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1. Establishment of patient-derived tumor organoids to functionally inform treatment decisions in metastatic colorectal cancer

Author

Martini, G., Belli, V., Napolitano, S., Ciaramella, V., Ciardiello, D., Belli, A., Izzo, F., Avallone, A., Selvaggi, F., Menegon Tasselli, F., Santaniello, W., Franco, R., Puig, I., Ramirez, L., Chicote, I., Mancuso, F., Caratu, G., Serres, X., Fasani, R., Jimenez, J., Ros, J., Baraibar, I., Mulet, N., Della Corte, C.M., Troiani, T., Vivancos, A., Dienstmann, R., Elez, E., Palmer, H.G., Tabernero, J., Martinelli, E., Ciardiello, F., and Argilés, G.

Published
2023
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4. Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study

Author

Van Cutsem, E., Danielewicz, I., Saunders, M.P., Pfeiffer, P., Argilés, G., Borg, C., Glynne-Jones, R., Punt, C.J.A., Van de Wouw, A.J., Fedyanin, M., Stroyakovskiy, D., Kroening, H., Garcia-Alfonso, P., Wasan, H., Falcone, A., Kanehisa, A., Egorov, A., Aubel, P., Amellal, N., and Moiseenko, V.

Published
2020
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9. AXL is a predictor of poor survival and of resistance to anti-EGFR therapy in RAS wild-type metastatic colorectal cancer

Author

Cardone C., Blauensteiner B., Moreno-Viedma V., Martini G., Simeon V., Vitiello P. P., Ciardiello D., Belli V., Matrone N., Troiani T., Morgillo F., Zito Marino F., Dentice M., Nappi A., Boccaccino A., Antoniotti C., Cremolini C., Pietrantonio F., Prager G. W., Normanno N., Maiello E., Argiles G., Elez E., Signoriello G., Franco R., Falcone A., Tabernero J., Sibilia M., Ciardiello F., Martinelli E., ZITO MARINO, Federica, Cardone, Claudia, Blauensteiner, Bernadette, Moreno-Viedma, Veronica, Martini, Giulia, Simeon, Vittorio, Vitiello, Pietro P, Ciardiello, Davide, Belli, Valentina, Matrone, Nunzia, Troiani, Teresa, Morgillo, Floriana, Zito Marino, Federica, Dentice, Monica, Nappi, Annarita, Boccaccino, Alessandra, Antoniotti, Carlotta, Cremolini, Chiara, Pietrantonio, Filippo, Prager, Gerald W, Normanno, Nicola, Maiello, Evaristo, Argiles, Guillem, Elez, Elena, Signoriello, Giuseppe, Franco, Renato, Falcone, Alfredo, Tabernero, Josep, Sibilia, Maria, Ciardiello, Fortunato, Martinelli, Erika, Cardone, C., Blauensteiner, B., Moreno-Viedma, V., Martini, G., Simeon, V., Vitiello, P. P., Ciardiello, D., Belli, V., Matrone, N., Troiani, T., Morgillo, F., Zito Marino, F., Dentice, M., Nappi, A., Boccaccino, A., Antoniotti, C., Cremolini, C., Pietrantonio, F., Prager, G. W., Normanno, N., Maiello, E., Argiles, G., Elez, E., Signoriello, G., Franco, R., Falcone, A., Tabernero, J., Sibilia, M., Ciardiello, F., Martinelli, E., and ZITO MARINO, Federica

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Colorectal cancer, Population, 03 medical and health sciences, Mice, 0302 clinical medicine, Growth factor receptor, Internal medicine, Cell Line, Tumor, Proto-Oncogene Proteins, Medicine, Animals, Humans, Epithelial–mesenchymal transition, Neoplasm Metastasis, education, education.field_of_study, Cetuximab, business.industry, AXL, EGFR resistance, RAS WT, Receptor Protein-Tyrosine Kinases, Transfection, medicine.disease, Xenograft Model Antitumor Assays, Axl Receptor Tyrosine Kinase, Blockade, ErbB Receptors, 030104 developmental biology, Genes, ras, Drug Resistance, Neoplasm, 030220 oncology & carcinogenesis, Immunohistochemistry, business, Colorectal Neoplasms, Biomarkers, medicine.drug
Abstract

Background RAS mutations are the only validated biomarkers in metastatic colorectal cancer (mCRC) for anti-epidermal growth factor receptor (EGFR) therapy. Limited clinical information is available on AXL expression, marker of epithelial to mesenchymal transition, in mCRC. Methods AXL was retrospectively assessed by immunohistochemistry in 307 patients. RAS wild-type (WT) patients (N = 136) received first-line anti-EGFR–based therapy; RAS mutant patients (N = 171) received anti-angiogenic–based regimens. Preclinical experiments were performed using human RAS WT CRC cell lines and xenograft models. AXL RNA levels were assessed in a cohort of patients with available samples at baseline and at progression to anti-EGFR treatment and in the GSE5851 dataset. Results AXL was expressed in 55/307 tumour tissues, correlating with worse survival in the overall population (AXL-positive, 23.7 months; AXL-negative, 30.8 months; HR, 1.455, P = 0.032) and in RAS WT patients (AXL-positive, 23.0 months; AXL-negative, 35.8 months; HR,1.780, P = 0.032). Progression-free survival (PFS) in the RAS WT cohort was shorter in the AXL-positive cohort (6.2 months versus 12.1 months; HR, 1.796, P = 0.013). Three-dimensional cultures obtained from a patient following anti-EGFR therapy resulted AXL-positive, showing resistance to anti-EGFR drugs and sensitivity to AXL inhibition. AXL transfection in CRC cell lines induced AXL overexpression and resistance to the EGFR blockade. At progression to cetuximab, 2/10 SW48-tumour xenograft mice showed AXL expression. Consistently, AXL RNA levels increased in 5/7 patients following anti-EGFR therapy. Moreover, in the GSE5851 dataset higher AXL RNA levels correlated with worse PFS with cetuximab in KRAS-exon2 WT chemorefractory patients. Conclusions AXL is a marker of poor prognosis in mCRC with consistent clinical and preclinical evidences of involvement in primary and acquired resistance to anti-EGFR drugs in RAS WT patients.

Published
2020

10. A phase 1b study of the MET inhibitor capmatinib combined with cetuximab in patients with MET-positive colorectal cancer who had progressed following anti-EGFR monoclonal antibody treatment

Author

Delord J, Argiles G, Fayette J, Wirth L, Kasper S, Siena S, Mesia R, Berardi R, Cervantes A, Dekervel J, Zhao S, Sun Y, Hao H, Tiedt R, Vicente S, Myers A, and Siu L

Subjects
digestive system diseases
Abstract

Background Overcoming resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) in patients with KRAS wildtype (WT) metastatic colorectal cancer (mCRC) could help meet the needs of patients with limited treatment options. Methods In this phase 1b study, patients with N/KRAS WT, MET-positive mCRC who had progressed following anti-EGFR mAb treatment received escalating oral doses of capmatinib (150, 300, and 400 mg) twice daily plus weekly intravenous cetuximab (at the approved dose). The primary objective was to establish a recommended dose for expansion (RDE) of capmatinib in combination with cetuximab. Safety, preliminary activity, pharmacokinetics, and pharmacodynamics were also explored. Results Thirteen patients were enrolled. No patients experienced a dose-limiting toxicity at investigated doses; the RDE was established as capmatinib 400 mg twice daily plus cetuximab. All patients experienced adverse events (AEs) suspected to be related to the study treatment. Five patients (38.5%) reported study-drug-related AEs of grade 3/4 in severity. No patients achieved a complete or partial response according to RECIST v1.1; however, tumor shrinkage of 29-44% was observed in 4 patients. Conclusions Capmatinib plus cetuximab was well tolerated. Preliminary signs of activity were observed. Further investigation is warranted to obtain efficacy data and refine predictive biomarkers of response. Clinical trial registration NCT02205398.

Published
2020

11. Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials

Author

Yoshino, T, Cleary, JM, Van Cutsem, E, Mayer, RJ, Ohtsu, A, Shinozaki, E, Falcone, A, Yamazaki, K, Nishina, T, Garcia-Carbonero, R, Komatsu, Y, Baba, H, Argiles, G, Tsuji, A, Sobrero, A, Yamaguchi, K, Peeters, M, Muro, K, Zaniboni, A, Sugimoto, N, Shimada, Y, Tsuji, Y, Hochster, HS, Moriwaki, T, Tran, B, Esaki, T, Hamada, C, Tanase, T, Benedetti, F, Makris, L, Yamashita, F, Lenz, H-J, Yoshino, T, Cleary, JM, Van Cutsem, E, Mayer, RJ, Ohtsu, A, Shinozaki, E, Falcone, A, Yamazaki, K, Nishina, T, Garcia-Carbonero, R, Komatsu, Y, Baba, H, Argiles, G, Tsuji, A, Sobrero, A, Yamaguchi, K, Peeters, M, Muro, K, Zaniboni, A, Sugimoto, N, Shimada, Y, Tsuji, Y, Hochster, HS, Moriwaki, T, Tran, B, Esaki, T, Hamada, C, Tanase, T, Benedetti, F, Makris, L, Yamashita, F, and Lenz, H-J

Abstract

BACKGROUND: The phase II J003 (N = 169) and phase III RECOURSE (N = 800) trials demonstrated a significant improvement in survival with trifluridine (FTD)/tipiracil (TPI) versus placebo in patients with refractory metastatic colorectal cancer. This post hoc analysis investigated pharmacokinetic data of FTD/TPI exposure and pharmacodynamic markers, such as chemotherapy-induced neutropenia (CIN) and clinical outcomes. PATIENTS AND METHODS: A total of 210 patients from RECOURSE were enrolled in this substudy. A limited sampling approach was used, with three pharmacokinetic samples drawn on day 12 of cycle 1. Patients were categorized as being above or below the median area under the plasma concentration-time curve (AUC) for FTD and TPI. We conducted a post hoc analysis using the entire RECOURSE population to determine the correlations between CIN and clinical outcome. We then carried out a similar analysis on the J003 trial to validate the results. RESULTS: In the RECOURSE subset, patients in the high FTD AUC group had a significantly increased CIN risk. Analyses of the entire population demonstrated that FTD/TPI-treated patients with CIN of any grade in cycles 1 and 2 had significantly longer median overall survival (OS) and progression-free survival (PFS) than patients who did not develop CIN and patients in the placebo group. Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN. Similar results were obtained in the J003 cohort. CONCLUSIONS: In RECOURSE, patients with higher FTD drug exposure had an increased CIN risk. FTD/TPI-treated patients who developed CIN had improved OS and PFS versus those in the placebo group and those who did not develop CIN. Similar findings were reported in the J003 cohort, thus validating the RECOURSE results. The occurrence of CIN may be a useful predictor of treatment outcomes for FTD/TPI-treated patients. CLINICALTRIALS. GOV IDENTIFIER: NCT0160795

Published
2020

13. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study

Author

Van Cutsem, E, Yoshino, T, Lenz, H J, Lonardi, S, Falcone, A, Limón, M L, Saunders, M, Sobrero, A, Park, Y S, Ferreiro, R, Hong, Y S, Tomasek, J, Taniguchi, H, Ciardiello, F, Stoehr, J, Oum'Hamed, Z, Vlassak, S, Studeny, M, Argiles, G, Universitat Autònoma de Barcelona, Van Cutsem, E, Yoshino, T, Lenz, H J, Lonardi, S, Falcone, A, Limón, M L, Saunders, M, Sobrero, A, Park, Y S, Ferreiro, R, Hong, Y S, Tomasek, J, Taniguchi, H, Ciardiello, F, Stoehr, J, Oum'Hamed, Z, Vlassak, S, Studeny, M, and Argiles, G

Subjects
0301 basic medicine, Oncology, Male, Indoles, chemorefractory metastatic colorectal cancer, Placebo-controlled study, Administration, Oral, law.invention, Placebos, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, nintedanib, angiogenesis inhibition, Hematology, Fatigue, Hazard ratio, Middle Aged, Progression-Free Survival, Angiogenesis inhibition, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Disease Progression, Nintedanib, Female, Chemical and Drug Induced Liver Injury, Colorectal Neoplasms, Adult, medicine.medical_specialty, Antineoplastic Agents, Adenocarcinoma, Placebo, 03 medical and health sciences, Double-Blind Method, Internal medicine, Regorafenib, Gastrointestinal Tumors, medicine, Humans, Progression-free survival, Protein Kinase Inhibitors, neoplasms, Aged, business.industry, Chemorefractory metastatic colorectal cancer, Original Articles, digestive system diseases, 030104 developmental biology, Receptors, Vascular Endothelial Growth Factor, chemistry, business
Abstract

BACKGROUND: Angiogenesis is critical to colorectal cancer (CRC) growth and metastasis. Phase I/II studies have demonstrated the efficacy of nintedanib, a triple angiokinase inhibitor, in patients with metastatic CRC. This global, randomized, phase III study investigated the efficacy and safety of nintedanib in patients with refractory CRC after failure of standard therapies. PATIENTS AND METHODS: Eligible patients (Eastern Cooperative Oncology Group performance status 0-1, with histologically/cytologically confirmed metastatic/locally advanced CRC adenocarcinoma unamenable to surgery and/or radiotherapy) were randomized 1 : 1 to receive nintedanib (200 mg twice daily) or placebo (twice daily), until disease progression or undue toxicity. Patients were stratified by previous regorafenib, time from onset of metastatic disease to randomization, and region. Co-primary end points were overall survival (OS) and progression-free survival (PFS) by central review. Secondary end points included objective tumor response and disease control by central review. RESULTS: From October 2014 to January 2016, 768 patients were randomized; 765 were treated (nintedanib n = 384; placebo n = 381). Median follow-up was 13.4 months (interquartile range 11.1-15.7). OS was not improved [median OS 6.4 months with nintedanib versus 6.0 months with placebo; hazard ratio (HR), 1.01; 95% confidence interval (CI), 0.86-1.19; P = 0.8659]. There was a significant but modest increase in PFS with nintedanib versus placebo (median PFS 1.5 versus 1.4 months, respectively; HR 0.58; 95% CI 0.49-0.69; P

Published
2018

15. Results of REARRANGE trial: A randomized phase 2 study comparing different dosing approaches for regorafenib (REG) during the first cycle of treatment in patients (pts) with metastatic colorectal cancer (mCRC)

Author

Argiles, G., primary, Margalef, N. Mulet, additional, Valladares-Ayerbes, M., additional, de Prado, J. Vieitez, additional, Grávalos, C., additional, Alfonso, P. García, additional, Santos, C., additional, Tobeña, M., additional, Sastre, J., additional, Benavides, M., additional, Cano, T., additional, Loupakis, F., additional, Garrote, M. Rodriguez, additional, Rivera, F., additional, Goldberg, R., additional, Falcone, A., additional, Bennouna, J., additional, Ciardiello, F., additional, Tabernero, J., additional, and Aranda, E., additional

Published
2019
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18. Refining criteria of hyperprogression (HPD) with immune checkpoint inhibitors (ICIs) to improve clinical applicability

Author

Matos Garcia, I., primary, García Ruiz, A., additional, Martin-Liberal, J., additional, Hierro, C., additional, Ochoa De Olza Amat, M., additional, Viaplana, C., additional, Mur, G., additional, Vieito Villar, M., additional, Brana, I., additional, Azaro, A., additional, Perez, C., additional, Rodriguez Freixinos, V., additional, Argiles, G., additional, Oliveira, M., additional, Felip Font, E., additional, Muñoz-Couselo, E., additional, Tabernero, J., additional, Dienstmann, R., additional, and Garralda, E., additional

Published
2018
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19. Droplet digital PCR of circulating tumour DNA for the detection of RAS/BRAF mutation in metastatic colorectal cancer

Author

Van Cutsem, E., primary, Lesniewski-Kmak, K., additional, Saunders, M.P., additional, Wasan, H., additional, Argiles, G., additional, Borg, C., additional, Creemers, G.-J.M., additional, Fedyanin, M., additional, Glynne-Jones, R., additional, Pfeiffer, P., additional, Punt, C.J.A., additional, Stroyakovskiy, D., additional, Ten Tije, A.J., additional, van de Wouw, A., additional, Cattan, V., additional, Desachy, G., additional, Amellal, N., additional, and Moiseyenko, V.M., additional

Published
2018
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20. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study

Author

Van Cutsem, E., primary, Yoshino, T., additional, Lenz, H.J., additional, Lonardi, S., additional, Falcone, A., additional, Limón, M.L., additional, Saunders, M., additional, Sobrero, A., additional, Park, Y.S., additional, Ferreiro, R., additional, Hong, Y.S., additional, Tomasek, J., additional, Taniguchi, H., additional, Ciardiello, F., additional, Stoehr, J., additional, Oum’Hamed, Z., additional, Vlassak, S., additional, Studeny, M., additional, and Argiles, G., additional

Published
2018
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21. Phase II study evaluating trifluridine/tipiracil + bevacizumab and capecitabine + bevacizumab in first-line unresectable metastatic colorectal cancer (mCRC) patients who are non-eligible for intensive therapy (TASCO1): Results of the primary analysis

Author

Lesniewski-Kmak, K., primary, Moiseenko, V., additional, Saunders, M., additional, Wasan, H., additional, Argiles, G., additional, Borg, C., additional, Creemers, G., additional, Fedyanin, M., additional, Glynne-Jones, R., additional, Pfeiffer, P., additional, Punt, C., additional, Stroyakovskiy, D., additional, Ten Tije, A., additional, Van de Wouw, A., additional, Kanehisa, A., additional, Fougeray, R., additional, Busto, N. Lopez, additional, Amellal, N., additional, and Van Cutsem, E., additional

Published
2018
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22. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with FOLFOX and Bevacizumab for First-Line Metastatic Colorectal Cancer

Author

Garcia-Carbonero, R, van Cutsem, E, Rivera, F, Jassem, J, Gore, I, Tebbutt, N, Braiteh, F, Argiles, G, Wainberg, ZA, Funke, R, Anderson, M, McCall, B, Stroh, M, Wakshull, E, Hegde, P, Ye, W, Chen, D, Chang, I, Rhee, I, Hurwitz, H, Garcia-Carbonero, R, van Cutsem, E, Rivera, F, Jassem, J, Gore, I, Tebbutt, N, Braiteh, F, Argiles, G, Wainberg, ZA, Funke, R, Anderson, M, McCall, B, Stroh, M, Wakshull, E, Hegde, P, Ye, W, Chen, D, Chang, I, Rhee, I, and Hurwitz, H

Abstract

LESSONS LEARNED: These negative phase II results for parsatuzumab highlight the challenges of developing an agent intended to enhance the efficacy of vascular endothelial growth factor inhibition without the benefit of validated pharmacodynamic biomarkers or strong predictive biomarker hypotheses.Any further clinical development of anti-EGFL7 is likely to require new mechanistic insights and biomarker development for antiangiogenic agents. BACKGROUND: EGFL7 (epidermal growth factor-like domain 7) is a tumor-enriched vascular extracellular matrix protein that supports endothelial cell survival. This phase II trial evaluated the efficacy of parsatuzumab (also known as MEGF0444A), a humanized anti-EGFL7 IgG1 monoclonal antibody, in combination with modified FOLFOX6 (mFOLFOX6) (folinic acid, 5-fluorouracil, and oxaliplatin) bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC). METHODS: One-hundred twenty-seven patients were randomly assigned to parsatuzumab, 400 mg, or placebo, in combination with mFOLFOX6 plus bevacizumab, 5 mg/kg. Treatment cycles were repeated every 2 weeks until disease progression or unacceptable toxicity for a maximum of 24 months, with the exception of oxaliplatin, which was administered for up to 8 cycles. RESULTS: The progression-free survival (PFS) hazard ratio was 1.17 (95% confidence interval [CI], 0.71-1.93; p = .548). The median PFS was 12 months for the experimental arm versus 11.9 months for the control arm. The hazard ratio for overall survival was 0.97 (95% CI, 0.46-2.1; p = .943). The overall response rate was 59% in the parsatuzumab arm and 64% in the placebo arm. The adverse event profile was similar in both arms. CONCLUSIONS: There was no evidence of efficacy for the addition of parsatuzumab to the combination of bevacizumab and chemotherapy for first-line mCRC. The Oncologist 2017;22:375-e30.

Published
2017

23. Career opportunities and benefits for young oncologists in the European Society for Medical Oncology (ESMO)

Author

Morgan, G., Lambertini, M., Kourie, H.R., Amaral, T., Argiles, G., Banerjee, S., Cardone, C., Corral, J., De Mattos-Arruda, L., Öztürk, A., Petrova, M., Poulsen, L., Strijbos, M., Tyulyandina, A., Vidra, R., Califano, R., de Azambuja, E., Garrido Lopez, P., Guarneri, V., Reck, M., Moiseyenko, V., Martinelli, E., Douillard, J.Y., Stahel, R., Voest, E., Arnold, D., Cardoso, F., Casali, P., Cervantes, A., Eggermont, A.M., Eniu, A., Jassem, J., Pentheroudakis, G., Peters, S., McGregor, K., Rauh, S., Zielinski, C.C., Ciardiello, F., Tabernero, J., and Preusser, M.

Abstract

The European Society for Medical Oncology (ESMO) is one of the leading societies of oncology professionals in the world. Approximately 30% of the 13 000 ESMO members are below the age of 40 and thus meet the society's definition of young oncologists (YOs). ESMO has identified the training and development of YOs as a priority and has therefore established a comprehensive career development programme. This includes a leadership development programme to help identify and develop the future leaders in oncology. Well-trained and highly motivated future generations of multidisciplinary oncologists are essential to ensure the optimal evolution of the field of oncology with the ultimate goal of providing the best possible care to patients with cancer. ESMO's career development portfolio is managed and continuously optimised by several dedicated committees composed of ESMO officers and is directly supervised by the ESMO Executive Board and the ESMO President. It offers unique resources for YOs at all stages of training and includes a broad variety of fellowship opportunities, educational courses, scientific meetings, publications and resources. In this article, we provide an overview of the activities and career development opportunities provided by ESMO to the next generation of oncologists.

Published
2016

24. Phase I studies of the novel carcinoembryonic antigen T-cell bispecific (CEA-CD3 TCB) antibody as a single agent and in combination with atezolizumab: Preliminary efficacy and safety in patients (pts) with metastatic colorectal cancer (mCRC)

Author

Segal, N.H., primary, Saro, J., additional, Melero, I., additional, Ros, W., additional, Argiles, G., additional, Marabelle, A., additional, Rodriguez Ruiz, M.E., additional, Albanell, J., additional, Calvo, E., additional, Moreno, V., additional, Cleary, J.M., additional, Eder, J.P., additional, Karanikas, V., additional, Bouseida, S., additional, Sandoval, F., additional, Sabanes, D., additional, Sreckovic, S., additional, Hurwitz, H.I., additional, Paz-Ares, L., additional, and Tabernero, J., additional

Published
2017
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25. Pharmacokinetics (PK) and pharmacodynamics (PD) of a novel carcinoembryonic antigen (CEA) T-cell bispecific antibody (CEA-CD3 TCB) for the treatment of CEA-positive solid tumors

Author

Melero, I., primary, Segal, N.H., additional, Saro, J., additional, Ros, W., additional, Martinez-Garcia, M., additional, Argiles, G., additional, Moreno, V., additional, Ponce, S., additional, Marabelle, A., additional, Cleary, J.M., additional, Hurwitz, H.I., additional, Eder, J.P., additional, Jamois, C., additional, Andersson, E., additional, Bouseida, S., additional, Sandoval, F., additional, Bacac, M., additional, Nayak, T., additional, Karanikas, V., additional, and Calvo, E., additional

Published
2017
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26. Efficacy and safety of Sym004 in refractory metastatic colorectal cancer with acquired resistance to anti-EGFR therapy: Results of a randomized phase II study (RP2S)

Author

Tabernero, J., primary, Ciardiello, F., additional, Montagut, C., additional, Ding, C., additional, Kopetz, S., additional, Tuxen Poulsen, T., additional, Bardelli, A., additional, Wyrwicz, L., additional, Cubillo, A., additional, Santos, C., additional, Fumi, G., additional, Zagonel, V., additional, Bennouna, J., additional, Siena, S., additional, Falcone, A., additional, Benavent, M., additional, Argiles, G., additional, Kragh, M., additional, Horak, I.D., additional, and Dvorkin, M., additional

Published
2017
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29. Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial

Author

Longo-Muñoz, F., primary, Argiles, G., additional, Tabernero, J., additional, Cervantes, A., additional, Gravalos, C., additional, Pericay, C., additional, Gil-Calle, S., additional, Mizuguchi, H., additional, Carrato-Mena, A., additional, Limón, M. L., additional, and Garcia-Carbonero, R., additional

Published
2016
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30. Safety and Activity of the First-in-Class Sym004 Anti-EGFR Antibody Mixture in Patients with Refractory Colorectal Cancer

Author

Dienstmann, R., Patnaik, A., Garcia-Carbonero, R., Cervantes, A., Benavent, M., Rosello, S., Tops, B.B.J., Post, R.S. van der, Argiles, G., Skartved, N.J., Hansen, U.H., Hald, R., Pedersen, M.W., Kragh, M., Horak, I.D., Braun, S., Cutsem, E. Van, Tolcher, A.W., Tabernero, J., Dienstmann, R., Patnaik, A., Garcia-Carbonero, R., Cervantes, A., Benavent, M., Rosello, S., Tops, B.B.J., Post, R.S. van der, Argiles, G., Skartved, N.J., Hansen, U.H., Hald, R., Pedersen, M.W., Kragh, M., Horak, I.D., Braun, S., Cutsem, E. Van, Tolcher, A.W., and Tabernero, J.

Abstract

Item does not contain fulltext, Tumor growth in the context of EGFR inhibitor resistance may remain EGFR-dependent and is mediated by mechanisms including compensatory ligand upregulation and de novo gene alterations. Sym004 is a two-antibody mixture targeting nonoverlapping EGFR epitopes. In preclinical models, Sym004 causes significant EGFR internalization and degradation, which translates into superior growth inhibition in the presence of ligands. In this phase I trial, we observed grade 3 skin toxicity and hypomagnesemia as mechanism-based dose-limiting events during dose escalation. In dose-expansion cohorts of 9 and 12 mg/kg of Sym004 weekly, patients with metastatic colorectal cancer and acquired EGFR inhibitor resistance were enrolled; 17 of 39 patients (44%) had tumor shrinkage, with 5 patients (13%) achieving partial response. Pharmacodynamic studies confirmed marked Sym004-induced EGFR downmodulation. MET gene amplification emerged in 1 patient during Sym004 treatment, and a partial response was seen in a patient with EGFR(S492R) mutation that is predictive of cetuximab resistance. SIGNIFICANCE: Potent EGFR downmodulation with Sym004 in patients with metastatic colorectal cancer and acquired resistance to cetuximab/panitumumab translates into significant antitumor activity and validates the preclinical hypothesis that a proportion of tumors remains dependent on EGFR signaling. Further clinical development and expanded correlative analyses of response patterns with secondary RAS/EGFR mutations are warranted. Cancer Discov; 5(6);598-609. (c)2015 AACR. See related commentary by Stintzing and Heinemann, p. 578 This article is highlighted in the In This Issue feature, p. 565.

Published
2015

34. O-022 - Phase II study evaluating trifluridine/tipiracil + bevacizumab and capecitabine + bevacizumab in first-line unresectable metastatic colorectal cancer (mCRC) patients who are non-eligible for intensive therapy (TASCO1): Results of the primary analysis

Author

Lesniewski-Kmak, K., Moiseenko, V., Saunders, M., Wasan, H., Argiles, G., Borg, C., Creemers, G., Fedyanin, M., Glynne-Jones, R., Pfeiffer, P., Punt, C., Stroyakovskiy, D., Ten Tije, A., Van de Wouw, A., Kanehisa, A., Fougeray, R., Busto, N. Lopez, Amellal, N., and Van Cutsem, E.

Published
2018
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35. Cavitation of lung metastases induced by regorafenib is associated with radiological response in metastatic colorectal cancer: data from the phase III correct study

Author

Ricotta, R., primary, Ghezzi, S., additional, Verrioli, A., additional, Porcu, L., additional, Cremolini, C., additional, Argiles, G., additional, Adenis, A., additional, Ychou, M., additional, Barone, C., additional, Bouche, O., additional, Humblet, Y., additional, Mineur, L., additional, Sobrero, A., additional, Pietrogiovanna, L., additional, Maiolani, M., additional, Galbiati, D., additional, Tosi, F., additional, Redaelli, D., additional, and Grothey, A., additional

Published
2015
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36. 2015 Cavitation of lung metastases induced by regorafenib in patients with colorectal carcinoma: Data from the phase III CORRECT study

Author

Ricotta, R., primary, Verrioli, A., additional, Ghezzi, S., additional, Grothey, A., additional, Cremolini, C., additional, Argiles, G., additional, Adenis, A., additional, Ychou, M., additional, Barone, C., additional, Bouchet, O., additional, Humblet, Y., additional, Mineur, L., additional, Sobrero, A., additional, Peeters, M., additional, Van Cutsem, E., additional, Porcu, L., additional, Amatu, A., additional, Sartore-Bianchi, A., additional, Vanzulli, A., additional, and Siena, S., additional

Published
2015
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37. PD-016 Developmental therapeutics activity portrait in metastatic colorectal cancer (mCRC): Vall d'Hebron Institute of Oncology Program

Author

Grasselli, J., primary, Elez, E., additional, Sauri, T., additional, Macarulla, T., additional, Alsina, M., additional, Capdevila, J., additional, Argiles, G., additional, Hierro, C., additional, Salva, F., additional, Sanz-García, E., additional, Racca, F., additional, Azaro, A., additional, Braña, I., additional, Ochoa de Olza, M., additional, Grau, I., additional, Sala, G., additional, Rodon, J., additional, Salazar, R., additional, and Tabernero, J., additional

Published
2015
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38. O-012 Nanofluidic digital PCR and extended genotyping of RAS, BRAF and PI3KCA for improved selection of metastatic colorectal cancer patients to anti-EGFR therapies

Author

Azuara, D., primary, Santos, C., additional, Lopez-Doriga, A., additional, Grasselli, J., additional, Nadal, M., additional, Sanjuan, X., additional, Marin, F., additional, Morell, M., additional, Montal, R., additional, Moreno, V., additional, Montagut, C., additional, Bellosillo, B., additional, Argiles, G., additional, Elez, E., additional, Tabernero, J., additional, Capellá, G., additional, and Salazar, R., additional

Published
2015
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40. 403P - Phase I studies of the novel carcinoembryonic antigen T-cell bispecific (CEA-CD3 TCB) antibody as a single agent and in combination with atezolizumab: Preliminary efficacy and safety in patients (pts) with metastatic colorectal cancer (mCRC)

Author

Segal, N.H., Saro, J., Melero, I., Ros, W., Argiles, G., Marabelle, A., Rodriguez Ruiz, M.E., Albanell, J., Calvo, E., Moreno, V., Cleary, J.M., Eder, J.P., Karanikas, V., Bouseida, S., Sandoval, F., Sabanes, D., Sreckovic, S., Hurwitz, H.I., Paz-Ares, L., and Tabernero, J.

Published
2017
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41. 104P - Pharmacokinetics (PK) and pharmacodynamics (PD) of a novel carcinoembryonic antigen (CEA) T-cell bispecific antibody (CEA-CD3 TCB) for the treatment of CEA-positive solid tumors

Author

Melero, I., Segal, N.H., Saro, J., Ros, W., Martinez-Garcia, M., Argiles, G., Moreno, V., Ponce, S., Marabelle, A., Cleary, J.M., Hurwitz, H.I., Eder, J.P., Jamois, C., Andersson, E., Bouseida, S., Sandoval, F., Bacac, M., Nayak, T., Karanikas, V., and Calvo, E.

Published
2017
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42. LBA-004 - Novel carcinoembryonic antigen T-cell bispecific (CEA-TCB) antibody: Preliminary clinical data as a single agent and in combination with atezolizumab in patients with metastatic colorectal cancer (mCRC)

Author

Argilés, G., Saro, J., Segal, N.H., Melero, I., Ros, W., Marabelle, A., Rodriguez, M.E., Albanell, J., Calvo, E., Moreno, V., Cleary, J.M., Eder, P., Paz-Ares, L., Hurwitz, H., Bacac, M., Perro, M., Bouseida, S., Sandoval, F., Sabanes Bove, D., Sreckovic, S., Jamois, C., Silva, A., Klein, C., Umana, P., Karanikas, V., and Tabernero, J.

Published
2017
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43. Évaluation des risques sanitaires liés à l’utilisation professionnelle des produits bitumineux et de leurs additifs – Résultats de l’expertise collective – Conclusions et recommandations de l’Anses

Author

Fourneau, C., primary, Boulanger, G., additional, Nerriere-Catelinois, E., additional, Cointot, M.-L., additional, Argiles, G., additional, Stücker, I., additional, Lafontaine, M., additional, Cesarini, J.-P., additional, Huynh, C.K., additional, Garçon, G., additional, Appenzeller, B., additional, Schroeder, H., additional, Sutter, B., additional, and Bourgeois, D., additional

Published
2014
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46. Poster session 6. Phase 1 studies

Author

Pollyea, D., primary, Gore, L., additional, Gutman, J., additional, Eckhardt, S. G., additional, Hagelstrom, N., additional, Coutre, S., additional, Thirman, M., additional, Byrd, J., additional, Massimini, G., additional, Laffranchi, B., additional, Rejeb, N., additional, Asatiani, E., additional, Milner, A., additional, von Richter, O., additional, Locatelli, G., additional, Ogden, J. A., additional, Osterwalder, B., additional, Meng, R., additional, Molife, L. R., additional, de Mattos-Arruda, L., additional, Hollebecque, A., additional, Isakoff, S. J., additional, Roda, D., additional, Yan, Y., additional, Cervantes, A., additional, Soria, J. C., additional, Mateo, J., additional, Argiles, G., additional, Bendell, J. C., additional, El-Khoueiry, A., additional, Jonker, D. J., additional, Sawyer, M. B., additional, Wong, L., additional, Becerra, C. R., additional, Chemidlin, J. M., additional, Kollia, G., additional, Nuyten, D. S. A., additional, Twelves, C. J., additional, Wilkins, D. K., additional, Anthoney, A., additional, Chappell, J., additional, Ng, W. T., additional, Turner, P. T., additional, Kristeleit, R., additional, Schoenborn-Kellenberger, O., additional, and Suder, A., additional

Published
2013
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48. Abstract P6-10-07: Phase I study of BYL719, an alpha-specific PI3K inhibitor, in patients with PIK3CA mutant advanced solid tumors: preliminary efficacy and safety in patients with PIK3CA mutant ER-positive (ER+) metastatic breast cancer (MBC)

Author

Juric, D, primary, Argiles, G, additional, Burris, HA, additional, Gonzalez-Angulo, AM, additional, Saura, C, additional, Quadt, C, additional, Douglas, M, additional, Demanse, D, additional, De Buck, S, additional, and Baselga, J, additional

Published
2012
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50. 2 Agents Targeting the mTOR-PI3K-Akt Pathway

Author

Tabernero, J., primary, Dienstmann, R., additional, Macarulla, T., additional, Saura, C., additional, Argiles, G., additional, Alsina, M., additional, Cruz, C., additional, Brana, I., additional, Cortes, J., additional, and Rodon, J., additional

Published
2012
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