Nagyiványi Krisztián, Budai Barna, Küronya Zsófia, Gyergyay Fruzsina, Bíró Krisztina, Bodrogi István, Géczi Lajos
National Institute of Oncology, Ráth Gy. u. 7-9, Budapest, 1122, Hungary.
Pathol Oncol Res. 2019 Jan;25(1):241-247. doi: 10.1007/s12253-017-0345-9. Epub 2017 Oct 30.
In practice it is still not clear whether a drug holiday in sunitinib (Su) treatment can be safety, without impairing the overall outcome of patients with metastatic renal cell carcinoma (mRCC). The aim was to retrospectively evaluate the outcome in patients who restarted Su after an interruption of ≥3 months and a combined analysis of case studies from literature. From 556 patients treated between January 2006 and March 2016 a group of 38 patients were selected whose treatment was interrupted for other reasons than disease progression. During interruption Su was restarted in case of RECIST-defined progression. The primary objective was the objective response (OR) and progression free survival (PFS) of baseline and restarted therapy. The secondary objective was the overall survival (OS) calculated from the start of baseline treatment. Multivariate survival analysis was also applied. The major causes of interruption were toxicity (39%) and patient' choice (24%). Median duration of interruption was 7 (range 3-41) months. The OR of baseline and restarted treatment was 63% and 39%, respectively. After a median follow-up of 76 (95% CI 65-79) months the median PFS of baseline and restarted treatment was 21 (18-27) and 14 (10-18) months, respectively. The median OS was 61 (56-80) months. In multivariate analysis the lack of OR of restated treatment was an independent predictor of shorter PFS of restarted Su. According to our findings and also on combined case studies from literature restarted Su can be effective in selected cases of patients who progressed during treatment holiday.
在实际应用中，尚不清楚舒尼替尼（Su）治疗中的药物假期是否安全，且不会损害转移性肾细胞癌（mRCC）患者的总体治疗效果。本研究旨在回顾性评估中断治疗≥3个月后重新开始使用舒尼替尼的患者的治疗效果，并对文献中的病例研究进行综合分析。在2006年1月至2016年3月期间接受治疗的556例患者中，选择了38例因疾病进展以外的其他原因中断治疗的患者。在中断治疗期间，若根据实体瘤疗效评价标准（RECIST）确定疾病进展，则重新开始使用舒尼替尼。主要观察指标为基线治疗和重新开始治疗后的客观缓解率（OR）及无进展生存期（PFS）。次要观察指标为从基线治疗开始计算的总生存期（OS）。同时进行多因素生存分析。中断治疗的主要原因是毒性反应（39%）和患者选择（24%）。中断治疗的中位持续时间为7（3-41）个月。基线治疗和重新开始治疗后的OR分别为63%和39%。在中位随访76（95%CI 65-79）个月后，基线治疗和重新开始治疗后的中位PFS分别为21（18-27）个月和14（10-18）个月。中位OS为61（56-80）个月。多因素分析显示，重新开始治疗后缺乏客观缓解是重新使用舒尼替尼后PFS缩短的独立预测因素。根据我们的研究结果以及文献中的综合病例研究，重新开始使用舒尼替尼在部分治疗假期期间病情进展的患者中可能有效。
