Contributions
Abstract: PB1958
Type: Publication Only
Background
The classic evolution of 3-phase CML (chronic, accelerated and blast) has been revolutionized by the advent of the tyrosine kinase inhibitors leading the way to Imatinib: we are now talking about a chronic disease. From April 2005 to October 2017, 222 patients (pts) with CML in the first phase were treated with Indian Imatinib: Imatib *.
Aims
Evaluation of Imatib (Indian Imatinib)
Methods
There are 115 men and 107 women (sex ratio: 1.07) with a median age of 44 years (13 - 77). The molecular study by qualitative RT-PCR specified the type of transcript in 219 pts (98.6%): b2a2 at 98 pts (45%), b3a2 at 117 pts (53%), a double transcript b2a2-b3a2 at 2 pts and variant BCR-ABL at 2 pts (c3a2 and e1a2). According to Sokal classification, 129 pts (58%) are at intermediate score, 57 pts (26%) at high risk and 36 pts (16%) at low risk. According to the Eutos score, 170 pts are at low risk (77%) and 52 pts at high risk (23%). All patients were treated with Imatib * 400mg after treatment with Hydroxy-Urea in 210 pts (94.5%) and de novo in 9 pts. It should be noted that 3 pts received pegylated interferon because of pregnancy diagnosis in the first trimester.
Results
In October 2017, 204 pts are evaluable with a median follow-up of 76 months (3-163). The response is complete hematologic in all pts and major molecular (residual disease <0.1% by quantitative RT-PCR) at 6, 12 and 24 months respectively in 80/172 pts (46.5%), 101/155 pts (65%) and 99/124 pts (80%). Primary or secondary resistance is observed in 53 pts / 204 (26%) with no RMM at least at 12 months in 26 pts, loss of RMM already obtained in 8 pts, ratio> 10% at 6 months in 5 pts and hematologic relapse in 14 pts. A progression to acute leukemia is observed in 12 pts (6%) but in no pt beyond 6 years. Sixteen pts / 204 (8%) died: 11 of acutization, 4 of a probable Imatib complication and one of a non-CML cause. At 12 years old, 142pts (69.5%) are still treated with Imatib * 400 mg including 72 in RMM4 and 7 in RMM3 more than 3 years of treatment. The actuarial overall survival (OS) and event free survival (EFS) are respectively 88.6% and 77% comparable to those of the IRIS study. According to Sokal score, the OS are 100, 88 and 84.3% and the EFS are 92.8; 76.3 and 71.6% respectively for low, intermediate and high risk with only a significant difference between low and high risk. According to Eutos, the OS and EFS are not significantly different for low and high risk, they are 91 and 85.3% for OS and 78.7 and 72.6% for EFS.
Conclusion
With a 12-years decline in use, we were able to confirm that the efficacy of Imatib is comparable to that of the originator molecule with a cost ten times lower, which made it possible to treat all the pts of the Algerian territory.
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, imatinib
Abstract: PB1958
Type: Publication Only
Background
The classic evolution of 3-phase CML (chronic, accelerated and blast) has been revolutionized by the advent of the tyrosine kinase inhibitors leading the way to Imatinib: we are now talking about a chronic disease. From April 2005 to October 2017, 222 patients (pts) with CML in the first phase were treated with Indian Imatinib: Imatib *.
Aims
Evaluation of Imatib (Indian Imatinib)
Methods
There are 115 men and 107 women (sex ratio: 1.07) with a median age of 44 years (13 - 77). The molecular study by qualitative RT-PCR specified the type of transcript in 219 pts (98.6%): b2a2 at 98 pts (45%), b3a2 at 117 pts (53%), a double transcript b2a2-b3a2 at 2 pts and variant BCR-ABL at 2 pts (c3a2 and e1a2). According to Sokal classification, 129 pts (58%) are at intermediate score, 57 pts (26%) at high risk and 36 pts (16%) at low risk. According to the Eutos score, 170 pts are at low risk (77%) and 52 pts at high risk (23%). All patients were treated with Imatib * 400mg after treatment with Hydroxy-Urea in 210 pts (94.5%) and de novo in 9 pts. It should be noted that 3 pts received pegylated interferon because of pregnancy diagnosis in the first trimester.
Results
In October 2017, 204 pts are evaluable with a median follow-up of 76 months (3-163). The response is complete hematologic in all pts and major molecular (residual disease <0.1% by quantitative RT-PCR) at 6, 12 and 24 months respectively in 80/172 pts (46.5%), 101/155 pts (65%) and 99/124 pts (80%). Primary or secondary resistance is observed in 53 pts / 204 (26%) with no RMM at least at 12 months in 26 pts, loss of RMM already obtained in 8 pts, ratio> 10% at 6 months in 5 pts and hematologic relapse in 14 pts. A progression to acute leukemia is observed in 12 pts (6%) but in no pt beyond 6 years. Sixteen pts / 204 (8%) died: 11 of acutization, 4 of a probable Imatib complication and one of a non-CML cause. At 12 years old, 142pts (69.5%) are still treated with Imatib * 400 mg including 72 in RMM4 and 7 in RMM3 more than 3 years of treatment. The actuarial overall survival (OS) and event free survival (EFS) are respectively 88.6% and 77% comparable to those of the IRIS study. According to Sokal score, the OS are 100, 88 and 84.3% and the EFS are 92.8; 76.3 and 71.6% respectively for low, intermediate and high risk with only a significant difference between low and high risk. According to Eutos, the OS and EFS are not significantly different for low and high risk, they are 91 and 85.3% for OS and 78.7 and 72.6% for EFS.
Conclusion
With a 12-years decline in use, we were able to confirm that the efficacy of Imatib is comparable to that of the originator molecule with a cost ten times lower, which made it possible to treat all the pts of the Algerian territory.
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, imatinib