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1. Molecular landscape and prognostic impact of FLT3-ITD insertion site in acute myeloid leukemia: RATIFY study results

Author

Rücker, F.G., Du, L., Luck, T.J., Benner, A., Krzykalla, J., Gathmann, I., Voso, M.T., Amadori, S., Prior, T.W., Brandwein, J.M., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Savoie, L., Sierra, J., Pallaud, C., Sanz, Mariano, Jansen, J.H., Niederwieser, D., Fischer, T., Ehninger, G., Heuser, M., Ganser, A., Bullinger, L., Larson, R.A., Bloomfield, C.D., Stone, R.M., Döhner, H., Thiede, C., Döhner, K., Rücker, F.G., Du, L., Luck, T.J., Benner, A., Krzykalla, J., Gathmann, I., Voso, M.T., Amadori, S., Prior, T.W., Brandwein, J.M., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Savoie, L., Sierra, J., Pallaud, C., Sanz, Mariano, Jansen, J.H., Niederwieser, D., Fischer, T., Ehninger, G., Heuser, M., Ganser, A., Bullinger, L., Larson, R.A., Bloomfield, C.D., Stone, R.M., Döhner, H., Thiede, C., and Döhner, K.

Abstract

Item does not contain fulltext

Published
2021

2. Midostaurin reduces relapse in FLT3-mutant acute myeloid leukemia: the Alliance CALGB 10603/RATIFY trial

Author

Larson, R.A., Mandrekar, S.J., Huebner, L.J., Sanford, B.L., Laumann, K., Geyer, S., Bloomfield, C.D., Thiede, C., Prior, T.W., Döhner, K., Marcucci, G., Voso, M.T., Klisovic, R.B., Galinsky, I., Wei, A.H., Sierra, J., Sanz, Mariano, Brandwein, J.M., Witte, T.J. de, Niederwieser, D., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Krauter, J., Schlenk, R.F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Gathmann, I., Döhner, H., Stone, R.M., Larson, R.A., Mandrekar, S.J., Huebner, L.J., Sanford, B.L., Laumann, K., Geyer, S., Bloomfield, C.D., Thiede, C., Prior, T.W., Döhner, K., Marcucci, G., Voso, M.T., Klisovic, R.B., Galinsky, I., Wei, A.H., Sierra, J., Sanz, Mariano, Brandwein, J.M., Witte, T.J. de, Niederwieser, D., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Krauter, J., Schlenk, R.F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Gathmann, I., Döhner, H., and Stone, R.M.

Abstract

Item does not contain fulltext, The prospective randomized, placebo-controlled CALGB 10603/RATIFY trial (Alliance) demonstrated a statistically significant overall survival benefit from the addition of midostaurin to standard frontline chemotherapy in a genotypically-defined subgroup of 717 patients with FLT3-mutant acute myeloid leukemia (AML). The risk of death was reduced by 22% on the midostaurin-containing arm. In this post hoc analysis, we analyzed the cumulative incidence of relapse (CIR) on this study and also evaluated the impact of 12 4-week cycles of maintenance therapy. CIR analyses treated relapses and AML deaths as events, deaths from other causes as competing risks, and survivors in remission were censored. CIR was improved on the midostaurin arm (HR = 0.71 (95% CI, 0.54-0.93); p = 0.01), both overall and within European LeukemiaNet 2017 risk classification subsets when post-transplant events were considered in the analysis as events. However, when transplantation was considered as a competing risk, there was overall no significant difference between the risks of relapse on the two randomized arms. Patients still in remission after consolidation with high-dose cytarabine entered the maintenance phase, continuing with either midostaurin or placebo. Analyses were inconclusive in quantifying the impact of the maintenance phase on the overall outcome. In summary, midostaurin reduces the CIR.

Published
2021

3. Midostaurin reduces relapse in FLT3-mutant acute myeloid leukemia: the Alliance CALGB 10603/RATIFY trial

Author

Larson, RA, Mandrekar, SJ, Huebner, LJ, Sanford, BL, Laumann, K, Geyer, S, Bloomfield, CD, Thiede, C, Prior, TW, Dohner, K, Marcucci, G, Voso, MT, Klisovic, RB, Galinsky, I, Wei, AH, Sierra, J, Sanz, MA, Brandwein, JM, de Witte, T, Niederwieser, D, Appelbaum, FR, Medeiros, BC, Tallman, MS, Krauter, J, Schlenk, RF, Ganser, A, Serve, H, Ehninger, G, Amadori, S, Gathmann, I, Dohner, H, Stone, RM, Larson, RA, Mandrekar, SJ, Huebner, LJ, Sanford, BL, Laumann, K, Geyer, S, Bloomfield, CD, Thiede, C, Prior, TW, Dohner, K, Marcucci, G, Voso, MT, Klisovic, RB, Galinsky, I, Wei, AH, Sierra, J, Sanz, MA, Brandwein, JM, de Witte, T, Niederwieser, D, Appelbaum, FR, Medeiros, BC, Tallman, MS, Krauter, J, Schlenk, RF, Ganser, A, Serve, H, Ehninger, G, Amadori, S, Gathmann, I, Dohner, H, and Stone, RM

Abstract

The prospective randomized, placebo-controlled CALGB 10603/RATIFY trial (Alliance) demonstrated a statistically significant overall survival benefit from the addition of midostaurin to standard frontline chemotherapy in a genotypically-defined subgroup of 717 patients with FLT3-mutant acute myeloid leukemia (AML). The risk of death was reduced by 22% on the midostaurin-containing arm. In this post hoc analysis, we analyzed the cumulative incidence of relapse (CIR) on this study and also evaluated the impact of 12 4-week cycles of maintenance therapy. CIR analyses treated relapses and AML deaths as events, deaths from other causes as competing risks, and survivors in remission were censored. CIR was improved on the midostaurin arm (HR = 0.71 (95% CI, 0.54-0.93); p = 0.01), both overall and within European LeukemiaNet 2017 risk classification subsets when post-transplant events were considered in the analysis as events. However, when transplantation was considered as a competing risk, there was overall no significant difference between the risks of relapse on the two randomized arms. Patients still in remission after consolidation with high-dose cytarabine entered the maintenance phase, continuing with either midostaurin or placebo. Analyses were inconclusive in quantifying the impact of the maintenance phase on the overall outcome. In summary, midostaurin reduces the CIR.

Published
2021

6. Impact of NPM1/FLT3-ITD genotypes defined by the 2017 European LeukemiaNet in patients with acute myeloid leukemia

Author

Dohner, K., Thiede, C., Jahn, N., Panina, E., Gambietz, A., Larson, R.A., Prior, T.W., Marcucci, G., Jones, Dan, Krauter, J., Heuser, M., Voso, M.T., Ottone, T., Nomdedeu, J.F., Mandrekar, S.J., Klisovic, R.B., Wei, A.H., Sierra, J., Sanz, Mariano, Brandwein, J.M., Witte, T.J. de, Jansen, J.H., Niederwieser, D., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Schlenk, R.F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Gathmann, I., Benner, A., Pallaud, C., Stone, R.M., Dohner, H., Bloomfield, C.D., Dohner, K., Thiede, C., Jahn, N., Panina, E., Gambietz, A., Larson, R.A., Prior, T.W., Marcucci, G., Jones, Dan, Krauter, J., Heuser, M., Voso, M.T., Ottone, T., Nomdedeu, J.F., Mandrekar, S.J., Klisovic, R.B., Wei, A.H., Sierra, J., Sanz, Mariano, Brandwein, J.M., Witte, T.J. de, Jansen, J.H., Niederwieser, D., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Schlenk, R.F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Gathmann, I., Benner, A., Pallaud, C., Stone, R.M., Dohner, H., and Bloomfield, C.D.

Abstract

Contains fulltext : 218279.pdf (Publisher’s version ) (Open Access), Patients with acute myeloid leukemia (AML) harboring FLT3 internal tandem duplications (ITDs) have poor outcomes, in particular AML with a high (>/=0.5) mutant/wild-type allelic ratio (AR). The 2017 European LeukemiaNet (ELN) recommendations defined 4 distinct FLT3-ITD genotypes based on the ITD AR and the NPM1 mutational status. In this retrospective exploratory study, we investigated the prognostic and predictive impact of the NPM1/FLT3-ITD genotypes categorized according to the 2017 ELN risk groups in patients randomized within the RATIFY trial, which evaluated the addition of midostaurin to standard chemotherapy. The 4 NPM1/FLT3-ITD genotypes differed significantly with regard to clinical and concurrent genetic features. Complete ELN risk categorization could be done in 318 of 549 trial patients with FLT3-ITD AML. Significant factors for response after 1 or 2 induction cycles were ELN risk group and white blood cell (WBC) counts; treatment with midostaurin had no influence. Overall survival (OS) differed significantly among ELN risk groups, with estimated 5-year OS probabilities of 0.63, 0.43, and 0.33 for favorable-, intermediate-, and adverse-risk groups, respectively (P < .001). A multivariate Cox model for OS using allogeneic hematopoietic cell transplantation (HCT) in first complete remission as a time-dependent variable revealed treatment with midostaurin, allogeneic HCT, ELN favorable-risk group, and lower WBC counts as significant favorable factors. In this model, there was a consistent beneficial effect of midostaurin across ELN risk groups.

Published
2020

10. PS968 GENETIC LANDSCAPE OF FLT3-MUTATED ACUTE MYELOID LEUKEMIA (AML) PATIENTS TREATED WITHIN THE RATIFY TRIAL: CALGB 10603 (ALLIANCE)

Author

Jahn, N., primary, Panina, E., additional, Bullinger, L., additional, Dolnik, A., additional, Herzig, J., additional, Blätte, T.J., additional, Benner, A., additional, Gambietz, A., additional, Krzykalla, J., additional, Gathmann, I., additional, Larson, R.A., additional, Lo-Coco, F., additional, Amadori, S., additional, Prior, T.W., additional, Brandwein, J.M., additional, Appelbaum, F.R., additional, Medeiros, B.C., additional, Tallman, M.S., additional, Tiecke, E., additional, Pallaud, C., additional, Ehninger, G., additional, Heuser, M., additional, Ganser, A., additional, Stone, R.M., additional, Thiede, C., additional, Döhner, H., additional, Bloomfield, C.D., additional, and Döhner, K., additional

Published
2019
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11. PF260 PROGNOSTIC AND PREDICTIVE IMPACT OF NPM1/FLT3-ITD GENOTYPES AS DEFINED BY 2017 EUROPEAN LEUKEMIANET RISK CATEGORIZATION FROM AML PATIENTS TREATED WITHIN THE INTERNATIONAL RATIFY STUDY

Author

Döhner, K., primary, Thiede, C., additional, Jahn, N., additional, Ekaterina, P., additional, Gambietz, A., additional, Prior, T.W., additional, Marcucci, G., additional, Jones, D., additional, Krauter, J., additional, Michael, H., additional, Lo-Coco, F., additional, Ottone, T., additional, Nomdedeu, J., additional, Mandrekar, S.J., additional, Huebner, L., additional, Laumann, K.M., additional, Geyer, S.M., additional, Klisovic, R.B., additional, Wei, A., additional, Sierra, J., additional, Sanz, M.A., additional, Brandwein, J.M., additional, de Witte, T.M., additional, Jansen, J.H., additional, Niederwieser, D., additional, Appelbaum, F.R., additional, Medeiros, B.C., additional, Tallman, M.S., additional, Schlenk, R.F., additional, Ganser, A., additional, Serve, H., additional, Ehninger, G., additional, Amadori, S., additional, Gathmann, I., additional, Axel, B., additional, Pallaud, C., additional, Larson, R.A., additional, Stone, R.M., additional, Döhner, H., additional, and Bloomfield, C.D., additional

Published
2019
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14. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia

Author

Druker, Bj, Guilhot, F, O'Brien, Sg, Gathmann, I, Kantarjian, H, Gattermann, N, Deininger, Mw, Silver, Rt, Goldman, Jm, Stone, Rm, Cervantes, F, Hochhaus, A, Powell, Bl, Gabrilove, Jl, Rousselot, P, Reiffers, J, Cornelissen, Jj, Hughes, T, Agis, H, Fischer, T, Verhoef, G, Shepherd, J, Saglio, Giuseppe, Gratwohl, A, Nielsen, Jl, Radich, Jp, Simonsson, B, Taylor, K, Baccarani, M, So, C, Letvak, L, Larson, Ra, and Iris, Investigators

Published
2006

17. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia

Author

Hochhaus, A., O'Brien, SG, Guilhot, François, Druker, BJ, Branford, S., Foroni, L., Goldman, JM, Müller, MC, Radich, JP, Rudoltz, M., Mone, M., Gathmann, I., Hughes, TP, Larson, RA, Martiat, Philippe, Hochhaus, A., O'Brien, SG, Guilhot, François, Druker, BJ, Branford, S., Foroni, L., Goldman, JM, Müller, MC, Radich, JP, Rudoltz, M., Mone, M., Gathmann, I., Hughes, TP, Larson, RA, and Martiat, Philippe

Abstract

info:eu-repo/semantics/published

Published
2009

19. Randomized comparison of artemether-benflumetol and artesunate-mefloquine in treatment of multidrug-resistant falciparum malaria

Author

van Vugt, M, Brockman, A, Gemperli, B, Luxemburger, C, Gathmann, I, Royce, C, Slight, T, Looareesuwan, S, White, N, Nosten, F, and Other departments

Subjects
parasitic diseases
Abstract

An open, randomized comparison of artemether-benflumetol (CGP 56 697; Novartis) with artesunate-mefloquine was conducted in 617 patients with acute uncomplicated multidrug-resistant falciparum malaria on the western border of Thailand. Both treatments rapidly and reliably cleared fever and parasitemia, and there was no significant difference in the initial therapeutic response parameters. Parasite genotyping was used to distinguish recrudescences from new infections. The 63-day cure rate for artesunate-mefloquine (94%) was significantly higher than the cure rate for artemether-benflumetol (81%) (P < 0.001). Both regimens were well tolerated. Nausea, vomiting, dizziness, sleep disorders, and other neurological side effects were between two and four times more common in the artesunate-mefloquine group than in the artemether-benflumetol group (P < 0.001). Artemether-benflumetol is effective and very well tolerated in the treatment of multidrug-resistant falciparum malaria. A higher dose than that used in the present study may improve efficacy.

Published
1998

20. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia

Author

Druker, B.J. (Brian), Guilhot, F. (François), O'Brien, S.G. (Stephen), Gathmann, I. (Insa), Kantarjian, H. (Hagop), Gattermann, N. (Norbert), Deininger, M.W.N. (Michael W.), Silver, R.A. (Angus), Goldman, J.M. (John), Stone, R. (Richard), Cervantes, F. (Francisco), Hochhaus, A. (Andreas), Powell, B.L. (Bayard), Gabrilove, J.L. (Janice), Rousselot, P. (Philippe), Reiffers, J. (Josy), Cornelissen, J.J. (Jan), Hughes, T. (Timothy), Agis, H. (Hermine), Fischer, T. (Thomas), Verhoef, G.E.G. (Gregor), Shepherd, J. (John), Saglio, G., Gratwohl, A. (Alois), Nielsen, J.L. (Johan), Radich, J.P. (Jerald), Simonsson, B. (Bengt), Taylor, K. (Kent), Baccarani, M. (Michele), So, C. (Charlene), Letvak, L. (Laurie), Larson, R.A. (Richard), Druker, B.J. (Brian), Guilhot, F. (François), O'Brien, S.G. (Stephen), Gathmann, I. (Insa), Kantarjian, H. (Hagop), Gattermann, N. (Norbert), Deininger, M.W.N. (Michael W.), Silver, R.A. (Angus), Goldman, J.M. (John), Stone, R. (Richard), Cervantes, F. (Francisco), Hochhaus, A. (Andreas), Powell, B.L. (Bayard), Gabrilove, J.L. (Janice), Rousselot, P. (Philippe), Reiffers, J. (Josy), Cornelissen, J.J. (Jan), Hughes, T. (Timothy), Agis, H. (Hermine), Fischer, T. (Thomas), Verhoef, G.E.G. (Gregor), Shepherd, J. (John), Saglio, G., Gratwohl, A. (Alois), Nielsen, J.L. (Johan), Radich, J.P. (Jerald), Simonsson, B. (Bengt), Taylor, K. (Kent), Baccarani, M. (Michele), So, C. (Charlene), Letvak, L. (Laurie), and Larson, R.A. (Richard)

Abstract

BACKGROUND: The cause of chronic myeloid leukemia (CML) is a constitutively active BCR-ABL tyrosine kinase. Imatinib inhibits this kinase, and in a short-term study was superior to interferon alfa plus cytarabine for newly diagnosed CML in the chronic phase. For 5 years, we followed patients with CML who received imatinib as initial therapy. METHODS: We randomly assigned 553 patients to receive imatinib and 553 to receive interferon alfa plus cytarabine and then evaluated them for overall and event-free survival; progression to accelerated-phase CML or blast crisis; hematologic, cytogenetic, and molecular responses; and adverse events. RESULTS: The median follow-up was 60 months. Kaplan-Meier estimates of cumulative best rates of complete cytogenetic response among patients receiving imatinib were 69% by 12 months and 87% by 60 months. An estimated 7% of patients progressed to accelerated-phase CML or blast crisis, and the estimated overall survival of patients who received imatinib as initial therapy was 89% at 60 months. Patients who had a complete cytogenetic response or in whom levels of BCR-ABL transcripts had fallen by at least 3 log had a significantly lower risk of disease progression than did patients without a complete cytogenetic response (P<0.001). Grade 3 or 4 adverse events diminished over time, and there was no clinically significant change in the profile of adverse events. CONCLUSIONS: After 5 years of follow-up, continuous treatment of chronic-phase CML with imatinib as initial therapy was found to induce durable responses in a high proportion of patients. Copyright

Published
2006
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22. Imatinib compared with interferon and low-dose cytarabine for newlydiagnosed chronic-phase chronic myeloid leukemia.

Author

O'Brien, SG, Guilhot, F, Larson, RA, Gathmann, I, Baccarani, M, Cervantes, F, Cornelissen, JJ, Fischer, T, Hochhaus, A, Hughes, T, Lechner, K, Nielsen, JL, Rousselot, P, Reiffers, J, Saglio, G, Shepherd, J, Simonsson, B, Gratwohl, A, Goldman, JM, Kantarjian, H, Taylor, K, Verhoef, G, Bolton, AE, Capdeville, R, Druker, BJ, O'Brien, SG, Guilhot, F, Larson, RA, Gathmann, I, Baccarani, M, Cervantes, F, Cornelissen, JJ, Fischer, T, Hochhaus, A, Hughes, T, Lechner, K, Nielsen, JL, Rousselot, P, Reiffers, J, Saglio, G, Shepherd, J, Simonsson, B, Gratwohl, A, Goldman, JM, Kantarjian, H, Taylor, K, Verhoef, G, Bolton, AE, Capdeville, R, and Druker, BJ

Published
2003

24. Satisfaction and Convenience of Chelation Therapy in Patients with Sickle Cell Disease (SCD): Comparison between Deferasirox (Exjade®, ICL670) and Deferoxamine (DFO).

Author

Vichinsky, E., primary, Fischer, R., primary, Pakbaz, Z., primary, Onyekwere, O., primary, Porter, J., primary, Swerdlow, P., primary, Coates, T., primary, Lane, P., primary, Files, B., primary, Mueller, B.U., primary, Coïc, L., primary, Forni, G., primary, Abetz, L., primary, Baladi, J.F., primary, Ressayre-Djaffer, C., primary, Gathmann, I., primary, Alberti, D., primary, and Marks, P., primary

Published
2005
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30. A Randomized, Controlled Phase II Trial in Sickle Cell Disease Patients with Chronic Iron Overload Demonstrates That the Once-Daily Oral Iron Chelator Deferasirox (Exjade®, ICL670) Is Well Tolerated and Reduces Iron Burden.

Author

Vichinsky, E., primary, Fischer, R., primary, Fung, E., primary, Onyekwere, O., primary, Porter, J., primary, Swerdlow, P., primary, Coates, T., primary, Lane, P., primary, Files, B., primary, Mueller, B. U., primary, Bernaudin, F., primary, Forni, G. L., primary, Ressayre-Djaffer, C., primary, Gathmann, I., primary, Holland, J., primary, Alberti, D., primary, and Marks, P., primary

Published
2005
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34. A randomized, double-blind, parallel-group, comparative safety, and efficacy trial of oral co-artemether versus oral chloroquine in the treatment of acute uncomplicated Plasmodium falciparum malaria in adults in India.

Author

Kshirsagar, N A, primary, Tilve, G H, additional, Sane, S P, additional, Dalvi, S S, additional, Chogle, A R, additional, Gathmann, I, additional, Gogtay, N J, additional, Sorabjee, J S, additional, Marathe, S N, additional, Bhatt, A D, additional, Moorthy, N S, additional, Garg, M R, additional, and Mull, R, additional

Published
2000
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38. A randomized controlled trial of artemether/benflumetol, a new antimalarial and pyrimethamine/sulfadoxine in the treatment of uncomplicated falciparum malaria in African children.

Author

von Seidlein, L, primary, Bojang, K, additional, Jaffar, S, additional, Royce, C, additional, Greenwood, B, additional, McAdam, K, additional, Pinder, M, additional, Doherty, T, additional, Obaro, S, additional, Haywood, M, additional, Snounou, G, additional, Gemperli, B, additional, Gathmann, I, additional, and Jones, P, additional

Published
1998
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41. Imatinib produces significantly superior molecular responses compared to interferon alfa plus cytarabine in patients with newly diagnosed chronic myeloid leukemia in chronic phase.

Author

Banford, S., Rudzki, Z., Harper, A., Grigg, A., Taylor, K., Durrant, S., Arthur, C., Browett, P., Schwarer, A.P., Ma, D., Seymour, J.F., Bradstock, K., Joske, D., Lynch, K., Gathmann, I., and Hughes, T.P.

Subjects
ACUTE myeloid leukemia, GENETIC mutation, IMATINIB, INTERFERONS, DRUG efficacy
Abstract

We analyzed molecular responses in 55 newly diagnosed chronic-phase chronic myeloid leukemia (CML) patients enrolled in a phase 3 study (the IRIS trial) comparing imatinib to interferon-alfa plus cytarabine (IFN+AraC). BCR-ABL/BCR% levels were measured by real-time quantitative RT-PCR and were significantly lower for the imatinib-treated patients at all time points up to 18 months, P<0.0001. The median levels for imatinib-treated patients continued to decrease and had not reached a plateau by 24 months. A total of 24 IFN+AraC-treated patients crossed over to imatinib. Once imatinib commenced, the median BCR-ABL/BCR% levels in these patients were not significantly different to those on first-line imatinib for the equivalent number of months. The incidence of progression in imatinib-treated patients, defined by hematologic, cytogenetic or quantitative PCR criteria, was significantly higher in the patients who failed to achieve a 1?log reduction by 3 months or a 2?log reduction by 6 months, P=0.002. A total of 49 patients were screened for BCR-ABL kinase domain mutations. Mutations were detected in two imatinib-treated patients who crossed over from IFN+AraC and both lost their imatinib response. In conclusion, first-line imatinib-treated patients had profound reductions in BCR-ABL/BCR%, which significantly exceeded those of IFN+AraC-treated patients and early measurements were predictive of subsequent response.Leukemia (2003) 17, 2401-2409. doi:10.1038/sj.leu.2403158 Published online 2 October 2003 [ABSTRACT FROM AUTHOR]

Published
2003
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42. Dose-Finding Study of the Efficacy of Fixed-Combination Artemether/Lumefantrine for the Treatment of Multidrug-Resistant Plasmodium falciparum Malaria in Thailand.

Author

Karbwang, J., Na-Bangchang, K., Thanavibul, A., Mull, R., and Gathmann, I.

Subjects
MALARIA treatment, PLASMODIUM falciparum
Abstract

Objective: To investigate the efficacy and tolerability of three different regimens of the fixed combination artemether/lumefantrine (artemether/benflumetol) in patients with multidrug-resistant Plasmodium falciparum malaria. Design: Randomised, double-blind, dose-finding study. Setting: Two centres in Thailand (the Bangkok Hospital for Tropical Diseases and Mae-Sot Malaria Clinic). Patients and Interventions: 260 patients (aged between 14 and 60 years and weighing ≥35kg) with acute uncomplicated P. falciparum malaria were randomised to receive one of three regimens of the fixed combination artemether/lumefantrine (CGP 56697; one tablet contains artemether 20mg and lumefantrine 120mg). Regimen I: four tablets at 0, 8, 24 and 48 hours (n = 87); Regimen II: two tablets at 0, 8, 24 and 48 hours (n = 87); Regimen III: four tablets at 0, 8 and 24 hours (n = 86). Main Outcome Measures and Results: With only one exception, all patients in the three groups had a rapid initial response with comparable parasite clearance time (PCT) and fever clearance time (FCT). 19, 35 and 37 patients receiving regimen I, II and III, respectively, had recrudescence between days 7 and 28 (median 17 days). The cure rate of 79.5% with regimen I was significantly higher than that with the other two regimens (54.7 and 55.3% for regimen II and III, respectively; both p < 0.001). Six patients (two and four in regimens I and III) who had P. vivax malaria on admission were cleared, although reappearance of P. vivax was seen in all groups. Conclusions: The low cure rates obtained in this study suggest that these three regimens of artemether/lumefantrine may not be optimal for multidrug-resistant P. falciparum strains in Thailand. The highest dose combination used in this trial was well tolerated and more effective than the other regimens. There is therefore still room for the use of a higher dose regimen of this combination in the treatment of multidrug-resistant falciparum in Thailand. [ABSTRACT FROM AUTHOR]

Published
2000
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43. Efficacy and safety of CGP 56697 (artemether and benflumetol) compared with chloroquine to treat acute falciparum malaria in Tanzanian children aged 1-5 years.

Author

Hatz, C, Abdulla, S, Mull, R, Schellenberg, D, Gathmann, I, Kibatala, P, Beck, H P, Tanner, M, and Royce, C

Abstract

A randomized, open trial involving 260 Tanzanian children, aged 1-5 years, with acute Plasmodium falciparum malaria was conducted to evaluate the efficacy of the combination antimalarial CGP 56697 (artemether and benflumetol), and to compare it with chloroquine, the standard drug used for malaria treatment in the Kilombero area. Children who had received rescue medication within the first 48 h or had a negative slide at the same time were excluded. Seven-day parasitological cure rates were 94% (95% CI 88-97.5) for CGP 56697 and 35.4% (95% CI 25.9-45.8) for chloroquine. Using the same definition, the 14-day parasitological cure rates were 86.4% (95% CI 78.5-92.2) for CGP 56697 and 10.3% (95% CI 5.1-18.1) for chloroquine. Gametocytes were more effectively suppressed by CGP 56697 than by chloroquine. There were no major adverse events with either drug. CGP 56697 is highly efficacious against P. falciparum in this area of Tanzania. The study contributes to the discussion on treatment strategies, particularly whether chloroquine may still fulfil its role as first-line drug in an area of high malaria transmission and very high levels of chloroquine resistance. [ABSTRACT FROM AUTHOR]

Published
1998
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47. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia.

Author

Hochhaus, A, O'Brien, S G, Guilhot, F, Druker, B J, Branford, S, Foroni, L, Goldman, J M, Müller, M C, Radich, J P, Rudoltz, M, Mone, M, Gathmann, I, Hughes, T P, and Larson, R A

Subjects
MYELOID leukemia, LEUKEMIA treatment
Abstract

A correction to the article "Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia," that was published in 2009 issue is presented.

Published
2010
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48. The prognosis for patients with chronic myeloid leukemia who have clonal cytogenetic abnormalities in philadelphia chromosome-negative cells

Author

Michael W. Deininger, Dietger Niederwieser, Byung Park, Douglas R. Smith, Michele Baccarani, Brian J. Druker, François Guilhot, Insa Gathmann, Thomas Fischer, Andreas Hochhaus, Richard Stone, John M. Goldman, Hagop M. Kantarjian, Jorge E. Cortes, Charlene So, Carlo Gambacorti-Passerini, Ron Paquette, Deininger, M, Cortes, J, Paquette, R, Park, B, Hochhaus, A, Baccarani, M, Stone, R, Fischer, T, Kantarjian, H, Niederwieser, D, GAMBACORTI PASSERINI, C, So, C, Gathmann, I, Goldman, J, Smith, D, Druker, B, Guilhot, F, Deininger MW, Cortes J, Paquette R, Park B, Hochhaus A, Baccarani M, Stone R, Fischer T, Kantarjian H, Niederwieser D, Gambacorti-Passerini C, So C, Gathmann I, Goldman JM, Smith D, Druker BJ, and Guilhot F.

Subjects
Oncology, Male, Cancer Research, Myeloid, Kaplan-Meier Estimate, Piperazines, hemic and lymphatic diseases, Treatment Failure, Aged, 80 and over, Myeloid leukemia, Middle Aged, Prognosis, Leukemia, medicine.anatomical_structure, Treatment Outcome, Benzamides, Cytogenetic Analysis, Imatinib Mesylate, Female, medicine.drug, Adult, medicine.medical_specialty, Neutropenia, Antineoplastic Agents, Philadelphia chromosome, Disease-Free Survival, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, chronic myeloid leukemia, Internal medicine, parasitic diseases, medicine, Humans, Aged, Chromosome Aberrations, Chi-Square Distribution, business.industry, Myelodysplastic syndromes, Cancer, Interferon-alpha, Imatinib, medicine.disease, Thrombocytopenia, Imatinib mesylate, Logistic Models, Pyrimidines, Myelodysplastic Syndromes, Chronic Disease, Cancer research, business, Follow-Up Studies
Abstract

BACKGROUND. Clonal cytogenetic abnormalities (CCA) were detected in Philadelphia chromosome (Ph)-negative cells in some patients with chronic myeloid leukemia (CML) who attained a cytogenetic response to imatinib mesylate. In some patients, CCA/Ph-negative status was associated with myelodysplasia or acute myeloid leukemia. The objective of the current study was to determine the prognostic impact of CCA/Ph-negative cells. METHODS. The authors compared the pretherapeutic risk factors (Kruskall-Wallis test), exposure to cytotoxic drugs (chi-square test), and overall and progression-free survival (Kaplan-Meyer and logistic regression analysis, respectively) of 515 patients with mostly chronic-phase CML who were treated with imatinib mesylate after failure of interferon-α according to whether they attained a major cytogenetic response (MCR) (n = 324 patients), an MCR with CCA/Ph-negative status (n = 30 patients), or no MCR (n = 161 patients). RESULTS. CCA/Ph-negative status most frequently involved chromosomes Y, 8, and 7. No significant differences in pretherapeutic risk factors were detected between patients who attained an MCR with and without CCA/Ph-negative cells, except that exposure to alkylating agents was more frequent in patients with CCA/Ph-negative cells, and overall and progression-free survival were identical. With a median follow-up of 51 months, only 2 patients developed myelodysplastic syndromes (MDS). CONCLUSIONS. The overall prognosis for patients who had CML with CCA/Ph-negative status was good and was driven by the CML response to imatinib mesylate. Isolated CCA/Ph-negative cells in the absence of morphologic evidence of MDS do not justify a change in therapy. Cancer 2007. © 2007 American Cancer Society.

Published
2007

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