Annals of Oncology | 2019
Risk stratification of CML-CP in a real-world scenario, comparison of S.H.E. with rate of fall of BCR/ABL
Abstract
Abstract Background Multiple studies in the past have elaborated the role of different risks stratification scores such as Sokal, Hasford, and Eutos (S.H.E.). These studies either correlated the risk stratification with survival, PFS, CcyR, MMR, or point BCR-ABL at different time intervals post-TKI. However, as we understand, all patients do not have a similar disease burden at the initiation of TKI. Also, using cut off level for different age group, gender, and disease burdens is an oversimplification of the disease remission criteria. There are very few studies on the rate (velocity) of the fall of BCR-ABL. The aim of this study was to compare the efficacy of various prognostic score in predicting the fall in BCR ABL over two years. Methods This is a prospective observational study comprising 653 (sample size predicted: 300) patients managed at a tertiary care center in north India based on a uniform treatment and evaluation protocol (Generic Imatinib 400\u2009mg OD and three monthly RQ-PCR-BCR/ABL-IS). Statistics were done using Python-13. Results The median age of the study population was 43 years (16-87). On comparing the three risk groups of Sokal, the high-risk patients had the least fall in BCR-ABL at any time point up to 2 years post intiation of TKI. Whereas, there was no difference between low and intermediate risk. The difference in the three groups was not statistically significant. There was also no statistically significant difference in the rate of fall of BCR/ABL in the three risk groups of Hasford. The two risk groups of Eutos score had a significant difference in the rate of fall of BCR/ABL, the high risk having a lower rate in comparison to low risk. Conclusions Of the three scoring systems, the EUTOS score outperforms as a prognostic model using rate of fall of BCR-ABL in newly diagnosed CML-CP patients upto two years on Generic Imatinib. Legal entity responsible for the study NA. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.