Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
Department of Natural Sciences, Leibniz University Hannover, Hannover, Germany.
World J Urol. 2018 Sep;36(9):1423-1429. doi: 10.1007/s00345-018-2297-4. Epub 2018 Apr 13.
Early tumor shrinkage (eTS) has prognostic value in metastatic renal cell carcinoma (mRCC). We aimed to validate the role of eTS in first line treatment from the COMPARZ study (NCT00720941).
1100 patients treated with sunitinib or pazopanib were analyzed for tumor response according to RECIST 1.0. eTS was defined as tumor shrinkage by ≥ 10%. A landmark analysis was performed on day (d) 42 and 90 and Cox proportional hazards regression was computed for the prognostic effect of eTS.
In patients with eTS median OS was 34.1 [CI 95% 28.4; not reached (NR)] and 33.6 (CI 95% 30.1; NR) months (mo) at d 42 and 90, respectively, compared to 19.6 (CI 95% 14.0; 28.9) and 15.1 (CI 95% 12.4; 18.7) mo for patients without eTS. There was no interaction between type of treatment and eTS (d 42 p = 0.79; d 90 p = 0.37). eTS ≥ 10% remained an independent prognostic marker in multivariable analyses at both d 42 and 90.
Similar results were found for eTS at the 42 and 90 days landmarks. eTS ≥ 10% has prognostic relevance in mRCC and reflects a putative tool to guide future clinical treatment.
早期肿瘤退缩(eTS)对转移性肾细胞癌(mRCC)具有预后价值。我们旨在通过 COMPARZ 研究(NCT00720941)验证一线治疗中 eTS 的作用。
根据 RECIST 1.0 对接受舒尼替尼或帕唑帕尼治疗的 1100 例患者的肿瘤反应进行分析。eTS 定义为肿瘤缩小≥10%。在第 42 天和第 90 天进行了一个里程碑分析,并对 eTS 的预后影响进行了 Cox 比例风险回归计算。
在有 eTS 的患者中,中位 OS 分别为 34.1 [95%CI 95% 28.4;未达到(NR)]和 33.6(95%CI 95% 30.1;NR)个月(mo),而无 eTS 的患者则分别为 19.6(95%CI 95% 14.0;28.9)和 15.1(95%CI 95% 12.4;18.7)mo。在 d42 和 d90 时,治疗类型和 eTS 之间没有交互作用(d42 p=0.79;d90 p=0.37)。在 d42 和 d90 的多变量分析中,eTS≥10%仍然是独立的预后标志物。
在第 42 和 90 天的两个时间点都发现了 eTS 的相似结果。eTS≥10%对 mRCC 具有预后意义,反映了一种潜在的指导未来临床治疗的工具。