培门冬酶治疗儿童初发急性淋巴细胞白血病的远期疗效

目的观察含培门冬酶注射液的VDPAP方案诱导治疗儿童急性淋巴细胞白血病(ALL)的远期疗效。方法选择初发ALL患儿,随机分成两组:试验组采用含国产培门冬酶注射液的VDPAP方案诱导治疗,对照组采用含左旋门冬酰胺酶(L-Asp)的VDLP方案。统计一疗程完全缓解(CR)率,并采用Kaplan-Meier法评估患儿的总生存(OS)率及疾病无进展生存(PFS)率,组间差异用Log-rank检验。结果入组患儿51例,可评估疗效者46例,其中试验组27例,CR率为96%,总有效率为96%;对照组19例,CR率为95%,总有效率为100%,两组间差异无统计学意义。试验组3年预计OS率为(78.8±8.4)%,5年预计OS率为(68.9±11.8)%;对照组3年预计OS率为(88.9±7.4)%,5年预计OS率为(82.1±9.5)%,两组间差异无统计学意义。试验组3年预计PFS率为(74.1±9.1)%,5年预计PFS率为(63.5±12.5)%;对照组3年预计PFS率为(83.3±8.8)%,5年预计PFS率为(77.8±9.8)%,两组间差异无统计学意义。结论含培门冬酶的VDPAP方案与含L-Asp的VDLP方案诱导治疗儿童ALL,其CR率及远期疗效相似,可以作为儿童ALL的一线治疗方案。

Long-term efficacy of polyethylene glycol conjugated asparaginase(PEG-Asp) in newly diagnosed childhood acute lymphoblastic leukemia(ALL)

Objective To evaluate the long-term efficacy of VDPAP induction regimen containing PEG-Asp in newly diagnosed childhood acute lymphoblastic leukemia(ALL).Methods Fifty one children with newly diagnosed ALL were randomized to two groups: the test group received PEG-Asp-containing VDPAP regimen,and the control group received L-asparaginase(L-asp)-containing VDLP regimen for induction therapy.The complete remission(CR) rate was observed.Kaplan-Meier method was used to evaluate the overall survival(OS) rate and progress free survival(PFS) rate.The differences between two groups were analyzed by 2-sided log-rank test.Results Both CR rate and total effective rate in test group were 96%,compared with 95% and 100% in control group respectively.There was no statistical significance in two groups(P>0.05).The estimated 3-year OS rates were(78.8±8.4)% and(88.9±7.4)%,5-year OS rates were(68.9±11.8)% and(82.1±9.5)%,the estimated 3-year PFS rates were(74.1±9.1)% and(83.3±8.8)%,5-year PFS rates were(63.5±12.5)% and(77.8±9.8)%(P>0.05) in test and control groups,respectively.There was no statistical significance in two groups(P>0.05).Conclusion The effectiveness of PEG-Asp and L-asp for treatment of pediatric ALL is similar.PEG-Asp could be used as the first-line treatment in pediatric ALL.