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转移性结直肠癌患者接受 mFOLFOX6 联合贝伐珠单抗治疗后,医师评估与患者报告的奥沙利铂诱导的周围神经病变之间的时间依赖性差异:一项事后分析(WJOG4407GSS2)。

Time-dependent discrepancies between physician-assessed and patient-reported oxaliplatin-induced peripheral neuropathy in patients with metastatic colorectal cancer who received mFOLFOX6 plus bevacizumab: a post hoc analysis (WJOG4407GSS2).

机构信息

Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.

Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.

出版信息

Support Care Cancer. 2021 Jul;29(7):3715-3723. doi: 10.1007/s00520-020-05891-2. Epub 2020 Nov 16.

Abstract

PURPOSE

Cumulative sensory neurotoxicity induced by oxaliplatin impairs patients' quality of life and treatment continuation. This study investigated the relationship between physician-assessed and patient-reported oxaliplatin-induced peripheral neuropathy (OIPN) during treatment of metastatic colorectal cancer (mCRC) over time.

METHODS

A post hoc analysis was conducted for 191 patients with mCRC who received mFOLFOX6 plus bevacizumab in the WJOG4407G trial. Physician-assessed OIPN was graded by CTCAE every 2 weeks. Patient-reported OIPN was assessed with the FACT/GOG-Ntx (11 items, best score 44) at baseline and at 3, 6, and 9 months. Physician underestimation was defined as when the highest scores of the NTX1-4 sensory subscale/CTCAE grade were 2/0, 3/0-1, or 4/0-1, and overestimation as 0/2-3, 1/2-3, or 2/3.

RESULTS

The median total dose (range) of oxaliplatin was 762 (85-5950) mg/m. Overall, the least squares mean of FACT/GOG-Ntx scores (standard error), estimated by a linear mixed model, were 36 (0.8), 34 (0.9), 29 (1.0), and 27 (1.1) for CTCAE grades 0, 1, 2, and 3, respectively. FACT/GOG-Ntx scores were weakly-to-moderately correlated with CTCAE grade (Spearman's r = - 0.24 [p = 0.0026], - 0.46 [p < 0.0001], and - 0.56 [p < 0.0001] at 3, 6, and 9 months, respectively). OIPN was underestimated in 85/159 (54%), 43/109 (39%), and 18/69 (26%) patients at 3, 6, and 9 months, respectively. In contrast, OIPN was overestimated in less than 5% of the patients at any time.

CONCLUSION

During early treatment, physician underestimation of OIPN in patients with mCRC is likely.

摘要

目的

奥沙利铂引起的累积感觉神经毒性会损害患者的生活质量并影响治疗的持续时间。本研究旨在探讨转移性结直肠癌(mCRC)患者在接受治疗过程中,医生评估的奥沙利铂诱导周围神经病变(OIPN)与患者报告的 OIPN 之间的关系。

方法

对 WJOG4407G 试验中 191 例接受 mFOLFOX6 联合贝伐珠单抗治疗的 mCRC 患者进行了一项事后分析。每 2 周通过 CTCAE 对 OIPN 进行分级。在基线以及 3、6 和 9 个月时,采用 FACT/GOG-Ntx(11 项,满分 44 分)评估患者报告的 OIPN。将 NTX1-4 感觉子量表/CTCAE 分级的最高评分定义为 2/0、3/0-1 或 4/0-1 时为低估,定义为 0/2-3、1/2-3 或 2/3 时为高估。

结果

奥沙利铂的中位总剂量(范围)为 762(85-5950)mg/m²。通过线性混合模型估计,FACT/GOG-Ntx 评分(标准误差)的最小二乘平均值分别为 CTCAE 分级 0、1、2 和 3 时的 36(0.8)、34(0.9)、29(1.0)和 27(1.1)。FACT/GOG-Ntx 评分与 CTCAE 分级呈弱至中度相关(Spearman's r 分别为-0.24[p=0.0026]、-0.46[p<0.0001]和-0.56[p<0.0001],分别在 3、6 和 9 个月时)。3、6 和 9 个月时,OIPN 分别有 85/159(54%)、43/109(39%)和 18/69(26%)例患者被低估。相比之下,OIPN 在任何时间点均被低估的患者不足 5%。

结论

在早期治疗中,医生对 mCRC 患者 OIPN 的评估可能存在低估。

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