Department of Urology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Eur Urol. 2011 Dec;60(6):1273-9. doi: 10.1016/j.eururo.2011.07.008. Epub 2011 Jul 14.
In metastatic renal cell carcinoma (mRCC) patients treated with targeted agents and their primary tumor (PT) in situ, early PT decrease in size correlates with improved overall PT response, but the effect on overall survival (OS) is unknown.
To evaluate whether early PT size reduction is associated with improved OS in patients with mRCC undergoing treatment with sunitinib.
DESIGN, SETTING, AND PARTICIPANTS: We reviewed the clinical and radiographic data of all mRCC patients seen at our institution between January 2004 and December 2009 without prior systemic treatment who received sunitinib with their PT in situ.
Two independent reviewers measured the diameter of the PT and metastatic disease at baseline and subsequent scans to assess response. Early minor response was defined as ≥10% decrease within 60 d of treatment initiation. Univariate and multivariate analyses were used to calculate a hazard ratio (HR) corresponding to the risk of death based on clinical and pathologic factors as well as PT response.
We identified 75 consecutive patients with a median follow-up of 15 mo. All patients were intermediate or poor risk by common risk stratification systems. Median initial PT diameter was 9.7cm. Median maximum PT size reduction was -10.2% overall and -36.4% in patients who had early minor PT response. Median OS for patients without minor PT response, with minor PT response after 60 d, and with early minor PT response was 10.3, 16.5, and 30.2 mo, respectively. On multivariate analysis, early minor response was an independent predictor of improved OS (HR: 0.26; p=0.031). Other significant predictors included venous thrombus, multiple bone metastases, lactate dehydrogenase above the upper limit of normal, symptoms at presentation, and more than two metastatic sites.
Early minor PT response is associated with improved OS. Future studies should evaluate this prognostic factor to identify patients with prolonged OS.
在接受靶向药物治疗且原发肿瘤（PT）仍存在于体内的转移性肾细胞癌（mRCC）患者中，PT 早期缩小与整体 PT 反应改善相关，但对总生存（OS）的影响尚不清楚。
评估 mRCC 患者在接受舒尼替尼治疗时，PT 早期缩小是否与 OS 改善相关。
设计、设置和参与者：我们回顾了 2004 年 1 月至 2009 年 12 月期间在我们机构就诊的所有未经系统治疗的 mRCC 患者的临床和影像学数据，这些患者接受了舒尼替尼联合其体内 PT 的治疗。
两名独立的审查员在基线和后续扫描时测量 PT 和转移性疾病的直径，以评估反应。早期微小反应定义为治疗开始后 60 天内下降≥10%。使用单变量和多变量分析根据临床和病理因素以及 PT 反应计算与死亡风险相关的风险比（HR）。
我们确定了 75 例连续患者，中位随访时间为 15 个月。所有患者根据常见风险分层系统均为中危或高危。初始 PT 直径中位数为 9.7cm。PT 最大缩小中位数为整体-10.2%，早期微小 PT 反应患者为-36.4%。无微小 PT 反应、60 天后出现微小 PT 反应和早期出现微小 PT 反应的患者的中位 OS 分别为 10.3、16.5 和 30.2 个月。多变量分析显示，早期微小反应是 OS 改善的独立预测因素（HR：0.26；p=0.031）。其他显著的预测因素包括静脉血栓、多处骨转移、乳酸脱氢酶高于正常值上限、首发症状和两个以上转移部位。
早期微小 PT 反应与 OS 改善相关。未来的研究应评估这一预后因素，以确定 OS 延长的患者。
