The Efficacy And Safety Of Chinese Generic Imatinib In Patients With Newly Diagnosed Chronic Myeloid Leukemia In The Chronic Phase

Objective To evaluate the efficacy and safety in newly-diagnosed patients with chronic myeloid leukemia in the chronic phase（CML-CP）and treated with the Chinese generic imatinib as the first-line treatment.Methods The basic clinical and the follow-up visit information were retrospectively collected from 110 newly-diagnosed patients.All the patients were diagnosed as CML-CP in our hospital between October 2013 and October 2021,and were treated with Chinese generic imatinib（Xinwei）400mg once daily as the first line treatment.The short-term and long-term efficacy and safety of primary CML-CP patients with generic imatinib were evaluated.The relevant clinical characteristics（including age,sex,spleen size,leukocyte count,platelet count,hemoglobin number,percentage of alkophcells,risk stratification,ect.）were analyzed.For comparison between groups,Mann-Whitney U test was used for continuous variables,χ2test for categorical variables,the Kaplan-Meier survival curves and the Log-rank test were used for treatment outcome（EFS）.COX regression model was used to explore the factors affecting MMR and EFS,and Logistic regression analysis was used to explore the factors affecting the early treatment response(3 months BCR-ABL1^IS≤10%).Observed as of January 2022.Results 1.Observed as of January 2022,there were 53,43,and 19 patients continued treatment for more than 3,5,and 7 years,respectively.After 3 months of treatment,among110 patients,the complete hematological responses（CHR）rate was 100%.Among the 54patients with evaluable cytogenetic response,the major cytogenetic response（MCR）rate was83.33%（45/54）.Among the 105 patients whose molecular response could be assessed,and80.0%（84/105）of patients had BCR-ABL1^IS≤10%,of whom obtained the major molecular response（MMR）was 18.10%（19/105）.After 6 months of treatment,the CHR rate was97.83%（90/92）.Among the 52 patients with evaluable cytogenetic response,the complete cytogenetic response（CCy R）rate was 76.92%（40/52）,and the proportion of patients with BCR-ABL1^IS<1%was 73.33%（66/90）,among which the MMR rate was 43.33%（39/90）.After 12 months of treatment,the CHR rate was 98.70（76/77）,the MMR rate and the complete cytogenetic response（CMR）rate were 64.94%（50/77）,33.77%（26/77）,respectively.2.At a median follow-up of 31（3–96）months,the cumulative achieved CHR rate of110 patients was 100%,the MMR rate was 65.45%,and the CMR rate was 60.0%.At 5 years of treatment,the estimated overall survival（OS）rate,the progression-free survival（PFS）rate,and the event-free survival（EFS）rate were 100%,100%,and 71.7%,respectively.The estimated OS,PFS,and EFS at 7 years of treatment were 97.1%,94.2%,and 69.4%,respectively.3.During treatment,patients with grade I-II adverse Hematological adverse effects were more common,including leukopenia,thrombocytopenia,and anemia in 29.09%,23.63%,and5.45%of patients,respectively.Edema（55.46%）,bone and pain（14.55%）,and rash or allergy（13.63%）were the more common non-hematologic toxicities.Most patients had mild symptoms but did not influence treatment.4.Univariate analysis of whether MMR can be obtained,the influencing factors were hemoglobin,spleen size,basophil ratio,Sokal score,EUTOS score,and whether obtain the best treatment response at 3 months(BCR-ABL1^IS≤10%)（P<0.05）.Univariate analysis of whether the best treatment response could be obtained at 3 months showed that the white blood cell count,hemoglobin,and Sokal score at initial diagnosis affected the obtain of the optimal treatment response at 3 months（P<0.05）.Univariate analysis of EFS,the influencing factors were the hemoglobin value,spleen size,Sokal score,EUTOS score,ELTS score,and whether the best treatment response was obtained after 3 months of treatment（P<0.05）.Including tically significant factors in univariate analysis into the multivariable analysis,showed that high risk for EUTOS score,BCR-ABL1^IS>10%at 3 months were risk factors for patients to obtain MMR（HR=2.079,P=0.028;HR=4.285,P=0.045）;anemia was an Independent risk factors for patients to obtain optimal treatment response at 3 months（HR=1.024,P=0.032）;achieving optimal treatment response at 3 months of treatment was an independent prognostic factor for EFS（HR=8.918,P<0.001）.Conclusion CML-CP patients who treated with the first-line treatment of Chinese generic imatinib regularly have excellent short-term and long-term efficacy and reliable long-term safety,adverse effects occur more early in treatment.For newly diagnosed CML-CP patients,Chinese generic imatinib is an effective,safe and economic treatment option.Patients who obtained the best treatment response early and were at low risk for EUTOS score were more likely to obtain MMR in the long term.Obtaining the best treatment response at 3 months of treatment was associated with higher EFS.Patients with anemia at the initial diagnosis have less optimal treatment at 3 months of treatment.