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1. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study

Author

Hochhaus, A, Gambacorti Passerini, C, Abboud, C, Gjertsen, B, Brummendorf, T, Smith, B, Ernst, T, Giraldo-Castellano, P, Olsson-Stromberg, U, Saussele, S, Bardy-Bouxin, N, Viqueira, A, Leip, E, Russell-Smith, T, Leone, J, Rosti, G, Watts, J, Giles, F, Abruzzese, E, Akard, L, Bosi, A, Cervantes, F, Charbonnier, A, Di Raimondo, F, Etienne, G, Garcia Gutierrez, V, Guerci-Bresler, A, Hjorth-Hansen, H, Karsenti, J, Kelly, K, Le Coutre, P, Martinez Chamorro, C, Oehler, V, Orti Pascual, G, Petzer, A, Pungolino, E, Rege-Cambrin, G, Rigal-Huguet, F, Roboz, G, Rousselot, P, Sanchez-Guijo, F, Sanz Santillana, G, Schafhausen, P, Scheid, C, Schmidt, S, Specchia, G, Steegmann, J, Stenke, L, Hochhaus A., Gambacorti Passerini C., Abboud C., Gjertsen B. T., Brummendorf T. H., Smith B. D., Ernst T., Giraldo-Castellano P., Olsson-Stromberg U., Saussele S., Bardy-Bouxin N., Viqueira A., Leip E., Russell-Smith T. A., Leone J., Rosti G., Watts J., Giles F. J., Abruzzese E., Akard L. P., Bosi A., Cervantes F., Charbonnier A., Di Raimondo F., Etienne G., Garcia Gutierrez V., Guerci-Bresler A. P., Hjorth-Hansen H., Karsenti J. M., Kelly K. R., Le Coutre P., Martinez Chamorro C., Oehler V. G., Orti Pascual G., Petzer A., Pungolino E., Rege-Cambrin G., Rigal-Huguet F., Roboz G. J., Rousselot P., Sanchez-Guijo F. M., Sanz Santillana G., Schafhausen P., Scheid C., Schmidt S., Specchia G., Steegmann J. L., Stenke L., Hochhaus, A, Gambacorti Passerini, C, Abboud, C, Gjertsen, B, Brummendorf, T, Smith, B, Ernst, T, Giraldo-Castellano, P, Olsson-Stromberg, U, Saussele, S, Bardy-Bouxin, N, Viqueira, A, Leip, E, Russell-Smith, T, Leone, J, Rosti, G, Watts, J, Giles, F, Abruzzese, E, Akard, L, Bosi, A, Cervantes, F, Charbonnier, A, Di Raimondo, F, Etienne, G, Garcia Gutierrez, V, Guerci-Bresler, A, Hjorth-Hansen, H, Karsenti, J, Kelly, K, Le Coutre, P, Martinez Chamorro, C, Oehler, V, Orti Pascual, G, Petzer, A, Pungolino, E, Rege-Cambrin, G, Rigal-Huguet, F, Roboz, G, Rousselot, P, Sanchez-Guijo, F, Sanz Santillana, G, Schafhausen, P, Scheid, C, Schmidt, S, Specchia, G, Steegmann, J, Stenke, L, Hochhaus A., Gambacorti Passerini C., Abboud C., Gjertsen B. T., Brummendorf T. H., Smith B. D., Ernst T., Giraldo-Castellano P., Olsson-Stromberg U., Saussele S., Bardy-Bouxin N., Viqueira A., Leip E., Russell-Smith T. A., Leone J., Rosti G., Watts J., Giles F. J., Abruzzese E., Akard L. P., Bosi A., Cervantes F., Charbonnier A., Di Raimondo F., Etienne G., Garcia Gutierrez V., Guerci-Bresler A. P., Hjorth-Hansen H., Karsenti J. M., Kelly K. R., Le Coutre P., Martinez Chamorro C., Oehler V. G., Orti Pascual G., Petzer A., Pungolino E., Rege-Cambrin G., Rigal-Huguet F., Roboz G. J., Rousselot P., Sanchez-Guijo F. M., Sanz Santillana G., Schafhausen P., Scheid C., Schmidt S., Specchia G., Steegmann J. L., and Stenke L.

Abstract

Bosutinib is approved for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML) and for Ph+ CP, accelerated (AP), or blast (BP) phase CML after prior treatment with tyrosine kinase inhibitors (TKIs). In the ongoing phase 4 BYOND study (NCT02228382), 163 CML patients resistant/intolerant to prior TKIs (n = 156 Ph+ CP CML, n = 4 Ph+ AP CML, n = 3 Ph-negative/BCR-ABL1+ CML) received bosutinib 500 mg once daily (starting dose). As of ≥1 year after last enrolled patient (median treatment duration 23.7 months), 56.4% of Ph+ CP CML patients remained on bosutinib. Primary endpoint of cumulative confirmed major cytogenetic response (MCyR) rate by 1 year was 75.8% in Ph+ CP CML patients after one or two prior TKIs and 62.2% after three prior TKIs. Cumulative complete cytogenetic response (CCyR) and major molecular response (MMR) rates by 1 year were 80.6% and 70.5%, respectively, in Ph+ CP CML patients overall. No patient progressed to AP/BP on treatment. Across all patients, the most common treatment-emergent adverse events were diarrhea (87.7%), nausea (39.9%), and vomiting (32.5%). The majority of patients had confirmed MCyR by 1 year and MMR by 1 year, further supporting bosutinib use for Ph+ CP CML patients resistant/intolerant to prior TKIs.

Published
2020

3. European LeukemiaNet recommendations for the management and avoidance of adverse events of treatment in chronic myeloid leukaemia

Author

University of Helsinki, Clinicum, Steegmann, J. L., Baccarani, M., Breccia, M., Casado, L. F., Garcia-Gutierrez, V., Hochhaus, A., Kim, D-W, Kim, T. D., Khoury, H. J., Le Coutre, P., Mayer, J., Milojkovic, D., Porkka, Kimmo, Rea, D., Rosti, G., Saussele, S., Hehlmann, R., Clark, R. E., University of Helsinki, Clinicum, Steegmann, J. L., Baccarani, M., Breccia, M., Casado, L. F., Garcia-Gutierrez, V., Hochhaus, A., Kim, D-W, Kim, T. D., Khoury, H. J., Le Coutre, P., Mayer, J., Milojkovic, D., Porkka, Kimmo, Rea, D., Rosti, G., Saussele, S., Hehlmann, R., and Clark, R. E.

Abstract

Most reports on chronic myeloid leukaemia (CML) treatment with tyrosine kinase inhibitors (TKIs) focus on efficacy, particularly on molecular response and outcome. In contrast, adverse events (AEs) are often reported as infrequent, minor, tolerable and manageable, but they are increasingly important as therapy is potentially lifelong and multiple TKIs are available. For this reason, the European LeukemiaNet panel for CML management recommendations presents an exhaustive and critical summary of AEs emerging during CML treatment, to assist their understanding, management and prevention. There are five major conclusions. First, the main purpose of CML treatment is the antileukemic effect. Suboptimal management of AEs must not compromise this first objective. Second, most patients will have AEs, usually early, mostly mild to moderate, and which will resolve spontaneously or are easily controlled by simple means. Third, reduction or interruption of treatment must only be done if optimal management of the AE cannot be accomplished in other ways, and frequent monitoring is needed to detect resolution of the AE as early as possible. Fourth, attention must be given to comorbidities and drug interactions, and to new events unrelated to TKIs that are inevitable during such a prolonged treatment. Fifth, some TKI-related AEs have emerged which were not predicted or detected in earlier studies, maybe because of suboptimal attention to or absence from the preclinical data. Overall, imatinib has demonstrated a good long-term safety profile, though recent findings suggest underestimation of symptom severity by physicians. Second and third generation TKIs have shown higher response rates, but have been associated with unexpected problems, some of which could be irreversible. We hope these recommendations will help to minimise adverse events, and we believe that an optimal management of them will be rewarded by better TKI compliance and thus better CML outcomes, together with better q

Published
2016

4. The EUTOS population-based registry : incidence and clinical characteristics of 2904 CML patients in 20 European Countries

Author

Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., Di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A. G., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J-L, Simonsson, Bengt, Clark, R. E., Covelli, A., Guidi, G., Hehlmann, R., Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., Di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A. G., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J-L, Simonsson, Bengt, Clark, R. E., Covelli, A., Guidi, G., and Hehlmann, R.

Abstract

This population-based registry was designed to provide robust and updated information on the characteristics and the epidemiology of chronic myeloid leukemia (CML). All cases of newly diagnosed Philadelphia positive, BCR-ABL1+ CML that occurred in a sample of 92.5 million adults living in 20 European countries, were registered over a median period of 39 months. 94.3% of the 2904 CML patients were diagnosed in chronic phase (CP). Median age was 56 years. 55.5% of patients had comorbidities, mainly cardiovascular (41.9%). High-risk patients were 24.7% by Sokal, 10.8% by EURO, and 11.8% by EUTOS risk scores. The raw incidence increased with age from 0.39/100 000/year in people 20-29 years old to 1.52 in those >70 years old, and showed a maximum of 1.39 in Italy and a minimum of 0.69 in Poland (all countries together: 0.99). The proportion of Sokal and Euro score high-risk patients seen in many countries indicates that trial patients were not a positive selection. Thus from a clinical point of view the results of most trials can be generalized to most countries. The incidences observed among European countries did not differ substantially. The estimated number of new CML cases per year in Europe is about 6370.

Published
2015
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5. ANALYSIS OF TREATMENT AND OUTCOME DATA OF 2904 PATIENTS FROM THE EUTOS POPULATION-BASED REGISTRY

Author

Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J. -L, Simonsson, Bengt, Clark, R., Hehlmann, R., Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J. -L, Simonsson, Bengt, Clark, R., and Hehlmann, R.

Published
2015

6. The Eutos Population-Based Registry : Evaluation of Baseline Characteristics and First Treatment Choices Of 2983 Newly Diagnosed Chronic Myeloid Leukemia (Cml) Patients from 20 European Countries

Author

Lindoerfer, D., Hoffmann, V. S., Rosti, G., Castagnetti, F., Saussele, S., Guilhot, J., Simonsson, Bengt, Steegmann, J. L., Mayer, J., Indrak, K., Turkina, A. G., Zaritskey, A., Labar, B., Zupan, I. P., Thielen, N., Clark, R. E., Thaler, J., Melanthiou, F., Everaus, H., Porkka, K., Bogdanovic, A. D., Schubert-Fritschle, G., Panagiotidis, P., Masszi, T., Lejniece, S., Griskevicius, L., Hellmann, A., Prejzner, W., Sacha, T., Almeida, A., Dyagil, I., Colita, A., Mihaylov, G., Hehlmann, R., Hasford, J., Baccarani, M., Lindoerfer, D., Hoffmann, V. S., Rosti, G., Castagnetti, F., Saussele, S., Guilhot, J., Simonsson, Bengt, Steegmann, J. L., Mayer, J., Indrak, K., Turkina, A. G., Zaritskey, A., Labar, B., Zupan, I. P., Thielen, N., Clark, R. E., Thaler, J., Melanthiou, F., Everaus, H., Porkka, K., Bogdanovic, A. D., Schubert-Fritschle, G., Panagiotidis, P., Masszi, T., Lejniece, S., Griskevicius, L., Hellmann, A., Prejzner, W., Sacha, T., Almeida, A., Dyagil, I., Colita, A., Mihaylov, G., Hehlmann, R., Hasford, J., and Baccarani, M.

Published
2014

9. Clonal expansion of T/NK-cells during tyrosine kinase inhibitor dasatinib therapy

Author

Mustjoki, S., Ekblom, M., Arstila, T. P., Dybedal, I., Epling-Burnette, P. K., Guilhot, F., Hjorth-Hansen, H., Höglund, Martin, Kovanen, P., Laurinolli, T., Liesveld, J., Paquette, R., Pinilla-Ibarz, J., Rauhala, A., Shah, N., Simonsson, Bengt, Sinisalo, M., Steegmann, J. L., Stenke, L., Porkka, K., Mustjoki, S., Ekblom, M., Arstila, T. P., Dybedal, I., Epling-Burnette, P. K., Guilhot, F., Hjorth-Hansen, H., Höglund, Martin, Kovanen, P., Laurinolli, T., Liesveld, J., Paquette, R., Pinilla-Ibarz, J., Rauhala, A., Shah, N., Simonsson, Bengt, Sinisalo, M., Steegmann, J. L., Stenke, L., and Porkka, K.

Abstract

Dasatinib, a broad-spectrum tyrosine kinase inhibitor (TKI), predominantly targets BCR-ABL and SRC oncoproteins and also inhibits off-target kinases, which may result in unexpected drug responses. We identified 22 patients with marked lymphoproliferation in blood while on dasatinib therapy. Clonality and immunophenotype were analyzed and related clinical information was collected. An abrupt lymphocytosis (peak count range 4-20 x 10(9)/l) with large granular lymphocyte (LGL) morphology was observed after a median of 3 months from the start of therapy and it persisted throughout the therapy. Fifteen patients had a cytotoxic T-cell and seven patients had an NK-cell phenotype. All T-cell expansions were clonal. Adverse effects, such as colitis and pleuritis, were common (18 of 22 patients) and were preceded by LGL lymphocytosis. Accumulation of identical cytotoxic T cells was also detected in pleural effusion and colon biopsy samples. Responses to dasatinib were good and included complete, unexpectedly long-lasting remissions in patients with advanced leukemia. In a phase II clinical study on 46 Philadelphia chromosome-positive acute lymphoblastic leukemia, patients with lymphocytosis had superior survival compared with patients without lymphocytosis. By inhibiting immunoregulatory kinases, dasatinib may induce a reversible state of aberrant immune reactivity associated with good clinical responses and a distinct adverse effect profile.

Published
2009
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