Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer: Results from GOG 184

Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer: Results from GOG 184
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DOI:
10.1016/j.ygyno.2010.08.022
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发表时间:
2010-12-01
影响因子:
4.7
通讯作者:
Spirtos, Nick M.
Spirtos, Nick M.
中科院分区:
医学2区
文献类型:
--
作者:
Cella, David;Huang, Helen;Spirtos, Nick M.

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目标。在COG184中,在顺铂和阿霉素的基础上加入紫杉醇并没有提供额外的临床益处,但与提供者评级的毒性增加有关。我们现在将治疗组和患者报告的神经病变与临床医生报告的神经病变进行比较。在入选的659例患者中,552例随机分为顺铂50 mg/m(2)+阿霉素45 mg/m(2)+G-CSF 5µg/kg(CD),或上述方案加紫杉醇160 mg/m(2)静脉滴注3h(CDP)。患者报告的神经病变在基线、化疗后4周和6个月时用11项癌症治疗神经毒性功能评估(FACT-Ntx)量表进行评估。通过对数据进行线性混合模型拟合,评估患者报告的神经病变随时间的分组差异,以及患者和提供者评级之间的一致性。在调整了神经病变的非显著基线差异后,接受CDP治疗的患者的平均神经病变(FACT-Ntx)评分降低/恶化5.2分(95%CI:4.0-6.5;p
Objective. In COG 184, the addition of paclitaxel to cisplatin and doxorubicin offered no additional clinical benefit, yet was associated with increased provider-rated toxicity. We now compare patient-reported neuropathy between treatment arms and patient reports to the clinician reports of neuropathy.Methods. Of 659 enrolled patients, 552 were randomly assigned to receive either cisplatin 50 mg/m(2)+ doxorubicin 45 mg/m(2)+ G-CSF 5 mu g/kg on days 2-11 ("CD"), or the above regimen plus paclitaxel 160 mg/m(2) infused over 3 h ("CDP"). Patient-reported neuropathy was measured with 11-item Functional Assessment of Cancer Therapy Neurotoxicity (FACT-Ntx) Scale, at baseline, and 4 weeks and 6 months post chemotherapy. Group differences on patient-reported neuropathy over time, and correspondence between patient and provider ratings, were evaluated by fitting linear mixed models to the data.Results. After adjusting for non-significant baseline differences in neuropathy, the average neuropathy (FACT-Ntx) score of CDP-treated patients was 5.2 points lower/worse (95% CI: 4.0-6.5; p