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氟达拉滨、米托蒽醌和地塞米松治疗难治性或复发性多发性骨髓瘤的初步报告

[Preliminary report of fludarabine, mitoxantrone and dexamethasone in treating refractory or relapsed multiple myeloma].

作者信息

Luo Shao-Kai, Li Juan, Hong Wen-De, Zhao Ying, Tong Xiu-Zhen

机构信息

Department of Hematology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510080, P. R. China.

出版信息

Ai Zheng. 2005 Dec;24(12):1518-21.

Abstract

BACKGROUND & OBJECTIVE: Multiple myeloma has low complete remission rate and high recurrence rate. Recurrence or relapse of the disease is almost inevitable for most of the patients after several cycles of combined chemotherapy. This study was designed to compare efficacy of fludarabine-based regimen (fludarabine, mitoxantrone and dexamethasone) with that of pirarubicin, vincristine and dexamethasone (VAD) on refractory or relapsed multiple myeloma, and analyze their toxicities.

METHODS

Twenty-two patients who had received VAD regimen were taken as a historical control group. A total of 11 patients received FND regimen. The differences between FND group and VAD group were observed and compared. The following indexes were assessed before, during, and after treatment: the partial remission (PR) rate, total response rate, time to achieve PR, the number of patients and time of serum M-component drop to more than 50% of the pre-treatment value, the ratio of myeloma cells in bone marrow drop to less than 5% or more than 80% of pre-treatment level, and the hemoglobin level increase to more than 20 g/Lû the white blood cell and platelet count of the peripheral blood, serum calcium, creatinine, beta2-microglobin and glutamic-oxaloacetic transaminase (GPT) level, adverse events were also analyzed.

RESULTS

The PR rate was significantly higher in FND group than in VAD group (45.5% vs. 22.7%, P<0.05). The median time to achieve PR was significantly longer in FND group than in VAD group (76 days vs. 68 days, P<0.05). The occurrence rates of M-component decrease and hemoglobin elevation were significantly higher in FND group than in VAD group [45.5% vs. 22.7%, and 54.5% vs. 18.2%, P<0.05]. There were no significant differences in serum calcium, creatinine and GPT level pre- and post-treatment between the 2 groups. The level of serum beta2-microglobin after treatment was significantly lower than that before treatment in FND group [(1 042.8+/-72.3) microg/L vs. (2 350.2+/-184.0) microg/L, P<0.05]. The nadir white blood cell count was significantly lower in FND group than in VAD group [(0.9+/-0.46)x10(9)/L vs. (2.09+/-0.6)x10(9)/L, P<0.05], and the occurrence rates of fever and cough was significantly higher in FND group than in VAD group (36.4% vs. 4.5%, 45.5% vs. 9.0%, P<0.05).

CONCLUSIONS

Compare with VAD regimen, FND regimen may enhance the PR rate of refractory or relapsed multiple myeloma patients, but it takes longer time to achieve PR, and shows obvious bone marrow inhibition, with no significant renal or hepatic toxicity. FND regimen is effective and safe in treating refractory or relapsed multiple myeloma.

摘要

背景与目的

多发性骨髓瘤完全缓解率低,复发率高。多数患者经多个周期联合化疗后,疾病复发或进展几乎不可避免。本研究旨在比较氟达拉滨为主的方案(氟达拉滨、米托蒽醌和地塞米松)与吡柔比星、长春新碱和地塞米松(VAD)方案治疗难治性或复发性多发性骨髓瘤的疗效,并分析其毒性。

方法

将22例接受过VAD方案治疗的患者作为历史对照组。共11例患者接受FND方案治疗。观察并比较FND组与VAD组之间的差异。在治疗前、治疗期间和治疗后评估以下指标:部分缓解(PR)率、总缓解率、达到PR的时间、血清M蛋白成分下降至治疗前值50%以上的患者数量和时间、骨髓中骨髓瘤细胞比例降至治疗前水平的5%以下或80%以上、血红蛋白水平升高至20 g/L以上、外周血白细胞和血小板计数、血清钙、肌酐、β2-微球蛋白和谷丙转氨酶(GPT)水平,同时分析不良事件。

结果

FND组PR率显著高于VAD组(45.5%对22.7%,P<0.05)。FND组达到PR的中位时间显著长于VAD组(76天对68天,P<0.05)。FND组M蛋白成分下降和血红蛋白升高的发生率显著高于VAD组[45.5%对22.7%,以及54.5%对18.2%,P<0.05]。两组治疗前后血清钙、肌酐和GPT水平无显著差异。FND组治疗后血清β2-微球蛋白水平显著低于治疗前[(1 042.8±72.3)μg/L对(2 350.2±184.0)μg/L,P<0.05]。FND组最低点白细胞计数显著低于VAD组[(0.9±0.46)×10⁹/L对(2.09±0.6)×10⁹/L,P<0.05],FND组发热和咳嗽的发生率显著高于VAD组(36.4%对4.5%,45.5%对9.0%,P<0.05)。

结论

与VAD方案相比,FND方案可提高难治性或复发性多发性骨髓瘤患者的PR率,但达到PR所需时间较长,且显示出明显的骨髓抑制,无显著肾毒性或肝毒性。FND方案治疗难治性或复发性多发性骨髓瘤有效且安全。

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