REAL-WORLD TREATMENT OF CHRONIC MYELOID LEUKEMIA (CML) IN PATIENTS WHO FAILED ≥2 PRIOR TYROSINE KINASE INHIBITORS (TKIS) AMONG US COMMUNITY ONCOLOGISTS
(Abstract release date: 05/19/16)
EHA Library. Huang H. 06/09/16; 134724; PB1824
Huiqiang Huang
Contributions
Contributions
Abstract
Abstract: PB1824
Type: Publication Only
Background
In the era of tyrosine kinase inhibitors (TKIs) most (chronic phase) CP-CML patients can expect to achieve excellent response with 1st-line (1L) therapy. However, in those who relapse, as many as one-third will not achieve a major molecular response in 2nd line (2L), and over time, up to one-half relapse. Lipton et al. (Leuk Res, 2015) reported that for CP-CML patients receiving a 3rd line (3L) TKI, sequential treatment with a 2nd-generation (2G) TKI after a prior 2G TKI failure is effective in only 22-26% of patients. Understanding real-world patterns of care and outcomes in this poor prognosis subset of CML patients is critical to developing new treatment strategies.
Aims
To document treatment patterns and measure real-world duration of treatment (DOT) across therapy lines in CML patients who were treated with ≥ 2 prior TKI lines.
Methods
In a retrospective study, the Navigating Cancer® electronic medical record (EMR) database was used to examine treatment patterns and estimate the benefit of TKI therapy in real-world practice. This database is comprised of community oncologists across the US. Patients with an ICD-9 code for diagnosis of CML, between August 2001-August 2015, who were treated with >2 prior lines of TKIs from pharmacy records were included. Patients included were > 18 years of age at index date (initiation of 3L treatment), with no prior history of concomitant treatment for secondary cancers. Disease phase was reported in clinical progress notes. Line of therapy (LOT) was assigned for each specific regimen. Treatment discontinuation was defined as a gap in therapy of > 90 days. As a surrogate for treatment benefit, DOT was calculated from prescription dates and days of therapy dispensed.
Results
One-hundred and fifty two CML patients met all inclusion criteria: 51% were female, and 67% Caucasian (16% unknown), with a mean age at index date of 58.7 years (23-88 years). Disease phase was available for 85 patients, among whom 64 were in CP-CML at most recent follow-up. For all 152 patients, the median DOT was 2.98 months in 1L, 1.01 months in 2L, and 5.45 months in 3L. For the 64 CP-CML, 3L DOT was 7.89 months. The most common treatment sequence for the first 3 lines was imatinib/dasatinib/nilotinib (observed in 20% of patients). 61% of 3L therapy received 2G agents (24% dasatinib, 28% nilotinib, 9% bosutinib), 30% received imatinib, and 9% received ponatinib. Among 3L patients, 35% discontinued treatment and 38% progressed to 4-6 total lines. Most common 4L treatment was dasatinib (33%) followed by imatinib (24%), ponatinib (16%) and nilotinib and bosutinib (both 14%). 52% of all 4L TKI use was in patients who had received the same drug in an earlier LOT.
Conclusion
Our analysis affirms the limited effectiveness of current therapies in patients who relapse after 2LTKI for CP-CML. Use of 2G TKI and imatinib in 3L remains common among community oncologists. Our analysis identifies a subset of CML patients who not only fail quickly after TKI initiation, but subsequent 2G TKI treatment has short DOT. A variety of treatment sequences were observed across patients in ≥3L, and early switching of therapy appears common, suggesting an absent standard of care. In addition, the observed 52% repeat use of TKI in 4L suggests significant unmet need. More research into understanding the optimal treatment of these poor prognosis patients is needed to address the unmet clinical need.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
Type: Publication Only
Background
In the era of tyrosine kinase inhibitors (TKIs) most (chronic phase) CP-CML patients can expect to achieve excellent response with 1st-line (1L) therapy. However, in those who relapse, as many as one-third will not achieve a major molecular response in 2nd line (2L), and over time, up to one-half relapse. Lipton et al. (Leuk Res, 2015) reported that for CP-CML patients receiving a 3rd line (3L) TKI, sequential treatment with a 2nd-generation (2G) TKI after a prior 2G TKI failure is effective in only 22-26% of patients. Understanding real-world patterns of care and outcomes in this poor prognosis subset of CML patients is critical to developing new treatment strategies.
Aims
To document treatment patterns and measure real-world duration of treatment (DOT) across therapy lines in CML patients who were treated with ≥ 2 prior TKI lines.
Methods
In a retrospective study, the Navigating Cancer® electronic medical record (EMR) database was used to examine treatment patterns and estimate the benefit of TKI therapy in real-world practice. This database is comprised of community oncologists across the US. Patients with an ICD-9 code for diagnosis of CML, between August 2001-August 2015, who were treated with >2 prior lines of TKIs from pharmacy records were included. Patients included were > 18 years of age at index date (initiation of 3L treatment), with no prior history of concomitant treatment for secondary cancers. Disease phase was reported in clinical progress notes. Line of therapy (LOT) was assigned for each specific regimen. Treatment discontinuation was defined as a gap in therapy of > 90 days. As a surrogate for treatment benefit, DOT was calculated from prescription dates and days of therapy dispensed.
Results
One-hundred and fifty two CML patients met all inclusion criteria: 51% were female, and 67% Caucasian (16% unknown), with a mean age at index date of 58.7 years (23-88 years). Disease phase was available for 85 patients, among whom 64 were in CP-CML at most recent follow-up. For all 152 patients, the median DOT was 2.98 months in 1L, 1.01 months in 2L, and 5.45 months in 3L. For the 64 CP-CML, 3L DOT was 7.89 months. The most common treatment sequence for the first 3 lines was imatinib/dasatinib/nilotinib (observed in 20% of patients). 61% of 3L therapy received 2G agents (24% dasatinib, 28% nilotinib, 9% bosutinib), 30% received imatinib, and 9% received ponatinib. Among 3L patients, 35% discontinued treatment and 38% progressed to 4-6 total lines. Most common 4L treatment was dasatinib (33%) followed by imatinib (24%), ponatinib (16%) and nilotinib and bosutinib (both 14%). 52% of all 4L TKI use was in patients who had received the same drug in an earlier LOT.
Conclusion
Our analysis affirms the limited effectiveness of current therapies in patients who relapse after 2LTKI for CP-CML. Use of 2G TKI and imatinib in 3L remains common among community oncologists. Our analysis identifies a subset of CML patients who not only fail quickly after TKI initiation, but subsequent 2G TKI treatment has short DOT. A variety of treatment sequences were observed across patients in ≥3L, and early switching of therapy appears common, suggesting an absent standard of care. In addition, the observed 52% repeat use of TKI in 4L suggests significant unmet need. More research into understanding the optimal treatment of these poor prognosis patients is needed to address the unmet clinical need.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
Abstract: PB1824
Type: Publication Only
Background
In the era of tyrosine kinase inhibitors (TKIs) most (chronic phase) CP-CML patients can expect to achieve excellent response with 1st-line (1L) therapy. However, in those who relapse, as many as one-third will not achieve a major molecular response in 2nd line (2L), and over time, up to one-half relapse. Lipton et al. (Leuk Res, 2015) reported that for CP-CML patients receiving a 3rd line (3L) TKI, sequential treatment with a 2nd-generation (2G) TKI after a prior 2G TKI failure is effective in only 22-26% of patients. Understanding real-world patterns of care and outcomes in this poor prognosis subset of CML patients is critical to developing new treatment strategies.
Aims
To document treatment patterns and measure real-world duration of treatment (DOT) across therapy lines in CML patients who were treated with ≥ 2 prior TKI lines.
Methods
In a retrospective study, the Navigating Cancer® electronic medical record (EMR) database was used to examine treatment patterns and estimate the benefit of TKI therapy in real-world practice. This database is comprised of community oncologists across the US. Patients with an ICD-9 code for diagnosis of CML, between August 2001-August 2015, who were treated with >2 prior lines of TKIs from pharmacy records were included. Patients included were > 18 years of age at index date (initiation of 3L treatment), with no prior history of concomitant treatment for secondary cancers. Disease phase was reported in clinical progress notes. Line of therapy (LOT) was assigned for each specific regimen. Treatment discontinuation was defined as a gap in therapy of > 90 days. As a surrogate for treatment benefit, DOT was calculated from prescription dates and days of therapy dispensed.
Results
One-hundred and fifty two CML patients met all inclusion criteria: 51% were female, and 67% Caucasian (16% unknown), with a mean age at index date of 58.7 years (23-88 years). Disease phase was available for 85 patients, among whom 64 were in CP-CML at most recent follow-up. For all 152 patients, the median DOT was 2.98 months in 1L, 1.01 months in 2L, and 5.45 months in 3L. For the 64 CP-CML, 3L DOT was 7.89 months. The most common treatment sequence for the first 3 lines was imatinib/dasatinib/nilotinib (observed in 20% of patients). 61% of 3L therapy received 2G agents (24% dasatinib, 28% nilotinib, 9% bosutinib), 30% received imatinib, and 9% received ponatinib. Among 3L patients, 35% discontinued treatment and 38% progressed to 4-6 total lines. Most common 4L treatment was dasatinib (33%) followed by imatinib (24%), ponatinib (16%) and nilotinib and bosutinib (both 14%). 52% of all 4L TKI use was in patients who had received the same drug in an earlier LOT.
Conclusion
Our analysis affirms the limited effectiveness of current therapies in patients who relapse after 2LTKI for CP-CML. Use of 2G TKI and imatinib in 3L remains common among community oncologists. Our analysis identifies a subset of CML patients who not only fail quickly after TKI initiation, but subsequent 2G TKI treatment has short DOT. A variety of treatment sequences were observed across patients in ≥3L, and early switching of therapy appears common, suggesting an absent standard of care. In addition, the observed 52% repeat use of TKI in 4L suggests significant unmet need. More research into understanding the optimal treatment of these poor prognosis patients is needed to address the unmet clinical need.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
Type: Publication Only
Background
In the era of tyrosine kinase inhibitors (TKIs) most (chronic phase) CP-CML patients can expect to achieve excellent response with 1st-line (1L) therapy. However, in those who relapse, as many as one-third will not achieve a major molecular response in 2nd line (2L), and over time, up to one-half relapse. Lipton et al. (Leuk Res, 2015) reported that for CP-CML patients receiving a 3rd line (3L) TKI, sequential treatment with a 2nd-generation (2G) TKI after a prior 2G TKI failure is effective in only 22-26% of patients. Understanding real-world patterns of care and outcomes in this poor prognosis subset of CML patients is critical to developing new treatment strategies.
Aims
To document treatment patterns and measure real-world duration of treatment (DOT) across therapy lines in CML patients who were treated with ≥ 2 prior TKI lines.
Methods
In a retrospective study, the Navigating Cancer® electronic medical record (EMR) database was used to examine treatment patterns and estimate the benefit of TKI therapy in real-world practice. This database is comprised of community oncologists across the US. Patients with an ICD-9 code for diagnosis of CML, between August 2001-August 2015, who were treated with >2 prior lines of TKIs from pharmacy records were included. Patients included were > 18 years of age at index date (initiation of 3L treatment), with no prior history of concomitant treatment for secondary cancers. Disease phase was reported in clinical progress notes. Line of therapy (LOT) was assigned for each specific regimen. Treatment discontinuation was defined as a gap in therapy of > 90 days. As a surrogate for treatment benefit, DOT was calculated from prescription dates and days of therapy dispensed.
Results
One-hundred and fifty two CML patients met all inclusion criteria: 51% were female, and 67% Caucasian (16% unknown), with a mean age at index date of 58.7 years (23-88 years). Disease phase was available for 85 patients, among whom 64 were in CP-CML at most recent follow-up. For all 152 patients, the median DOT was 2.98 months in 1L, 1.01 months in 2L, and 5.45 months in 3L. For the 64 CP-CML, 3L DOT was 7.89 months. The most common treatment sequence for the first 3 lines was imatinib/dasatinib/nilotinib (observed in 20% of patients). 61% of 3L therapy received 2G agents (24% dasatinib, 28% nilotinib, 9% bosutinib), 30% received imatinib, and 9% received ponatinib. Among 3L patients, 35% discontinued treatment and 38% progressed to 4-6 total lines. Most common 4L treatment was dasatinib (33%) followed by imatinib (24%), ponatinib (16%) and nilotinib and bosutinib (both 14%). 52% of all 4L TKI use was in patients who had received the same drug in an earlier LOT.
Conclusion
Our analysis affirms the limited effectiveness of current therapies in patients who relapse after 2LTKI for CP-CML. Use of 2G TKI and imatinib in 3L remains common among community oncologists. Our analysis identifies a subset of CML patients who not only fail quickly after TKI initiation, but subsequent 2G TKI treatment has short DOT. A variety of treatment sequences were observed across patients in ≥3L, and early switching of therapy appears common, suggesting an absent standard of care. In addition, the observed 52% repeat use of TKI in 4L suggests significant unmet need. More research into understanding the optimal treatment of these poor prognosis patients is needed to address the unmet clinical need.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
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