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Your search keyword '"I.G. Manolescu"' showing total 2 results
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2 results on '"I.G. Manolescu"'

1. Clinically relevant bleeding in cancer patients treated for venous thromboembolism from the CATCH study

Author

P.W. Kamphuisen, A.Y.Y. Lee, G. Meyer, R. Bauersachs, M.S. Janas, M.F. Jarner, A.A. Khorana, R. Bella Santiago, S. Cerana, J.J. Zarbá, J. Andel, C.H. Barrios, A. Borba Reiriz, F. Cesario, S. de Azevedo, A.F. Ferreira Filho, F.A. Franke, S. Padilha, R. Paiva Queiroz, A. Pimenta, J. Rerin, R. Rigo, S.B. van Eyll Rocha, G. Santos Borges, G. Vacaro, V. Anastasov, T. Dragneva, G. Georgiev, P. Champion, P. Kuruvilla, C. Gonzalez, P. Ditl, J. Förster, B. Lubomir, J. Vydra, R.A. El Hassan, S. Sabri, N. Allahloubi, A. Elzawawy, S.S. Ezzat, M.S. El Kady, L. Bacchus, J. Beyer‐Westendorf, U. Kamphausen, D. Niederwieser, H. Ostermann, M. Sosada, N. Anagnostopoulos, G. Fountzilas, C. Ioannou, C. Liapis, J.F.B. Schaeffer, S. Atilli, S. Balsubramanian, S. Bondarde, S.C. Desai, C. Deshmukh, D.P. Singh, F. Gharami, L. Goyal, S. Gupta, S. Gupte, K.K. Mukherjee, S. Krishnan, K. Kumar, A. Mehta, K. Mishra, R. Naik, S. Pawar, R.V. Nagarkar, N. Warrier, B. Brenner, I. Gavish, G. Lugassy, M. Kolin, B. Enrico, M.G. Mazzucconi, G. Visani, A. Awidi, N. Novikovs, J. Miscuks, D. Abigerges, F. Farhat, P. Khoueiry, J. Makarem, O. Alvarez Ordorica, E. Anaya Santacruz, G. Calderillo Ruiz, J.H. de la Concha Ureta, W.S.R. Pantigoso, M. Philco, A.R. Pineda, E.A.V. Queszada, K. Gawrychowski, W. Witkiewicz, E. Macias, E. Teixeira, T.‐E. Ciuleanu, C.C. Ligia, D. Lungulescu, I.G. Manolescu, A. Rodica, C. Volovat, Y. Burov, I. Katelnitsky, D. Svistov, K. Ahmad, F. Algahtani, H. Al‐Zahrani, M. Qari, D. Jovanovic, N. Milanovic, B. Perin, V. Stojanovic, L. Tomasic, J. Chovanec, O. Herman, V. Kissova, F. Sasvary, S. Špánik, M. Szentivanyi, F. Barón, E. Gallardo, D. Jiménez, O. Remedios, A. Sanchez, J. Engelbrecht, N. Jonas, G. McAdam, M. Patel, B. Rapoport, B. Robertson, D. Oh, H. Kim, H.‐K. Kim, H.J. Kim, H.S. Kim, J.S. Ahn, J. Chung, J. Jang, K.U. Park, S.‐W. Shin, S.H. Kim, S‐S. Yoon, Y.‐K. Kim, C.‐F. Chiu, C.‐S. Chang, J.‐H. Liu, K.‐M. Rau, S.‐W. Chen, S. Chittima, T. Ekkapong, K. Nonglak, A. Pantep, M. Pramook, S. Thanakrit, S. Patrapim, T. Sumitra, C. Udomluck, I. Kobza, O. Nykonenko, V. Prasol, I. Vladychuk, and Cardiovascular Centre (CVC)

Subjects
Male, medicine.medical_specialty, anticoagulants, Time Factors, INTRACRANIAL HEMORRHAGE, venous thromboembolism, neoplasms, BRAIN METASTASES, Hemorrhage, 030204 cardiovascular system & hematology, Malignancy, Risk Assessment, ANTICOAGULANT TREATMENT, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Medicine, Humans, Prospective Studies, THERAPEUTIC RANGE, Aged, COMPLICATIONS, tinzaparin, business.industry, Incidence, Hazard ratio, RIETE REGISTRY, Warfarin, Cancer, Hematology, Tinzaparin, MOLECULAR-WEIGHT HEPARIN, Middle Aged, medicine.disease, bleeding, Thrombosis, Confidence interval, Exact test, WARFARIN PATIENTS, Treatment Outcome, 030220 oncology & carcinogenesis, INTERNATIONAL NORMALIZED RATIO, ATRIAL-FIBRILLATION, Female, Drug Monitoring, business, medicine.drug
Abstract

Essentials Cancer patients receiving anticoagulants for venous thromboembolism have an elevated bleeding risk. This secondary analysis of CATCH assessed characteristics of clinically relevant bleeding (CRB). CRB occurs in 15% of cancer patients with thrombosis using therapeutic doses of anticoagulation. After multivariate analysis, risk factors for CRB were age >75 years and intracranial malignancy. Summary Background Cancer patients with acute venous thromboembolism (VTE) receiving anticoagulant treatment have an increased bleeding risk. Objectives We performed a prespecified secondary analysis of the randomized, open-label, Phase III CATCH trial (NCT01130025) to assess the rate and sites of and the risk factors for clinically relevant bleeding (CRB). Patients/Methods Patients with active cancer and acute, symptomatic VTE received either tinzaparin 175 IU kg-1 once daily or warfarin (target International Normalized Ratio [INR] of 2.0-3.0) for 6 months. Fisher's exact test was used to screen prespecified clinical risk factors; those identified as being significantly associated with an increased risk of CRB then underwent competing risk regression analysis of time to first CRB. Results Among 900 randomized patients, 138 (15.3%) had 180 CRB events. CRB occurred in 60 patients (81 events) in the tinzaparin group and in 78 patients (99 events) in the warfarin group (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.45-0.89). Common bleeding sites were gastrointestinal (36.7%; n = 66), genitourinary (22.8%; n = 41), and nasal (10.0%; n = 18). In multivariate analysis, the risk of CRB increased with age > 75 years (HR 1.83, 95% CI 1.14-2.94) and intracranial malignancy (HR 1.97, 95% CI 1.07-3.62). In the warfarin group, 40.4% of CRB events occurred in patients with with an INR of 75 years and intracranial malignancy.

Published
2018

2. Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)

Author

S. Ramalingam, J. Crawford, A. Chang, C. Manegold, R. Perez-Soler, J.-Y. Douillard, N. Thatcher, F. Barlesi, T. Owonikoko, Y. Wang, P. Pultar, J. Zhu, R. Malik, G. Giaccone, S. Della-Fiorentina, S. Begbie, R. Jennens, J. Dass, K. Pittman, N. Ivanova, T. Koynova, P. Petrov, A. Tomova, V. Tzekova, F. Couture, V. Hirsh, R. Burkes, R. Sangha, M. Ambrus, T. Janaskova, J. Musil, J. Novotny, P. Zatloukal, J. Jakesova, K. Klenha, J. Roubec, J. Vanasek, J. Fayette, J. Bennouna-Louridi, C. Chouaid, J. Mazières, H. Vallerand, G. Robinet, P.-J. Souquet, D. Spaeth, R. Schott, H. Lena, Y. Martinet, C. El Kouri, N. Baize, A. Scherpereel, O. Molinier, F. Fuchs, K.M. Josten, N. Marschner, F. Schneller, T. Overbeck, M. Thomas, J. von Pawel, M. Reck, W. Schuette, V. Hagen, C.-P. Schneider, V. Georgoulias, I. Varthalitis, K. Zarogoulidis, K. Syrigos, C. Papandreou, C. Bocskei, E. Csanky, E. Juhasz, G. Losonczy, Z. Mark, I. Molnar, Z. Papai-Szekely, S. Tehenes, I. Vinkler, S. Almel, A. Bakshi, S. Bondarde, A. Maru, A. Pathak, R.M. Pedapenki, K. Prasad, S.V.S.S. Prasad, N. Kilara, D. Gorijavolu, C.D. Deshmukh, S. John, L.M. Sharma, D. Amoroso, E. Bajetta, P. Bidoli, A. Bonetti, F. De Marinis, M. Maio, R. Passalacqua, S. Cascinu, A. Bearz, M. Bitina, A. Brize, G. Purkalne, M. Skrodele, A.A. Baba, K. Ratnavelu, M.H. Saw, M.C. Samson-Fernando, G.E. Ladrera, J. Jassem, P. Koralewski, P. Serwatowski, M. Krzakowski, C. Cebotaru, D. Filip, D.E. Ganea-Motan, C.H. Ianuli, I.G. Manolescu, A. Udrea, O. Burdaeva, M. Byakhov, A. Filippov, S. Lazarev, I. Mosin, S. Orlov, D. Udovitsa, A. Khorinko, S. Protsenko, H.L. Lim, Y.O. Tan, E.H. Tan, R. Bastus Piulats, J. Garcia-Foncillas, J. Valdivia, J. de Castro, M. Domine Gomez, S.W. Kim, J.-S. Lee, H.K. Kim, J.S. Lee, S.W. Shin, D.-W. Kim, Y.-C. Kim, K.C. Park, C.-S. Chang, G.-C. Chang, Y.-G. Goan, W.-C. Su, C.-M. Tsai, H.-P. Kuo, M. Benekli, G. Demir, E. Gokmen, A. Sevinc, M. Haigentz, M. Agarwal, S. Pandit, R. Araujo, N. Vrindavanam, P. Bonomi, A. Berg, J. Wade, R. Bloom, B. Amin, R. Camidge, D. Hill, M. Rarick, P. Flynn, L. Klein, K. Lo Russo, M. Neubauer, P. Richards, R. Ruxer, M. Savin, D. Weckstein, R. Rosenberg, T. Whittaker, D. Richards, W. Berry, C. Ottensmeier, A. Dangoor, N. Steele, Y. Summers, E. Rankin, K. Rowley, S. Giridharan, H. Kristeleit, C. Humber, P. Taylor, Ramalingam, S, Crawford, J, Chang, A, Manegold, C, Perez-Soler, R, Douillard, J, Thatcher, N, Barlesi, F, Owonikoko, T, Wang, Y, Pultar, P, Zhu, J, Malik, R, Giaccone, G, and Bidoli, P

Subjects
Male, medicine.medical_specialty, Population, Kaplan-Meier Estimate, Placebo, Gastroenterology, Disease-Free Survival, Drug Administration Schedule, Placebos, Double-Blind Method, Talactoferrin Alfa, Carcinoma, Non-Small-Cell Lung, Internal medicine, Talactoferrin, Humans, Medicine, Phase III study, Progression-free survival, education, Lung cancer, Survival rate, Aged, Neoplasm Staging, education.field_of_study, business.industry, Surrogate endpoint, Hazard ratio, Hematology, Middle Aged, medicine.disease, Surgery, oral dendritic cell (DC)-mediated immunotherapy, Lactoferrin, Treatment Outcome, Oncology, Female, Immunotherapy, Immunotherapy, Non-small-cell lung cancer, Phase III study, Talactoferrin, business, Non-small-cell lung cancer
Abstract

Background Talactoferrin alfa is an oral dendritic cell (DC)-mediated immunotherapy (DCMI). We tested whether talactoferrin was superior to placebo in advanced non-small-cell lung cancer (NSCLC). Patients and methods An FORTIS-M trial was an international, multicenter, randomized, double-blind comparison of talactoferrin (1.5g p.o. BID) versus placebo BID, in patients with stage IIIB/IV NSCLC whose disease had failed two or more prior regimens. Treatment was administered for a maximum of five 14-week cycles. The primary efficacy end point was overall survival (OS); secondary end points included 6- and 12-month survival, progression-free survival (PFS), and disease control rate (DCR). Results Seven hundred and forty-two patients were randomly assigned (2:1) to talactoferrin (497) or placebo (245). The median OS in the intent-to-treat (ITT) population was 7.66 months in the placebo arm and 7.49 months in the talactoferrin arm [hazard ratio (HR), 1.04; 95% CI, 0.873–1.24; P = 0.6602]. The 6-month survival rates were 59.9% (95% CI, 53.4% to 65.8%) and 55.7% (95% CI, 51.1% to 59.9%), respectively. The 12-month survival rates were 32.2% (95% CI, 26.3% to 38.2%) and 30.9% (95% CI, 26.8% to 35%), respectively. The median PFS rates were 1.64 months and 1.68 months, respectively (HR, 0.99; 95% CI, 0.835–1.16; P = 0.8073). The DCRs were 38.4 and 37.6%, respectively [stratified odds ratio (OR), 0.96; 95% CI, 0.698–1.33; P = 0.8336]. The safety profiles were comparable between arms. Conclusions There was no improvement in efficacy with talactoferrin alfa in patients with advanced NSCLC whose disease had failed two or more previous regimens.

Published
2013
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