Miyake Hideaki, Imai Satoshi, Harada Ken-Ichi, Fujisawa Masato
Division of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Division of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Clin Genitourin Cancer. 2016 Feb;14(1):e19-24. doi: 10.1016/j.clgc.2015.08.002. Epub 2015 Aug 15.
UNLABELLED: Several adverse events (AEs) are known to be commonly observed during treatment with different tyrosine kinase inhibitors (TKIs) in patients with metastatic renal cell carcinoma (mRCC) patients. However, no significant correlation appears present in the profiles of such AEs between first- and second-line TKI therapies. Therefore, a second-line targeted agent for patients with mRCC could be selected irrespective of the AE profile during first-line TKI therapy. BACKGROUND: Several adverse events (AEs) commonly observed during treatment with different tyrosine kinase inhibitors (TKIs). The objective of the present study was to investigate whether the appearance of such AEs during treatment with first-line TKIs significantly affects the occurrence of AEs during second-line TKI therapy for patients with metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: The present study included 154 consecutive patients with mRCC treated with second-line TKIs after the discontinuation of first-line TKIs. The association of AEs, including diarrhea, fatigue, hand-foot syndrome, hypertension, and hypothyroidism, between first- and second-line therapies was analyzed in these 154 patients. RESULTS: For all 5 AEs assessed in the present study, the proportion of patients experiencing AEs or those grade ≥ 3 during second-line TKI therapy was not significantly different among the following 3 groups: patients without AEs, those with grade ≤ 2 AEs, and those with grade ≥ 3 AEs during first-line TKI therapy. Furthermore, no significant difference was seen in progression-free or overall survival after the introduction of second-line TKIs between patients with and without grade ≥ 3 AEs during treatment with first-line TKIs. CONCLUSION: The incidence of AEs or grade ≥ 3 AEs during second-line TKI therapy are not dependent on the profiles of AEs during first-line TKI therapy in patients with mRCC. Therefore, AEs that occur during first-line TKI therapy should not affect the selection of second-line targeted agents for patients with mRCC.
未标注：已知在转移性肾细胞癌（mRCC）患者使用不同酪氨酸激酶抑制剂（TKI）治疗期间通常会观察到几种不良事件（AE）。然而，一线和二线TKI治疗中此类不良事件的特征之间似乎没有显著相关性。因此，mRCC患者的二线靶向药物可以不考虑一线TKI治疗期间的AE特征来选择。 背景：在使用不同酪氨酸激酶抑制剂（TKI）治疗期间通常会观察到几种不良事件（AE）。本研究的目的是调查一线TKI治疗期间此类AE的出现是否会显著影响转移性肾细胞癌（mRCC）患者二线TKI治疗期间AE的发生。 患者和方法：本研究纳入了154例一线TKI停药后接受二线TKI治疗的连续性mRCC患者。在这154例患者中分析了一线和二线治疗之间不良事件的相关性，包括腹泻、疲劳、手足综合征、高血压和甲状腺功能减退。 结果：对于本研究评估的所有5种不良事件，在以下3组患者中，二线TKI治疗期间发生不良事件或不良事件≥3级的患者比例无显著差异：一线TKI治疗期间无不良事件的患者、不良事件≤2级的患者和不良事件≥3级的患者。此外，一线TKI治疗期间有和无不良事件≥3级的患者在引入二线TKI后的无进展生存期或总生存期无显著差异。 结论：mRCC患者二线TKI治疗期间不良事件或不良事件≥3级的发生率不依赖于一线TKI治疗期间的AE特征。因此，一线TKI治疗期间发生的不良事件不应影响mRCC患者二线靶向药物的选择。
Acta Med Indones. 2016-10
Transl Oncol. 2020-6
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