uu.seUppsala University Publications
Change search
Link to record
Permanent link

Direct link
BETA
Simonsson, Bengt
Alternative names
Publications (10 of 42) Show all publications
Hehlmann, R., Cortes, J. E., Zyczynski, T., Gambacorti-Passerini, C., Goldberg, S. L., Mauro, M. J., . . . Paquette, R. L. (2019). Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY. American Journal of Hematology, 94(1), 46-54
Open this publication in new window or tab >>Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY
Show others...
2019 (English)In: American Journal of Hematology, ISSN 0361-8609, E-ISSN 1096-8652, Vol. 94, no 1, p. 46-54Article in journal (Refereed) Published
Abstract [en]

SIMPLICITY (NCT01244750) is an observational study exploring tyrosine kinase inhibitor (TKI) use and management patterns in patients with chronic phase-chronic myeloid leukemia in the US and Europe in routine clinical practice. Herein we describe interruptions, discontinuations and switching of TKI therapy during the initial 2 years of treatment among 1121 patients prospectively enrolled between October 1, 2010 and March 7, 2017. Patient characteristics were broadly similar between the imatinib (n = 370), dasatinib (n = 376), and nilotinib (n = 375) cohorts. Treatment interruptions occurred in 16.4% (year 1) and 4.0% (year 2) of patients, mainly attributed to hematologic intolerances. Treatment discontinuations occurred in 21.8% (year 1) and 10.2% (year 2) of patients, with the highest rate within the first 3 months for intolerance. Switching of TKI was seen in 17.8% (year 1) and 9.5% (year 2) of patients. Significant associations were found between TKI switching and female gender (year 1), age >= 65 years at diagnosis (year 2) and treatment with imatinib (year 2). Intolerance was the most common reason given for patients discontinuing and for switching TKI therapy; however resistance was also cited. Lack of response monitoring in routine clinical practice may have resulted in lower identification of resistance in this dataset. Data from SIMPLICITY suggest that, in routine clinical practice, intolerance and resistance to TKIs influence decisions to change treatment. Changes in TKI therapy are frequent, with nearly a third of patients discontinuing their first-line TKI.

Place, publisher, year, edition, pages
WILEY, 2019
National Category
Hematology Cancer and Oncology
Identifiers
urn:nbn:se:uu:diva-373314 (URN)10.1002/ajh.25306 (DOI)000453909800022 ()30290003 (PubMedID)
Available from: 2019-01-16 Created: 2019-01-16 Last updated: 2019-01-16Bibliographically approved
Goldberg, S. L., Cortes, J. E., Gambacorti-Passerini, C., Hehlmann, R., Khoury, H. J., Michallet, M., . . . Mauro, M. J. (2017). First-line treatment selection and early monitoring patterns in chronic phase-chronic myeloid leukemia in routine clinical practice: SIMPLICITY. American Journal of Hematology, 92(11), 1214-1223
Open this publication in new window or tab >>First-line treatment selection and early monitoring patterns in chronic phase-chronic myeloid leukemia in routine clinical practice: SIMPLICITY
Show others...
2017 (English)In: American Journal of Hematology, ISSN 0361-8609, E-ISSN 1096-8652, Vol. 92, no 11, p. 1214-1223Article in journal (Refereed) Published
Abstract [en]

Achieving successful outcomes in chronic phase-chronic myeloid leukemia (CP-CML) requires careful monitoring of cytogenetic/molecular responses (CyR/MR). SIMPLICITY (NCT01244750) is an observational study exploring tyrosine kinase inhibitor use and management patterns in patients with CP-CML receiving first-line imatinib (n = 416), dasatinib (n = 418) or nilotinib (n = 408) in the US and 6 European countries in routine clinical practice. Twelve-month follow-up data of 1242 prospective patients (enrolled October 01 2010-September 02 2015) are reported. 81% of patients had baseline comorbidities. Treatment selection was based on perceived efficacy over patient comorbidity profile. There was a predominance of imatinib-treated patients enrolled earlier in the study, with subsequent shift toward dasatinib- and nilotinib-treated patients by 2013/2014. Monitoring for either CyR/MR improved over time and was documented for 36%, 82%, and 95% of patients by 3, 6, and 12 months, respectively; 5% had no documentation of CyR/MR monitoring during the first year of therapy. Documentation of MR/CyR testing was higher in Europe than the US (P < .001) and at academic versus community practices (P = .001). Age <65 years, patients being followed at sites within Europe, those followed at academic centers and patients no longer on first-line therapy were more likely to be monitored by 12 months. SIMPLICITY demonstrates that the NCCN and ELN recommendations on response monitoring have not been consistently translated into routine clinical practice. In the absence of appropriate monitoring practices, clinical response to TKI therapy cannot be established, any needed changes to treatment strategy will thus not be implemented, and long-term patient outcomes are likely to be impacted.

National Category
Hematology
Identifiers
urn:nbn:se:uu:diva-339738 (URN)10.1002/ajh.24887 (DOI)000413166800023 ()28815757 (PubMedID)
Available from: 2018-01-26 Created: 2018-01-26 Last updated: 2018-01-26Bibliographically approved
Perez Encinas, M., Goldberg, S. L., Michallet, M., Hehlmann, R., Zyczynski, T., Foreman, A., . . . Mauro, M. (2017). PATRONES DE CAMBIO DE LOS INHIBIDORES DE LA TIROSINA CINASA BCR-ABL1 EN PACIENTES CON LMC EN FASE CRÓNICA EN LA PRÁCTICA CLÍNICA RUTINARIA ESTUDIO SIMPLICITY. Paper presented at 59th National Congress of the Spanish-Society-of-Hematology-and-Hemotherapy, OCT 26-28, 2017, Malaga, SPAIN. Haematologica, 102, 285-285
Open this publication in new window or tab >>PATRONES DE CAMBIO DE LOS INHIBIDORES DE LA TIROSINA CINASA BCR-ABL1 EN PACIENTES CON LMC EN FASE CRÓNICA EN LA PRÁCTICA CLÍNICA RUTINARIA ESTUDIO SIMPLICITY
Show others...
2017 (English)In: Haematologica, ISSN 0390-6078, E-ISSN 1592-8721, Vol. 102, p. 285-285Article in journal, Meeting abstract (Other academic) Published
Place, publisher, year, edition, pages
Ferrata Storti Foundation, 2017
National Category
Hematology
Identifiers
urn:nbn:se:uu:diva-366318 (URN)000440252400485 ()
Conference
59th National Congress of the Spanish-Society-of-Hematology-and-Hemotherapy, OCT 26-28, 2017, Malaga, SPAIN
Note

Title in WoS: PATTERNS OF CHANGE OF THE INHIBITORS OF THE TYROSINE KINASE BCR-ABL1 IN PATIENTS WITH CML IN CHRONIC PHASE IN THE ROUTINE CLINICAL PRACTICE SIMPLICITY STUDY

Available from: 2018-11-20 Created: 2018-11-20 Last updated: 2018-11-20Bibliographically approved
Hoffmann, V. S., Baccarani, M., Hasford, J., Castagnetti, F., Di Raimondo, F., Casado, L. F., . . . Hehlmann, R. (2017). Treatment and outcome of 2904 CML patients from the EUTOS population-based registry. Leukemia, 31(3), 593-601
Open this publication in new window or tab >>Treatment and outcome of 2904 CML patients from the EUTOS population-based registry
Show others...
2017 (English)In: Leukemia, ISSN 0887-6924, E-ISSN 1476-5551, Vol. 31, no 3, p. 593-601Article in journal (Refereed) Published
Abstract [en]

The European Treatment and Outcome Study (EUTOS) population-based registry includes data of all adult patients newly diagnosed with Philadelphia chromosome-positive and/or BCR-ABL1+ chronic myeloid leukemia (CML) in 20 predefined countries and regions of Europe. Registration time ranged from 12 to 60 months between January 2008 and December 2013. Median age was 55 years and median observation time was 29 months. Eighty percent of patients were treated first line with imatinib, and 17% with a second-generation tyrosine kinase inhibitor, mostly according to European LeukemiaNet recommendations. After 12 months, complete cytogenetic remission (CCyR) and major molecular response (MMR) were achieved in 57% and 41% of patients, respectively. Patients with high EUTOS risk scores achieved CCyR and MMR significantly later than patients with low EUTOS risk. Probabilities of overall survival (OS) and progression-free survival for all patients at 12, 24 and 30 months was 97%, 94% and 92%, and 95%, 92% and 90%, respectively. The new EUTOS long-term survival score was validated: the OS of patients differed significantly between the three risk groups. The probability of dying in remission was 1% after 24 months. The current management of patients with tyrosine kinase inhibitors resulted in responses and outcomes in the range reported from clinical trials. These data from a large population-based, patient sample provide a solid benchmark for the evaluation of new treatment policies.Leukemia advance online publication, 23 September 2016; doi:10.1038/leu.2016.246.

National Category
Cancer and Oncology Hematology
Identifiers
urn:nbn:se:uu:diva-310823 (URN)10.1038/leu.2016.246 (DOI)000395887600010 ()27568522 (PubMedID)
Available from: 2016-12-20 Created: 2016-12-20 Last updated: 2019-01-25Bibliographically approved
Zyczynski, T., Khoury, J., Goldberg, S., Mauro, M., Michallet, M., Paquette, R., . . . Simonsson, B. (2016). Imatinib Discontinuation And Tki Switching Patterns In The Retrospective And Prospective Cohorts In Simplicity, A Study Of Chronic-Phase Chronic Myeloid Leukemia (Cp-Cml) Patients (Pts) In Routine Clinical Practice. Value in Health, 19(7), A894-A895
Open this publication in new window or tab >>Imatinib Discontinuation And Tki Switching Patterns In The Retrospective And Prospective Cohorts In Simplicity, A Study Of Chronic-Phase Chronic Myeloid Leukemia (Cp-Cml) Patients (Pts) In Routine Clinical Practice
Show others...
2016 (English)In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 19, no 7, p. A894-A895Article in journal (Refereed) Published
Place, publisher, year, edition, pages
ELSEVIER SCIENCE INC, 2016
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
urn:nbn:se:uu:diva-321264 (URN)000396606303306 ()
Available from: 2017-05-02 Created: 2017-05-02 Last updated: 2017-05-02Bibliographically approved
Söderlund, S., Christiansson, L., Persson, I., Hjorth-Hansen, H., Richter, J., Simonsson, B., . . . Loskog, A. (2016). Plasma Proteomics In Chronic Myeloid Leukemia Patients Before And After Initiation Of Tyrosine Kinase Inhibitor Therapy Reveals Induced Th1 Immunity And Loss Of Angiogenic Stimuli. Paper presented at 21st Congress of the European-Hematology-Association, JUN 09-12, 2016, Copenhagen, DENMARK. Haematologica, 101, 730-730
Open this publication in new window or tab >>Plasma Proteomics In Chronic Myeloid Leukemia Patients Before And After Initiation Of Tyrosine Kinase Inhibitor Therapy Reveals Induced Th1 Immunity And Loss Of Angiogenic Stimuli
Show others...
2016 (English)In: Haematologica, ISSN 0390-6078, E-ISSN 1592-8721, Vol. 101, p. 730-730Article in journal, Meeting abstract (Other academic) Published
National Category
Hematology
Identifiers
urn:nbn:se:uu:diva-301462 (URN)000379484602600 ()
Conference
21st Congress of the European-Hematology-Association, JUN 09-12, 2016, Copenhagen, DENMARK
Available from: 2016-08-23 Created: 2016-08-23 Last updated: 2017-11-28Bibliographically approved
Pfirrmann, M., Baccarani, M., Saussele, S., Guilhot, J., Cervantes, F., Ossenkoppele, G., . . . Simonsson, B. (2016). Prognosis of long-term survival considering disease-specific death in patients with chronic myeloid leukemia. Leukemia, 30(1), 48-56
Open this publication in new window or tab >>Prognosis of long-term survival considering disease-specific death in patients with chronic myeloid leukemia
Show others...
2016 (English)In: Leukemia, ISSN 0887-6924, E-ISSN 1476-5551, Vol. 30, no 1, p. 48-56Article in journal (Refereed) Published
Abstract [en]

In patients with chronic myeloid leukemia (CML), first-line imatinib treatment leads to 8-year overall survival (OS) probabilities above 80%. Many patients die of reasons unrelated to CML. This work tackled the reassessment of prognosis under particular consideration of the probabilities of dying of CML. Analyses were based on 2290 patients with chronic phase CML treated with imatinib in six clinical trials. 'Death due to CML' was defined by death after disease progression. At 8 years, OS was 89%. Of 208 deceased patients, 44% died of CML. Higher age, more peripheral blasts, bigger spleen and low platelet counts were significantly associated with increased probabilities of dying of CML and determined a new long-term survival score with three prognostic groups. Compared with the low-risk group, the patients of the intermediate-and the high-risk group had significantly higher probabilities of dying of CML. The score was successfully validated in an independent sample of 1120 patients. In both samples, the new score differentiated probabilities of dying of CML better than the Sokal, Euro and the European Treatment and Outcome Study (EUTOS) score. The new score identified 61% low-risk patients with excellent long-term outcome and 12% high-risk patients. The new score supports the prospective assessment of long-term antileukemic efficacy and risk-adapted treatment.

National Category
Cancer and Oncology Hematology
Identifiers
urn:nbn:se:uu:diva-279640 (URN)10.1038/leu.2015.261 (DOI)000369481600006 ()26416462 (PubMedID)
Available from: 2016-03-08 Created: 2016-03-02 Last updated: 2017-11-30Bibliographically approved
Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., . . . Hehlmann, R. (2015). ANALYSIS OF TREATMENT AND OUTCOME DATA OF 2904 PATIENTS FROM THE EUTOS POPULATION-BASED REGISTRY. Paper presented at 20th Congress of European-Hematology-Association, JUN 11-14, 2015, Vienna, AUSTRIA. Haematologica, 100, 181-181
Open this publication in new window or tab >>ANALYSIS OF TREATMENT AND OUTCOME DATA OF 2904 PATIENTS FROM THE EUTOS POPULATION-BASED REGISTRY
Show others...
2015 (English)In: Haematologica, ISSN 0390-6078, E-ISSN 1592-8721, Vol. 100, p. 181-181Article in journal, Meeting abstract (Other academic) Published
National Category
Hematology
Identifiers
urn:nbn:se:uu:diva-266171 (URN)000361204901392 ()
Conference
20th Congress of European-Hematology-Association, JUN 11-14, 2015, Vienna, AUSTRIA
Available from: 2015-11-09 Created: 2015-11-05 Last updated: 2017-12-01Bibliographically approved
Paquette, R., Mauro, M., Simonsson, B., Abruzzese, E., Andorksy, D., Hansen, R., . . . Goldberg, S. L. (2015). CARDIOVASCULAR (CV)-RELATED HOSPITALIZATION IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) IN SIMPLICITY, A PROSPECTIVE OBSERVATIONAL STUDY. Paper presented at 20th Congress of European-Hematology-Association, JUN 11-14, 2015, Vienna, AUSTRIA. Haematologica, 100, 437-437
Open this publication in new window or tab >>CARDIOVASCULAR (CV)-RELATED HOSPITALIZATION IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) IN SIMPLICITY, A PROSPECTIVE OBSERVATIONAL STUDY
Show others...
2015 (English)In: Haematologica, ISSN 0390-6078, E-ISSN 1592-8721, Vol. 100, p. 437-437Article in journal, Meeting abstract (Other academic) Published
National Category
Hematology
Identifiers
urn:nbn:se:uu:diva-266177 (URN)000361204903081 ()
Conference
20th Congress of European-Hematology-Association, JUN 11-14, 2015, Vienna, AUSTRIA
Available from: 2015-11-06 Created: 2015-11-05 Last updated: 2017-12-01Bibliographically approved
Hjorth-Hansen, H., Stenke, L., Söderlund, S., Dreimane, A., Ehrencrona, H., Gedde-Dahl, T., . . . Richter, J. (2015). Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006). European Journal of Haematology, 64(3), 243-250
Open this publication in new window or tab >>Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006)
Show others...
2015 (English)In: European Journal of Haematology, ISSN 0902-4441, E-ISSN 1600-0609, Vol. 64, no 3, p. 243-250Article in journal (Refereed) Published
Abstract [en]

We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100 mg QD or imatinib 400 mg QD and report outcome as an intention-to-treat analysis with 36 months follow-up. Early cytogenetic and molecular responses were superior in the dasatinib group, with a tendency that imatinib patients caught up with time. For instance, MR(3.0) was reached at 3 months in 36% vs. 8% (P = 0.02), at 12 months in 81% vs. 46% (P = 0.02) and at 18 months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR(4.5) was consistently superior in the dasatinib group at all time points from 6 months onwards, reaching 61% vs. 21% (P < 0.05) at 36 months. Sixty-four vs. 71% of the patients in the dasatinib and imatinib arms, respectively, remained on assigned drug. Dasatinib dose was frequently reduced, but with maintained excellent effect. One imatinib patient progressed to blastic phase, but no CML-related deaths occurred. In conclusion, our data compare favourably with those of the dasatinib registration study, DASISION. The fast and deep molecular responses induced by dasatinib compared with imatinib may be exploited to increase the proportion of patients who can achieve a treatment-free remission after treatment discontinuation.

National Category
Hematology
Identifiers
urn:nbn:se:uu:diva-233784 (URN)10.1111/ejh.12423 (DOI)000350357900008 ()25082346 (PubMedID)
Note

De två sista författarna delar sistaförfattarskapet.

Available from: 2014-10-10 Created: 2014-10-10 Last updated: 2017-12-05Bibliographically approved
Organisations

Search in DiVA

Show all publications