2013 EUROPEAN LEUKEMIANET RESPONSE CRITERIA VALIDATION IN CHRONIC MYELOID LEUKEMIA PATIENTS TREATED FRONTLINE WITH 3 AVAILABLE TKIS OUTSIDE CLINICAL TRIALS
(Abstract release date: 05/19/16)
EHA Library. Breccia M. 06/09/16; 134727; PB1827
Dr. Massimo Breccia
Contributions
Contributions
Abstract
Abstract: PB1827
Type: Publication Only
Background
2013 ELN recommendations defined endpoints in the treatment of chronic myeloid leukemia patients, introducing the concept of early molecular and warning response, but did not provide precise indications on timing of possible early switch to overcome negative prognosis.
Aims
Aim of our study is to evaluate how Italian physicians are adherent to ELN recommendations and how the different use of available TKIs would have changed therapeutic strategies.
Methods
We collected 218 patients treated consecutively, outside clinical trials, in 13 different Italian centers.
Results
There were 124 males and 94 females, median age 58 years (range 18-90), 20 patients with a previous neoplasia. Ten patients had at baseline ACA (6 major routes). According to Sokal risk, 50% of patients were low, 35% were intermediate and 16% were high risk. According to Eutos risk, 87% were low and 13% were high risk. As frontline treatment 55 patients received dasatinib (52 patients started with 100 mg, 3 at reduced dose), 82 patients received nilotinib 300 mg BID and 81 patients started imatinib (67 patients at 400 mg, 14 at <400 mg). Median age and comorbidities at baseline strongly influenced choice of TKI at baseline. At 3 months, in the dasatinib-treated cohort, 81% of patients were classified as optimal responders and 7% were warning but none of them changed therapy, due to concomitant comorbidities or toxicity experienced that allowed modification of dose. At 6 months, 84% of patients were in the optimal response category, 6% in the warning response (none of them changed) and 4% in failure category (1 patient increased the dose to 140 mg/day). At 12 months, 72% were in the optimal category, 25% in the warning category (none of them changed due to BCR-ABL/ABL ratio slightly above 0.1%) and 6% were in failure category (1 patient switched to nilotinib). At 3 months, in the nilotinib-treated cohort, 90% of patients were classified as optimal responders and 4.8% as failure (1 patient switched to dasatinib). At 6 months, 87% of patients were optimal, 6% warning (none of them changed) and 3% were failure (only 1 patient switched to dasatinib). At 12 months, 80% were in the optimal category, 16% in the warning category (none of them changed due to a ratio BCR-ABL/ABL slightly above 0.1%) and 9% in the failure category (1 patient switched to dasatinib and 1 patient switched to ponatinib). In the imatinib-treated cohort, at 3 months, 74% of patients were classified as optimal responders, 16% patients were warning (5 switched to second-generation TKIs), 3.7% were failure (2 switched to other TKIs). At 6 months, 72% of patients were in the optimal category, 27% were in the warning category (1 patient only changed therapy) and 3% were failure (only 1 patient switched to dasatinib). At 12 months, 52% were in the optimal category, 32% were warning category (none of them changed due to comorbidities) and 15% were in failure category (3 patients switched to nilotinib or dasatinib, 1 patient to high dose imatinib). Cytogenetic analysis at 6 and 12 months was not performed in 40% of patients already in MR3.
Conclusion
The results of this retrospective analysis indicated that with frontline second-generation TKIs, warning and failure category were reduced at 3 and 6 months and that with this approach, Italian physicians were less likely to perform an early switch.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
Type: Publication Only
Background
2013 ELN recommendations defined endpoints in the treatment of chronic myeloid leukemia patients, introducing the concept of early molecular and warning response, but did not provide precise indications on timing of possible early switch to overcome negative prognosis.
Aims
Aim of our study is to evaluate how Italian physicians are adherent to ELN recommendations and how the different use of available TKIs would have changed therapeutic strategies.
Methods
We collected 218 patients treated consecutively, outside clinical trials, in 13 different Italian centers.
Results
There were 124 males and 94 females, median age 58 years (range 18-90), 20 patients with a previous neoplasia. Ten patients had at baseline ACA (6 major routes). According to Sokal risk, 50% of patients were low, 35% were intermediate and 16% were high risk. According to Eutos risk, 87% were low and 13% were high risk. As frontline treatment 55 patients received dasatinib (52 patients started with 100 mg, 3 at reduced dose), 82 patients received nilotinib 300 mg BID and 81 patients started imatinib (67 patients at 400 mg, 14 at <400 mg). Median age and comorbidities at baseline strongly influenced choice of TKI at baseline. At 3 months, in the dasatinib-treated cohort, 81% of patients were classified as optimal responders and 7% were warning but none of them changed therapy, due to concomitant comorbidities or toxicity experienced that allowed modification of dose. At 6 months, 84% of patients were in the optimal response category, 6% in the warning response (none of them changed) and 4% in failure category (1 patient increased the dose to 140 mg/day). At 12 months, 72% were in the optimal category, 25% in the warning category (none of them changed due to BCR-ABL/ABL ratio slightly above 0.1%) and 6% were in failure category (1 patient switched to nilotinib). At 3 months, in the nilotinib-treated cohort, 90% of patients were classified as optimal responders and 4.8% as failure (1 patient switched to dasatinib). At 6 months, 87% of patients were optimal, 6% warning (none of them changed) and 3% were failure (only 1 patient switched to dasatinib). At 12 months, 80% were in the optimal category, 16% in the warning category (none of them changed due to a ratio BCR-ABL/ABL slightly above 0.1%) and 9% in the failure category (1 patient switched to dasatinib and 1 patient switched to ponatinib). In the imatinib-treated cohort, at 3 months, 74% of patients were classified as optimal responders, 16% patients were warning (5 switched to second-generation TKIs), 3.7% were failure (2 switched to other TKIs). At 6 months, 72% of patients were in the optimal category, 27% were in the warning category (1 patient only changed therapy) and 3% were failure (only 1 patient switched to dasatinib). At 12 months, 52% were in the optimal category, 32% were warning category (none of them changed due to comorbidities) and 15% were in failure category (3 patients switched to nilotinib or dasatinib, 1 patient to high dose imatinib). Cytogenetic analysis at 6 and 12 months was not performed in 40% of patients already in MR3.
Conclusion
The results of this retrospective analysis indicated that with frontline second-generation TKIs, warning and failure category were reduced at 3 and 6 months and that with this approach, Italian physicians were less likely to perform an early switch.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
Abstract: PB1827
Type: Publication Only
Background
2013 ELN recommendations defined endpoints in the treatment of chronic myeloid leukemia patients, introducing the concept of early molecular and warning response, but did not provide precise indications on timing of possible early switch to overcome negative prognosis.
Aims
Aim of our study is to evaluate how Italian physicians are adherent to ELN recommendations and how the different use of available TKIs would have changed therapeutic strategies.
Methods
We collected 218 patients treated consecutively, outside clinical trials, in 13 different Italian centers.
Results
There were 124 males and 94 females, median age 58 years (range 18-90), 20 patients with a previous neoplasia. Ten patients had at baseline ACA (6 major routes). According to Sokal risk, 50% of patients were low, 35% were intermediate and 16% were high risk. According to Eutos risk, 87% were low and 13% were high risk. As frontline treatment 55 patients received dasatinib (52 patients started with 100 mg, 3 at reduced dose), 82 patients received nilotinib 300 mg BID and 81 patients started imatinib (67 patients at 400 mg, 14 at <400 mg). Median age and comorbidities at baseline strongly influenced choice of TKI at baseline. At 3 months, in the dasatinib-treated cohort, 81% of patients were classified as optimal responders and 7% were warning but none of them changed therapy, due to concomitant comorbidities or toxicity experienced that allowed modification of dose. At 6 months, 84% of patients were in the optimal response category, 6% in the warning response (none of them changed) and 4% in failure category (1 patient increased the dose to 140 mg/day). At 12 months, 72% were in the optimal category, 25% in the warning category (none of them changed due to BCR-ABL/ABL ratio slightly above 0.1%) and 6% were in failure category (1 patient switched to nilotinib). At 3 months, in the nilotinib-treated cohort, 90% of patients were classified as optimal responders and 4.8% as failure (1 patient switched to dasatinib). At 6 months, 87% of patients were optimal, 6% warning (none of them changed) and 3% were failure (only 1 patient switched to dasatinib). At 12 months, 80% were in the optimal category, 16% in the warning category (none of them changed due to a ratio BCR-ABL/ABL slightly above 0.1%) and 9% in the failure category (1 patient switched to dasatinib and 1 patient switched to ponatinib). In the imatinib-treated cohort, at 3 months, 74% of patients were classified as optimal responders, 16% patients were warning (5 switched to second-generation TKIs), 3.7% were failure (2 switched to other TKIs). At 6 months, 72% of patients were in the optimal category, 27% were in the warning category (1 patient only changed therapy) and 3% were failure (only 1 patient switched to dasatinib). At 12 months, 52% were in the optimal category, 32% were warning category (none of them changed due to comorbidities) and 15% were in failure category (3 patients switched to nilotinib or dasatinib, 1 patient to high dose imatinib). Cytogenetic analysis at 6 and 12 months was not performed in 40% of patients already in MR3.
Conclusion
The results of this retrospective analysis indicated that with frontline second-generation TKIs, warning and failure category were reduced at 3 and 6 months and that with this approach, Italian physicians were less likely to perform an early switch.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
Type: Publication Only
Background
2013 ELN recommendations defined endpoints in the treatment of chronic myeloid leukemia patients, introducing the concept of early molecular and warning response, but did not provide precise indications on timing of possible early switch to overcome negative prognosis.
Aims
Aim of our study is to evaluate how Italian physicians are adherent to ELN recommendations and how the different use of available TKIs would have changed therapeutic strategies.
Methods
We collected 218 patients treated consecutively, outside clinical trials, in 13 different Italian centers.
Results
There were 124 males and 94 females, median age 58 years (range 18-90), 20 patients with a previous neoplasia. Ten patients had at baseline ACA (6 major routes). According to Sokal risk, 50% of patients were low, 35% were intermediate and 16% were high risk. According to Eutos risk, 87% were low and 13% were high risk. As frontline treatment 55 patients received dasatinib (52 patients started with 100 mg, 3 at reduced dose), 82 patients received nilotinib 300 mg BID and 81 patients started imatinib (67 patients at 400 mg, 14 at <400 mg). Median age and comorbidities at baseline strongly influenced choice of TKI at baseline. At 3 months, in the dasatinib-treated cohort, 81% of patients were classified as optimal responders and 7% were warning but none of them changed therapy, due to concomitant comorbidities or toxicity experienced that allowed modification of dose. At 6 months, 84% of patients were in the optimal response category, 6% in the warning response (none of them changed) and 4% in failure category (1 patient increased the dose to 140 mg/day). At 12 months, 72% were in the optimal category, 25% in the warning category (none of them changed due to BCR-ABL/ABL ratio slightly above 0.1%) and 6% were in failure category (1 patient switched to nilotinib). At 3 months, in the nilotinib-treated cohort, 90% of patients were classified as optimal responders and 4.8% as failure (1 patient switched to dasatinib). At 6 months, 87% of patients were optimal, 6% warning (none of them changed) and 3% were failure (only 1 patient switched to dasatinib). At 12 months, 80% were in the optimal category, 16% in the warning category (none of them changed due to a ratio BCR-ABL/ABL slightly above 0.1%) and 9% in the failure category (1 patient switched to dasatinib and 1 patient switched to ponatinib). In the imatinib-treated cohort, at 3 months, 74% of patients were classified as optimal responders, 16% patients were warning (5 switched to second-generation TKIs), 3.7% were failure (2 switched to other TKIs). At 6 months, 72% of patients were in the optimal category, 27% were in the warning category (1 patient only changed therapy) and 3% were failure (only 1 patient switched to dasatinib). At 12 months, 52% were in the optimal category, 32% were warning category (none of them changed due to comorbidities) and 15% were in failure category (3 patients switched to nilotinib or dasatinib, 1 patient to high dose imatinib). Cytogenetic analysis at 6 and 12 months was not performed in 40% of patients already in MR3.
Conclusion
The results of this retrospective analysis indicated that with frontline second-generation TKIs, warning and failure category were reduced at 3 and 6 months and that with this approach, Italian physicians were less likely to perform an early switch.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
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