| Background and ObjectiveChronic lymphocytic leukemia(CLL)is a monoclonal disorder characterized by a progressive accumulation of functionally incompetent lymphocytes.It is the most common form of leukemia found in adults in Western countries,while is extremely rare in Asian countries.Patients with CLL present with a wide range of symptoms and signs.Onset is insidious,and it is not unusual for CLL to be discovered incidentally after a blood cell count is performed for another reason.Chemotherapy is not needed in CLL until patients become symptomatic or display evidence of rapid progression of disease.Monotherapy with alkylating agents has served as initial front-line therapy for CLL for several decades.The advantages of aklylating are its low toxicity,low cost and convenience as an oral drug;its major disadvantages are its low to non-existent CR rate and some side effects that may occur after extended use(prolonged cytopenia,myelodysplasia and secondary acute leukemia).Purine analogues are currently used in CLL.Fludarabine is a kind of fluorinated purine analogues with major activity against indolent lymphoid malignancies,including CLL.Fludarabine monotherapy(F)and combination chemotherapy with fludarabine plus cyclophosphamide(FC)are the major treatments used in clinic.In order to evaluate the efficacy and safety of fludarabine-based regimen for the patients with CLL,a retrospective analysis of60cases who received chemotherapy with F or FC in the Department of Hematology of the First Affiliated Hospital of Zhengzhou University from April,2004to November,2011was performed.Method1.According to the therapeutic schedule,60cases were classified into F group(28cases)and FC group(32cases).2.The CR rate and overall response(OR)rate including CR and partial response(PR)rate,adverse reactions including myelosuppression and immunosupression were evaluated.3.The data were analyzed using Software SPSS15.0.Qualitative date were analyzed by chi-square test,Statistical significance was defined as P below0.05.Result1.Research objectives:60cases including42males(70%)and18females(30%)were involved in this study and the median age was65(40～76)years.28cases received F regimen and32cases received FC regimen.Comparison of patients in the2treatment groups indicated no significant difference regarding the age,sex,Rai stage,ECOG performance status.60cases completed249courses.2.Response to treatment:The rate of CR,PR and OR of60cases was26.7%(16/60),56.7%(34/60)and83.3%(50/60)respectively.The CR rate of FC group was significantly higher than F group(40.6%VS10.7%,P<0.05)while the OR rate was not statistically significant(75.0%VS90.6%,P>0.05).The rate of CR and OR of patients in Rai Ⅰ-Ⅱ stage was significantly higher than that of patients in Rai Ⅲ-Ⅳ stage(32.4%VS8.7%,94.2%VS65.2%,P<0.05).Among the patients of Rai Ⅰ-Ⅱ stage,there was statistically significant in the CR rate between F group and FC group(12.5%VS50.0%,P<0.05),while there was no statistical significance in the OR rate(87.5%VS100.0%P>0.05).However,among the patients of Rai Ⅲ-Ⅳ stage,there was no significant difference in the rate of CR and OR between the two groups(CR0VS16.7%,OR54.5%VS75.0%,P>0.05).3.Adverse reactions:Myelosuppression was the major adverse effect in both groups.No significant differences were noted as to the leukocytopenia,treatment-related anemia and thrombocytopenia.The rates of infections were similar in both treatment groups.In the FC group,one case of fungal pneumonia occurred and died of septic shock.Furthermore,the rate of gastrointestinal side effects such as nausea,vomiting,mucositis,and gastritis were similar.Autoimmune hemolytic anemia(AIHA),tumor lysis sundrome and transfusion-associated graft-versus-host disease(TA-GVHD)were not observed in this study.Conclusions1.Fludarabine based regimen is effective in the treatment of CLL.FC regimen can give higher CR rate as compared with F regimen,especially for the patients in the Rai Ⅰ-Ⅱ stage.2.Fludarabine based regimen is safe regimen for patients with CLL. |
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