Ezz El Din Mai
Department of Clinical Oncology and Nuclear Medicine, Ain-Shams University Hospitals, Cairo, Egypt.
Clin Genitourin Cancer. 2017 Jun;15(3):e455-e462. doi: 10.1016/j.clgc.2016.10.010. Epub 2017 Jan 4.
Sunitinib first-line treatment is one of the standards of care in metastatic renal cell carcinoma (mRCC). However, the adverse events associated with its use can hinder adequate dosing and hence have detrimental effects on treatment outcome. Alternative schedules, such as 2-weeks-on treatment and 1-week-off treatment (2/1 schedule), might solve this dilemma. Therefore, an analysis was performed to compare both schedules in terms of toxicity and efficacy.
Data regarding first-line sunitinib treatment of mRCC patients using the 4/2 and 2/1 schedules were collected. The data from 56 patients were reviewed. Of the 56 patients, 30 started sunitinib using the 4/2 schedule (group 1) and 26 using the 2/1 schedule (group 2). The primary endpoint was toxicity assessment. The secondary endpoints were the response rate, progression-free survival, and overall survival.
The overall incidence of adverse events was less for the 2/1 group, and the difference reached statistical significance for fatigue (P = .018), hand-foot syndrome (P = .008), mucositis (P = .010), hypertension (P = .038), diarrhea (P = .03), and thrombocytopenia (P = .023). The objective response rates were better for group 2 (modified schedule) in the first and subsequent response evaluations. The median progression-free survival was 15 months and 17 months in groups 1 and 2, respectively. The median overall survival was 24 months and 23 months for groups 1 and 2, respectively.
The alternative 2/1 schedule of sunitinib demonstrated improved toxicity compared with the traditional 4/2 schedule, with similar survival.
舒尼替尼一线治疗是转移性肾细胞癌（mRCC）的标准治疗方案之一。然而，其使用过程中相关的不良事件可能会妨碍足量给药，从而对治疗结果产生不利影响。替代给药方案，如2周治疗、1周停药（2/1方案），可能会解决这一难题。因此，进行了一项分析以比较两种给药方案在毒性和疗效方面的差异。
收集了使用4/2和2/1方案一线治疗mRCC患者的舒尼替尼相关数据。对56例患者的数据进行了回顾。在这56例患者中，30例开始使用4/2方案接受舒尼替尼治疗（第1组），26例使用2/1方案（第2组）。主要终点是毒性评估。次要终点是缓解率、无进展生存期和总生存期。
2/1组不良事件的总体发生率较低，疲劳（P = .018）、手足综合征（P = .008）、黏膜炎（P = .010）、高血压（P = .038）、腹泻（P = .03）和血小板减少症（P = .023）方面的差异具有统计学意义。在首次及后续缓解评估中，第2组（改良方案）的客观缓解率更高。第1组和第2组的中位无进展生存期分别为15个月和17个月。第1组和第2组的中位总生存期分别为24个月和23个月。
与传统的4/2方案相比，舒尼替尼的替代2/1方案毒性有所改善，生存期相似。
