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2. Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients

Author

Goldhaber, Sz, Leizorovicz, A, Kakkar, A, Haas, Sk, Merli, G, Weitz, Ji, Ceresetto, Jm, Kyrle, P, Gallus, A, Cools, F, Saraiva, J, Faucher, Jp, Chlumsky, J, Husted, S, Emmerich, J, Bauersachs, R, Zeltser, D, Prandoni, Paolo, Ghiraduzzi, A, Leiva, J, Sparby, Ja, Torbiki, A, Kobalava, Z, Jacobson, B, Suarez, C, Fu, M, Savas, I, Parkhomenko, A, Ansell, J, Landis, Jr, Elliott, Cg, Borris, Lc, Samama, Mm, Pinede, L, Becker, F, Coppere, B, Nony, P, Merah, A, Alves, M, Boulet, H, Loppinet, A, Nicol, C, Ohanessian, L, Roncato, C, Knabb, Rm, Liaw, D, Smith, K, Hess, T, Rossi, L, Chen, D, Doan, C, Doran, J, Matheis, E, Ballard, M, Tsarova, O, Levenstein, S, Tvedegaard, M, Akkal, Z, Jure, H, Mercado, Da, Zangroniz, P, Constantino, M, Bello, F, Giumelli, C, de Sagastizabal, D, Risso Patron, F, Ceresetto, J, Dran, R, Vita, N, Baratta, S, Ahuad Guerrero, R, Penchasky, D, Rubinfeld, A, Layden, M, Karrasch, J, Coughlin, P, Peters, M, Gibbs, H, Ward, Ch, Hahn, U, Pilger, E, Minar, E, El Allaf, D, Marechal, P, Motte, S, Verhamme, P, Wollaert, B, Duck, L, Freire, A, Piegas, L, Jorge, Jm, Guimaraes, H, Oliveira, M, Blacher, C, Leães, P, Toniolo, J, Okoshi, M, Rosa, Dd, Cunha, C, Lobo, S, Leader, R, Dhar, A, Tarabain, O, Miron, M, Brossoit, R, Kahn, S, Kassis, J, Douketis, J, Spencer, F, Faucher, J, Alarcon, Ma, Gutierrez Valenzuela, F, Bisbal Malig, C, Vejar, M, Jaramillo, N, Saaibi, D, Londono, D, Kolman, P, Reiterer, P, Ballek, L, Spacek, R, Soucek, M, Patek, F, Vitovec, M, Kovarova, K, Ceska, R, Podpera, I, Faber, J, Oestergaard, L, Vejby Christensen, H, Frost, L, Rasmussen, Sl, Tuxen, C, Ingerslev, J, Knudsen, T, Torp Pedersen, C, Pedersen, C, Nielsen, H, Mottier, D, Simoneau, G, Leduc, J, Lorcerie, B, Paleiron, N, Proust, A, Conri, C, Pernod, G, Mismetti, P, Achkar, A, Maignan, M, Harenberg, J, Beyer, J, Horacek, T, Lawall, H, Hecker, U, Hammerstingl, C, Weil, J, Fischer, D, Brachmann, J, Klepzig, H, Cheng, G, Soltesz, P, Schnabel, R, Futo, L, Jobbagy, L, Singh, P, Talwar, D, Bhadade, R, Bharani, A, Krishnamurthy, S, Goyal, A, Mehta, P, Samiuddin, M, D'Souza, G, Sinha, S, Sathe, P, Sethuraman, S, Jaganmani, S, Sundaram, P, Saxena, A, Mehta, M, Omar, A, Rajkumar, J, Jog, S, Kumar, S, Hayek, T, Hussein, O, Lahav, M, Efrati, S, Elias, M, Grossman, E, Lugassy, G, Porath, A, Porreca, E, Prandoni, P, Tosetto, A, Imberti, D, Pierfranceschi, G, Ghirarduzzi, A, Scannapieco, G, Testa, S, Ling, P, Yusoff, K, Yusof, Z, Lopez Rosas, E, Hernandez, I, Nanez Terreros, H, Flota, L, Campos, E, Alcocer, M, Viergever, P, Sparby, J, Cotrina, R, Salas, M, Pamo, O, Fajardo, L, Horna, M, Ulloa, V, Toce, L, Moncada, Z, Salazar, O, Habaluyas, R, Collado, F, Edmilao, M, Abola, T, Sevilla, R, Torbicki, A, Tracz, W, Kasprzak, J, Jastrzebski, D, Psuja, P, Hiczkiewicz, J, Piepiorka, M, Pulkowski, G, Tyszkiewicz, I, Kuc, K, Gordeev, I, Boyarkin, M, Privalov, D, Abrosimov, V, Reshetko, O, Goloshchekin, B, Vishnevsky, A, Boldueva, S, Kostenko, V, Mkrtchian, V, Chernichka, I, Belenkov, Y, Rodoman, G, Andreev, D, Shvarts, Y, Aleksandrov, O, Zadionchenko, V, Klochkov, O, Tay, J, Jagadesan, R, Basson, M, Siebert, R, Viljoen, J, Gray, T, Abdool Gaffar, M, Suh, G, In, K, Choi, D, Kim, S, Baek, S, Chung, H, Shin, J, Alvarez Sala, L, Cepeda, J, Ferrer, M, Mallibovsky, L, Garcia Morillo, J, Villalta, J, Gomez Cerezo, J, Capitán, F, Gonzalez Garrido, F, Guijarro, C, Jimenez, D, Richart, C, Elf, J, Ueng, K, Huang, T, Karan, A, Erten, N, Abrahamovych, O, Chopey, I, Gavrysiuk, V, Kraiz, I, Karpenko, A, Volkov, V, Denesyuk, V, Kharchenko, N, Tseluyko, V, Batushkin, V, Sushko, V, Yagensky, A, Ignatenko, G, Dziublyk, O, Cohen, A, Bareford, D, Kesteven, P, Mccollum, P, Das, S, Conrad, S, Botnick, W, Nathanson, A, Hamad, A, Fraiz, J, Goytia Leos, D, Fulmer, J, Mclaren, G, Streiff, M, Hahn, B, Ardolic, B, Klausner, H, Welch, M, Pullman, J, Phillips, D, Felt, J, Mitchell, G, Margolis, B, Pendleton, R, Mahesh, A, Barney, J, Shadan, F, Schuller, D, Joslin, S, Feldman, J, Pearl, R, Welker, J, Hazelrigg, M, Stevens, S, Siegel, M, Meade, A, Bates, J, Tahirkheli, N, Rosenberg, D, Dishman, K, Ikerd, T, Feldman, G, O'Connell, C, Vaince, U, Dabbagh, O, Eyster, E, Weinstein, G, Ginsberg, R, Fine, J, Tillinghast, A, Alabi, F, Nathan, R, Haught, H, Oliver, M., Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Thrombosis Research Institute (AKK), University College of London [London] (UCL), Institute for Experimental Oncology and Therapy Research (IEOTR), Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), Jefferson Medical College (JMC), Thomas Jefferson University Hospitals, Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, MESH: Pulmonary Embolism, Placebo-controlled study, MESH: Hospitalization, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, MESH: Venous Thromboembolism, chemistry.chemical_compound, 0302 clinical medicine, MESH: Aged, 80 and over, Randomized controlled trial, law, Risk Factors, MESH: Risk Factors, Medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Treatment Outcome, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, General Medicine, Orvostudományok, Venous Thromboembolism, Middle Aged, 3. Good health, Pulmonary embolism, Hospitalization, Treatment Outcome, Acute Disease, MESH: Acute Disease, Apixaban, Female, Respiratory Insufficiency, MESH: Hemorrhage, medicine.drug, Adult, medicine.medical_specialty, Randomization, MESH: Enoxaparin, Pyridones, Medicina, Hemorrhage, MESH: Anticoagulants, MESH: Drug Administration Schedule, Klinikai orvostudományok, Drug Administration Schedule, 03 medical and health sciences, Double-Blind Method, Internal medicine, MESH: Pyridones, Humans, Risk factor, Enoxaparin, MESH: Kaplan-Meier Estimate, Aged, Heart Failure, MESH: Humans, business.industry, Anticoagulants, MESH: Adult, medicine.disease, MESH: Male, Surgery, chemistry, Relative risk, Betrixaban, MESH: Heart Failure, Pyrazoles, business, Pulmonary Embolism, MESH: Female, MESH: Pyrazoles, MESH: Respiratory Insufficiency, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

The efficacy and safety of prolonging prophylaxis for venous thromboembolism in medically ill patients beyond hospital discharge remain uncertain. We hypothesized that extended prophylaxis with apixaban would be safe and more effective than short-term prophylaxis with enoxaparin. METHODS: In this double-blind, double-dummy, placebo-controlled trial, we randomly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban, administered orally at a dose of 2.5 mg twice daily for 30 days, or enoxaparin, administered subcutaneously at a dose of 40 mg once daily for 6 to 14 days. The primary efficacy outcome was the 30-day composite of death related to venous thromboembolism, pulmonary embolism, symptomatic deep-vein thrombosis, or asymptomatic proximal-leg deep-vein thrombosis, as detected with the use of systematic bilateral compression ultrasonography on day 30. The primary safety outcome was bleeding. All efficacy and safety outcomes were independently adjudicated. RESULTS: A total of 6528 subjects underwent randomization, 4495 of whom could be evaluated for the primary efficacy outcome - 2211 in the apixaban group and 2284 in the enoxaparin group. Among the patients who could be evaluated, 2.71% in the apixaban group (60 patients) and 3.06% in the enoxaparin group (70 patients) met the criteria for the primary efficacy outcome (relative risk with apixaban, 0.87; 95% confidence interval [CI], 0.62 to 1.23; P = 0.44). By day 30, major bleeding had occurred in 0.47% of the patients in the apixaban group (15 of 3184 patients) and in 0.19% of the patients in the enoxaparin group (6 of 3217 patients) (relative risk, 2.58; 95% CI, 1.02 to 7.24; P = 0.04). CONCLUSIONS: In medically ill patients, an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin. Apixaban was associated with significantly more major bleeding events than was enoxaparin, Supported by Bristol-Myers Squibb and Pfizer

Published
2011

3. A randomized controlled phase III study comparing hadrontherapy with carbon ions versus conventional radiotherapy - including photon and proton therapy - for the treatment of radioresistant tumors: the ETOILE trial.

Author

Balosso J, Febvey-Combes O, Iung A, Lozano H, Alloh AS, Cornu C, Hervé M, Akkal Z, Lièvre M, Plattner V, Valvo F, Bono C, Fiore MR, Vitolo V, Vischioni B, Patin S, Allemand H, Gueyffier F, Margier J, Guerre P, Chabaud S, Orecchia R, and Pommier P

Subjects
Carbon adverse effects, Humans, Ions therapeutic use, Photons adverse effects, Prospective Studies, Protons, Quality of Life, Carcinoma, Adenoid Cystic, Heavy Ion Radiotherapy adverse effects, Proton Therapy adverse effects, Sarcoma drug therapy, Soft Tissue Neoplasms drug therapy
Abstract

Background: Some cancers such as sarcomas (bone and soft tissue sarcomas) and adenoid cystic carcinomas are considered as radioresistant to low linear energy transfer radiation (including photons and protons) and may therefore beneficiate from a carbon ion therapy. Despite encouraging results obtained in phase I/II trials compared to historical data with photons, the spread of carbon ions has been limited mainly because of the absence of randomized medical data. The French health authorities stressed the importance of having randomized data for carbon ion therapy., Methods: The ETOILE study is a multicenter prospective randomized phase III trial comparing carbon ion therapy to either advanced photon or proton radiotherapy for inoperable or macroscopically incompletely resected (R2) radioresistant cancers including sarcomas and adenoid cystic carcinomas. In the experimental arm, carbon ion therapy will be performed at the National Center for Oncological Hadrontherapy (CNAO) in Pavia, Italy. In the control arm, photon or proton radiotherapy will be carried out in referent centers in France. The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival and local control, toxicity profile, and quality of life. In addition, a prospective health-economic study and a radiobiological analysis will be conducted. To demonstrate an absolute improvement in the 5-year PFS rate of 20% in favor of carbon ion therapy, 250 patients have to be included in the study., Discussion: So far, no clinical study of phase III has demonstrated the superiority of carbon ion therapy compared to conventional radiotherapy, including proton therapy, for the treatment of radioresistant tumors., Trial Registration: ClinicalTrials.gov identifier: NCT02838602 . Date of registration: July 20, 2016. The posted information will be updated as needed to reflect protocol amendments and study progress., (© 2022. The Author(s).)

Published
2022
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