Wang T Y, Yi S H, Wang Y, Lyu R, Wang Q, Deng S H, Sui W W, Fu M W, Huang W Y, Liu W, An G, Zhao Y Z, Qiu L G
State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China.
Zhonghua Xue Ye Xue Za Zhi. 2021 Jul 14;42(7):543-548. doi: 10.3760/cma.j.issn.0253-2727.2021.07.003.
To investigate the efficacy of fludarabine and cyclophosphamide combined with rituximab (FCR) in previously untreated patients with chronic lymphocytic leukemia (CLL) . The clinical data of 43 enrolled patients from May 2004 to December 2017 were analyzed the efficacy and survival results. A total of 43 patients with 31 males and 12 females, and the median age was 58 years old (range 36 to72) before treatment. There were 8 patients with symptom B. The median number of peripheral blood lymphocyte was 26 (3-550) ×10(9)/L. IGHV unmutated was detected in 62.1% (18/29) patients, P53 deletion in 14% (6/43) patients, RB1 deletion in 18.6% (8/43) patients, Trisomy 12 in 25.6% (11/33) patients, ATM deletion in 16.7% (7/42) patients, respectively. The median number of treatment courses administered was 4 (range 2-6) . Twenty patients obtained CR (46.5%) , 18 patients obtained PR, 4 patients were SD, 1 patient was PD. The overall response rate (ORR) was 88.37%. Seven patients obtained MRD negative. After the median follow-up time of 51 (6-167) months, median PFS was 67 (29-105) months, median OS was not reach, 5-year PFS was (62.1±8.6) %, 10-year PFS was (31±14.3) %, 5-year OS was (70.5±8.3) %, and 10-year OS was (51.3±13.8) %. Less than 4 courses predicted adverse OS (<0.05) . P53 deletion and less than 4 courses were associated with poor PFS (<0.001) , and the prognostic value still remained after multivariate analysis[=7.65 (95% 1.74-33.60) , =0.007; =3.75 (95% 1.19-11.80) , =0.025]. Eighteen patients (41.9%) appeared grade 2-3 infection after chemotherapy, and 19 patients (44.2%) appeared grade 3-4 hematological adverse reactions. One patient (2.3%) was developed tumor lysis syndrome. All adverse reactions were controlled or recovered spontaneously. Previously untreated CLL patients treated with FCR had a high response rate and good survival rate, which is an important treatment choice for fit patients.
探讨氟达拉滨、环磷酰胺联合利妥昔单抗(FCR)方案治疗初治慢性淋巴细胞白血病(CLL)患者的疗效。分析2004年5月至2017年12月纳入的43例患者的临床资料,观察疗效及生存结果。43例患者中,男性31例,女性12例,治疗前中位年龄58岁(范围36至72岁)。有8例B症状患者。外周血淋巴细胞中位数为26(3至550)×10⁹/L。62.1%(18/29)的患者检测到IGHV未突变,14%(6/43)的患者检测到P53缺失,18.6%(8/43)的患者检测到RB1缺失,25.6%(11/33)的患者检测到12号染色体三体,16.7%(7/42)的患者检测到ATM缺失。中位治疗疗程数为4(范围2至6)。20例患者获得完全缓解(CR,46.5%),18例患者获得部分缓解,4例患者病情稳定,1例患者疾病进展。总缓解率(ORR)为88.37%。7例患者微小残留病检测为阴性。中位随访时间51(6至167)个月后,中位无进展生存期(PFS)为67(29至105)个月,中位总生存期(OS)未达到,5年PFS为(62.1±8.6)%,10年PFS为(31±14.3)%,5年OS为(70.5±8.3)%,10年OS为(51.3±13.8)%。少于4个疗程预示不良的总生存期(<0.05)。P53缺失和少于4个疗程与不良的无进展生存期相关(<0.001),多因素分析后预后价值仍然存在[=7.65(95% 1.74至33.60),=0.007;=3.75(95% 1.19至11.80),=0.025]。18例患者(41.9%)化疗后出现2至3级感染,19例患者(44.2%)出现3至4级血液学不良反应。1例患者(2.3%)发生肿瘤溶解综合征。所有不良反应均得到控制或自行恢复。初治CLL患者接受FCR方案治疗有较高的缓解率和良好的生存率,是适合患者的重要治疗选择。