Contributions
Abstract: PB1936
Type: Publication Only
Background
The advent of the tyrosine kinase inhibitor (TKI) Imatinib has drastically improved survival in Chronic myeloid leukemia (CML). Recent evidence suggests that patients with Sokal intermediate or high risk CML-CP may preferentially benefit from upfront 2nd generation TKI therapy.1
Aims
Our study reports the complete hematological response (CHR) & early molecular response rates at 3 months of treatment with generic Imatinib in newly diagnosed Sokal intermediate & high-risk CML-CP patients in the severely resource-constrained setting of a tertiary care institution in north India.
Methods
The study included 40 newly diagnosed CML-CP patients with either Sokal intermediate or high risk disease, who were diagnosed between March 2016 & October 2017. All the patients in the study hailed from very poor socio-economic background with severe financial constraint, and none of them had any medical insurance. All the patients were treated with generic Imatinib mesylate 400 mg/day which was available free of cost at the hospital. None of the patients could afford one of the two 2nd generation TKI drugs (Nilotinib & Dasatinib) which are available in India, despite adequate counseling & information regarding the efficacy of 2nd generation TKIs. Treatment response was monitored and defined as per European LeukemiaNet recommendations.2 Hematological response was assessed at 3 months for CHR. Molecular response was assessed at 3 months, 6 months & 12 months of Imatinib treatment if patients could afford BCR-ABL Q-PCR (IS) test.
Results
The median age of patients was 30 years (range 18-75 years). Male:female ratio was 4:3. The median interval from symptom onset to diagnosis was 4 months (range 2-12 months). The median spleen size was 10 cm below costal margin (range 3-28 cm). The median total leukocyte count at diagnosis was 257 x 109/L (range 36-700 x 109/L, and the median platelet count was 338 x 109/L (range 102-1160 x 109/L). At 3 months, CHR was achieved by 90% (36/40) patients; rest had no CHR (Imatinib failure). Molecular response at 3 months could be assessed in 33 out of the 40 patients. Optimal molecular response at 3 months (BCR-ABL ≤ 10% I.S.) was achieved in 21 out of these 33 patients (63.6%); the rest had BCR-ABL > 10%. Imatinib failure was documented at 6 months in 5 patients (BCR-ABL > 10% after 6 months). On follow up, major molecular response (BCR-ABL ≤ 0.1% I.S) at 12 months has been documented in four patients. None of the patients with Imatinib failure could afford BCR-ABL kinase domain mutation analysis. Only one patient switched to Nilotinib therapy after Imatinib failure at 6 months; Imatinib dose has been increased to 800 mg/day in the rest. Five patients have been lost to follow up.
Conclusion
The real scenario of CML treatment in developing countries with resource-constrained settings is very much different from that in the developed countries. The response rates to generic Imatinib therapy in Sokal intermediate & high risk CML-CP patients are not impressive. There is scope for improvement in treatment response with upfront 2nd generation TKI therapy, if these drugs can be made available at lower costs which each & every CML patient can afford.
References: 1. Chronic myeloid leukemia. NCCN Guidelines version 4.2018 – January 24, 2018. www.NCCN.org 2. European LeukemiaNet Recommendations for Management of CML (2013).
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): imatinib, Chronic myeloid leukemia, High risk
Abstract: PB1936
Type: Publication Only
Background
The advent of the tyrosine kinase inhibitor (TKI) Imatinib has drastically improved survival in Chronic myeloid leukemia (CML). Recent evidence suggests that patients with Sokal intermediate or high risk CML-CP may preferentially benefit from upfront 2nd generation TKI therapy.1
Aims
Our study reports the complete hematological response (CHR) & early molecular response rates at 3 months of treatment with generic Imatinib in newly diagnosed Sokal intermediate & high-risk CML-CP patients in the severely resource-constrained setting of a tertiary care institution in north India.
Methods
The study included 40 newly diagnosed CML-CP patients with either Sokal intermediate or high risk disease, who were diagnosed between March 2016 & October 2017. All the patients in the study hailed from very poor socio-economic background with severe financial constraint, and none of them had any medical insurance. All the patients were treated with generic Imatinib mesylate 400 mg/day which was available free of cost at the hospital. None of the patients could afford one of the two 2nd generation TKI drugs (Nilotinib & Dasatinib) which are available in India, despite adequate counseling & information regarding the efficacy of 2nd generation TKIs. Treatment response was monitored and defined as per European LeukemiaNet recommendations.2 Hematological response was assessed at 3 months for CHR. Molecular response was assessed at 3 months, 6 months & 12 months of Imatinib treatment if patients could afford BCR-ABL Q-PCR (IS) test.
Results
The median age of patients was 30 years (range 18-75 years). Male:female ratio was 4:3. The median interval from symptom onset to diagnosis was 4 months (range 2-12 months). The median spleen size was 10 cm below costal margin (range 3-28 cm). The median total leukocyte count at diagnosis was 257 x 109/L (range 36-700 x 109/L, and the median platelet count was 338 x 109/L (range 102-1160 x 109/L). At 3 months, CHR was achieved by 90% (36/40) patients; rest had no CHR (Imatinib failure). Molecular response at 3 months could be assessed in 33 out of the 40 patients. Optimal molecular response at 3 months (BCR-ABL ≤ 10% I.S.) was achieved in 21 out of these 33 patients (63.6%); the rest had BCR-ABL > 10%. Imatinib failure was documented at 6 months in 5 patients (BCR-ABL > 10% after 6 months). On follow up, major molecular response (BCR-ABL ≤ 0.1% I.S) at 12 months has been documented in four patients. None of the patients with Imatinib failure could afford BCR-ABL kinase domain mutation analysis. Only one patient switched to Nilotinib therapy after Imatinib failure at 6 months; Imatinib dose has been increased to 800 mg/day in the rest. Five patients have been lost to follow up.
Conclusion
The real scenario of CML treatment in developing countries with resource-constrained settings is very much different from that in the developed countries. The response rates to generic Imatinib therapy in Sokal intermediate & high risk CML-CP patients are not impressive. There is scope for improvement in treatment response with upfront 2nd generation TKI therapy, if these drugs can be made available at lower costs which each & every CML patient can afford.
References: 1. Chronic myeloid leukemia. NCCN Guidelines version 4.2018 – January 24, 2018. www.NCCN.org 2. European LeukemiaNet Recommendations for Management of CML (2013).
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): imatinib, Chronic myeloid leukemia, High risk