7 results on '"Castellano, D."'
Search Results
2. Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy
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Grande, E., Alonso-Gordoa, T., Reig, O., Esteban, E., Castellano, D., Garcia-del-Muro, X., Mendez, M.J., García-Donas, J., González Rodríguez, M., Arranz-Arija, J.A., Lopez-Criado, P., Molina-Cerrillo, J., Mellado, B., Alvarez-Fernandez, C., De Velasco, G., Cuéllar-Rivas, M.A., Rodríguez-Alonso, R.M., Rodríguez-Moreno, J.F., and Suarez-Rodriguez, C.
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- 2022
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3. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study
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de Wit, R., Wülfing, C., Castellano, D., Kramer, G., Eymard, J.-C., Sternberg, C.N., Fizazi, K., Tombal, B., Bamias, A., Carles, J., Iacovelli, R., Melichar, B., Sverrisdóttir, Á., Theodore, C., Feyerabend, S., Helissey, C., Foster, M.C., Ozatilgan, A., Geffriaud-Ricouard, C., and de Bono, J.
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- 2021
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4. SAUL, a single-arm study of atezolizumab for chemotherapy-pretreated locally advanced or metastatic carcinoma of the urinary tract: outcomes by key baseline factors, PD-L1 expression and prior platinum therapy
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Bamias, A., Merseburger, A.S., Loriot, Y., James, N., Choy, E., Castellano, D., Lopez-Rios, F., Calabrò, F., Kramer, M., de Velasco, G., Zakopoulou, R., Tzannis, K., and Sternberg, C.N.
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- 2021
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5. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study
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Ásgerður Sverrisdóttir, Gero Kramer, Aristotle Bamias, R. de Wit, Ayse Ozatilgan, Cora N. Sternberg, Bohuslav Melichar, M.C. Foster, J.S. de Bono, Roberto Iacovelli, Susan Feyerabend, Christian Wülfing, Carole Helissey, Christine Geffriaud-Ricouard, Bertrand Tombal, Daniel Castellano, Joan Carles, Christine Theodore, J.-C. Eymard, Karim Fizazi, Medical Oncology, Institut Català de la Salut, [de Wit R] Department of Medical Oncology, Erasmus Medical Center, Rotterdam, the Netherlands. [Wülfing C] Department of Urology, Asklepios Tumorzentrum, Hamburg, Germany. [Castellano D] Department of Medical Oncology, University Hospital 12 de Octubre, Madrid, Spain. [Kramer G] Department of Urology, Medical University of Vienna, Vienna, Austria. [Eymard JC] Department of Medical Oncology, Institute Jean Godinot, Reims, France. [Sternberg CN] Division of Hematology and Medical Oncology, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, USA. [Carles J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, and UCL - (SLuc) Service d'urologie
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Male ,Oncology ,Cancer Research ,Neutrophils ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Prostate cancer ,chemistry.chemical_compound ,abiraterone ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Lymphocytes ,prognostic factor ,Original Research ,enzalutamide ,Hazard ratio ,terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Prognosis ,Prostatic Neoplasms, Castration-Resistant ,Docetaxel ,Cabazitaxel ,Benzamides ,Biomarker (medicine) ,Androstenes ,Taxoids ,medicine.drug ,medicine.medical_specialty ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Quimioteràpia combinada ,SDG 3 - Good Health and Well-being ,neutrophil-to-lymphocyte ratio ,Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Internal medicine ,Nitriles ,Phenylthiohydantoin ,Humans ,Pròstata - Càncer - Prognosi ,Enzalutamide ,Neutrophil to lymphocyte ratio ,Diagnosis::Prognosis [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,diagnóstico::pronóstico [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,business.industry ,fungi ,cabazitaxel ,Pròstata - Càncer - Tractament ,medicine.disease ,Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Male::Prostatic Neoplasms::Prostatic Neoplasms, Castration-Resistant [DISEASES] ,Confidence interval ,metastatic castration-resistant prostate cancer ,chemistry ,neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales masculinos::neoplasias de la próstata::neoplasias prostáticas resistentes a la castración [ENFERMEDADES] ,business - Abstract
Background There is growing evidence that a high neutrophil-to-lymphocyte ratio (NLR) is associated with poor overall survival (OS) for patients with metastatic castration-resistant prostate cancer (mCRPC). In the CARD study (NCT02485691), cabazitaxel significantly improved radiographic progression-free survival (rPFS) and OS versus abiraterone or enzalutamide in patients with mCRPC previously treated with docetaxel and the alternative androgen-receptor-targeted agent (ARTA). Here, we investigated NLR as a biomarker. Patients and methods CARD was a multicenter, open-label study that randomized patients with mCRPC to receive cabazitaxel (25 mg/m2 every 3 weeks) versus abiraterone (1000 mg/day) or enzalutamide (160 mg/day). The relationships between baseline NLR [< versus ≥ median (3.38)] and rPFS, OS, time to prostate-specific antigen progression, and prostate-specific antigen response to cabazitaxel versus ARTA were evaluated using Kaplan–Meier estimates. Multivariable Cox regression with stepwise selection of covariates was used to investigate the prognostic association between baseline NLR and OS. Results The rPFS benefit with cabazitaxel versus ARTA was particularly marked in patients with high NLR {8.5 versus 2.8 months, respectively; hazard ratio (HR) 0.43 [95% confidence interval (CI) 0.27-0.67]; P < 0.0001}, compared with low NLR [7.5 versus 5.1 months, respectively; HR 0.69 (95% CI 0.45-1.06); P = 0.0860]. Higher NLR (continuous covariate, per 1 unit increase) independently associated with poor OS [HR 1.05 (95% CI 1.02-1.08); P = 0.0003]. For cabazitaxel, there was no OS difference between patients with high versus low NLR (15.3 versus 12.9 months, respectively; P = 0.7465). Patients receiving an ARTA with high NLR, however, had a worse OS versus those with low NLR (9.5 versus 13.3 months, respectively; P = 0.0608). Conclusions High baseline NLR predicts poor outcomes with an ARTA in patients with mCRPC previously treated with docetaxel and the alternative ARTA. Conversely, the activity of cabazitaxel is retained irrespective of NLR., Highlights • Baseline NLR was evaluated as a biomarker in patients with mCRPC treated with cabazitaxel versus abiraterone or enzalutamide. • High baseline NLR predicted poor outcomes with abiraterone or enzalutamide in patients with mCRPC. • Clinical benefit from cabazitaxel was retained in higher baseline NLR patients.
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- 2021
6. Induction avelumab followed by chemoimmunotherapy and maintenance versus chemotherapy alone as first-line therapy in cis-ineligible metastatic urothelial carcinoma (INDUCOMAIN): a randomized phase II study.
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Rodriguez-Vida A, Valderrama BP, Castellano D, Pinto A, Mellado B, Puente J, Climent MA, Domenech M, Vazquez F, Perez-Gracia JL, Bonfill T, Morales-Barrera R, Gonzalez-Billalabeitia E, Garcia-Del-Muro X, Maroto P, Navarro-Gorro N, Juanpere N, Juan O, and Bellmunt J
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Background: Platinum-based chemotherapy (ChT) has been the standard first-line treatment for metastatic urothelial carcinoma (mUC). The purpose of this study was to evaluate the use of induction avelumab followed by avelumab in combination with carboplatin-gemcitabine (carbo/gem) followed by avelumab maintenance. We tested the hypothesis that induction immunotherapy (IO) could enhance the response to ChT and prevent its detrimental effect on immune cells., Materials and Methods: INDUCOMAIN is a multicenter, randomized, investigator-initiated, open-label phase II study evaluating the safety and efficacy of induction avelumab before carboplatin-gemcitabine-avelumab, followed by avelumab maintenance (arm A), compared to carbo/gem (arm B). Eligibility criteria included patients with mUC, no prior systemic therapy, and ineligibility for cisplatin by Galsky criteria. Patients were stratified by the presence/absence of visceral metastasis and Eastern Cooperative Oncology Group performance status 0-1 versus 2. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety., Results: Eighty-five patients were included and randomized to arm A (n = 42) and arm B (n = 43), respectively. ORR was similar between treatment arms: 59.5% in arm A and 53.5% in arm B (P = 0.57). Fourteen patients (33%) in arm A early progressed/died before or at first response assessment, compared to three patients (7%) in arm B. Median OS was 11.1 months in arm A and 13.2 months in arm B [hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.57-1.46, P = 0.69]. Median PFS was 6.9 months in arm A versus 7.4 months in arm B (HR 0.99, 95% CI 0.61-1.60, P = 0.95). Treatment-related adverse events of grade 3-4 occurred in 70.7% of patients in arm A and in 72.1% in arm B. No predictive role of programmed death-ligand 1 expression was found., Conclusions: The hypothesis that induction avelumab could enhance the efficacy of subsequent ChT was not proven. Administering IO alone as induction before ChT is not an adequate strategy., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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7. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial.
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Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthélémy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Saggi SS, McHenry MB, and Motzer RJ
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- Antineoplastic Combined Chemotherapy Protocols adverse effects, Follow-Up Studies, Humans, Ipilimumab adverse effects, Nivolumab adverse effects, Sunitinib therapeutic use, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms drug therapy
- Abstract
Purpose: To report updated analyses of the phase III CheckMate 214 trial with extended minimum follow-up assessing long-term outcomes with first-line nivolumab plus ipilimumab (NIVO+IPI) versus (vs) sunitinib (SUN) in patients with advanced renal cell carcinoma (aRCC)., Methods: Patients with aRCC with a clear cell component were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk and randomised to NIVO (3 mg/kg) plus IPI (1 mg/kg) every three weeks ×4 doses, followed by NIVO (3 mg/kg) every two weeks; or SUN (50 mg) once per day ×4 weeks (6-week cycle). Efficacy endpoints included overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) per independent radiology review committee in patients with intermediate/poor-risk disease (I/P; primary), intent-to-treat patients (ITT; secondary) and in patients with favourable-risk disease (FAV; exploratory)., Results: Overall, 1096 patients were randomised (ITT: NIVO+IPI, n=550, SUN, n=546; I/P: NIVO+IPI, n=425, SUN, n=422; FAV: NIVO+IPI, n=125, SUN, n=124). After 4 years minimum follow-up, OS (HR; 95% CI) remained superior with NIVO+IPI vs SUN in ITT (0.69; 0.59 to 0.81) and I/P patients (0.65; 0.54 to 0.78). Four-year PFS probabilities were 31.0% vs 17.3% (ITT) and 32.7% vs 12.3% (I/P), with NIVO+IPI vs SUN. ORR remained higher with NIVO+IPI vs SUN in ITT (39.1% vs 32.4%) and I/P (41.9% vs 26.8%) patients. In FAV patients, the HRs (95% CI) for OS and PFS were 0.93 (0.62 to 1.40) and 1.84 (1.29 to 2.62); ORR was lower with NIVO+IPI vs SUN. However, more patients in all risk groups achieved complete responses with NIVO+IPI: ITT (10.7% vs 2.6%), I/P (10.4% vs 1.4%) and FAV (12.0% vs 6.5%). Probability (95% CI) of response ≥4 years was higher with NIVO+IPI vs SUN (ITT, 59% (0.51 to 0.66) vs 30% (0.21 to 0.39); I/P, 59% (0.50 to 0.67) vs 24% (0.14 to 0.36); and FAV, 60% (0.41 to 0.75) vs 38% (0.22 to 0.54)) regardless of risk category. Safety remained favourable with NIVO+IPI vs SUN., Conclusion: After long-term follow-up, NIVO+IPI continues to demonstrate durable efficacy benefits vs SUN, with manageable safety., Trial Registration Details: ClinicalTrials.gov identifier: NCT02231749., Competing Interests: Competing interests: LA reports consulting fees from Pfizer, Novartis, Bristol Myers Squibb (BMS), Ipsen, Roche, MSD, AstraZeneca, Merck, Amgen, Astellas and Exelixis; and other fees from Corvus Pharmaceuticals and Peloton Therapeutics. NMT reports research funding from BMS, Calithera Biosciences, Nektar Therapeutics, Exelixis, Pfizer, Novartis, Arrowhead Pharmaceuticals, Mirati Therapeutics, Takeda, Epizyme and Eisai Medical Research; consulting and advisory fees from BMS, Calithera Biosciences, Nektar Therapeutics, Exelixis, Pfizer, Novartis, Eisai Medical Research, Ipsen, Lilly Oncology, Neoleukin Therapeutics, Surface Oncology, ONO Pharmaceutical and Oncorena; and travel accommodations and expenses from BMS, Calithera Biosciences, Nektar Therapeutics, Exelixis, Pfizer, Novartis, Eisai Medical Research, Ipsen, Lilly Oncology, Neoleukin Therapeutics, Surface Oncology, ONO Pharmaceutical and Oncorena. MB reports advisory and speaker fees from Roche, MSD, BMS, AstraZeneca and Sanofi. DM reports research funding from BMS, Merck, Genentech/Roche, Novartis, Peloton Therapeutics, Alkermes and Prometheus Laboratories; consulting or advisory fees from BMS, Merck, Genentech/Roche, Pfizer, Exelixis, Novartis, X4 Pharma, Array BioPharma, Peloton Therapeutics, EMD Serono, Jounce Therapeutics, Alkermes and Lilly; and other fees from Beth Israel Deaconess Medical Center. ERP reports research funding (institutional) from BMS, AstraZeneca, Merck, Peloton Therapeutics, Pfizer and Astellas; consulting fees from AstraZeneca, BMS, Genentech, Merck, Pfizer, Clovis, Exelixis, Incyte, Seattle Genetics, Janssen, Flatiron Health, Infinity Pharma and McKesson; fees for development of educational presentations from BMS and Merck; and US Patent Application No. 14/588,503. PB reports consulting or advisory fees from BMS, Pfizer, MSD Oncology, Novartis, Ipsen, Roche and Janssen Cilag; travel accommodations and expenses from Amgen; and honoraria from Astellas Pharma. CP reports consulting or advisory fees from BMS, MSD, Pfizer, Ipsen Eusa, Eisai and General Electric; speaker fees from BMS, MSD, Pfizer, Ipsen, Eusa, Eisai, General Electric, Janssen and AstraZeneca; research funding from Pfizer; expert testimony fees from Pfizer and Eusa; and travel accommodations and expenses from Roche. TP reports consulting fees from AstraZeneca, BMS, Exelixis, Incyte, Ipsen, Merck/MSD, Pfizer, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson, Eisai and Roche; honoraria from AstraZeneca, BMS, Exelixis, Incyte, Ipsen, Merck/MSD, Pfizer, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson, Eisai and Roche; research funding (institutional) from AstraZeneca, Roche, BMS, Exelixis, Ipsen, Merck/MSD, Novartis, Pfizer, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson and Eisai; and travel accommodations and expenses from Roche, Pfizer, MSD, AstraZeneca and Ipsen. FD reports research funding (institutional) from MSD, Pfizer and Ipsen. SG reports research funding from Bayer, BMS, Pfizer, Novartis, Corvus, Pfizer, Acceleron, Merck, Agensys, Seattle Genetics, Calithera, Immunomedics, Corvus and Eisai; and consulting or advisory fees from Bayer, BMS, Exelixis, Corvus, Genentech, Sanofi/Genzyme, Pfizer, Seattle Genetics, Eisai, Merck and EMD Serono. CKK reports advisory board fees from Janssen, Astellas, Pfizer, Ipsen, Eisai, Roche, Merck and BMS; and lecture fees from Pfizer, Ipsen, Eisai and BMS. HG reports advisory board fees from Pfizer, Astellas, Ipsen, Roche and BMS. M-OG reports research funding from Novartis, BMS and Intuitive Surgical; advisory fees from Novartis, BMS, Pfizer, Bayer HealthCare, Astellas, Intuitive Surgical, AstraZeneca, MSD, Janssen Cilag, ONO Pharmaceutical, Ipsen Pharma and Merck Serono; and lecture fees from Novartis, BMS, Pfizer, Astellas, Hexal, Apogepha, AstraZeneca, MSD, ONO Pharmaceutical, Ipsen Pharma, Medac and Merck Serono. YT reports research funding from ONO Pharmaceutical, Pfizer and Takeda; consulting or advisory fees from ONO Pharmaceutical; and honoraria from ONO Pharmaceutical, BMS and Pfizer. DC reports research funding (institutional) from Janssen Oncology; consulting or advisory fees from Janssen Oncology, Roche/Genentech, Astellas Pharma, AstraZeneca, Novartis, Ipsen, BMS, MSD Oncology, Bayer, Lilly, Sanofi, Pierre Fabre and Boehringer Ingelheim; and travel accommodations and expenses from Pfizer, Roche, BMS and AstraZeneca Spain. BIR reports research funding from Pfizer, Merck, GNE/Roche, Aveo, AstraZeneca and BMS; consulting fees from BMS, Pfizer, GNE/Roche, Aveo, Novartis, Synthorx, Peloton, Compugen, Merck, Arravive, Surface Oncology and 3D Medicines; and stock ownership in PTC therapeutics. TKC reports clinical trial grants from BMS, Exelixis, Pfizer, Merck, AstraZeneca, Lilly, Eisai, Novartis, GSK and EMD Serono; consulting or advisory fees from BMS, Exelixis, Pfizer, Merck, AstraZeneca, Lilly, Eisai, Novartis, GSK and EMD Serono; manuscript preparation fees from BMS, Exelixis, Pfizer, Merck, AstraZeneca, Lilly, Eisai, Novartis, GSK and EMD Serono; travel accommodations and expenses from BMS, Exelixis, Pfizer, Merck, AstraZeneca, Lilly, Eisai, Novartis, GSK and EMD Serono; and patent related to biomarkers of immune-oncology and cfmethDNA pending. SSS is an employee of and has stock ownership in BMS. MBM is an employee of and has stock ownership in BMS. RJM reports research funding (institutional) from Pfizer, Novartis, Eisai, Genentech, Roche and BMS; and consulting or advisory fees from Pfizer, Novartis, Eisai, Exelixis, Merck, Genentech, Incyte, Lilly, Roche and BMS., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)
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- 2020
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