10 results on '"Bairey O"'
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2. A cross-trial comparison of single-agent ibrutinib versus chlorambucil-obinutuzumab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Tedeschi, A, Greil, R, Demirkan, F, Robak, T, Moreno, C, Barr, PM, Anz, B, Simpson, D, Gaidano, G, Bairey, O, Stevens, D, Gill, D, Flinn, IW, Kipps, TJ, Burger, JA, Lin, J, Webb, T, Fedorov, V, Styles, L, Gribben, JG, Tedeschi, A, Greil, R, Demirkan, F, Robak, T, Moreno, C, Barr, PM, Anz, B, Simpson, D, Gaidano, G, Bairey, O, Stevens, D, Gill, D, Flinn, IW, Kipps, TJ, Burger, JA, Lin, J, Webb, T, Fedorov, V, Styles, L, and Gribben, JG
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- 2020
3. Frontline treatment with the combination obinutuzumab ± chlorambucil for chronic lymphocytic leukemia outside clinical trials: Results of a multinational, multicenter study by ERIC and the Israeli CLL study group
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Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, Luca, Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, Marino, Scarfo, L., Tedeschi, Alessandra, Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Tedeschi A., Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, Luca, Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, Marino, Scarfo, L., Tedeschi, Alessandra, Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., and Tedeschi A.
- Abstract
In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O ± Clb in unfit patients with CLL, in a “real-world” setting. Patients with documented del (17p13.1)/TP53 mutation were excluded. A total of 437 patients (median age, 75.9 years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min) were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95% CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del (11q22.3) and/or IGHV-unmutated], lymph nodes of diameter > 5 cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a “real-world” setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del (11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease.
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- 2020
4. Single-agent ibrutinib versus chemoimmunotherapy regimens for treatment-naive patients with chronic lymphocytic leukemia: A cross-trial comparison of phase 3 studies
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Robak, T, Burger, JA, Tedeschi, A, Barr, PM, Owen, C, Bairey, O, Hillmen, P, Simpson, D, Grosicki, S, Devereux, S, McCarthy, H, Coutre, SE, Quach, H, Gaidano, G, Maslyak, Z, Stevens, DA, Moreno, C, Gill, DS, Flinn, IW, Gribben, JG, Mokatrin, A, Cheng, M, Styles, L, James, DF, Kipps, TJ, Ghia, P, Robak, T, Burger, JA, Tedeschi, A, Barr, PM, Owen, C, Bairey, O, Hillmen, P, Simpson, D, Grosicki, S, Devereux, S, McCarthy, H, Coutre, SE, Quach, H, Gaidano, G, Maslyak, Z, Stevens, DA, Moreno, C, Gill, DS, Flinn, IW, Gribben, JG, Mokatrin, A, Cheng, M, Styles, L, James, DF, Kipps, TJ, and Ghia, P
- Abstract
Chemoimmunotherapy (CIT) and targeted therapy with single-agent ibrutinib are both recommended first-line treatments for chronic lymphocytic leukemia (CLL), although their outcomes have not been directly compared. Using ibrutinib data from the RESONATE-2 (PCYC-1115/1116) study conducted in patients ≥65 years without del(17p), we performed a cross-trial comparison with CIT data from published phase 3 studies in first-line treatment of CLL. Progression-free survival (PFS), overall survival (OS), and safety data for ibrutinib (median follow-up 35.7 months) were evaluated alongside available CIT data. CIT regimens included: fludarabine + cyclophosphamide + rituximab (CLL8, CLL10), bendamustine + rituximab (CLL10), obinutuzumab + chlorambucil and rituximab + chlorambucil (CLL11), and ofatumumab + chlorambucil (COMPLEMENT-1). Median age across studies was 61-74 years, with older populations receiving ibrutinib, obinutuzumab + chlorambucil, or rituximab + chlorambucil. Median follow-up varied across studies/regimens (range 14.5-37.4 months). Among all patients, PFS appeared longer with ibrutinib relative to CIT and OS appeared comparable. Relative to CIT studies that similarly excluded patients with del(17p) (CLL10) or enrolled older/less-fit patients (CLL11), PFS appeared favorable for ibrutinib in high-risk subgroups, including advanced disease, bulky lymph nodes, unmutated IGHV status, and presence of del(11q). Grade ≥ 3 infections ranged from 9% (ofatumumab + chlorambucil) to 40% (fludarabine + cyclophosphamide + rituximab), and was 25% with ibrutinib. Grade ≥ 3 neutropenia was 12% for ibrutinib and 26%-84% for CIT. Although definitive conclusions cannot be made due to inherent limitations of cross-trial comparisons, this report suggests that ibrutinib has a favorable benefit/risk profile and may potentially eliminate the need for chemotherapy in some patients. Randomized, comparative studies are needed to support these findings.
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- 2018
5. First-line treatment and outcome of elderly patients with primary central nervous system lymphoma (PCNSL)—a systematic review and individual patient data meta-analysis
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Kasenda, B., Ferreri, A. J. M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J. Y., Hoang-Xuan, K., Pulczynski, E. J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B. P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T. T., Illerhaus, G., Briel, M., Kasenda, B., Ferreri, A. J. M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J. Y., Hoang-Xuan, K., Pulczynski, E. J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B. P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T. T., Illerhaus, G., and Briel, M.
- Abstract
Evidence for prognosis and treatment of elderly patient with primary central nervous system is limited. High-dose methotrexate should be applied whenever possible, especially combination with oral alkylating agents is a promising approach. Further combinations with other intravenous drugs do not seem to improve outcome. More prospective trials designed for elderly PCNSL patients are warranted
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- 2017
6. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study
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Chanan-Khan, Asher, Cramer, Paula, Demirkan, Fatih, Fraser, Graeme, Silva, Rodrigo Santucci, Grosicki, Sebastian, Pristupa, Aleksander, Janssens, Ann, Mayer, Jiri, Bartlett, Nancy L., Dilhuydy, Marie-Sarah, Pylypenko, Halyna, Loscertales, Javier, Avigdor, Abraham, Rule, Simon, Villa, Diego, Samoilova, Olga, Panagiotidis, Panagiots, Goy, Andre, Mato, Anthony, Pavlovsky, Miguel A., Karlsson, Claes, Mahler, Michelle, Salman, Mariya, Sun, Steven, Phelps, Charles, Balasubramanian, Sriram, Howes, Angela, Hallek, Michael, Assouline, S., Bence-Bruckler, I., Buckstein, R., Fraser, G., Larratt, L., Minuk, L., Villa, D., Angevine, A., Bartlett, N., Bixby, D., Caimi, P., Chanan-Khan, A., Craig, M., Forero-Torres, A., Ganguly, S., Goy, A., Heffner, L., Hermann, R., Lansigan, F., Leis, J., Letzer, J., Link, B., Liu, D., McCaul, K., McGuire, E., Skinner, W., Starodub, A., Stuart, R., Thirman, M., Tirumali, N., Yang, J., Janssens, A., Offner, F., Van den Neste, E., Van Hoof, A., Mayer, J., Novak, J., Trneny, M., Cartron, G., Dartigeas, C., Dilhuydy, M., Ghez, D., Haioun, C., Leblond, V., Salles, G., Balser, C., Cramer, P., Dreger, P., Durig, J., Eckart, M., Heinrich, B., Illmer, T., Jentsch-Ullrich, K., Pfreundschuh, M., Schetelig, J., Schlag, R., Soling, U., Stilgenbaue, S., Anagnostopoulos, A., Dimopoulos, A., Panagiotidis, P., Vrakidou, E., Bairey, O., Ben Yehuda, D., Braester, A., Fineman, R., Herishanu, Y., Nagler, A., Ruchlemer, R., Tadmor, T., Grosicki, S., Homenda, W., Jurczak, W., Pluta, A., Woszczyk, D., Espirito Santo, A., Luis, R., Raposo, J., Viveiros, C., Alexeeva, J., Dunaev, Y., Golubeva, M., Khuageva, N., Loginov, A., Lysenko, I., Osmanov, E., Pavlov, V., Pristupa, A., Proydakov, A., Rossiev, V., Samarina, I., Samoilova, O., Serduk, O., Shneider, T., Udovitsa, D., Voloshin, S., Gayoso, J., Gonzalez, M., Gonzalez Barca, E., Hernandez Rivas, J., Jargue, I., Loscertales, J., Karlsson, C., Sender, M., Aktan, M., Arslan, O., Demirkan, F., Ferhanoglu, B., Kaynar, L., Sayinalp, N., Vaural, F., Yagci, M., Dyagil, I., Kaplan, P., Masliak, Z., Oliynyk, H., Popovska, T., Pylypenko, H., Rekhtman, G., Dearden, C., Morley, N., Moss, P., Rule, S., Pavlovsky, M., Riveros, D., Santucci-Silva, R., Romeo, M., Scheliga, A., Salazar, L., Gomez, D., Ramirez, E., Jung, C., Chanan-Khan, Asher, Cramer, Paula, Demirkan, Fatih, Fraser, Graeme, Silva, Rodrigo Santucci, Grosicki, Sebastian, Pristupa, Aleksander, Janssens, Ann, Mayer, Jiri, Bartlett, Nancy L., Dilhuydy, Marie-Sarah, Pylypenko, Halyna, Loscertales, Javier, Avigdor, Abraham, Rule, Simon, Villa, Diego, Samoilova, Olga, Panagiotidis, Panagiots, Goy, Andre, Mato, Anthony, Pavlovsky, Miguel A., Karlsson, Claes, Mahler, Michelle, Salman, Mariya, Sun, Steven, Phelps, Charles, Balasubramanian, Sriram, Howes, Angela, Hallek, Michael, Assouline, S., Bence-Bruckler, I., Buckstein, R., Fraser, G., Larratt, L., Minuk, L., Villa, D., Angevine, A., Bartlett, N., Bixby, D., Caimi, P., Chanan-Khan, A., Craig, M., Forero-Torres, A., Ganguly, S., Goy, A., Heffner, L., Hermann, R., Lansigan, F., Leis, J., Letzer, J., Link, B., Liu, D., McCaul, K., McGuire, E., Skinner, W., Starodub, A., Stuart, R., Thirman, M., Tirumali, N., Yang, J., Janssens, A., Offner, F., Van den Neste, E., Van Hoof, A., Mayer, J., Novak, J., Trneny, M., Cartron, G., Dartigeas, C., Dilhuydy, M., Ghez, D., Haioun, C., Leblond, V., Salles, G., Balser, C., Cramer, P., Dreger, P., Durig, J., Eckart, M., Heinrich, B., Illmer, T., Jentsch-Ullrich, K., Pfreundschuh, M., Schetelig, J., Schlag, R., Soling, U., Stilgenbaue, S., Anagnostopoulos, A., Dimopoulos, A., Panagiotidis, P., Vrakidou, E., Bairey, O., Ben Yehuda, D., Braester, A., Fineman, R., Herishanu, Y., Nagler, A., Ruchlemer, R., Tadmor, T., Grosicki, S., Homenda, W., Jurczak, W., Pluta, A., Woszczyk, D., Espirito Santo, A., Luis, R., Raposo, J., Viveiros, C., Alexeeva, J., Dunaev, Y., Golubeva, M., Khuageva, N., Loginov, A., Lysenko, I., Osmanov, E., Pavlov, V., Pristupa, A., Proydakov, A., Rossiev, V., Samarina, I., Samoilova, O., Serduk, O., Shneider, T., Udovitsa, D., Voloshin, S., Gayoso, J., Gonzalez, M., Gonzalez Barca, E., Hernandez Rivas, J., Jargue, I., Loscertales, J., Karlsson, C., Sender, M., Aktan, M., Arslan, O., Demirkan, F., Ferhanoglu, B., Kaynar, L., Sayinalp, N., Vaural, F., Yagci, M., Dyagil, I., Kaplan, P., Masliak, Z., Oliynyk, H., Popovska, T., Pylypenko, H., Rekhtman, G., Dearden, C., Morley, N., Moss, P., Rule, S., Pavlovsky, M., Riveros, D., Santucci-Silva, R., Romeo, M., Scheliga, A., Salazar, L., Gomez, D., Ramirez, E., and Jung, C.
- Abstract
Background Most patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma relapse after initial therapy. Bendamustine plus rituximab is often used in the relapsed or refractory setting. We assessed the efficacy and safety of adding ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase (BTK), to bendamustine plus rituximab in patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma. Methods The HELIOS trial was an international, double-blind, placebo-controlled, phase 3 study in adult patients (>= 18 years of age) who had active chronic lymphocytic leukaemia or small lymphocytic lymphoma with measurable lymph node disease (>1.5 cm) by CT scan, and had relapsed or refractory disease following one or more previous lines of systemic therapy consisting of at least two cycles of a chemotherapy-containing regimen, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate bone marrow, liver, and kidney function. Patients with del(17p) were excluded because of known poor response to bendamustine plus rituximab. Patients who had received previous treatment with ibrutinib or other BTK inhibitors, refractory disease or relapse within 24 months with a previous bendamustine-containing regimen, or haemopoietic stem-cell transplant were also excluded. Patients were randomly assigned (1:1) by a web-based system to receive bendamustine plus rituximab given in cycles of 4 weeks' duration (bendamustine: 70 mg/m.intravenously on days 2-3 in cycle 1, and days 1-2 in cycles 2-6; rituximab: 375 mg/m.on day 1 of cycle 1, and 500 mg/m.on day 1 of cycles 2-6 for a maximum of six cycles) with either ibrutinib (420 mg daily orally) or placebo until disease progression or unacceptable toxicity. Patients were stratified according to whether they were refractory to purine analogues and by number of previous lines of therapy. The primary endpoint was independent review committee (IRC)-assessed progression-fre
- Published
- 2016
7. First-line treatment and outcome of elderly patients with primary central nervous system lymphoma (PCNSL)-a systematic review and individual patient data meta-analysis
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Kasenda, B. (Benjamin), Ferreri, A.J.M. (Andrés J.M.), Marturano, E., Forst, D., Bromberg, J.E.C. (Jacoline), Ghesquieres, H., Ferlay, C., Blay, J.Y. (Jean Yves), Hoang-Xuan, K. (Khê), Pulczynski, E.J., Fosså, A., Okoshi, Y., Chiba, S. (Shigeru), Fritsch, K. (Kristina), Omuro, A., O'Neill, B.P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T.T. (Tracy), Illerhaus, G. (Gerald), Brie, M., Kasenda, B. (Benjamin), Ferreri, A.J.M. (Andrés J.M.), Marturano, E., Forst, D., Bromberg, J.E.C. (Jacoline), Ghesquieres, H., Ferlay, C., Blay, J.Y. (Jean Yves), Hoang-Xuan, K. (Khê), Pulczynski, E.J., Fosså, A., Okoshi, Y., Chiba, S. (Shigeru), Fritsch, K. (Kristina), Omuro, A., O'Neill, B.P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T.T. (Tracy), Illerhaus, G. (Gerald), and Brie, M.
- Abstract
Background: To investigate prognosis and effects of first-line therapy in elderly primary central nervous system lymphoma (PCNSL) patients. Patients and methods: A systematic review of studies about first-line therapy in immunocompetent patients ≥60 years with PCNSL until 2014 and a meta-analysis of individual patient data from eligible studies and international collaborators were carried out. Results: We identified 20 eligible studies; from 13
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- 2015
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8. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia.
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Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., Janssens A., Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., and Janssens A.
- Abstract
Summary: Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.Copyright © 2014 John Wiley & Sons Ltd.
- Published
- 2015
9. Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia: extended phase 3 results from RESONATE-2.
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Barr, P.M., Robak, T., Owen, C., Tedeschi, A., Bairey, O., Bartlett, N.L., Burger, J.A., Hillmen, P., Coutre, S., Devereux, S., Grosicki, S., McCarthy, Helen, Li, J., Simpson, D., Offner, F., Moreno, C., Zhou, C., Styles, L., James, D., Kipps, T.J., Ghia, P., Barr, P.M., Robak, T., Owen, C., Tedeschi, A., Bairey, O., Bartlett, N.L., Burger, J.A., Hillmen, P., Coutre, S., Devereux, S., Grosicki, S., McCarthy, Helen, Li, J., Simpson, D., Offner, F., Moreno, C., Zhou, C., Styles, L., James, D., Kipps, T.J., and Ghia, P.
- Abstract
Results of RESONATE-2 (PCYC-1115/1116) supported approval of ibrutinib for first-line treatment of chronic lymphocytic leukemia. Extended analysis of RESONATE-2 was conducted to determine long-term efficacy and safety of ibrutinib in older patients with chronic lymphocytic leukemia. A total of 269 patients aged ≥65 years with previously untreated chronic lymphocytic leukemia without del(17p) were randomized 1:1 to ibrutinib (n=136) or chlorambucil (n=133) on days 1 and 15 of a 28-day cycle for 12 cycles. Median ibrutinib treatment duration was 28.5 months. Ibrutinib significantly prolonged progression-free survival versus chlorambucil (median, not reached vs 15 months; hazard ratio, 0.12; 95% confidence interval, 0.07-0.20; P<0.0001). The 24-month progression-free survival was 89% with ibrutinib (97% and 89% in patients with del[11q] and unmutated immunoglobulin heavy chain variable region gene, respectively). Progression-free survival rates at 24 months were also similar regardless of age (<75 years [88%], ≥75 years [89%]). Overall response rate was 92% (125/136). Rate of complete response increased substantially from 7% at 12 months to 18% with extended follow up. Greater quality of life improvements occurred with ibrutinib versus chlorambucil in Functional Assessment of Chronic Illness Therapy-Fatigue (P=0.0013). The most frequent grade ≥3 adverse events were neutropenia (12%), anemia (7%), and hypertension (5%). Rate of discontinuations due to adverse events was 12%. Results demonstrated that first-line ibrutinib for elderly patients with chronic lymphocytic leukemia provides sustained response and progression-free survival benefits over chemotherapy, with depth of response improving over time without new toxicity concerns. This trial was registered at clinicaltrials.gov identifier 01722487 and 01724346.
10. First-line treatment and outcome of elderly patients with primary central nervous system lymphoma (PCNSL)—a systematic review and individual patient data meta-analysis
- Author
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Kasenda, B., Ferreri, A. J. M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J. Y., Hoang-Xuan, K., Pulczynski, E. J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B. P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T. T., Illerhaus, G., Briel, M., Kasenda, B., Ferreri, A. J. M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J. Y., Hoang-Xuan, K., Pulczynski, E. J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B. P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T. T., Illerhaus, G., and Briel, M.
- Abstract
Evidence for prognosis and treatment of elderly patient with primary central nervous system is limited. High-dose methotrexate should be applied whenever possible, especially combination with oral alkylating agents is a promising approach. Further combinations with other intravenous drugs do not seem to improve outcome. More prospective trials designed for elderly PCNSL patients are warranted
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