, Moore, Jennifer, additional, and O'Sullivan, Jacintha, additional

Published
2023
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29. Contributors

Author

Abbruzzese, James L., primary, Abdel-Wahab, Omar, additional, Abou-Alfa, Ghassan K., additional, Abrahm, Janet L., additional, Abrams, Jeffrey S., additional, Abramson, Jeremy S., additional, Aisner, Dara L., additional, Alonso-Basanta, Michelle, additional, Anampa, Jesus, additional, Anderson, Megan E., additional, Antonarakis, Emmanuel S., additional, Aplenc, Richard, additional, Appelbaum, Frederick R., additional, Araujo, Luiz H., additional, Asban, Ammar, additional, Ashwood, Edward, additional, Awan, Farrukh T., additional, Aylward, Juliet L., additional, Balar, Arjun V., additional, Balentine, Courtney J., additional, Barta, Stefan K., additional, Bartlett, Nancy, additional, Basen-Engquist, Karen, additional, Beaupin, Lynda Kwon, additional, Berkowitz, Ross S., additional, Berry, Donald A., additional, Bevers, Therese, additional, Boggess, John F., additional, Brahmer, Julie R., additional, Brown, Janet, additional, Brown, Karen, additional, Brown, Powel, additional, Browner, Ilene, additional, Bunn, Paul A., additional, Burns, William R., additional, Byrd, John C., additional, Cadoo, Karen, additional, Carbone, David P., additional, Carter, H. Ballentine, additional, Castillo, Jorge J., additional, Chang, Alfred E., additional, Chang, Eric, additional, Chanock, Stephen J., additional, Chapuy, Claudia I., additional, Chauhan, Vikash P., additional, Chen, Herbert, additional, Chen, Ronald C., additional, Cheung, Nai-Kong V., additional, Choe, Jennifer H., additional, Christian, Michaele C., additional, Cinciripini, Paul M., additional, Clarke, Michael F., additional, Coleman, Robert E., additional, Coleman, Robert L., additional, Coletta, Adriana M., additional, Collins, Jerry M., additional, Connors, Jean M., additional, Cools, Michael, additional, Coombes, Kevin R., additional, Cortes, Jorge, additional, Costa, Mauro W., additional, Covey, Anne, additional, Cowan, Kenneth H., additional, Crane, Christopher H., additional, Crawford, Jeffrey, additional, Crooks, Kristy, additional, Culkin, Daniel J., additional, Czito, Brian G., additional, Dalerba, Piero, additional, Dalmau, Josep, additional, Dang, Mai, additional, D'Angelica, Michael, additional, Davies, Kurtis D., additional, Davis, Myrtle, additional, Dea, Nicolas, additional, De Jesus-Acosta, Ana, additional, DeMarzo, Angelo M., additional, DeWeese, Theodore L., additional, Diehn, Maximilian, additional, Digumarthy, Subba R., additional, Dispenzieri, Angela, additional, Do, Khanh T., additional, Dobrenkov, Konstantin, additional, Dome, Jeffrey S., additional, Doroshow, James H., additional, Dorsey, Jay F., additional, Dubard-Gault, Marianne, additional, DuBois, Steven G., additional, Duda, Dan G., additional, Dunlop, Malcolm, additional, Duska, Linda R., additional, Duvic, Madeleine, additional, El Dika, Imane, additional, El-Serag, Hashem, additional, Engelmann, Jeffrey M., additional, Ettinger, David S., additional, Fashoyin-Aje, Lola A., additional, Fearon, Eric R., additional, Ford, James M., additional, Franklin, Wilbur A., additional, Freer, Phoebe E., additional, Freidlin, Boris, additional, Freifeld, Alison G., additional, Friedlander, Terence W., additional, Friedman, Debra L., additional, Fuller, Arian F., additional, Galluzzi, Lorenzo, additional, Gebhardt, Mark C., additional, George, Daniel J., additional, Geyer, Mark B., additional, Giaccia, Amato J., additional, Gilbert, Mark R., additional, Goldner, Whitney, additional, Goldstein, Donald P., additional, Goodman, Annekathryn, additional, Goodman, Karyn A., additional, Gordon, Kathleen, additional, Graeff-Armas, Laura, additional, Greenstein, Alexander J., additional, Grossman, Stuart A., additional, Grupp, Stephan, additional, Gupta, Arjun, additional, Haider, Irfanullah, additional, Haigentz, Missak, additional, Hainsworth, John D., additional, Haithcock, Benjamin E., additional, Hallemeier, Christopher L., additional, Hanash, Samir, additional, Hanrahan, Aphrothiti J., additional, Harding, James, additional, Harrison, Michael R., additional, Hasham, Muneer G., additional, Hawk, Ernest, additional, Hayman, Jonathan, additional, Heinlen, Jonathan E., additional, Henry, N. Lynn, additional, Herman, Joseph, additional, Hobbs, Brian P., additional, Holen, Ingunn, additional, Horn, Leora, additional, Horowitz, Neil S., additional, Horwitz, Steven M., additional, Houghton, Odette, additional, Howard, Scott C., additional, Hudis, Clifford A., additional, Hunger, Stephen P., additional, Hurria, Arti, additional, Ilson, David H., additional, Im, Annie, additional, Iyer, Gopa, additional, Jaffee, Elizabeth M., additional, Jagsi, Reshma, additional, Jain, Rakesh K., additional, Jarnagin, William, additional, Jatoi, Aminah, additional, Jhingran, Anuja, additional, Johnson, David H., additional, Johnston, Brian, additional, Johnston, Patrick G., additional, Judy, Kevin D., additional, Kachnic, Lisa A., additional, Kaidar-Person, Orit, additional, Kalva, Sanjeeva, additional, Kamin, Deborah Y., additional, Kantarjian, Hagop, additional, Karakousis, Giorgos, additional, Karam-Hage, Maher, additional, Kaskas, Nadine M., additional, Kastan, Michael B., additional, Katabi, Nora, additional, Kaul, Daniel R., additional, Kelley, Scott R., additional, Kemeny, Nancy, additional, Kent, Erin E., additional, Kepp, Oliver, additional, Khagi, Simon, additional, Kilgore, Joshua E., additional, Kim, D. Nathan, additional, Kleinschmidt-DeMasters, Bette K., additional, Korn, Edward L., additional, Kroemer, Guido, additional, Ku, Geoffrey Y., additional, Kummar, Shivaani, additional, Ky, Bonnie, additional, Laheru, Daniel A., additional, Lambert, Paul F., additional, Lawler, Mark, additional, Le-Rademacher, Jennifer G., additional, Lee, John Y.K., additional, Lee, Nancy Y., additional, Lee, Susanna L., additional, Leeman, Jonathan E., additional, Linkermann, Andreas, additional, Liu, Jinsong, additional, Lo, Simon, additional, Locasale, Jason W., additional, Loprinzi, Charles L., additional, Lowery, Maeve, additional, Ludwig, Emmy, additional, Lunning, Matthew A., additional, Lustig, Robert A., additional, Machtay, Mitchell, additional, Mackall, Crystal, additional, Mahvi, David A., additional, Mahvi, David M., additional, Maity, Amit, additional, Majithia, Neil, additional, Malumbres, Marcos, additional, Maresso, Karen Colbert, additional, Martin, John D., additional, Matsuo, Koji, additional, Matthews, Natalie H., additional, Mauro, Lauren, additional, Mayer, R. Samuel, additional, McCaskill-Stevens, Worta, additional, McNamara, Megan A., additional, Mehta-Shah, Neha, additional, Merritt, Robert E., additional, Milowsky, Matthew I., additional, Minasian, Lori M., additional, Mitchell, Tara C., additional, Mitsis, Demytra, additional, Mollica, Michelle, additional, Mooney, Margaret, additional, Moustafa, Farah, additional, Nabati, Lida, additional, Naidoo, Jarushka, additional, Narang, Amol, additional, Nelson, Heidi, additional, Nelson, William G., additional, Nesbit, Suzanne, additional, Niglas, Mark, additional, O'Connor, Tracey, additional, Offit, Kenneth, additional, Onciu, Mihaela, additional, O’Reilly, Eileen M., additional, Ostrander, Elaine A., additional, Pappas-Taffer, Lisa, additional, Pardoll, Drew, additional, Park, Jae H., additional, Patel, Anery, additional, Patel, Anish J., additional, Patierno, Steven R., additional, Pavletic, Steven Z., additional, Phillips, Peter C., additional, Post, Miriam D., additional, Pruitt, Amy A., additional, Querfeld, Christiane, additional, Rabius, Vance A., additional, Rajkumar, S. Vincent, additional, Ramadan, Mohammad O., additional, Rankin, Erinn B., additional, Reddy, Sushanth, additional, Reid, Michael A., additional, Reznik, Scott, additional, Rizack, Tina, additional, Robinson, Jason D., additional, Robinson-Bostom, Leslie, additional, Rodriguez-Galindo, Carlos, additional, Romesser, Paul B., additional, Rosen, Steven T., additional, Rosenfeld, Myrna R., additional, Rosenthal, Nadia, additional, Ross, Meredith, additional, Rowland, Julia H., additional, Russell, Anthony H., additional, Sabel, Michael S., additional, Sahgal, Arjun, additional, Salinas, Ryan D., additional, Salo-Mullen, Erin E., additional, Salto-Tellez, Manuel, additional, Sanderson, Sydney M., additional, Sandlund, John T., additional, Santana, Victor M., additional, Savage, Michelle, additional, Schreiber, Eric C., additional, Schuchter, Lynn, additional, Schultz, Liora, additional, Seiden, Michael V., additional, Sellers, Morgan M., additional, Shah, Payal D., additional, Shia, Jinru, additional, Shilo, Konstantin, additional, Small, Eric, additional, Smith, Angela B., additional, Snow, Stephen N., additional, Solit, David B., additional, Sood, Anil K., additional, Soto-Perez-de-Celis, Enrique, additional, Sparano, Joseph A., additional, Spiegelman, Vladimir S., additional, Spunt, Sheri L., additional, Stadler, Zsofia K., additional, Steensma, David P., additional, Stone, Richard M., additional, Stranne, Steven Kent, additional, Stratton, Kelly, additional, Sugden, Bill, additional, Swanson, Andrew M., additional, Tallman, Martin S., additional, Talmadge, James E., additional, Teachey, David T., additional, Teba, Catalina V., additional, Tefferi, Ayalew, additional, Teh, Bin Tean, additional, Teng, Joyce M.C., additional, Tepper, Joel E., additional, Thaker, Premal H., additional, Thrift, Aaron P., additional, Tran, Arthur-Quan, additional, Triska, Grace, additional, Trump, Donald, additional, Tsai, Kenneth, additional, Tseng, Chia-Lin, additional, Tseng, Diane, additional, Van Schaeybroeck, Sandra, additional, Van Tine, Brian A., additional, Vanness, Erin R., additional, Varadhachary, Gauri, additional, Varella-Garcia, Marileila, additional, Wahl, Richard L., additional, Walsh, Michael F., additional, Wang, Thomas, additional, Weiss, Jared, additional, Weissman, Irving L., additional, Westin, Shannon N., additional, White, Jeffrey D., additional, Wilson, Richard, additional, Wong, Richard J., additional, Wood, Gary S., additional, Xu, Yaohui G., additional, Xu-Welliver, Meng, additional, Yust-Katz, Shlomit, additional, Zagar, Timothy, additional, Zeman, Elaine M., additional, Zhang, Tian, additional, and Zwiebel, James A., additional

Published
2020
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30. Liver and Bile Duct Cancer

Author

Abou-Alfa, Ghassan K., primary, Jarnagin, William, additional, El Dika, Imane, additional, D'Angelica, Michael, additional, Lowery, Maeve, additional, Brown, Karen, additional, Ludwig, Emmy, additional, Kemeny, Nancy, additional, Covey, Anne, additional, Crane, Christopher H., additional, Harding, James, additional, Shia, Jinru, additional, and O'Reilly, Eileen M., additional

Published
2020
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32. Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma

Author

Lowery, Maeve A., Kelsen, David P., Capanu, Marinela, Smith, Sloane C., Lee, Jonathan W., Stadler, Zsofia K., Moore, Malcolm J., Kindler, Hedy L., Golan, Talia, Segal, Amiel, Maynard, Hannah, Hollywood, Ellen, Moynahan, MaryEllen, Salo-Mullen, Erin E., Do, Richard Kinh Gian, Chen, Alice P., Yu, Kenneth H., Tang, Laura H., and O'Reilly, Eileen M.

Published
2018
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35. First-line pembrolizumab (pembro) plus chemotherapy (chemo) for advanced gastroesophageal junction cancer (GEJC) and esophageal adenocarcinoma (EAC): Analysis of KEYNOTE-590 and KEYNOTE-859 by tumor type.

Author

Wainberg, Zev A., Shiu, Kai-Keen, Rivera, Fernando, Medley, Louise C., Aghmesheh, Morteza, Dunne, Richard Francis, Roy, Rajarshi, Wyrwicz, Lucjan S., Larson, Timothy, Metges, Jean-Philippe, Mansoor, Wasat, Goekkurt, Eray, Moreira Antunes, Luiz Carlos, Castro Oliden, Victor, Jensen, Erin, Shah, Sukrut, Bordia, Sonal, Bhagia, Pooja, and Lowery, Maeve Aine

Published
2024
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36. Supplementary Figures from Isoform Switching as a Mechanism of Acquired Resistance to Mutant Isocitrate Dehydrogenase Inhibition

Author

Harding, James J., primary, Lowery, Maeve A., primary, Shih, Alan H., primary, Schvartzman, Juan M., primary, Hou, Shengqi, primary, Famulare, Christopher, primary, Patel, Minal, primary, Roshal, Mikhail, primary, Do, Richard K., primary, Zehir, Ahmet, primary, You, Daoqi, primary, Selcuklu, S. Duygu, primary, Viale, Agnes, primary, Tallman, Martin S., primary, Hyman, David M., primary, Reznik, Ed, primary, Finley, Lydia W.S., primary, Papaemmanuil, Elli, primary, Tosolini, Alessandra, primary, Frattini, Mark G., primary, MacBeth, Kyle J., primary, Liu, Guowen, primary, Fan, Bin, primary, Choe, Sung, primary, Wu, Bin, primary, Janjigian, Yelena Y., primary, Mellinghoff, Ingo K., primary, Diaz, Luis A., primary, Levine, Ross L., primary, Abou-Alfa, Ghassan K., primary, Stein, Eytan M., primary, and Intlekofer, Andrew M., primary

Published
2023
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37. Supplementary Methods from Isoform Switching as a Mechanism of Acquired Resistance to Mutant Isocitrate Dehydrogenase Inhibition

Author

Harding, James J., primary, Lowery, Maeve A., primary, Shih, Alan H., primary, Schvartzman, Juan M., primary, Hou, Shengqi, primary, Famulare, Christopher, primary, Patel, Minal, primary, Roshal, Mikhail, primary, Do, Richard K., primary, Zehir, Ahmet, primary, You, Daoqi, primary, Selcuklu, S. Duygu, primary, Viale, Agnes, primary, Tallman, Martin S., primary, Hyman, David M., primary, Reznik, Ed, primary, Finley, Lydia W.S., primary, Papaemmanuil, Elli, primary, Tosolini, Alessandra, primary, Frattini, Mark G., primary, MacBeth, Kyle J., primary, Liu, Guowen, primary, Fan, Bin, primary, Choe, Sung, primary, Wu, Bin, primary, Janjigian, Yelena Y., primary, Mellinghoff, Ingo K., primary, Diaz, Luis A., primary, Levine, Ross L., primary, Abou-Alfa, Ghassan K., primary, Stein, Eytan M., primary, and Intlekofer, Andrew M., primary

Published
2023
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38. Supplemental Tables 1 - 3 and Figures 1 - 2 from Pharmacogenomic Modeling of Circulating Tumor and Invasive Cells for Prediction of Chemotherapy Response and Resistance in Pancreatic Cancer

Author

Yu, Kenneth H., primary, Ricigliano, Mark, primary, Hidalgo, Manuel, primary, Abou-Alfa, Ghassan K., primary, Lowery, Maeve A., primary, Saltz, Leonard B., primary, Crotty, Joseph F., primary, Gary, Kristen, primary, Cooper, Brandon, primary, Lapidus, Rena, primary, Sadowska, Mariola, primary, and O'Reilly, Eileen M., primary

Published
2023
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39. Supplementary Figure 1 from Comprehensive Molecular Profiling of Intrahepatic and Extrahepatic Cholangiocarcinomas: Potential Targets for Intervention

Author

Lowery, Maeve A., primary, Ptashkin, Ryan, primary, Jordan, Emmet, primary, Berger, Michael F., primary, Zehir, Ahmet, primary, Capanu, Marinela, primary, Kemeny, Nancy E., primary, O'Reilly, Eileen M., primary, El-Dika, Imane, primary, Jarnagin, William R., primary, Harding, James J., primary, D'Angelica, Michael I., primary, Cercek, Andrea, primary, Hechtman, Jaclyn F., primary, Solit, David B., primary, Schultz, Nikolaus, primary, Hyman, David M., primary, Klimstra, David S., primary, Saltz, Leonard B., primary, and Abou-Alfa, Ghassan K., primary

Published
2023
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40. Supplementary Table 1 from Comprehensive Molecular Profiling of Intrahepatic and Extrahepatic Cholangiocarcinomas: Potential Targets for Intervention

Author

Lowery, Maeve A., primary, Ptashkin, Ryan, primary, Jordan, Emmet, primary, Berger, Michael F., primary, Zehir, Ahmet, primary, Capanu, Marinela, primary, Kemeny, Nancy E., primary, O'Reilly, Eileen M., primary, El-Dika, Imane, primary, Jarnagin, William R., primary, Harding, James J., primary, D'Angelica, Michael I., primary, Cercek, Andrea, primary, Hechtman, Jaclyn F., primary, Solit, David B., primary, Schultz, Nikolaus, primary, Hyman, David M., primary, Klimstra, David S., primary, Saltz, Leonard B., primary, and Abou-Alfa, Ghassan K., primary

Published
2023
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41. Trimodality therapy versus perioperative chemotherapy in the management of locally advanced adenocarcinoma of the oesophagus and oesophagogastric junction (Neo-AEGIS):an open-label, randomised, phase 3 trial

Author

Reynolds, John V., Preston, Shaun R., O'Neill, Brian, Lowery, Maeve A., Baeksgaard, Lene, Crosby, Thomas, Cunningham, Moya, Cuffe, Sinead, Griffiths, Gareth O., Parker, Imelda, Risumlund, Signe Lenora, Roy, Rajarshi, Falk, Stephen, Hanna, George B., Bartlett, Frederick R., Alvarez-Iglesias, Alberto, Achiam, Michael P., Nilsson, Magnus, Piessen, Guillaume, Ravi, Narayanasamy, O'Toole, Dermot, Johnston, Ciaran, McDermott, Raymond S., Turkington, Richard C., Wahed, Shajahan, Sothi, Sharmila, Ford, Hugo, Wadley, Martin S., Power, Derek, Reynolds, John V., Preston, Shaun R., O'Neill, Brian, Lowery, Maeve A., Baeksgaard, Lene, Crosby, Thomas, Cunningham, Moya, Cuffe, Sinead, Griffiths, Gareth O., Parker, Imelda, Risumlund, Signe Lenora, Roy, Rajarshi, Falk, Stephen, Hanna, George B., Bartlett, Frederick R., Alvarez-Iglesias, Alberto, Achiam, Michael P., Nilsson, Magnus, Piessen, Guillaume, Ravi, Narayanasamy, O'Toole, Dermot, Johnston, Ciaran, McDermott, Raymond S., Turkington, Richard C., Wahed, Shajahan, Sothi, Sharmila, Ford, Hugo, Wadley, Martin S., and Power, Derek

Abstract

Background: The optimum curative approach to adenocarcinoma of the oesophagus and oesophagogastric junction is unknown. We aimed to compare trimodality therapy (preoperative radiotherapy with carboplatin plus paclitaxel [CROSS regimen]) with optimum contemporaneous perioperative chemotherapy regimens (epirubicin plus cisplatin or oxaliplatin plus fluorouracil or capecitabine [a modified MAGIC regimen] before 2018 and fluorouracil, leucovorin, oxaliplatin, and docetaxel [FLOT] subsequently). Methods: Neo-AEGIS (CTRIAL-IE 10-14) was an open-label, randomised, phase 3 trial done at 24 centres in Europe. Patients aged 18 years or older with clinical tumour stage T2–3, nodal stage N0–3, and M0 adenocarcinoma of the oesophagus and oesophagogastric junction were randomly assigned to perioperative chemotherapy (three preoperative and three postoperative 3-week cycles of intravenous 50 mg/m2 epirubicin on day 1 plus intravenous 60 mg/m2 cisplatin or intravenous 130 mg/m2 oxaliplatin on day 1 plus continuous infusion of 200 mg/m2 fluorouracil daily or oral 625 mg/m2 capecitabine twice daily up to 2018, with four preoperative and four postoperative 2-week cycles of 2600 mg/m2 fluorouracil, 85 mg/m2 oxaliplatin, 200 mg/m2 leucovorin, and 50 mg/m2 docetaxel intravenously on day 1 as an option from 2018) or trimodality therapy (41·4 Gy in 23 fractions on days 1−5, 8−12, 15–19, 22–26, and 29–31 with intravenous area under the curve 2 mg/mL per min carboplatin plus intravenous 50 mg/m2 paclitaxel on days 1, 8, 15, 22, and 29). The primary endpoint was overall survival, assessed in all randomly assigned patients who received at least one dose of study drug, regardless of which study drug they received, by intention to treat. Secondary endpoints were disease-free survival, site of treatment failure, operative complications, toxicity, pathological response (complete [ypT0N0

Published
2023

44. Neo-AEGIS (Neoadjuvant Trial in Adenocarcinoma of the Esophagus and Esophago-Gastric Junction International Study): Final primary outcome analysis.

Author

Reynolds, John V., primary, Preston, Shaun R., additional, O'Neill, Brian, additional, Lowery, Maeve Aine, additional, Baeksgaard, Lene, additional, Crosby, Thomas, additional, Cunningham, Moya, additional, Cuffe, Sinead, additional, Griffiths, Gareth Owen, additional, Roy, Rajarshi, additional, Falk, Stephen, additional, Hanna, George, additional, Bartlett, Frederick R., additional, Parker, Imelda, additional, Alvarez-Iglesias, Alberto, additional, Nilsson, Magnus, additional, Piessen, Guillaume, additional, Risum, Signe, additional, Ravi, Narayanasamy, additional, and McDermott, Raymond S., additional

Published
2023
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46. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients

Author

Zehir, Ahmet, Benayed, Ryma, Shah, Ronak H, Syed, Aijazuddin, Middha, Sumit, Kim, Hyunjae R, Srinivasan, Preethi, Gao, Jianjiong, Chakravarty, Debyani, Devlin, Sean M, Hellmann, Matthew D, Barron, David A, Schram, Alison M, Hameed, Meera, Dogan, Snjezana, Ross, Dara S, Hechtman, Jaclyn F, DeLair, Deborah F, Yao, JinJuan, Mandelker, Diana L, Cheng, Donavan T, Chandramohan, Raghu, Mohanty, Abhinita S, Ptashkin, Ryan N, Jayakumaran, Gowtham, Prasad, Meera, Syed, Mustafa H, Rema, Anoop Balakrishnan, Liu, Zhen Y, Nafa, Khedoudja, Borsu, Laetitia, Sadowska, Justyna, Casanova, Jacklyn, Bacares, Ruben, Kiecka, Iwona J, Razumova, Anna, Son, Julie B, Stewart, Lisa, Baldi, Tessara, Mullaney, Kerry A, Al-Ahmadie, Hikmat, Vakiani, Efsevia, Abeshouse, Adam A, Penson, Alexander V, Jonsson, Philip, Camacho, Niedzica, Chang, Matthew T, Won, Helen H, Gross, Benjamin E, Kundra, Ritika, Heins, Zachary J, Chen, Hsiao-Wei, Phillips, Sarah, Zhang, Hongxin, Wang, Jiaojiao, Ochoa, Angelica, Wills, Jonathan, Eubank, Michael, Thomas, Stacy B, Gardos, Stuart M, Reales, Dalicia N, Galle, Jesse, Durany, Robert, Cambria, Roy, Abida, Wassim, Cercek, Andrea, Feldman, Darren R, Gounder, Mrinal M, Hakimi, A Ari, Harding, James J, Iyer, Gopa, Janjigian, Yelena Y, Jordan, Emmet J, Kelly, Ciara M, Lowery, Maeve A, Morris, Luc G T, Omuro, Antonio M, Raj, Nitya, Razavi, Pedram, Shoushtari, Alexander N, Shukla, Neerav, Soumerai, Tara E, Varghese, Anna M, Yaeger, Rona, Coleman, Jonathan, Bochner, Bernard, Riely, Gregory J, Saltz, Leonard B, Scher, Howard I, Sabbatini, Paul J, Robson, Mark E, Klimstra, David S, Taylor, Barry S, Baselga, Jose, Schultz, Nikolaus, Hyman, David M, Arcila, Maria E, Solit, David B, Ladanyi, Marc, and Berger, Michael F

Subjects
Cancer -- Genetic aspects -- Research, Gene mutation -- Research, Cancer metastasis -- Genetic aspects -- Development and progression, Biological sciences, Health
Abstract

Tumor molecular profiling is a fundamental component of precision oncology, enabling the identification of genomic alterations in genes and pathways that can be targeted therapeutically. The existence of recurrent targetable alterations across distinct histologically defined tumor types, coupled with an expanding portfolio of molecularly targeted therapies, demands flexible and comprehensive approaches to profile clinically relevant genes across the full spectrum of cancers. We established a large-scale, prospective clinical sequencing initiative using a comprehensive assay, MSK-IMPACT, through which we have compiled tumor and matched normal sequence data from a unique cohort of more than 10,000 patients with advanced cancer and available pathological and clinical annotations. Using these data, we identified clinically relevant somatic mutations, novel noncoding alterations, and mutational signatures that were shared by common and rare tumor types. Patients were enrolled on genomically matched clinical trials at a rate of 11%. To enable discovery of novel biomarkers and deeper investigation into rare alterations and tumor types, all results are publicly accessible., Author(s): Ahmet Zehir [1]; Ryma Benayed [1]; Ronak H Shah [1]; Aijazuddin Syed [1]; Sumit Middha [1]; Hyunjae R Kim [1]; Preethi Srinivasan [1]; Jianjiong Gao [2]; Debyani Chakravarty [2]; [...]

Published
2017
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