Sharma T, Tajzler C, Kapoor A
Division of Urology, Department of Surgery, McMaster University, Hamilton, ON.
Curr Oncol. 2018 Oct;25(5):e444-e453. doi: 10.3747/co.25.3865. Epub 2018 Oct 31.
Although surgical resection remains the standard of care for localized kidney cancers, a significant proportion of patients experience systemic recurrence after surgery and hence might benefit from effective adjuvant therapy. So far, several treatment options have been evaluated in adjuvant clinical trials, but only a few have provided promising results. Nevertheless, with the recent development of targeted therapy and immunomodulatory therapy, a series of clinical trials are in progress to evaluate the potential of those novel agents in the adjuvant setting. In this paper, we provide a narrative review of the progress in this field, and we summarize the results from recent adjuvant trials that have been completed.
A literature search was conducted. The primary search strategy at the medline, Cochrane reviews, and http://ClinicalTrials.gov/databases included the keywords "adjuvant therapy," "renal cell carcinoma," and "targeted therapy or/and immunotherapy."
Data from the s-trac study indicated that, in the "highest risk for recurrence" patient population, disease-free survival was increased with the use of adjuvant sunitinib compared with placebo. The assure trial showed no benefit for adjuvant sunitinib or sorafenib in the "intermediate- to high-risk" patient population. The ariser (adjuvant girentuximab) and protect (adjuvant pazopanib) trials indicated no survival benefit, but subgroup analyses in both trials recommended further investigation. The inconsistency in some of the current results can be attributed to a variety of factors pertaining to the lack of standardization across the trials. Nevertheless, patients in the "high risk of recurrence" category after surgery for their disease would benefit from a discussion about the potential benefits of adjuvant treatment and enrolment in ongoing adjuvant trials.
尽管手术切除仍是局限性肾癌的标准治疗方法,但相当一部分患者术后会出现全身复发,因此可能受益于有效的辅助治疗。到目前为止,已有几种治疗方案在辅助治疗的临床试验中得到评估,但只有少数取得了有前景的结果。然而,随着靶向治疗和免疫调节治疗的最新进展,一系列临床试验正在进行,以评估这些新型药物在辅助治疗中的潜力。在本文中,我们对该领域的进展进行了叙述性综述,并总结了近期已完成的辅助治疗试验的结果。
进行了文献检索。在Medline、Cochrane系统评价和http://ClinicalTrials.gov数据库中的主要检索策略包括关键词“辅助治疗”、“肾细胞癌”以及“靶向治疗或/和免疫治疗”。
来自S-TRAC研究的数据表明,在“复发风险最高”的患者群体中,与安慰剂相比,使用辅助性舒尼替尼可提高无病生存率。ASSURE试验表明,在“中高危”患者群体中,辅助性舒尼替尼或索拉非尼并无益处。ARISER(辅助性吉伦妥昔单抗)和PROTECT(辅助性帕唑帕尼)试验表明并无生存获益,但两项试验的亚组分析均建议进一步研究。目前部分结果的不一致可归因于各项试验缺乏标准化的多种因素。尽管如此,术后疾病处于“高复发风险”类别的患者将受益于关于辅助治疗潜在益处的讨论,并可参与正在进行的辅助治疗试验。