16 results on '"Boris Alekseev"'
Number of results to display per page
Search Results
2. LBA4 IPATential150: Phase III study of ipatasertib (ipat) plus abiraterone (abi) vs placebo (pbo) plus abi in metastatic castration-resistant prostate cancer (mCRPC)
- Author
-
Kim N. Chi, Rustem Gafanov, Gary L. Buchschacher, Michael Borre, G. Chen, Nobuaki Matsubara, Boris Alekseev, Cora N. Sternberg, Josep Garcia, M-L. Harle-Yge, L. Corrales, Matthew Wongchenko, J.S. de Bono, Shahneen Sandhu, Christophe Massard, Francis Parnis, Sergio Bracarda, G. Vasconcelos Alves, Christopher Sweeney, and David Olmos
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,Hematology ,Castration resistant ,medicine.disease ,Placebo ,Ipatasertib ,Abiraterone ,chemistry.chemical_compound ,Prostate cancer ,chemistry ,Internal medicine ,medicine ,business - Published
- 2020
- Full Text
- View/download PDF
3. 698O Patient-reported outcomes (PROs) from IMvigor130: A global, randomised, partially blinded phase III study of atezolizumab (atezo) + platinum-based chemotherapy (PBC) vs placebo (PBO) + PBC in previously untreated locally advanced or metastatic urothelial carcinoma (mUC)
- Author
-
M. De Santis, Ian D. Davis, X. Garcia del Muro, U. De Giorgi, Marina Mencinger, Kouji Izumi, Boris Alekseev, Mahmut Gumus, Enrique Grande, S. Bernhard, S.H. Park, Aristotle Bamias, J-R. Li, Javier Puente, C. Quach, Eiji Kikuchi, Javier Arranz, Matthew D. Galsky, Beiying Ding, and B. Mellado Gonzalez
- Subjects
Oncology ,medicine.medical_specialty ,Chemotherapy ,Metastatic Urothelial Carcinoma ,business.industry ,medicine.medical_treatment ,Locally advanced ,Hematology ,Placebo ,Atezolizumab ,Internal medicine ,medicine ,business - Published
- 2020
- Full Text
- View/download PDF
4. 223P Overall survival (OS) results of phase III ARAMIS study of darolutamide (DARO) added to androgen deprivation therapy (ADT) for non-metastatic castration-resistant prostate cancer (nmCRPC)
- Author
-
N.D. Shore, M. Luz, Toni Sarapohja, Sergey Polyakov, Albertas Ulys, M-A. Le Berre, Amir Snapir, Iris Kuss, Matthew R. Smith, Boris Alekseev, T Tammela, Mindaugas Jievaltas, Oana Petrenciuc, Karim Fizazi, and Egils Vjaters
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,Hematology ,Castration resistant ,medicine.disease ,Androgen deprivation therapy ,Prostate cancer ,Darolutamide ,Internal medicine ,medicine ,Overall survival ,Non metastatic ,business - Published
- 2020
- Full Text
- View/download PDF
5. ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups
- Author
-
Antonio Alcaraz, Brad Rosbrook, Arnauld Villers, Gabriel P. Haas, Arun Azad, Daniel P. Petrylak, Jeffrey M. Holzbeierlein, Krishnan Ramaswamy, Taro Iguchi, Russell Z. Szmulewitz, Robert Morlock, Benoit Baron, N.D. Shore, Arnulf Stenzl, Boris Alekseev, and Andrew J. Armstrong
- Subjects
Oncology ,medicine.medical_specialty ,Surrogate endpoint ,business.industry ,Hematology ,medicine.disease ,Placebo ,Androgen deprivation therapy ,chemistry.chemical_compound ,Prostate cancer ,Prostate-specific antigen ,chemistry ,Internal medicine ,medicine ,Enzalutamide ,Progression-free survival ,Antiandrogen Therapy ,business - Published
- 2019
- Full Text
- View/download PDF
6. IMvigor130: Efficacy and safety from a phase III study of atezolizumab (atezo) as monotherapy or combined with platinum-based chemotherapy (PBC) vs placebo + PBC in previously untreated locally advanced or metastatic urothelial carcinoma (mUC)
- Author
-
Sanjeev Mariathasan, U. De Giorgi, Marina Mencinger, M. De Santis, Fabio A.B. Schutz, Aristotle Bamias, Enrique Grande, A. Thåström, Ian D. Davis, Matthew D. Galsky, Mahmut Gumus, Almut Mecke, Sung-Ji Park, J-R. Li, J.A. Arranz Arija, Boris Alekseev, X. Garcia del Muro, Eiji Kikuchi, Mustafa Ozguroglu, and A. Rezazadeh Kalebasty
- Subjects
Oncology ,Brachial Plexus Neuritis ,medicine.medical_specialty ,Chemotherapy ,Metastatic Urothelial Carcinoma ,business.industry ,medicine.medical_treatment ,Locally advanced ,Hematology ,Placebo ,Chemotherapy regimen ,Atezolizumab ,Internal medicine ,Visual accommodation ,medicine ,business - Published
- 2019
- Full Text
- View/download PDF
7. Efficacy and safety of darolutamide in non-metastatic castration-resistant prostate cancer (nmCRPC) in the ARAMIS trial
- Author
-
Toni Sarapohja, Amir Snapir, Sergey Polyakov, Egils Vjaters, Mindaugas Jievaltas, J.S.-T. Pang, M. Luz, T Tammela, Matthew R. Smith, M.-A. Le Berre, Karim Fizazi, Iris Kuss, Albertas Ulys, N.D. Shore, and Boris Alekseev
- Subjects
medicine.medical_specialty ,Urinary symptoms ,business.industry ,Disease progression ,Stock options ,PSA PROGRESSION ,Hematology ,Castration resistant ,Cytotoxic chemotherapy ,Darolutamide ,Oncology ,Family medicine ,medicine ,Non metastatic ,business - Abstract
Background Asymptomatic nmCRPC patients (pts) would benefit from treatments (Tx) that delay disease progression and maintain quality of life (QoL), with minimal Tx-related adverse events (AEs). In ARAMIS, darolutamide (DARO) prolonged metastasis-free survival vs placebo (PBO) (40 vs 18 months; HR 0.41; 95% CI 0.34–0.50; P Methods Pts were randomized to DARO 600 mg twice daily (n = 955) or PBO (n = 554), while androgen deprivation therapy continued in both arms. Secondary/exploratory endpoints included safety, time to cytotoxic chemotherapy, time to antineoplastic therapy, time to PSA progression, and QoL. Results DARO substantially delayed times to PSA progression (33 vs 7 months; HR 0.13; 95% CI 0.11–0.16; P 10% of pts. Discontinuation rates due to AEs were 8.9% with DARO and 8.7% with PBO. AEs noted with other androgen receptor inhibitors (including fracture, falls, seizures, hypertension and cognitive disorder) showed minimal or no difference in incidence between groups. DARO maintained QoL, and delayed the onset of pain and disease-related urinary symptoms compared with PBO. Conclusions DARO delays disease progression and subsequent Tx for metastatic castration-resistant prostate cancer vs PBO, maintaining QoL without increasing incidence of key AEs. Clinical trial identification NCT02200614. Editorial acknowledgement Medical writing support for the development of this abstract was provided by Lucy Smithers, PhD, and editorial support, including formatting, proofreading, and submission was provided by Beth King, both of Scion Medica, London, supported by Bayer according to Good Publication Practice guidelines. Legal entity responsible for the study Orion Corporation, Orion Pharma and Bayer AG. Funding Orion Corporation and Bayer AG. Disclosure J.S-T. Pang: Non-remunerated activity/ies, Writing support: Bayer. N. Shore: Advisory / Consultancy, Research grant / Funding (self): Ferring; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy, Research grant / Funding (self): Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Janssen; Advisory / Consultancy, Research grant / Funding (self): Dendreon; Advisory / Consultancy, Research grant / Funding (self): Tolmar; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy, Research grant / Funding (self): Genentech/Roche; Advisory / Consultancy, Research grant / Funding (self): Myovant Sciences; Advisory / Consultancy, Research grant / Funding (self): Merck; Advisory / Consultancy, Research grant / Funding (self): BMS; Advisory / Consultancy, Research grant / Funding (self): Nymox. M.R. Smith: Honoraria (self): Amgen; Honoraria (self): Astellas; Honoraria (self): Bayer; Honoraria (self): Clovis; Honoraria (self): Gilead; Honoraria (self): Janssen; Honoraria (self): Lilly; Honoraria (self): Novartis; Honoraria (self): Pfizer. T.L. Tammela: Advisory / Consultancy, Research grant / Funding (self): Bayer; Advisory / Consultancy: Janssen; Advisory / Consultancy, Research grant / Funding (self): Lidds AB; Advisory / Consultancy, Research grant / Funding (self): Astellas. E. Vjaters: Research grant / Funding (self): Ipsen; Research grant / Funding (self): Bayer; Research grant / Funding (self): Janssen; Advisory / Consultancy, Research grant / Funding (self): Orion. M. Jievaltas: Honoraria (self): Bayer; Honoraria (self): Ipsen; Honoraria (self): Janssen. M. Luz: Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas; Advisory / Consultancy, Research grant / Funding (self): Janssen; Research grant / Funding (self): AstraZeneca; Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Bayer; Research grant / Funding (self): Ferring; Speaker Bureau / Expert testimony: Sanofi. B. Alekseev: Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: Bayer; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: AstraZeneca; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: Astellas; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: BMS; Honoraria (self), Non-remunerated activity/ies: Ferring; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: Janssen; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: MSD; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: Pfizer; Research grant / Funding (self), Non-remunerated activity/ies: Sanofi. I. Kuss: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bayer. M-A. Le Berre: Full / Part-time employment: Bayer Healthcare. A. Snapir: Full / Part-time employment: Orion Pharma. T. Sarapohja: Full / Part-time employment: Orion Corporation. K. Fizazi: Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Honoraria (self): Merck; Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy: Sanofi; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bayer; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Curevac; Advisory / Consultancy: ESSA; Advisory / Consultancy: Orion Pharma; Advisory / Consultancy: Roche/Genentech. All other authors have declared no conflicts of interest.
- Published
- 2019
- Full Text
- View/download PDF
8. Efficacy and biomarker analysis of patients (pts) with advanced renal cell carcinoma (aRCC) with sarcomatoid histology (sRCC): Subgroup analysis from the phase III JAVELIN renal 101 trial of first-line avelumab plus axitinib (A + Ax) vs sunitinib (S)
- Author
-
Balaji Venugopal, Toni K. Choueiri, A. di Pietro, Laurence Albiges, Hideaki Miyake, Aleksander Chudnovsky, Paul B. Robbins, Bo Huang, G. Gravis, Keith A. Ching, Mehmet Asim Bilen, J.M.G. Larkin, Mariangela Mariani, Boris Alekseev, Robert J. Motzer, and Sumanta K. Pal
- Subjects
medicine.medical_specialty ,Kidney ,business.industry ,Sunitinib ,Urology ,Cancer ,Subgroup analysis ,Hematology ,medicine.disease ,Axitinib ,Avelumab ,medicine.anatomical_structure ,Oncology ,Renal cell carcinoma ,medicine ,Progression-free survival ,business ,medicine.drug - Published
- 2019
- Full Text
- View/download PDF
9. First-line pembrolizumab (pembro) monotherapy for advanced non-clear cell renal cell carcinoma (nccRCC): Updated follow-up for KEYNOTE-427 cohort B
- Author
-
T. Alonso Gordoa, Cezary Szczylik, J.-L. Lee, S.J. Shin, Charles Schloss, Scott S. Tykodi, Paweł Wiechno, Frede Donskov, Michael B. Atkins, Vsevolod Matveev, David F. McDermott, Jahangeer Malik, J.M.G. Larkin, Frédéric Pouliot, R. Kloss Silverman, Boris Alekseev, Rodolfo F. Perini, Rustem Gafanov, Poul F. Geertsen, and Piotr Tomczak
- Subjects
0301 basic medicine ,Antitumor activity ,business.industry ,First line ,Steering committee ,Stock options ,Hematology ,Management ,03 medical and health sciences ,Safety profile ,030104 developmental biology ,0302 clinical medicine ,Oncology ,030220 oncology & carcinogenesis ,Medicine ,In patient ,business ,Sarcomatoid Differentiation ,Objective response - Abstract
Background KEYNOTE-427 (NCT02853344) is a single-arm, open-label, phase 2 study of pembro monotherapy in patients (pts) with advanced clear cell RCC (cohort A) and nccRCC (cohort B). Updated cohort B results with additional follow-up are presented. Methods 165 pts with histologically confirmed nccRCC, no prior systemic therapy, and measurable disease (RECIST v1.1) enrolled. Pts received pembro 200 mg IV Q3W for 35 cycles (∼2 y) or until progressive disease, unacceptable toxicity, or withdrawal. Primary end point: objective response rate (ORR, RECIST v1.1 by blinded independent central review). Additional end points: duration of response (DOR), PFS, OS, data by sarcomatoid differentiation, histology, and PD-L1 expression (combined positive score [CPS] ≥1 for PD-L1+). Results Histology by central pathology review: papillary 72% (n = 118), chromophobe 13% (n = 21), unclassified 16% (n = 26); 62% were PD-L1+. Median follow-up: 15.0 mo (range, 0.9-25.4). Overall ORR was 26.1% (95% CI, 19.5-33.5; 10 [6.1%] CR, 33 [20.0%] PR) and median (range) DOR was 15.3 mo (2.8-21.0+). For responders, 57.3% had a response ≥12 mo. 12-mo PFS and OS rates were 24.7% and 73.7%, respectively. ORR (95% CI) was 28.0% (20.1-37.0) in papillary, 9.5% (1.2-30.4) in chromophobe, and 30.8% (14.3-51.8) in unclassified nccRCC; for responders, 55.4%, 50.0%, and 71.4% in the papillary, chromophobe and unclassified groups had a response ≥12 mo. Median (range) DOR was not reached in the unclassified and was 15.3 mo (2.8-21.0+) for the papillary group. ORR (95% CI) was 42.1% (26.3-59.2) for pts with sarcomatoid differentiation (n = 38). ORR (95% CI) in pts with CPS≥1 and CPS Conclusions Single-agent pembro continued to show encouraging antitumor activity in nccRCC, especially with papillary or unclassified histology and CPS≥1. Safety profile of pembro was as expected. Clinical trial identification NCT02853344, August 2, 2016. Editorial acknowledgement Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA), funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Legal entity responsible for the study Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Disclosure C. Suarez: Advisory / Consultancy: Astellas, BMS, Eusa, Ipsen, Novartis, Pfizer, Sanofi-Aventis; Research grant / Funding (self): Ipsen; Speaker Bureau / Expert testimony: AstraZeneca, BMS, Ipsen, Pfizer; Travel / Accommodation / Expenses: Roche, Pfizer, Ipsen; Research grant / Funding (institution): AB Science, Aragon Pharmaceuticals, Arog Pharmaceuticals, INC, Astellas Pharma., AstraZeneca AB, Aveo Pharmaceuticals INC, Bayer AG, Blueprint Medicines Corporation, BN Immunotherapeutics INC, Boehringer Ingelheim Espana, S.A., Bristol-Myers Squibb Intern; Non-remunerated activity/ies: Roche Steering Committee. J. Lee: Honoraria (self): Novartis Korea, BMS Korea; Advisory / Consultancy: Pfizer Korea, Janssen, Sanofi Aventis, Astellas Korea, BMS Korea, Ipsen Korea; Leadership role: Korea Cancer Study Group. M. Ziobro: Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Novartis. V.B. Matveev: Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: Astellas. F. Donskov: Honoraria (institution): Pfizer; Honoraria (institution): Ipsen. F. Pouliot: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Astellas; Honoraria (self), Honoraria (institution), Advisory / Consultancy: Janssen; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Progenics. B.Y. Alekseev: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Astellas; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Ferring; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Janssen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi. P.J. Wiechno: Honoraria (self): Bayer; Honoraria (self): BMS; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self): Astellas; Honoraria (self): Ipsen; Honoraria (self): Janssen-Cilag; Honoraria (self): Novartis. M.A. Climent: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy: Pfizer. R. Kloss Silverman: Full / Part-time employment: Merck & Co., Inc. R.F. Perini: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. C. Schloss: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. D.F. McDermott: Honoraria (self), Research grant / Funding (self): BMS; Honoraria (self), Research grant / Funding (self): Pfizer; Honoraria (self), Research grant / Funding (self): Merck; Honoraria (self), Research grant / Funding (self): Novartis; Honoraria (self), Research grant / Funding (self): Exelixis; Honoraria (self): Array BioPharm; Honoraria (self), Research grant / Funding (self): Genentech BioOncology; Honoraria (self), Research grant / Funding (self): Alkermes, Inc.; Honoraria (self): Jounce Therapeutics; Honoraria (self), Research grant / Funding (self): X4 Pharma; Honoraria (self), Research grant / Funding (self): Peloton Therapeutics; Honoraria (self): EMD Serono; Honoraria (self): Eli Lilly and Company; Research grant / Funding (self): Prometheus Laboratories. M.B. Atkins: Advisory / Consultancy, Research grant / Funding (self): Merck; Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy, Research grant / Funding (self): Genentech/Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Eisai; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Array; Advisory / Consultancy, Research grant / Funding (self): BMS. All other authors have declared no conflicts of interest.
- Published
- 2019
- Full Text
- View/download PDF
10. RANGE, a phase III, randomized, placebo-controlled, double-blind trial of ramucirumab (RAM) and docetaxel (DOC) in platinum-refractory urothelial carcinoma (UC): Overall survival results
- Author
-
Alexandra Drakaki, F. Russo, Annamaria Zimmermann, Aristotle Bamias, Daniel P. Petrylak, Kim N. Chi, Boris Alekseev, Nobuaki Matsubara, Syed A. Hussain, Andrea Necchi, Katherine M Bell-McGuinn, Richard A. Walgren, Thomas Powles, Cora N. Sternberg, Hiroyuki Nishiyama, Evan Y. Yu, Daniel Castellano, Aude Flechon, M.S. van der Heijden, and R. de Wit
- Subjects
0301 basic medicine ,medicine.medical_specialty ,business.industry ,Urology ,Hematology ,Placebo ,Ramucirumab ,Double blind ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Oncology ,Docetaxel ,030220 oncology & carcinogenesis ,Platinum resistance ,medicine ,Overall survival ,business ,medicine.drug ,Urothelial carcinoma - Published
- 2018
- Full Text
- View/download PDF
11. LATITUDE study: PSA response characteristics and correlation with overall survival (OS) and radiological progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving ADT+abiraterone acetate and prednisone (AAP) or placebo (PBO)
- Author
-
A. Rodriguez Antolin, Giri Sulur, Susan Li, K. Fazazi, Kim N. Chi, Nobuaki Matsubara, Boris Alekseev, Luis Fein, P. De Porre, Suneel Mundle, Andrew Protheroe, Mustafa Ozguroglu, Namphuong Tran, and Susan Feyerabend
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,030232 urology & nephrology ,Abiraterone acetate ,Hematology ,medicine.disease ,Placebo ,03 medical and health sciences ,chemistry.chemical_compound ,Prostate-specific antigen ,Prostate cancer ,0302 clinical medicine ,chemistry ,Prednisone ,030220 oncology & carcinogenesis ,Internal medicine ,Radiological weapon ,medicine ,Progression-free survival ,business ,medicine.drug ,Hormone - Published
- 2018
- Full Text
- View/download PDF
12. RANGE: A randomized, double-blind, placebo-controlled phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma
- Author
-
Nobuaki Matsubara, Oday Hamid, Aristotle Bamias, Daniel P. Petrylak, M.S. van der Heijden, Annamaria Zimmermann, Kim N. Chi, Cora N. Sternberg, Hiroyuki Nishiyama, Evan Y. Yu, Syed A. Hussain, Richard A. Walgren, R. de Wit, Katherine M Bell-McGuinn, Alexandra Drakaki, Aude Flechon, Thomas Powles, Boris Alekseev, I.J. Percent, and Daniel Castellano
- Subjects
Oncology ,medicine.medical_specialty ,Metastatic Urothelial Carcinoma ,business.industry ,Phases of clinical research ,Hematology ,010501 environmental sciences ,Placebo ,030226 pharmacology & pharmacy ,01 natural sciences ,Ramucirumab ,Double blind ,03 medical and health sciences ,0302 clinical medicine ,Docetaxel ,Internal medicine ,Platinum resistance ,Medicine ,business ,0105 earth and related environmental sciences ,medicine.drug - Published
- 2017
- Full Text
- View/download PDF
13. genitourinary tumours, prostate Final overall survival (OS) from the AFFINITY phase 3 trial of custirsen and cabazitaxel/prednisone in men with previously treated metastatic castration-resistant prostate cancer (mCRPC)
- Author
-
Vsevolod Matveev, Fred Saad, G. Gravis, Aude Flechon, Florence Joly, Zafar Malik, Patricia S. Stewart, Karim Fizazi, Cindy Jacobs, Boris Alekseev, Tomasz M. Beer, S.J. Hotte, and Kim N. Chi
- Subjects
Oncology ,medicine.medical_specialty ,Genitourinary system ,business.industry ,Hematology ,Castration resistant ,medicine.disease ,Prostate cancer ,Cabazitaxel ,Prednisone ,Internal medicine ,medicine ,Overall survival ,Previously treated ,business ,medicine.drug - Published
- 2016
- Full Text
- View/download PDF
14. 239O RECORD-4: Multicenter phase 2 trial of second-line everolimus (EVE) in patients (pts) with metastatic renal cell carcinoma (mRCC): Asian versus non-Asian population subanalysis
- Author
-
Thomas Brechenmacher, Anna Alyasova, Robert J. Motzer, LaTonya Collins, G. Kurteva, Andrey Karpenko, Thomas Cosgriff, Ruben Dario Kowalyszyn, Oleg Karyakin, Y. Neron, Ling Yang, Hanzhong Li, Boris Alekseev, Liping Xie, J. Lin, L. Morgan, and D. Ye
- Subjects
Oncology ,Brachial Plexus Neuritis ,medicine.medical_specialty ,Everolimus ,business.industry ,Hematology ,medicine.disease ,Surgery ,Second line ,Renal cell carcinoma ,Internal medicine ,Asian population ,Medicine ,In patient ,business ,medicine.drug - Published
- 2015
- Full Text
- View/download PDF
15. RANDOMIZED PHASE II STUDY OF FIRST-LINE EVEROLIMUS (EVE) + BEVACIZUMAB (BEV) VERSUS INTERFERON ALFA-2A (IFN) + BEV IN PATIENTS (PTS) WITH METASTATIC RENAL CELL CARCINOMA (MRCC): RECORD-2
- Author
-
Rickard Sandin, Javier Diaz, David Smith, investigators, H. Pandha, A. Damato, M. Del Prete, M. Reckova, E. Korbenfeld, A. Seth, Cristina Suarez, P. Celiz, S. Liskova, R.K. Sahoo, A. Felici, A. Suder, Francesco Cognetti, P. Gronesova, G. Martignoni, M. Jebali, E. Fernández-Parra, C. Bokemeyer, Yingwei Peng, M.C. Sebastia, H. Mullot, Daniele Raggi, D. Urosa Velasco, Begoña Mellado, J. Chester, Corina Andresen, Sally Ellis, N. Nicolai, A. Omar, A. Ambavane, Georg A. Bjarnason, Frank Priou, A. Vieillefond, T. Wahlgren, U. Harmenberg, H. Nemeth, M. Rivoire, Guru Sonpavde, C. Binder, V. Prati, M. Witkowski, R. Delva, J.F. Rodríguez-Moreno, L. Stern, V. Calderero, O. Bauduceau, Andrea Viqueira, K. Kaiser, Maurizio Colecchia, M.P. López Martí, M.E. Lampron, J.T. Hartmann, D. Tunali, Reza Elaidi, V. Galvis, Z. Sycova-Mila, Veg Team, R. von Moos, Jose Carlos Benitez, Simon Chowdhury, H. Mergenthaler, F. Arpaci, S. Cascinu, G. Erdem, A. Comte, J.M. Sepulveda Sanchez, K. Slimane, Mustafa Benekli, Paul Nathan, S. Van Belle, B. Metzner, Hussein M. Khaled, Q. Wang, Denice D. Tsao-Wei, J. Jin, H. Cortes-Funes, N. Clottens, P. Wilson, G. Procopio, A.L. Gentile, L. Burattini, Robert E. Hawkins, R. Montironi, G.R. Pond, Viorel Jinga, B. Ceccaldi, Tanya B. Dorff, S. Lata, Sergio Bracarda, P. Palacka, N. Karadurmus, S. Tumolo, Mario Sznol, A. Guillot, H. Spliid, C. Kahl, Cora N. Sternberg, K. Nagyivanyi, N. Sarwar, G. Krekeler, G. Fischer, S. Le Moulec, Brian I. Rini, R. Casciano, Derek Raghavan, F. Mehmud, N.V. Jensen, Suleyman Buyukberber, J.P. Fusco, Kim Edmonds, C. Messina, H.G. Sayer, Sanjiv S. Agarwala, R.J. Jones, J. Ribeiro, T. Geldart, A. González del Alba, E. López Juarez, G. Mead, Ben Challacombe, I. Brindel, T. M-H, F. Lumachi, S.M. M. Basso, E.Q. Bergan, R. Morales-Barrera, J.L. Perez Gracia, P. Cislo, I. Victoria, B. Sarsık, M. Cakar, S. Lee, Marc Campayo, R. Roy, A. Necchi, M. Ozturk, Hai T. Tran, R. Mondéjar Solís, M. Schmidt, N. Dalal, J. Coombs, Danka Cholujova, Ashok Kumar Gupta, C. Poehlein, S. Ozkan, B. Maughan, W.E. Berdel, C. Masini, F. Pili, A. Vuillemin, R. Martínez-Monge, J.J. Zudaire, F. Orlandi, C. Cianci, J. Bay, J. Thompson, C. Theodore, L. McCann, Anne Gold, N. Muzaffar, A. Houlgatte, L. Bergmann, X. Ren, G.B. Chiara, M. Ktiouet, Muhammad A. Khattak, J. Eymard, N. Nagaraj, J. Yu, Alfredo Falcone, Oezlem Anak, C. Korn, Karim Fizazi, P. Biron, V. Usakova, E. Gökmen, A. Flechon, R.R. Prasad, R. Bianco, M.E. Zudaire, S.J. Park, U. De Giorgi, Brad Rosbrook, F. Selle, A. Zurita-Saavedra, E. Verzoni, Günter Niegisch, J.L. Álvarez-Ossorio, Börje Ljungberg, N. Lainez, T.M. Kim, Irina Proskorovsky, C. Rodriguez-Antona, L. Maute, Komel Khabra, F. Algaba, A.C. Palozzo, L. Bodnar, O. Etxaniz, L. Galli, J.-P. Lotz, S.S. Sridhar, Yongchel Ahn, G. El Hussiny, E. Paze, M. Bianconi, E. Esteban, I. Fernandes, Omid Hamid, V. Kruse, P.F. Geertsen, Laurence Albiges, Joseph C. Cappelleri, M. Gaulet, Mayer Fishman, W. Kong, Aslam Sohaib, L. Formisano, B. Biswas, Heui June Ahn, C. Nicolau, G. Ye, P. Beuzeboc, C. Arqueros, A. Bair, H. Abdel Azim, F. Riet, T. Turker, J. Fouque, John D. Powderly, G. Velasco, J. Areal, G. Papiani, B. Wittig, D.R. Siemens, U. Anido, G. Anguera, J. Medioni, K. Pennert, G.G. Hermann, Igor Puzanov, D. Herchenhorn, James Larkin, B. Bui, P. Srinivasan, I. Waxman, J. Garcia-Donas, M. Ermani, J. Malet, R. Buzzoni, C. Emmanouilides, L. Kumar, Xin-Yun Huang, J. Beaumont, M. Bragagni, F. Fabbri, M. Santoni, A. Castillo, A. Pantuck, S. Imbevaro, G. Chahine, K. Zhang, D. Ondrus, Parminder Singh, Francesco Massari, S. Spanik, Svetozar Gogov, J. Kowalski, N. Pardo, J.M. Miclea, Dae Ho Lee, P. Gerletti, P. Rocca Cossu, H.J. Choi, Stéphane Oudard, J. Guo, A. Berkenblit, Pablo Maroto, A.R. Jazeih, L. Hodge, D. Ye, Daniel Castellano, David Cella, I.G. Sullivan, Vsevolod Matveev, I. Temby, Gwenaelle Gravis, J. Khalil, R. Fougeray, M. Wheater, G. Di Lorenzo, P. Landsman-Blumberg, A.J. Birtle, S. Zanetta, M. Harza, Y. Su, A. Badran, A. Alcaraz, K. Wood, S. Weikert, D. Chen, M. Bonomi, B. Paño, E. Garanzini, L. Ciuffreda, Lisa Derosa, D.J. George, L. Cerbone, J-H Ahn, A.J. McPartlin, E. Barsoum, J. Droz, Antonin Levy, T. Brechenmacher, J. Kim, A. Ozet, S Songül Yalçin, P.A. Zucali, F. Brusa, L. Steelman, J.J. Sánchez, O.E. Carranza, I. Bodrogi, Alain Ravaud, E. Boleti, L. Santomé, I. Chaib, J.V. Heymach, B. Sanchez, E. Matczak, Ying Chen, E. Castanon Alvarez, C. Farfan, J-P. Machiels, J. P. Maroto, J.H. Hong, S. Babakulov, G. Elhussiny, D. Santeufemia, L. Chen, A. Shamseddine, Jacek Pinski, S. Stergiopoulos, J.L. Cuadra Urteaga, A. Boeckenhoff, Viktor Grünwald, P. Sandström, C. Ketchens, S. Rudman, L. Costa, I. Cañamares, Shaowen Qin, M.C. Lopez Lopez, Darrel P. Cohen, A. Cappetta, R. De Vivo, M.J. Méndez-Vidal, Georgia Kollia, U. Kube, K.M. Boucher, Tim O'Brien, Z. Küronya, A.M. Molina, Y.-N. Wong, C. Ferrario, A.M. Gianni, M.D. Michaelson, R. Salvioni, Walter M. Stadler, M. Taron, S. Sarker, B. Kopf, L. Wang, B. Lutiger, Jon M. Wigginton, C. Sacco, J. Shanks, Sarvendra Kumar, C. Buges, L. Wood, M. Domenech, Riccardo Giampieri, M.P. Trojniak, R. Sabbatini, N. Leonhartsberger, R. Lewis, L. Anton-Aparicio, A.J. Zurita Saavedra, Yohann Loriot, D. Giannarelli, M. Cichowicz, M. Aglietta, E. Horn, N. Bonnin, J. Wang, M. Nicodemo, A. Bamias, X. Xiao, M. Calderon, P. Giannatempo, K. Dykstra, Lisa Pickering, Patricia A. English, G. Rosti, J. Ma, G. Guderian, Jean Jacques Patard, Andrew G. Bushmakin, N. Siddqui, P. Sabin Domínguez, C. Chevreau, J. Carles, D. Muskett, I.F. Tannock, A. Scarpa, G. Deplanque, Emilio Bria, L. Védrine, C. Chen, H. Villavicencio, S. Pan, Bohuslav Melichar, J. Palou, W. Kozłowski, Michal Mego, E. Jones, H. Ozturk, J.A. Arranz Arija, A. Benedict, C. Helissey, R. González Beca, G. Kooiman, Yuan Liu, C. May, K. Bíró, E. Hall, S. Vazquez-Estevez, M. Morente, R. Rosa, Raika Durusoy, A. Caty, R. Keyser, A. Shablak, J.A. Williams, D. Burcoveanu, M. Tschaika, S. Navruzov, E. Weith, F. de Braud, R. Kockelbergh, Begoña Perez-Valderrama, A.V. Soerensen, J.A. Peña, Christophe Massard, A. Chandra, M. Staehler, L.E. Abella, W. Arafat, G. Fargues, A. Darwish, E. De Coene, H. Sun, C. Martin Lorente, Robin Wiltshire, Cyrus Chargari, A. Louveau, E. Aitini, L. van Bortel, A. Onofri, A.A. Patel, I. Chirivella Gonzalez, F. Villacampa, J. Rajec, D. Biasoni, C. Szczylik, J. Schmitz, U. Mueller, P.F. Conte, M. Carducci, G. Tapia Rico, Anne Schuckman, Xun Lin, I. Alemany, A. Farnesi, E. Arevalo, Meral Kurt, M.O. Giganti, C. Song, I.G. Schmidt-Wolf, J. Pan, M. De Fromont, M. Schmidinger, K. Das, M. Yaman, C. Teghom, C. Boni, I. Ozer-Stillman, F. Maines, B. Moya Ortega, T.B. Powles, S. Pusceddu, I. Barista, I. Duran, S. Cierniak, M.E. Gore, R. Rosell, Jamal Tarazi, E. Kurt, D. Svetlovska, G. Li, F. Gyergyay, W. Yin, C. Porta, I. Park, M. Smoter, G. Rottenberg, S. Crabb, M. Rizzo, G. Gravis-Mescam, A. Spencer-Shaw, David M. Berman, R. Janciauskiene, F. Pons Valladares, I. Testa, E. Bajetta, Olga Valota, M. Lazaro, B. Esteves, Mario Scartozzi, M. Catanzaro, M. Arzoz, David F. McDermott, E. Sevin, Charles G. Drake, L. Ye, Ugur Coskun, A. Lorch, D. Pelov, D. Xanthaki, L. Nappi, G. Lo Re, Giampaolo Tortora, L. Ruiz, Kolette D. Fly, P. Mendez, M. Johnson, M. Jakobsson, Y. Lin, Sinil Kim, J.Y. Yuan, I. Chiappino, I.A. Muazzam, Xudong Zhang, K.J. Park, Stéphane Culine, C. Papandreou, S. Hauser, B. Paolini, O. Fernandez, D. Kalanovic, L. León, C. De La Piedra, R. Iacovelli, S. Provent, P.D. Simmonds, Michele Milella, D. Jäger, K. Massopust, G. Miolo, J. Neves, D. Amadori, F.L. Lim, M. Ramos Vazquez, A. De Both, S. Ozaydin, O. Reig Torras, E. Villa, G. Mickisch, T. Nguyen, R. Stec, M. Schroff, Cristina Suarez Rodriguez, S. Rottey, Boris Alekseev, O. Rick, D. Condori, W.J. Mackillop, J. Gligorov, Christopher M. Booth, A. Fontana, A.S. Ataergin, L. Capdevila, J.-F. Martini, M. Jimenez, J. Loewy, Piotr Tomczak, J. Hu, K.L. Baker-Neblett, M. Pastorek, P. Rescigno, V. Miskovska, F. Atzori, Thomas Gauler, K. Fode, Ü.E. Bagriacik, D. Nosov, Y. Kim, P.C. Lara, Frede Donskov, Michael B. Atkins, L. Géczi, V. Lorusso, Kiruthikah Thillai, F. Zhou, A.M. Aparicio, B. González, Susan Groshen, M. Aieta, R. Cathomas, E. Calvo, A. Lopez, S. Hernando, D.S. Heo, F. Goldwasser, F. Boccardo, Carlos H. Barrios, V. Damiano, Toni K. Choueiri, L.N. Pandite, F.J. Afonso, Jonathan Shamash, Fiona C Thistlethwaite, G.R. Hudes, Mellar P. Davis, D. Macedo, A. Font, Joaquim Bellmunt, S. Lundstam, Ignacio Gil-Bazo, T. Eisen, J. Qiu, Siamak Daneshmand, David I. Quinn, Ashok Panneerselvam, S. De Placido, L. Jacobasch, M. Climent, Luca Faloppi, Petri Bono, B.K. Mohanti, F. Valduga, Y. Huang, M. Zemanova, M. Fehr, E. Biasco, A. Kaprin, T. Montella, Cristian Loretelli, O. Ekinci, S. S¸en, C. Bailly, Sylvie Negrier, L. Ozkan, Beata Korytowsky, T. de Revel, A. Somers, B. Escudier, Umut Demirci, K. Stauch, Helen Boyle, A. Jirillo, C. Kim, R.A. Figlin, N. Shi, Joseph K. T. Lee, A. Jouinot, G. Abdel Metaal, R. Marconcini, C. Dubot, A. Pinto, L. Crino, T.E. Hutson, Thomas Powles, J. Mardiak, D. Cesic, Sook Ryun Park, D. Kim, S. Cetintas, Subramanian Hariharan, Alessandro Bittoni, M. Cotreau, J. Donovan, J. Obertova, Robert J. Motzer, and T. Steiner
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Prostate ,Internal medicine ,medicine ,Stomatitis ,Objective response ,030304 developmental biology ,0303 health sciences ,Proteinuria ,Genitourinary system ,business.industry ,Treatment options ,Hematology ,medicine.disease ,Nephrectomy ,3. Good health ,medicine.anatomical_structure ,Oncology ,Tolerability ,030220 oncology & carcinogenesis ,medicine.symptom ,business - Abstract
Background Study results demonstrated that IFN augments BEV activity and improves median PFS in pts with mRCC. Thus, combination BEV + IFN is a standard first-line treatment option for mRCC. Combining BEV with the mTOR inhibitor EVE may be an efficacious and well-tolerated treatment option. The open-label, phase II RECORD-2 trial compared first-line EVE + BEV and IFN + BEV in mRCC. Patients and methods: Therapy-naive pts with clear cell mRCC and prior nephrectomy were randomized 1:1 to BEV 10 mg/kg IV every 2 weeks with either EVE 10 mg oral daily or IFN (9 MIU SC 3 times/week, if tolerated). Tumour assessments were every 12 weeks. Primary objective was treatment effect on progression-free survival (PFS) per central review based on an estimate of the chance of a subsequent phase III trial success (50% threshold for phase II success). Results In EVE + BEV (n = 182) and IFN + BEV (n = 183) arms, median age was 60/60 years, 76/72% of pts were men, MSKCC risk was favourable/intermediate/poor in 36/57/7% and 36/57/7% of pts, and 43/46% of pts had >2 organs involved, respectively. For EVE + BEV and IFN + BEV, median treatment duration was 8.5/8.3 months, respectively; 23/26% of pts discontinued due to AEs. In EVE + BEV and IFN + BEV arms, median PFS by central review was 9.3/10.0 months (HRIFN/EVE, 0.91; 95% CI, 0.69-1.19; P =0.485), respectively; probability of subsequent phase III success was 5.1%. Results of central and local PFS analysis were consistent. Objective response rate was 27/28% in EVE + BEV and IFN + BEV arms, respectively. Median overall survival (OS) was not reached in the EVE + BEV arm and was 25.9 months (95% CI: 21.1, 30.2) in the IFN + BEV arm. Most frequent AEs (%) were stomatitis (63), proteinuria (49), diarrhoea (39), hypertension (38), and epistaxis (35) in EVE + BEV arm and decreased appetite (45), fatigue (41), proteinuria (37), and pyrexia (35) in IFN + BEV arm. Conclusions In RECORD-2, PFS and tolerability were similar for first-line EVE + BEV and IFN + BEV. Final OS analysis will occur after 2-year follow-up. Disclosure A. Ravaud: Alain Ravaud is a member of global, European, and/or French boards on urological tumors for Pfizer, Novartis, GlaxoSmithKline, Bayer-Schering, and Dendreon, and has received institutional grant support from Pfizer, Novartis, and Roche. O. Anak: Ozlem Anak is an employee of Novartis Pharma AG. D. Pelov: Diana Pelov is an employee of Novartis Pharmaceuticals Corporation. A. Louveau: Anne-Laure Louveau is an employee of Novartis Pharma S.A.S. T. M-H: Tay M-H is a speaker for an advisory board for Novartis Pharmaceuticals Corporation. B. Melichar: Bohuslav Melichar has received honoraria from Novartis and Roche and served on an advisory board for Roche. All other authors have declared no conflicts of interest.
- Published
- 2012
- Full Text
- View/download PDF
16. Bevacizumab (BEV) + Low-Dose Interferon-α2A (IFN) for First-Line Treatment of Metastatic Renal Cell Carcinoma (MRCC): Final Safety and Efficacy Data from the Prospective Bevlin Study
- Author
-
R. Janciauskiene, Bohuslav Melichar, A. Kaprin, Joaquim Bellmunt, M. E. Gore, G. Mickisch, Vsevolod Matveev, Sergio Bracarda, Boris Alekseev, and B. Lutiger
- Subjects
medicine.medical_specialty ,Bevacizumab ,Nausea ,business.industry ,Low dose ,Phases of clinical research ,Hematology ,medicine.disease ,Gastroenterology ,First line treatment ,Oncology ,Renal cell carcinoma ,Internal medicine ,medicine ,medicine.symptom ,Dose Reduced ,Adverse effect ,business ,medicine.drug - Abstract
Background In the AVOREN trial, first-line BEV + IFN (9 MIU three times in a week [tiw]) was effective in patients (pts) with mRCC. A retrospective analysis found that efficacy was maintained and IFN-related toxicity was improved in pts with IFN dose reduced to 6 or 3 MIU. BEVLiN (MO21609) prospectively assesses the safety and efficacy of BEV with low-dose IFN (3 MIU) in mRCC. Methods BEVLiN is an open-label single arm, multinational phase 2 study. Nephrectomized, treatment-naive pts with clear cell mRCC and favourable/intermediate Motzer scores were treated with BEV 10mg/kg q2w + IFN 3 MIU tiw until disease progression. BEVLiN was designed to allow descriptive, cross-trial comparison with the BEV + IFN 9 MIU-treated favourable/intermediate Motzer score AVOREN subgroup. Primary end points are safety (specific grade [Gr] ≥3 IFN-associated adverse events [AEs]) and progression-free survival (PFS). Secondary end points are overall survival (OS); overall response rate (ORR); any Gr ≥3, overall, and serious AEs. Results 147 pts were enrolled in BEVLiN. Baseline pt characteristics were similar to the comparator AVOREN subgroup. The median follow-up was 29.4 months. Pts received a median of 22.5 cycles of BEV (18.0 in the AVOREN subgroup). Median PFS was 15.3 mos (95% CI: 11.7; 18.0) vs 10.5 mos (95% CI: 10.1; 12.9); median OS was 30.7 mos (95% CI: 25.7; not reached) vs 25.8 mos (95% CI: 22.7; 29.4); and ORR was 29% vs 36% in BEVLiN and the AVOREN subgroup, respectively. The rates of any-Gr and Gr ≥3 IFN-associated AEs were markedly lower in BEVLiN than in the AVOREN subgroup (Table). Overall rates of AEs of special interest were similar between studies, despite longer BEV duration in BEVLiN. AE, % (95% CI) BEVLiN n = 146 a AVOREN subgroup n = 283 a Any Gr Gr ≥3 Any Gr Gr ≥3 Any IFN-related AE 53 (45–62) 10 (6–16) 89 (85–92) 27 (22–32) · Asthenia/fatigue 37 (29–45) 10 (5–16) 63 (57–68) 21 (16–26) · Pyrexia 19 (13–27) 0 (0–2) 45 (39-51) 2 (1–4) · Nausea 9 (5–15) 1 (0–4) 29 (23–34) 1 (0–3) · Anorexia 0 (0–2) 0 (0–2) 36 (30–42) 3 (1–5) Any BEV-related AE of special interest b 59 (50–67) 23 (17–31) 60 (54–66) 23 (18–28) a Treated pts. b Includes hypertension, proteinuria, bleeding, and other AEs. Conclusions Use of low-dose IFN with BEV in BEVLiN resulted in a reduction in IFN-related AEs without compromising efficacy outcomes compared with a control AVOREN subgroup. Disclosure B. Melichar: Dr. Bohuslav Melichar has received honoraria for lectures from Roche and participated in an advisory board meeting. S. Bracarda: Dr. Sergio Bracarda is an Advisory Board Member for Novartis, Pfizer, GSK, Bayer, Aveo/Astellas, Jannsen &Jannsen and Sanofi-Aventis. He has received honoraria for lectures from Novartis, Sanofi-Aventis and Pfizer. R. Janciauskiene: Dr. Janciauskiene has been principal investigator in a Hoffmann-La Roche sponsored trial and has been an invited speaker for Hoffmann-La Roche. B. Lutiger: Beatrix Lutiger is an employee of F. Hoffmann-La Roche AG. M.E. Gore: Dr. Martin Gore has participated advisory board meetings and is on the speaker's bureau for Roche. G. Mickisch: Dr. Gerald Mickisch is a member of the BEVLiN Steering Committee. J. Bellmunt: Dr. Joaquim Bellmunt has participated in an advisory board meeting, and received a lectures fee from Roche. All other authors have declared no conflicts of interest.
- Published
- 2012
- Full Text
- View/download PDF
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.