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Efficacy and Safety of Individualized Schedule of Sunitinib by Drug Monitoring in Patients with Metastatic Renal Cell Carcinoma
Cancer Management and Research ( IF 3.3 ) Pub Date : 2021-08-31 , DOI: 10.2147/cmar.s327029 Xudong Zhu 1, 2 , Xingming Zhang 1, 2 , Guangxi Sun 1, 2 , Zhenhua Liu 1, 2 , Haoran Zhang 1, 2 , Yaojing Yang 1, 2 , Yuchao Ni 1, 2 , Jindong Dai 1, 2 , Sha Zhu 1, 2 , Junru Chen 1, 2 , Jinge Zhao 1, 2 , Zhipeng Wang 1, 2 , Hao Zeng 1, 2 , Pengfei Shen 1, 2
Cancer Management and Research ( IF 3.3 ) Pub Date : 2021-08-31 , DOI: 10.2147/cmar.s327029 Xudong Zhu 1, 2 , Xingming Zhang 1, 2 , Guangxi Sun 1, 2 , Zhenhua Liu 1, 2 , Haoran Zhang 1, 2 , Yaojing Yang 1, 2 , Yuchao Ni 1, 2 , Jindong Dai 1, 2 , Sha Zhu 1, 2 , Junru Chen 1, 2 , Jinge Zhao 1, 2 , Zhipeng Wang 1, 2 , Hao Zeng 1, 2 , Pengfei Shen 1, 2
Affiliation
Purpose: To investigate the survival benefit and safety of individualized schedules for sunitinib in patients with metastatic renal cell carcinoma (mRCC) through plasma concentration monitoring.
Methods: A total of 105 patients with mRCC were enrolled. The schedule was adjusted in two ways: therapeutic drug monitoring (TDM) and toxicity-adjusted schedule (TAS). One group of patients were without any schedule adjustment (maintained schedule, MAS). Progression-free survival (PFS), overall survival (OS), tumor response, and adverse events (AEs) were compared. The relationship between AEs and steady-state concentration or consecutive monitoring curves was explored. Further monitoring of individualized schedules was also conducted.
Results: Based on the plasma concentration, the schedules of 18 patients were adjusted in the TDM group. The schedules were adjusted in 37 patients due to severe AEs in the TAS group, while 50 patients were without any schedule adjustment. The median PFS and OS were better in the TDM group than the other two groups (p = 0.001 and p = 0.004, respectively). Univariate and multivariate analyses indicated that TDM could decrease the risk of death independently (p = 0.026). Moreover, the incidence of grades 3/4 AEs decreased from 88.9% to 33.3% in the TDM group (p = 0.001). Sunitinib concentration in 150– 200ng/mL was regarded as a “transitional zone” due to severe AEs mainly happened when concentration elevated over it. After TDM, further plasma concentration monitoring indicated that individualized schedules enabled sunitinib concentration to fluctuate in a much safer range.
Conclusion: Treatment-related toxicities could be minimized through plasma concentration monitoring. Patients with adjusted schedules by therapeutic drug monitoring could achieve better survival benefits.
Keywords: sunitinib, plasma concentration, metastatic renal cell carcinoma, individualized schedule adjustment, clinical outcomes
中文翻译：
通过药物监测对转移性肾细胞癌患者进行舒尼替尼个体化时间表的疗效和安全性
目的：通过血浆浓度监测研究转移性肾细胞癌（mRCC）患者接受舒尼替尼个体化治疗的生存获益和安全性。
方法：共纳入 105 例 mRCC 患者。时间表以两种方式调整：治疗药物监测（TDM）和毒性调整时间表（TAS）。一组患者没有任何时间表调整（维持时间表，MAS）。比较了无进展生存期（PFS）、总生存期（OS）、肿瘤反应和不良事件（AE）。探索了 AE 与稳态浓度或连续监测曲线之间的关系。还进行了对个性化时间表的进一步监测。
结果：根据血浆浓度，调整了 TDM 组 18 名患者的时间表。由于 TAS 组中的严重 AE，37 名患者的日程安排进行了调整，而 50 名患者没有任何日程安排调整。TDM 组的中位 PFS 和 OS 优于其他两组（分别为 p = 0.001 和 p = 0.004）。单变量和多变量分析表明，TDM 可以独立降低死亡风险（p = 0.026）。此外，TDM 组 3/4 级 AE 的发生率从 88.9% 降至 33.3% (p = 0.001)。舒尼替尼浓度在 150-200ng/mL 被认为是一个“过渡区”，因为严重的 AE 主要发生在浓度升高时。在 TDM 之后，
结论：通过血浆浓度监测可以最大限度地减少治疗相关的毒性。通过治疗药物监测调整时间表的患者可以获得更好的生存益处。
关键词：舒尼替尼，血浆浓度，转移性肾细胞癌，个体化时间表调整，临床结果
更新日期：2021-08-31
Methods: A total of 105 patients with mRCC were enrolled. The schedule was adjusted in two ways: therapeutic drug monitoring (TDM) and toxicity-adjusted schedule (TAS). One group of patients were without any schedule adjustment (maintained schedule, MAS). Progression-free survival (PFS), overall survival (OS), tumor response, and adverse events (AEs) were compared. The relationship between AEs and steady-state concentration or consecutive monitoring curves was explored. Further monitoring of individualized schedules was also conducted.
Results: Based on the plasma concentration, the schedules of 18 patients were adjusted in the TDM group. The schedules were adjusted in 37 patients due to severe AEs in the TAS group, while 50 patients were without any schedule adjustment. The median PFS and OS were better in the TDM group than the other two groups (p = 0.001 and p = 0.004, respectively). Univariate and multivariate analyses indicated that TDM could decrease the risk of death independently (p = 0.026). Moreover, the incidence of grades 3/4 AEs decreased from 88.9% to 33.3% in the TDM group (p = 0.001). Sunitinib concentration in 150– 200ng/mL was regarded as a “transitional zone” due to severe AEs mainly happened when concentration elevated over it. After TDM, further plasma concentration monitoring indicated that individualized schedules enabled sunitinib concentration to fluctuate in a much safer range.
Conclusion: Treatment-related toxicities could be minimized through plasma concentration monitoring. Patients with adjusted schedules by therapeutic drug monitoring could achieve better survival benefits.
Keywords: sunitinib, plasma concentration, metastatic renal cell carcinoma, individualized schedule adjustment, clinical outcomes
中文翻译：
通过药物监测对转移性肾细胞癌患者进行舒尼替尼个体化时间表的疗效和安全性
目的：通过血浆浓度监测研究转移性肾细胞癌（mRCC）患者接受舒尼替尼个体化治疗的生存获益和安全性。
方法：共纳入 105 例 mRCC 患者。时间表以两种方式调整：治疗药物监测（TDM）和毒性调整时间表（TAS）。一组患者没有任何时间表调整（维持时间表，MAS）。比较了无进展生存期（PFS）、总生存期（OS）、肿瘤反应和不良事件（AE）。探索了 AE 与稳态浓度或连续监测曲线之间的关系。还进行了对个性化时间表的进一步监测。
结果：根据血浆浓度，调整了 TDM 组 18 名患者的时间表。由于 TAS 组中的严重 AE，37 名患者的日程安排进行了调整，而 50 名患者没有任何日程安排调整。TDM 组的中位 PFS 和 OS 优于其他两组（分别为 p = 0.001 和 p = 0.004）。单变量和多变量分析表明，TDM 可以独立降低死亡风险（p = 0.026）。此外，TDM 组 3/4 级 AE 的发生率从 88.9% 降至 33.3% (p = 0.001)。舒尼替尼浓度在 150-200ng/mL 被认为是一个“过渡区”，因为严重的 AE 主要发生在浓度升高时。在 TDM 之后，
结论：通过血浆浓度监测可以最大限度地减少治疗相关的毒性。通过治疗药物监测调整时间表的患者可以获得更好的生存益处。
关键词：舒尼替尼，血浆浓度，转移性肾细胞癌，个体化时间表调整，临床结果
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