# Response Assessment of Generic Tyrosine Kinase Inhibitors in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase: A Prospective Study from a Tertiary Care Centre in North Eastern India

## TL;DR

This study shows that generic tyrosine kinase inhibitors are effective in treating chronic myeloid leukemia in India, with most patients showing good responses and manageable side effects.

## Contribution

The study provides real-world evidence of generic TKI efficacy and safety in a specific Indian population with CML.

## Key findings

- Most patients achieved complete hematological response with generic TKIs.
- BCR-ABL levels significantly decreased over time in the majority of cases.
- Adverse effects were generally mild and manageable.

## Abstract

This study evaluated the efficacy of generic tyrosine kinase inhibitors (TKIs) in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) and analyzed Breakpoint Cluster Region-Abelson (BCR-ABL) kinase domain mutations in patients exhibiting TKI resistance. Eighty-five recently diagnosed CML patients (65 males and 20 female participants) of mean age 39.93±10.13 years, who had CP, were enrolled in this prospective study, and their response to generic TKI was evaluated. Furthermore, BCR-ABL TK domain mutations were assessed in individuals who did not respond well to generic TKI. Male preponderance was observed, representing 65 (76.5%) and 79 (92.9%) of the patients from Assam. The mean baseline hemoglobin (Hb) was 7.6 g/dl, and the mean blast percentage was 2.97. Following treatment with a generic TKI, mean BCR‑ABL levels fell by 10% at three months in 62 cases (77.5%), by 1% at six months in 64 cases (80%), and to 0.1% by 12 months in 48 cases (60%). A complete hematological response (CHR) was noted in 80 (94.11%) of the patients. The non-compliance rate to TKI in this study was seen in 10 (11.76%) out of the 85 cases. The most common drug-related hematological adverse effect was neutropenia in seven (8.2%) and anemia in five (5.9%) patients, respectively. The most common drug-related non-hematological adverse effect was edema in 12 (14.1%) and fatigue in 10 (11.7%) patients. Significant clinical, hematological, and molecular responses were reported by the study. The drug was found to be easily tolerated, and any negative effects observed were effectively managed with appropriate care.