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3. CXCR2 antagonist navarixin in combination with pembrolizumab in select advanced solid tumors: a phase 2 randomized trial

Author

Armstrong, AJ, Geva, R, Chung, HC, Lemech, C, Miller Jr., WH, Hansen, AR, Lee, J-S, Tsai, F, Solomon, BJ, Kim, TM, Rolfo, C, Giranda, V, Ren, Y, Liu, F, Kandala, B, Freshwater, T, Wang, JS, Armstrong, AJ, Geva, R, Chung, HC, Lemech, C, Miller Jr., WH, Hansen, AR, Lee, J-S, Tsai, F, Solomon, BJ, Kim, TM, Rolfo, C, Giranda, V, Ren, Y, Liu, F, Kandala, B, Freshwater, T, and Wang, JS

Abstract

C-X-C motif chemokine receptor 2 (CXCR2) has a role in tumor progression, lineage plasticity, and reduction of immune checkpoint inhibitor efficacy. Preclinical evidence suggests potential benefit of CXCR2 inhibition in multiple solid tumors. In this phase 2 study (NCT03473925), adults with previously treated advanced or metastatic castration-resistant prostate cancer (CRPC), microsatellite-stable colorectal cancer (MSS CRC), or non-small-cell lung cancer (NSCLC) were randomized 1:1 to the CXCR2 antagonist navarixin 30 or 100 mg orally once daily plus pembrolizumab 200 mg intravenously every 3 weeks up to 35 cycles. Primary endpoints were investigator-assessed objective response rate (RECIST v1.1) and safety. Of 105 patients (CRPC, n=40; MSS CRC, n=40; NSCLC, n=25), 3 had a partial response (2 CRPC, 1 MSS CRC) for ORRs of 5%, 2.5%, and 0%, respectively. Median progression-free survival was 1.8-2.4 months without evidence of a dose-response relationship, and the study was closed at a prespecified interim analysis for lack of efficacy. Dose-limiting toxicities occurred in 2/48 patients (4%) receiving navarixin 30 mg and 3/48 (6%) receiving navarixin 100 mg; events included grade 4 neutropenia and grade 3 transaminase elevation, hepatitis, and pneumonitis. Treatment-related adverse events occurred in 70/105 patients (67%) and led to treatment discontinuation in 7/105 (7%). Maximal reductions from baseline in absolute neutrophil count were 44.5%-48.2% (cycle 1) and 37.5%-44.2% (cycle 2) and occurred within 6-12 hours postdose in both groups. Navarixin plus pembrolizumab did not demonstrate sufficient efficacy in this study. Safety and tolerability of the combination were manageable. (Trial registration: ClinicalTrials.gov , NCT03473925).

Published
2024

5. 161TiP A phase I/II, open-label study of an anti-ILT2 (LILRB1) antibody, SAR444881, administered alone and in combination with pembrolizumab, with or without chemotherapy, or cetuximab in patients with advanced solid tumors

Author

Perets, R., primary, Stemmer, S.M., additional, Geva, R., additional, Golan, T., additional, Fakih, M., additional, Cohen, J., additional, Lieu, C., additional, Jin, Z., additional, Lorusso, P., additional, Ashtamker, N., additional, Friedman, I., additional, Hakim, M., additional, Crawford, N., additional, Perez, R., additional, Agarwal, M., additional, Abbadessa, G., additional, Wu, M., additional, Lin, J., additional, Deantonio, C., additional, and Borad, M., additional

Published
2023
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6. Comparing the Broad Socio-Cognitive Profile of Youth with Williams Syndrome and 22Q11.2 Deletion Syndrome

Author

Weisman, O., Feldman, R., Burg-Malki, M., Keren, M., Geva, R., Diesendruck, G., and Gothelf, D.

Abstract

Background: Numerous studies have assessed the socio-cognitive profile in Williams syndrome (WS) and, independently, in 22q11.2 deletion syndrome (22q11.2DS). Yet, a cross-syndrome comparison of these abilities between individuals with these two syndromes with known social deficits has not been conducted. Methods: Eighty-two children participated in four study groups: WS (n = 18), 22q112.DS (n = 24), age-matched individuals with idiopathic developmental disability (IDD; n = 20) and typically developing (TD) controls (n = 20). Participants completed four socio-cognitive tests: facial emotion recognition, mental state attribution, differentiating real from apparent emotions and trait inference based on motives and actions-outcomes. Results: The current findings demonstrate that children with WS were better in labelling happy faces compared with children with 22q11.2DS, partially reflecting their exaggerated social drive. In the false belief task, however, the WS and IDD groups performed poorly compared with the 22q11.2DS group, possibly due to their difficulty to interpret subtle social cues. When asked to identify the gap between real-negative vs. apparent-positive emotions, the 22q11.2DS group performed similarly to TD children but better than the WS group, possibly due to their anxious personality and their innate bias towards negatively valence cues. Finally, individuals with WS were more willing to become friends with a story character even when the character's motives were negative, reflecting their difficulty to avoid potentially harmful real-life situations. Conclusions: Overall, our multi-facet socio-cognitive battery uncovered strengths and weaknesses in social cognition that are syndrome-specific, shared among the genetic syndromes, or common to the three clinical groups compared with healthy controls. Our findings underscore the need to devise age-specific and condition-specific assessment tools and intervention programs towards improving these children's socio-cognitive deficits.

Published
2017
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7. Long term durable effect of PectaSol-C Modified Citrus Pectin (P-MCP) treatment (tx) in non- metastatic Biochemically Relapsed Prostate Cancer (BRPC-M0) patients (pts): Results of a prospective Phase II Study

Author

Keizman, D., primary, Frenkel, M., additional, Peer, A., additional, Kushnir, I., additional, Rosenbaum, E., additional, Sarid, D., additional, Leibovitch, I., additional, Mano, R., additional, Yossepowitch, O., additional, Margel, D., additional, Wolf, I., additional, Geva, R., additional, Rouvinov, K., additional, Dresler, H., additional, and Eliaz, I., additional

Published
2022
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8. 990O Final results from phase I, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors

Author

Perets, R., Stemmer, S.M., Geva, R., Golan, T., Fakih, M., Cohen, J.E., Lieu, C., Jin, Z., Lorusso, P., Friedman, I., Hakim, M., Haves Ziv, D., Hashmueli, S., Mandel, I., Ben Moshe, T., Crawford, N., Abbadessa, G., Perez, R., Wu, M., and Borad, M.

Published
2024
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9. P-81 Phase 3 study of MK4280A (coformulated favezelimab and pembrolizumab) versus standard of care in previously treated PD-L1–positive metastatic colorectal cancer (mCRC)

Author

Kim, T., primary, Taieb, J., additional, Passhak, M., additional, Kim, T., additional, Kim, S., additional, Geva, R., additional, Hofsli, E., additional, Perl, G., additional, Yalcin, S., additional, Hubert, A., additional, Somer, B., additional, Wong, Z., additional, Wang, A., additional, Leconte, P., additional, Fogelman, D., additional, and Heinemann, V., additional

Published
2022
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10. Verbal Short-Term Memory Span in Children: Long-Term Modality Dependent Effects of Intrauterine Growth Restriction

Author

Geva, R., Eshel, R., Leitner, Y., Fattal-Valevski, A., and Harel, S.

Abstract

Background: Recent reports showed that children born with intrauterine growth restriction (IUGR) are at greater risk of experiencing verbal short-term memory span (STM) deficits that may impede their learning capacities at school. It is still unknown whether these deficits are modality dependent. Methods: This long-term, prospective design study examined modality-dependent verbal STM functions in children who were diagnosed at birth with IUGR (n = 138) and a control group (n = 64). Their STM skills were evaluated individually at 9 years of age with four conditions of the Visual-Aural Digit Span Test (VADS; Koppitz, 1981): auditory-oral, auditory-written, visuospatial-oral and visuospatial-written. Cognitive competence was evaluated with the short form of the Wechsler Intelligence Scales for Children-revised (WISC-R95; Wechsler, 1998). Results: We found IUGR-related specific auditory-oral STM deficits (p less than 0.036) in conjunction with two double dissociations: an auditory-visuospatial (p less than 0.014) and an input-output processing distinction (p less than 0.014). Cognitive competence had a significant effect on all four conditions; however, the effect of IUGR on the auditory-oral condition was not overridden by the effect of intelligence quotient (IQ). Conclusions: Intrauterine growth restriction affects global competence and inter-modality processing, as well as distinct auditory input processing related to verbal STM functions. The findings support a long-term relationship between prenatal aberrant head growth and auditory verbal STM deficits by the end of the first decade of life. Empirical, clinical and educational implications are presented.

Published
2008
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13. Molecular markers and biological targeted therapies in metastatic colorectal cancer: expert opinion and recommendations derived from the 11th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2009

Author

Van Cutsem, E., Dicato, M., Arber, N., Berlin, J., Cervantes, A., Ciardiello, F., De Gramont, A., Diaz-Rubio, E., Ducreux, M., Geva, R., Glimelius, B., Jones, R. Glynne, Grothey, A., Gruenberger, T., Haller, D., Haustermans, K., Labianca, R., Lenz, H.J., Minsky, B., Nordlinger, B., Ohtsu, A., Pavlidis, N., Rougier, P., Schmiegel, W., Van de Velde, C., Schmoll, H.J., Sobrero, A., and Tabernero, J.

Published
2010
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14. 476P Open-label phase I/II study evaluating the tolerability and antitumor activity of selinexor (SEL) and pembrolizumab (pembro) in colorectal cancer (CRC)

Author

Kutiel, T. Shentzer, primary, Golan, T., additional, Geva, R., additional, Gottfried, M., additional, Zick, A., additional, Shai, A., additional, Dudnik, J., additional, Netiv, E., additional, Yang, F., additional, Sharoni, S., additional, Meng, C., additional, Duic, P., additional, Michel, D., additional, Sbar, E., additional, Shah, J., additional, Kauffman, M.G., additional, Shacham, S., additional, and Zer, A., additional

Published
2021
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15. 432P Pembrolizumab (pembro) for previously treated, microsatellite instability–high (MSI-H)/mismatch repair–deficient (dMMR) metastatic colorectal cancer (mCRC): Final analysis of KEYNOTE-164

Author

Le, D.T., primary, Diaz, L., additional, Kim, T.W., additional, Van Cutsem, E., additional, Geva, R., additional, Jäger, D., additional, Hara, H., additional, Burge, M., additional, O'Neil, B., additional, Kavan, P., additional, Yoshino, T., additional, Guimbaud, R., additional, Taniguchi, H., additional, Elez, E., additional, Al-Batran, S-E., additional, Boland, P., additional, Cui, Y., additional, Leconte, P., additional, Marinello, P., additional, and André, T., additional

Published
2021
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20. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib

Author

Hammel P., Kindler H. L., Reni M., Van Cutsem E., MacArulla T., Hall M. J., Park J. O., Hochhauser D., Arnold D., Oh D. -Y., Reinacher-Schick A., Tortora G., Algul H., O'Reilly E. M., McGuinness D., Cui K. Y., Joo S., Yoo H. K., Patel N., Golan T., Chantrill L., Goldstein D., Joubert W., Pavlakis N., Tognela A., Van Fraeyenhove F., Van Laethem J. -L., Peeters M., Dhani N., Kavan P., Lemay F., Adenis A., Artru P., Baba-Hamed N., Belletier C., Ben Abdelghani M., Blanc J. -F., Borg C., Coriat R., Deplanque G., Faroux R., Follana P., Guimbaud R., El Hajbi F., Hautefeuille V., Malka D., Metges J. -P., Tougeron D., Walter T., Ettrich T., Hacker U. T., Hennes E., Jacobasch L., Kanzler S., Pession U., Scholz C., Sinn M., Stein A., Strassburg C., Vogel A., Ben-Shahar M., Brenner R., Epelbaum R., Geva R., Gluzman A., Idelevich E., Kolin M., Semenisty V., Shai A., Stemmer S., Yarom N., Celio L., Conte P., Garufi C., Gianni L., Leonardi F., Maiello E., Di Marco M., Milella M., Pinto C., Santini D., Scartozzi M., Vaccaro V., Vasile E., Kim J. -W., Oh Park J., Wilmink H., Gallego R. A., Ogalla G. D., Velasco A. G., Cabanas E. G., Gomez Martin C., Ponce C. G., Saez B. L., Lopez R., Martin A. M., Pazo R., Pijaume C. P., Rodriguez J., Yaya-Tur R., Arora A., Anthoney D. A., Jeffrey Evans T. R., Harrison M., Palmer D., Sarker D., Starling N., Valle J., Wall L., Agajanian R., Bearden J., Bekaii-Saab T., Carter C., Cohen D., Distefano A., Dragovich T., Ejadi S., Ford J., Grabelsky S., Hall M., Hochster H., Hosein P., Javle M., Kindler H., Lacy J., Laheru D., Leong S., Lowery M., Marsh R., Noonan A., Oberstein P., Ocean A., O'Reilly E., Ryan D., Seery T., Subramaniam S., Van Echo D., Wang-Gillam A., Weekes C., Welch S., Hammel P., Kindler H.L., Reni M., Van Cutsem E., MacArulla T., Hall M.J., Park J.O., Hochhauser D., Arnold D., Oh D.-Y., Reinacher-Schick A., Tortora G., Algul H., O'Reilly E.M., McGuinness D., Cui K.Y., Joo S., Yoo H.K., Patel N., Golan T., Chantrill L., Goldstein D., Joubert W., Pavlakis N., Tognela A., Van Fraeyenhove F., Van Laethem J.-L., Peeters M., Dhani N., Kavan P., Lemay F., Adenis A., Artru P., Baba-Hamed N., Belletier C., Ben Abdelghani M., Blanc J.-F., Borg C., Coriat R., Deplanque G., Faroux R., Follana P., Guimbaud R., El Hajbi F., Hautefeuille V., Malka D., Metges J.-P., Tougeron D., Walter T., Ettrich T., Hacker U.T., Hennes E., Jacobasch L., Kanzler S., Pession U., Scholz C., Sinn M., Stein A., Strassburg C., Vogel A., Ben-Shahar M., Brenner R., Epelbaum R., Geva R., Gluzman A., Idelevich E., Kolin M., Semenisty V., Shai A., Stemmer S., Yarom N., Celio L., Conte P., Garufi C., Gianni L., Leonardi F., Maiello E., Di Marco M., Milella M., Pinto C., Santini D., Scartozzi M., Vaccaro V., Vasile E., Kim J.-W., Oh Park J., Wilmink H., Gallego R.A., Ogalla G.D., Velasco A.G., Cabanas E.G., Gomez Martin C., Ponce C.G., Saez B.L., Lopez R., Martin A.M., Pazo R., Pijaume C.P., Rodriguez J., Yaya-Tur R., Arora A., Anthoney D.A., Jeffrey Evans T.R., Harrison M., Palmer D., Sarker D., Starling N., Valle J., Wall L., Agajanian R., Bearden J., Bekaii-Saab T., Carter C., Cohen D., Distefano A., Dragovich T., Ejadi S., Ford J., Grabelsky S., Hall M., Hochster H., Hosein P., Javle M., Kindler H., Lacy J., Laheru D., Leong S., Lowery M., Marsh R., Noonan A., Oberstein P., Ocean A., O'Reilly E., Ryan D., Seery T., Subramaniam S., Van Echo D., Wang-Gillam A., Weekes C., Welch S., Institut Català de la Salut, [Hammel P] Department of Digestive Oncology, Hôpital Beaujon (AP-HP), Clichy, and University Paris VII, Paris, France. [Kindler HL] Department of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, USA. [Reni M] Department of Oncology, IRCCS Ospedale San Raffaele Scientific Institute, Milan, Italy. [Van Cutsem E] Division of Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium. [Macarulla T] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology, Barcelona, Spain. [Hall MJ] Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, USA, Vall d'Hebron Barcelona Hospital Campus, CCA - Cancer Treatment and Quality of Life, and Oncology

Subjects
Male, 0301 basic medicine, Oncology, medicine.medical_treatment, BRCA, pancreatic cancer, Disease, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Piperazines, Germline, Medicaments antineoplàstics, chemistry.chemical_compound, 0302 clinical medicine, Quality of life, Neoplasm Metastasis, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], ambiente y salud pública::salud pública::medidas epidemiológicas::demografía::estado de salud::calidad de vida [ATENCIÓN DE SALUD], BRCA1 Protein, Neoplasms::Neoplastic Processes::Neoplasm Metastasis [DISEASES], Hematology, Middle Aged, Progression-Free Survival, humanities, 3. Good health, metastatic, health-related quality of life, 030220 oncology & carcinogenesis, Female, Adult, medicine.medical_specialty, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Poly(ADP-ribose) Polymerase Inhibitors, Placebo, olaparib, Olaparib, 03 medical and health sciences, Double-Blind Method, Metàstasi, Pancreatic cancer, Internal medicine, Gastrointestinal Tumors, medicine, Humans, Germ-Line Mutation, Aged, BRCA2 Protein, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], Chemotherapy, Pàncrees - Càncer, business.industry, BRCA mutation, Original Articles, medicine.disease, Pancreatic Neoplasms, Environment and Public Health::Public Health::Epidemiologic Measurements::Demography::Health Status::Quality of Life [HEALTH CARE], 030104 developmental biology, chemistry, neoplasias::procesos neoplásicos::metástasis neoplásica [ENFERMEDADES], Quality of Life, Phthalazines, Neoplasm Recurrence, Local, business
Abstract

Qualitat de vida relacionada amb la salut; Olaparib; Càncer de pàncrees Calidad de vida relacionada con la salud; Olaparib, Cáncer de páncreas Health-related quality of life; Olaparib; Pancreatic cancer Background Patients with metastatic pancreatic cancer often have a detriment in health-related quality of life (HRQoL). In the randomized, double-blind, phase III POLO trial progression-free survival was significantly longer with maintenance olaparib, a poly(ADP-ribose) polymerase inhibitor, than placebo in patients with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) and metastatic pancreatic cancer whose disease had not progressed during first-line platinum-based chemotherapy. The prespecified HRQoL evaluation is reported here. Patients and methods Patients were randomized to receive maintenance olaparib (300 mg b.i.d.; tablets) or placebo. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module at baseline, every 4 weeks until disease progression, at discontinuation, and 30 days after last dose. Scores ranged from 0 to 100; a ≥10-point change or difference between arms was considered clinically meaningful. Adjusted mean change from baseline was analysed using a mixed model for repeated measures. Time to sustained clinically meaningful deterioration (TSCMD) was analysed using a log-rank test. Results Of 154 randomized patients, 89 of 92 olaparib-arm and 58 of 62 placebo-arm patients were included in HRQoL analyses. The adjusted mean change in Global Health Status (GHS) score from baseline was

Published
2019

21. First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD-L1×4–1BB (GEN1046) in patients with advanced solid tumors

Author

Garralda, E. (Elena), Geva, R. (Ravit), Ben-Ami, E. (Eytan), Maurice-Dror, C. (Corinne), Calvo, E. (Emiliano), LoRusso, P. (Patricia), Türec, Ö. (Özlem), Niewood, M. (Michelle), Sahin, U. (Ugur), Jure-Kunkel, M. (María), Forssmann, U. (Ulf), Ahmadi, T. (Tahamtan), and Melero, I. (Ignacio)

Subjects
Cancer immunotherapies, T cells, Monotherapy
Abstract

Agonistic 4-1BB monoclonal antibodies were preclinically validated as promising cancer immunotherapies, both as monotherapy and as potentiators of the activity of PD-(L) 1–blocking agents. However, toxicity and a narrow therapeutic window have hampered their clinical development. DuoBodyPD-L1×4-1BB, a first-in-class, bispecific, next-generation checkpoint immunotherapy, was designed to overcome these limitations by activating T cells through conditional 4-1BB costimulation, while simultaneously blocking the PD-L1 axis. We present preliminary data from the ongoing, first-in-human, open-label, phase I/IIa trial of DuoBody-PD-L1×4-1BB in advanced solid tumors (NCT03917381).

Published
2020

22. The diagnosis and management of gastric cancer: expert discussion and recommendations from the 12th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2010

Author

Van Cutsem, E., Dicato, M., Geva, R., Arber, N., Bang, Y., Benson, A., Cervantes, A., Diaz-Rubio, E., Ducreux, M., Glynne-Jones, R., Grothey, A., Haller, D., Haustermans, K., Kerr, D., Nordlinger, B., Marshall, J., Minsky, B. D., Kang, Y. K., Labianca, R., Lordick, F., Ohtsu, A., Pavlidis, N., Roth, A., Rougier, P., Schmoll, H. J., Sobrero, A., Tabernero, J., Van de Velde, C., and Zalcberg, J.

Published
2011
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23. 524O Initial results of a phase I study of MK-4830, a first-in-class anti–immunoglobulin-like transcript 4 (ILT4) myeloid-specific antibody in patients (pts) with advanced solid tumours

Author

Siu, L.L., primary, Wang, D., additional, Hilton, J., additional, Geva, R., additional, Rasco, D., additional, Abraham, A.K., additional, Markensohn, J.F., additional, Suttner, L., additional, Siddiqi, S., additional, Altura, R.A., additional, and Maurice-Dror, C., additional

Published
2020
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27. 40. Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, Sun W, Jalal SI, Shah MA, Metges JP, Garrido M, Golan T, Mandala M, Wainberg ZA, Catenacci DV, Ohtsu A, Shitara K, Geva R, Bleeker J, Ko AH, Ku G, Philip P, Enzinger PC, Bang YJ, Levitan D, Wang J, Rosales M, Dalal RP, Yoon HH

Author

Fuchs, Cs, Doi, T, Jang, Rw, Muro, K, Satoh, T, Machado, M, Sun, W, Jalal, Si, Shah, Ma, Metges, Jp, Garrido, M, Golan, T, Mandala', M, Wainberg, Za, Catenacci, Dv, Ohtsu, A, Shitara, K, Geva, R, Bleeker, J, Ko, Ah, Ku, G, Philip, P, Enzinger, Pc, Bang, Yj, Levitan, D, Wang, J, Rosales, M, Dalal, Rp, and Yoon, Hh.

Published
2018

28. Bevacizumab as adjuvant treatment for colon cancer: Updated results from the AVANT phase III study by the GERCOR group

Author

André, T., primary, Vernerey, D., additional, Im, S.-A., additional, Bodoky, G.M., additional, Buzzoni, R., additional, Reingold, S., additional, Rivera, F., additional, McKendrick, J., additional, Scheithauer, W., additional, Geva, R., additional, Fountzilas, G., additional, Yong, W.P., additional, Isaacs, R., additional, Österlund, P., additional, Liang, J.-T., additional, Creemers, G.-J., additional, Van Cutsem, E., additional, Cunningham, D., additional, Tabernero, J., additional, and De Gramont, A., additional

Published
2019
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29. Pembrolizumab in patients with MSI-H advanced endometrial cancer from the KEYNOTE-158 study

Author

O'Malley, D., primary, Marabelle, A., additional, De Jesus-Acosta, A., additional, Piha-Paul, S.A., additional, Arkhipov, A., additional, Longo, F., additional, Motola-Kuba, D., additional, Shapira-Frommer, R., additional, Geva, R., additional, Rimel, B.J., additional, Lopez-Martin, J.A., additional, Hansen, A.R., additional, Mehnert, J.M., additional, Chen, X., additional, Jin, F., additional, Norwood, K., additional, and Ott, P.A., additional

Published
2019
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30. Pembrolizumab in microsatellite instability high cancers: Updated analysis of the phase II KEYNOTE-164 and KEYNOTE-158 studies

Author

Diaz, L.A., primary, Le, D., additional, Maio, M., additional, Ascierto, P.A., additional, Geva, R., additional, Motola-Kuba, D., additional, André, T., additional, Van Cutsem, E., additional, Gottfried, M., additional, Elez, E., additional, Delord, J.-P., additional, Jäger, D., additional, Kim, T.W., additional, Guimbaud, R., additional, Yoshino, T., additional, Chen, M., additional, Norwood, K., additional, Marinello, P., additional, and Marabelle, A., additional

Published
2019
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31. Effect of Primary Tumor Side on Survival Outcomes in Untreated Patients With Metastatic Colorectal Cancer When Selective Internal Radiation Therapy Is Added to Chemotherapy: Combined Analysis of Two Randomized Controlled Studies.

Author

Helmberger T., Findlay M.P.N., Isaacs R., O'Donnell A., Perez D., Rodriguez J., Vera-Garcia R., Amin P., Bloomgarden D., Bui J., Carlisle J., Chai S., Chen Y.-J., Chuong M., Coveler A., Facchini F., Frenette G., Frick J., Garofalo M., George B., Gordon M., Gulec S., Hannigan J., Holtzman M., Kaubisch A., Kaiser A., Kooy T., Limentani S., Margolis J., Martin R., Ozer H., Padia S., Rilling W., Savin M., Schneiderman E., Seeger G., Shibata S., Smith R., Wang E., Whiting S., Aghmesheh M., Cooray P., Feeney K., Lim L., Singh M., Underhill C., Durand A., Faivre S., Ferru A., Hammel P., Bremer C., De Wit M., Ayala H., Heching N., Shani A., Granetto C., Masi G., Mosconi S., Numico G., Trogu A., Kim Y.H., Sae-Won H., Fragoso M., Tan I., Casado A.R., Liang J.T., Liu J.H., Ades S., Auber M., Boland P., Bowers C., Crain M., Dowling K., Iyer R., Ratner L., Sanchez F., Stoltzfus P., Westcott M., Segelov E., Strickland A., Gibbs P., Heinemann V., Sharma N., Taieb J., Ricke J., Peeters M., Robinson B.A., Jackson C., Gebski V., Van Buskirk M., Zhao H., van Hazel G., Brown M., Burge M., Cardaci G., Clarke S., Eliadis P., Ferguson T., Ganju V., James P., Karapetis C., Liauw W., Marx G., Matos M., Nott L., Pavlakis N., Powell A., Price T., Ransom D., Shannon J., Singhal N., Walpole E., Craninx M., Delaunoit T., Deleporte A., Ferrante M., Geboes K., Hendlisz A., Hendrickx K., De Man M., Monsaert E., Moons V., Polus M., Boucher E., Balosso J., Chevallier P., Louafi S., Pracht M., Rebischung C., Smith D., Terrebonne E., Bruch H.-R., Gehbauer G., Ko Y.-D., Kroning H., Lammert F., Nusch A., Pluntke S., Ridwelski K., Riera-Knorrenschild J., Riess H., Riera J.R., Sauerbruch T., Scheidhauer K., Stotzer O., Tatsch K., Vehling-Kaiser U., Vogl T., Beny A., Geva R., Shacham-Shmueli E., Stemmer S., Tichler T., Wolf I., Angelelli B., Martoni A., Helmberger T., Findlay M.P.N., Isaacs R., O'Donnell A., Perez D., Rodriguez J., Vera-Garcia R., Amin P., Bloomgarden D., Bui J., Carlisle J., Chai S., Chen Y.-J., Chuong M., Coveler A., Facchini F., Frenette G., Frick J., Garofalo M., George B., Gordon M., Gulec S., Hannigan J., Holtzman M., Kaubisch A., Kaiser A., Kooy T., Limentani S., Margolis J., Martin R., Ozer H., Padia S., Rilling W., Savin M., Schneiderman E., Seeger G., Shibata S., Smith R., Wang E., Whiting S., Aghmesheh M., Cooray P., Feeney K., Lim L., Singh M., Underhill C., Durand A., Faivre S., Ferru A., Hammel P., Bremer C., De Wit M., Ayala H., Heching N., Shani A., Granetto C., Masi G., Mosconi S., Numico G., Trogu A., Kim Y.H., Sae-Won H., Fragoso M., Tan I., Casado A.R., Liang J.T., Liu J.H., Ades S., Auber M., Boland P., Bowers C., Crain M., Dowling K., Iyer R., Ratner L., Sanchez F., Stoltzfus P., Westcott M., Segelov E., Strickland A., Gibbs P., Heinemann V., Sharma N., Taieb J., Ricke J., Peeters M., Robinson B.A., Jackson C., Gebski V., Van Buskirk M., Zhao H., van Hazel G., Brown M., Burge M., Cardaci G., Clarke S., Eliadis P., Ferguson T., Ganju V., James P., Karapetis C., Liauw W., Marx G., Matos M., Nott L., Pavlakis N., Powell A., Price T., Ransom D., Shannon J., Singhal N., Walpole E., Craninx M., Delaunoit T., Deleporte A., Ferrante M., Geboes K., Hendlisz A., Hendrickx K., De Man M., Monsaert E., Moons V., Polus M., Boucher E., Balosso J., Chevallier P., Louafi S., Pracht M., Rebischung C., Smith D., Terrebonne E., Bruch H.-R., Gehbauer G., Ko Y.-D., Kroning H., Lammert F., Nusch A., Pluntke S., Ridwelski K., Riera-Knorrenschild J., Riess H., Riera J.R., Sauerbruch T., Scheidhauer K., Stotzer O., Tatsch K., Vehling-Kaiser U., Vogl T., Beny A., Geva R., Shacham-Shmueli E., Stemmer S., Tichler T., Wolf I., Angelelli B., and Martoni A.

Abstract

The primary tumor side is emerging as a prognostic factor for patients with liver metastatic colorectal cancer (mCRC). In a combined analysis of data from 2 randomized studies, the addition of selective internal radiation therapy to first-line chemotherapy in patients with mCRC was associated with statistically and clinically significant overall survival gains for patients with a right-sided primary tumor. Background(s): The primary tumor side is emerging as a major prognostic factor for patients with metastatic colorectal cancer (mCRC). We examined the survival data from 2 randomized studies to determine whether the outcomes differ between patients with mCRC with right-sided primary (RSP) tumors and those with left-sided primary (LSP) tumors after selective internal radiation therapy (SIRT) plus mFOLFOX6 (folinic acid [leucovorin], 5-fluorouracil, oxaliplatin) chemotherapy, versus chemotherapy alone. Patients and Methods: Separate and combined analyses were performed on the data from the SIRFLOX and FOXFIRE global trials, which compared chemotherapy plus SIRT with chemotherapy alone for patients with mCRC liver metastases. The primary tumor side data were prospectively collected. The principal outcome measure was overall survival (OS) stratified by treatment and primary tumor side. Result(s): In the combined analysis of all 739 patients enrolled, SIRT had no effect on OS (median OS, 24.3 vs. 24.6 months; hazard ratio [HR], 1.021; P =.810). For the 179 patients (24.2%) with a RSP tumor, OS was improved with the addition of SIRT (median, 22.0 vs. 17.1 months HR, 0.641; P =.008). The addition of SIRT was not associated with a significant difference in OS among the 540 patients with a LSP tumor (median, 24.6 vs. 26.6 months; HR, 1.120; P =.264). A test of treatment interaction by primary tumor side was statistically significant for RSP and SIRT (P =.002). Conclusion(s): The addition of SIRT for patients with RSP tumors, but not for those with LSP tumors, was associated

Published
2018

32. A phase IIa trial to assess the safety and efficacy of BL-8040 and pembrolizumab in patients with metastatic pancreatic adenocarcinoma (PDAC)

Author

Hidalgo, M., primary, Epelbaum, R., additional, Wolpin, B.M., additional, Stemmer, S.M., additional, Geva, R., additional, Golan, T., additional, Borazanci, E., additional, Borad, M., additional, Pedersen, K.S., additional, Park, J.O., additional, Ramirez, R., additional, Peled, A., additional, Lustig, T.M., additional, Bohana Kashtan, O., additional, Rosenfeld, O., additional, Sorani, E., additional, Schlienger, K., additional, Vainstein Haras, A., additional, and Von Hoff, D.D., additional

Published
2018
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33. Safety and antitumor activity of pembrolizumab in patients with advanced microsatellite instability–high (MSI-H) colorectal cancer: KEYNOTE-164

Author

Le, D., primary, Kavan, P., additional, Kim, T., additional, Burge, M., additional, Van Cutsem, E., additional, Hara, H., additional, Boland, P., additional, Van Laethem, J., additional, Geva, R., additional, Taniguchi, H., additional, Crocenzi, T., additional, Sharma, M., additional, Atreya, C., additional, Diaz, L., additional, Liang, L., additional, Marinello, P., additional, Dai, T., additional, and O’Neill, B., additional

Published
2018
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35. Bevacizumab plus chemotherapy as salvage treatment in chemorefractory patients with metastatic colorectal cancer

Author

Geva R, Vecchione L, Tejpar S, Piessevaux H, Van Cutsem E, and Prenen H

Subjects
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282, digestive system diseases
Abstract

Ravit Geva,1,2 Loredana Vecchione,2 Sabine Tejpar,2 Hubert Piessevaux,3 Eric Van Cutsem,2 Hans Prenen21Gastrointestinal Malignancies Service, Oncology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; 2Department of Gastroenterology, Digestive Oncology Unit, University Hospitals Leuven, Leuven, Belgium; 3Department of Gastroenterology, Cliniques Universitaires Saint-Luc, Brussels, BelgiumPurpose: The combination of chemotherapy and bevacizumab, a monoclonal antibody targeting the vascular endothelial growth factor, is consistently being used as first- and second-line treatment in patients with metastatic colorectal cancer (mCRC). There is little data of the activity of bevacizumab in chemorefractory mCRC patients. The aim of this retrospective single center study was to evaluate the activity of bevacizumab combined with chemotherapy in this study population.Methods: Forty-six consecutive mCRC patients treated in the University Hospital Gasthuisberg (Leuven, Belgium) receiving bevacizumab in advanced lines following failure of conventional chemotherapy were included in this study. Treatment regimen consisted of bevacizumab 5 mg/kg in combination with leucovorin, 5-fluorouracil, and oxaliplatin (FOLFOX) or leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI).Results: Bevacizumab plus chemotherapy was used in third-line treatment in eight (17%) patients and in fourth-line treatment or more in 38 patients (83%). All patients previously failed irinotecan-based chemotherapy, 44 (96%) failed oxaliplatin-based regimens, and 40 (87%) failed treatment with cetuximab. Bevacizumab was given in combination with irinotecan-based chemotherapy in 36 patients, oxaliplatin-based chemotherapy in nine patients, and with single agent 5-fluorouracil in one patient. Objective response was demonstrated in ten patients (22%) and disease control in 38 (83%) with a median progression-free survival of 8.9 months and a median overall survival of 13.8 months. Only four patients experienced grade III and above bevacizumab-related toxicity.Conclusion: Taking into account the retrospective nature of the study which can influence the selection of patients, bevacizumab given in advanced lines after failure of conventional chemotherapy and antiepidermal growth factor receptor agents can result in high disease control rates in patients with mCRC.Keywords: colorectal cancer, bevacizumab, chemorefractory

Published
2013

36. The diagnosis and management of gastric cancer: expert discussion and recommendations from the 12th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2010

Author

Van Cutsem, E., Dicato, M., Geva, R., Arber, N., Bang, Y., Benson, A., Cervantes, A., Diaz-Rubio, E., Ducreux, M., Glynne-Jones, R., Grothey, A., Haller, D., Haustermans, K., Kerr, D., Nordlinger, B., Marshall, J., Minsky, B. D., Kang, Y. K., Labianca, R., Lordick, F., Ohtsu, A., Pavlidis, N., Roth, A., Rougier, P., Schmoll, H. J., Sobrero, A., Tabernero, J., Van de Velde, C., Zalcberg, J., Van Cutsem, E., Dicato, M., Geva, R., Arber, N., Bang, Y., Benson, A., Cervantes, A., Diaz-Rubio, E., Ducreux, M., Glynne-Jones, R., Grothey, A., Haller, D., Haustermans, K., Kerr, D., Nordlinger, B., Marshall, J., Minsky, B. D., Kang, Y. K., Labianca, R., Lordick, F., Ohtsu, A., Pavlidis, N., Roth, A., Rougier, P., Schmoll, H. J., Sobrero, A., Tabernero, J., Van de Velde, C., and Zalcberg, J.

Abstract

Well-recognized experts in the field of gastric cancer discussed during the 12th European Society Medical Oncology (ESMO)/World Congress Gastrointestinal Cancer (WCGIC) in Barcelona many important and controversial topics on the diagnosis and management of patients with gastric cancer. This article summarizes the recommendations and expert opinion on gastric cancer. It discusses and reflects on the regional differences in the incidence and care of gastric cancer, the definition of gastro-esophageal junction and its implication for treatment strategies and presents the latest recommendations in the staging and treatment of primary and metastatic gastric cancer. Recognition is given to the need for larger and well-designed clinical trials to answer many open questions

Published
2017

37. Molecular markers and biological targeted therapies in metastatic colorectal cancer: expert opinion and recommendations derived from the 11th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2009

Author

Cutsem, E. Van, Dicato, M., Arber, N., Berlin, J., Cervantes, A., Ciardiello, F., Gramont, A. De, Diaz-Rubio, E., Ducreux, M., Geva, R., Glimelius, B., Glynne-Jones, R., Grothey, Axel, Gruenberger, T., Haller, D., Haustermans, K., Labianca, R., Lenz, H. J., Minsky, B., Nordlinger, B., Ohtsu, A., Pavlidis, Nicholas, Rougier, P., Schmiegel, W., Velde, C. Van de, Schmoll, H. J., Sobrero, A., Tabernero, Josep, and Pavlidis, Nicholas [0000-0002-2195-9961]

Subjects
Oncology, Colorectal cancer, medicine.medical_treatment, Braf protein, Gastroenterology, Metastasis, Drug antagonism, Targeted therapy, Antineoplastic agents, Pathology, Conference paper, Biological markers, Predictive marker, Hematology, Prognosis, Chemotherapy regimen, Antineoplastic agent, Proto-oncogene proteins, Ras protein, Human, Receptor, medicine.medical_specialty, Neoplasm metastasis, Ras proteins, MEDLINE, Oncoprotein, Colorectal neoplasms, Proto-oncogene proteins b-raf, Internal medicine, Genetics, medicine, Humans, Gastrointestinal cancer, Colorectal tumor, B raf kinase, Epidermal growth factor receptor, Kras protein, business.industry, Epidermal growth factor, Cancer, medicine.disease, digestive system diseases, Biological marker, Metabolism, Spain, Mutation, Carcinoembryonic antigen, Microsatellite instability, business
Abstract

The article summarizes the expert discussion and recommendations on the use of molecular markers and of biological targeted therapies in metastatic colorectal cancer (mCRC), as well as a proposed treatment decision strategy for mCRC treatment. The meeting was conducted during the 11th ESMO/World Gastrointestinal Cancer Congress (WGICC) in Barcelona in June 2009. The manuscript describes the outcome of an expert discussion leading to an expert recommendation. The increasing knowledge on clinical and molecular markers and the availability of biological targeted therapies have major implications in the optimal management in mCRC. 21 Suppl 6 vi1 10

Published
2010

40. Efficacy of pembrolizumab in phase 2 KEYNOTE-164 and KEYNOTE-158 studies of microsatellite instability high cancers

Author

Diaz, L., primary, Marabelle, A., additional, Kim, T.W., additional, Geva, R., additional, Van Cutsem, E., additional, André, T., additional, Ascierto, P.A., additional, Maio, M., additional, Delord, J-P., additional, Gottfried, M., additional, Guimbaud, R., additional, Jaeger, D., additional, Elez, E., additional, Yoshino, T., additional, Joe, A., additional, Lam, B., additional, Ding, J., additional, Pruitt, S., additional, Kang, S.P., additional, and Le, D.T., additional

Published
2017
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43. KEYNOTE-059 Update: Efficacy and safety of pembrolizumab alone or in combination with chemotherapy in patients with advanced gastric or gastroesophageal (G/GEJ) cancer

Author

Wainberg, Z.A., primary, Jalal, S., additional, Muro, K., additional, Yoon, H.H., additional, Garrido, M., additional, Golan, T., additional, Doi, T., additional, Catenacci, D.V., additional, Geva, R., additional, Ku, G., additional, Bleeker, J., additional, Bang, Y-J., additional, Hara, H., additional, Chung, H.C., additional, Savage, M., additional, Wang, J., additional, Koshiji, M., additional, Dalal, R., additional, and Fuchs, C.S., additional

Published
2017
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50. Molecular markers and biological targeted therapies in metastatic colorectal cancer: expert opinion and recommendations derived from the 11th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2009

Author

Van Cutsem, E, Dicato, M, Arber, N, Berlin, J, Cervantes, A, Ciardiello, F, De Gramont, A, Diaz Rubio, E, Ducreux, M, Geva, R, Glimelius, B, Glynne Jones, R, Grothey, A, Gruenberger, T, Haller, D, Haustermans, K, Labianca, R, Lenz, Hj, Minsky, B, Nordlinger, B, Ohtsu, A, Pavlidis, N, Rougier, P, Schmiegel, W, Van de Velde, C, Schmoll, Hj, Sobrero, Alberto, Tabernero, J., VAN CUTSEM, E, Dicato, M, Arber, N, Berlin, J, Cervantes, A, Ciardiello, Fortunato, DE GRAMONT, A, DIAZ RUBIO, E, Ducreux, M, Geva, R, Glimelius, B, GLYNNE JONES, R, Grothey, A, Gruenberger, T, Haller, D, Haustermans, K, Labianca, R, Lenz, Hj, Minsky, B, Nordlinger, B, Ohtsu, A, Pavlidis, N, Rougier, P, Schmiegel, W, VAN DE VELDE, C, Schmoll, Hj, Sobrero, A, and Tabernero, J.

Subjects
Biological Markers/metabolism, Receptor, Epidermal Growth Factor/antagonists & inhibitors, ras Proteins/genetics, Antineoplastic Agents/adverse effects, Carcinoembryonic Antigen/analysis, Prognosis, Proto-Oncogene Proteins/genetics, Colorectal Neoplasms/*drug therapy/genetics/pathology, Spain, Mutation, Proto-Oncogene Proteins B-raf/genetics, Humans, Microsatellite Instability, phase-iii trial fluorouracil-based chemotherapy randomized controlled-trial advanced pancreatic-cancer cetuximab plus irinotecan microsatellite instability thymidylate synthase carcinoembryonic antigen combination chemotherapy 1st-line treatment, Neoplasm Metastasis
Abstract

The article summarizes the expert discussion and recommendations on the use of molecular markers and of biological targeted therapies in metastatic colorectal cancer (mCRC), as well as a proposed treatment decision strategy for mCRC treatment. The meeting was conducted during the 11th ESMO/World Gastrointestinal Cancer Congress (WGICC) in Barcelona in June 2009. The manuscript describes the outcome of an expert discussion leading to an expert recommendation. The increasing knowledge on clinical and molecular markers and the availability of biological targeted therapies have major implications in the optimal management in mCRC. Ann Oncol

Published
2010

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