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剂量密集型紫杉醇联合卡铂治疗引起的重度贫血是否会影响上皮性卵巢癌患者的生存?日本妇科肿瘤学组 3016 试验的回顾性分析。

Does severe anemia caused by dose-dense paclitaxel-Carboplatin combination therapy have an effect on the survival of patients with epithelial ovarian cancer? Retrospective analysis of the Japanese gynecologic oncology group 3016 trial.

机构信息

Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Iwate, Japan.

出版信息

Int J Gynecol Cancer. 2011 Dec;21(9):1585-91. doi: 10.1097/IGC.0b013e318229266a.

DOI:10.1097/IGC.0b013e318229266a
PMID:22123713
Abstract

INTRODUCTION

To evaluate the incidence of anemia in patients with epithelial ovarian cancer receiving paclitaxel-carboplatin combination therapy (TC) using data from the Japanese Gynecologic Oncology Group (JGOG) 3016 trial, and to examine the effect of severe anemia on survival during dose-dense TC.

METHODS

Retrospective analysis was conducted in patients enrolled in the JGOG 3016 trial who underwent at least one cycle of the protocol therapy (n = 622). Hemoglobin values at enrollment and during each cycle of TC were collected. One-to-one matching was performed between patients with and patients without grade 3/4 anemia during TC (anemia and nonanemia groups) to adjust the baseline characteristics of the patients. The cumulative survival curve and median progression-free survival were estimated using the Kaplan-Meier method.

RESULTS

Grades 2 to 4 anemia was observed in 19.8% of patients before first-line TC. The incidence of grade 3/4 anemia rapidly increased to 56.1% after the fourth cycle of dose-dense TC. After matching, the median progression-free survival in the anemia (hemoglobin <8.0 g/dL) and nonanemia (hemoglobin >8.0 g/dL) groups was 777 and 1100 days, respectively (P = 0.3493) for patients receiving dose-dense TC. The median progression-free survival in patients receiving conventional TC was similar between the 2 groups.

CONCLUSIONS

The difference in progression-free survival between patients with epithelial ovarian cancer with and those without severe anemia during TC was not statistically significant, but for patients receiving dose-dense TC, severe anemia seems to have prognostic relevance. Prospective trials are needed to investigate whether the optimal management of chemotherapy-induced anemia, including appropriate use of erythropoiesis-stimulating agents, would further improve the survival of patients with ovarian cancer receiving dose-dense TC.

摘要

简介

本研究旨在利用日本妇科肿瘤学组(JGOG)3016 试验的数据评估接受紫杉醇-卡铂联合治疗(TC)的上皮性卵巢癌患者贫血的发生率,并探讨在 TC 密集剂量治疗期间严重贫血对生存的影响。

方法

对 JGOG 3016 试验中接受至少一个疗程方案治疗的患者(n=622)进行回顾性分析。收集患者入组时和 TC 每个周期的血红蛋白值。对 TC 期间出现 3/4 级贫血的患者(贫血组)和未出现 3/4 级贫血的患者(非贫血组)进行 1:1 匹配,以调整患者的基线特征。采用 Kaplan-Meier 法估计累积生存曲线和中位无进展生存期。

结果

在一线 TC 前,19.8%的患者出现 2-4 级贫血。在密集剂量 TC 的第 4 个周期后,3/4 级贫血的发生率迅速增加至 56.1%。匹配后,在接受密集剂量 TC 的患者中,贫血组(血红蛋白<8.0 g/dL)和非贫血组(血红蛋白>8.0 g/dL)的中位无进展生存期分别为 777 和 1100 天(P=0.3493)。接受常规 TC 的患者中,两组的中位无进展生存期相似。

结论

在 TC 期间有严重贫血和无严重贫血的上皮性卵巢癌患者的无进展生存期差异无统计学意义,但对于接受密集剂量 TC 的患者,严重贫血似乎具有预后意义。需要前瞻性试验来研究化疗引起的贫血的最佳管理,包括适当使用促红细胞生成素刺激剂,是否会进一步改善接受密集剂量 TC 的卵巢癌患者的生存。

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