Institute of Oncology, Istanbul University, Istanbul, Turquía.
Department of Medical Oncology, Bakirkoy Education and Research Hospital, Istanbul, Turquía.
Actas Urol Esp (Engl Ed). 2020 Jan-Feb;44(1):27-33. doi: 10.1016/j.acuro.2019.06.007. Epub 2019 Nov 16.
Sunitinib (SUN) and pazopanib (PAZ) are 2 oral tyrosine kinase inhibitors against vascular endothelial growth factor. Their efficacy and safety in metastatic renal cell carcinoma has been proven with phase iii studies. However, real world data is limited. The objective of this study is to assess the clinical benefit of SUN and PAZ in routine practice.
We reviewed the medical records of 79 metastatic renal cell carcinoma patients treated with SUN (50mg/day on 4/2-schedule) or PAZ (800mg/day continuously). Patients were assessed retrospectively at 2 Turkish hospitals between 2006 and 2016.
For the entire cohort median age of patients was 60 (28-87) years and 70% of them were male. The objective response rate and disease control rate in SUN/PAZ groups were 34/37% (P=.96) and 78/87% (P=.046), respectively. With a median follow up duration of 15 months, median progression-free survival and overall survival in SUN/PAZ groups were 8/8 months (P=.83) and 22/21 months (P=.53), respectively. The common all grade toxicities for SUN vs. PAZ were fatigue (59 vs. 74%), skin changes (44 vs. 44%), anemia (35 vs. 42%), hypothyroidism (37 vs. 19%; P=.02) and hypertension (33 vs. 50%). In patients treated with SUN, total grade 3-4 toxicities (mean number of toxic events per patients) were 0.71, whereas in patients treated with PAZ, total grade 3-4 toxicities were 0.11 (P<.001). SUN was associated with an increased incidence of grade 3-4 fatigue (P=.007), anemia (P=.001) and hypothyroidism that needed therapy (P=.02). Dose reduction in 49 and 24% of patients (P=.02), and treatment cessation in 37 and 26% of patients (P=.37) were required in the SUN and PAZ groups, respectively.
In our study, there was no difference in terms of survival outcomes between 2 agents. However, patients treated with SUN had more grade 3-4 adverse events which prompted dose reduction.
舒尼替尼（SUN）和帕唑帕尼（PAZ）是两种针对血管内皮生长因子的口服酪氨酸激酶抑制剂。它们在转移性肾细胞癌中的疗效和安全性已在 III 期研究中得到证实。然而，实际数据有限。本研究的目的是评估 SUN 和 PAZ 在常规实践中的临床获益。
我们回顾了 2006 年至 2016 年期间在土耳其的 2 家医院接受 SUN（50mg/天，4/2 方案）或 PAZ（800mg/天连续）治疗的 79 例转移性肾细胞癌患者的病历。患者进行了回顾性评估。
整个队列中患者的中位年龄为 60 岁（28-87 岁），其中 70%为男性。SUN/PAZ 组的客观缓解率和疾病控制率分别为 34/37%（P=.96）和 78/87%（P=.046）。SUN/PAZ 组的中位随访时间为 15 个月，中位无进展生存期和总生存期分别为 8/8 个月（P=.83）和 22/21 个月（P=.53）。SUN 与 PAZ 常见的所有等级毒性为乏力（59% vs. 74%）、皮肤改变（44% vs. 44%）、贫血（35% vs. 42%）、甲状腺功能减退（37% vs. 19%；P=.02）和高血压（33% vs. 50%）。接受 SUN 治疗的患者中，总 3-4 级毒性（每名患者的平均毒性事件数）为 0.71，而接受 PAZ 治疗的患者中，总 3-4 级毒性为 0.11（P<.001）。SUN 导致 3-4 级乏力（P=.007）、贫血（P=.001）和需要治疗的甲状腺功能减退症（P=.02）的发生率增加。SUN 和 PAZ 组分别有 49%和 24%的患者需要减少剂量（P=.02），37%和 26%的患者需要停止治疗（P=.37）。
在我们的研究中，两种药物在生存结果方面没有差异。然而，接受 SUN 治疗的患者出现更多的 3-4 级不良事件，需要减少剂量。
