儿童急性淋巴细胞白血病南方ALL99方案临床疗效分析

Analysis of therapeutic effectiveness of Nanfang ALL 99 protocol in childhood acute lymphoblastic leukemia patients

目的对82例儿童急性淋巴细胞白血病(acute lymphoblastic leukemia,ALL)治疗结果进行分析,探讨如何提高儿童ALL无病生存率。方法应用南方ALL99方案治疗82例ALL患儿。该方案引进德国BFM95和香港-新加坡ALL97方案,作了少许改动,形成南方ALL99方案。改动方面包括将三联鞘注中的氢化可的松换成地塞米松,将外院不规则化疗过的标危患者按中危治疗,将每一疗程开始时的中性粒细胞和血小板的标准提高到中性粒细胞≥1×109/L,血小板≥100×109/L。采用SPSS软件进行寿命表法分析。结果对1999年4月至2003年9月收治的82例ALL患儿按南方ALL99方案进行治疗,78例获完全缓解(completeremission,CR),CR率为95%;13例患者因经济困难或其他原因失访。其中按南方ALL99方案坚持治疗的69例,预期2年无病生存率91%,预期5年以上无病生存率75%;因感染死亡3例(死亡率为4%),复发死亡6例。结论引进德国BFM95和香港-新加坡ALL97方案而成的南方ALL99方案治疗儿童ALL疗效好,化疗相关死亡率低,该方案对中国人耐受性好,值得推广应用。

Objective With more precise diagnostic criteria and risk classifications, more effective therapy administered in clinical trials, and better supportive care, the outcome of children with acute lymphoblastic leukemia （ALL） has been improved dramatically. Today, approximately 80% of children treated for this disease in developed countries enjoy long-term event free survival （EFS） and in most instances, would be cured. In this study, treatment outcome of 82 childhood ALL patients in the hospital were analyzed, and ways for how to improve the EFS rate in childhood ALL were explored. Methods Eighty-two patients with ALL were enrolled into the Nanfang ALL 99 protocol which derived from German BFM ALL 95 and Hong Kong-Singapore acute lymphoblastic leukemia 97 （HK-SG ALL 97 ）. Dexamethasone instead of hydrocortisone was used for triple intrathecal therapy. Standard at risk patients who had been irregularly treated in other hospitals for short periods of time were classified as at intermediate risk. When ANC was ≥ 1.0 × 10^9/L and platelet ≥ 100 × 10^9/L, chemotherapy was started. Life table method was used to estimate survival rate and statistical analysis was done by using software SPSS for Windows. Results From March 1999 to September 2003, 82 childhood ALL patients were treated with the Nanfang ALL 99 protocol and 78 （95. 1% ） patients attained complete remission （CR） in a median time of 33 days. Out of 82 patients, 13 patients dropped out of the the Nanfang ALL 99 protocol because of financial difficulty or other reasons. Sixty nine patients were consecutively treated with the Nanfang ALL 99 protocol. The overall EFS rate at 2 years,3 years and 5 years were 91.3%, 85. 9% and 75.2%, respectively, with a median observation duration of 34 months. Three patients died of complications （4. 3% ）. The disease relapsed in 6 patients and they died finally. Conclusion The outcome of patients treated with the Nanfang ALL 99 protocol was favorable, and the mortality rate of this chemotherapeutic protocol was low. This protocol was well tolerated by Chinese patients and therefore the protocol is worthy of application in China.