Tannir Nizar M, Figlin Robert A, Gore Martin E, Michaelson M Dror, Motzer Robert J, Porta Camillo, Rini Brian I, Hoang Caroline, Lin Xun, Escudier Bernard
Division of Cancer Medicine, Department of Genitourinary Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX.
Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA.
Clin Genitourin Cancer. 2017 Jun 20. doi: 10.1016/j.clgc.2017.06.005.
We characterized clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) treated with sunitinib who were long-term responders (LTRs), defined as patients having progression-free survival (PFS) > 18 months.
A retrospective analysis of data from 5714 patients with mRCC treated with sunitinib in 8 phase II/III clinical trials and the expanded access program. Duration on-study and objective response rate (ORR) were compared between LTRs and patients with PFS ≤ 18 months ("others"). PFS and overall survival (OS) were summarized using Kaplan-Meier methodology.
Overall, 898 (15.7%) patients achieved a long-term response and 4816 (84.3%) patients did not achieve long-term response. The median (range) duration on-study was 28.6 (16.8-70.7) months in LTRs and 5.5 (0-68.8) months in others. ORR was 51% in LTRs versus 14% in others (P < .0001). Median PFS in LTRs was 32.11 months and median OS was not reached. LTRs had higher percentage of early tumor shrinkage ≥ 10% at the first scan (67.1% vs. 51.2%; P = .0018) and greater median maximum on-study tumor shrinkage from baseline (-56.9 vs. -27.1; P < .0001) versus others. White race, Eastern Cooperative Oncology Group performance status 0, time from diagnosis to treatment ≥ 1 year, clear cell histology, no liver metastasis, lactate dehydrogenase ≤ 1.5 upper limit of normal (ULN), corrected calcium ≤ 10 mg/dL, hemoglobin greater than the lower limit of normal, platelets less than or equal to ULN, body mass index ≥ 25 kg/m, and low neutrophil-to-lymphocyte ratio were associated with LTR.
A subset of patients with mRCC treated with sunitinib achieved long-term response. LTRs had improved ORR, PFS, and OS.
我们对接受舒尼替尼治疗的转移性肾细胞癌（mRCC）患者的临床结局进行了特征分析，这些患者为长期缓解者（LTR），定义为无进展生存期（PFS）> 18个月的患者。
对8项II/III期临床试验及扩大准入项目中5714例接受舒尼替尼治疗的mRCC患者的数据进行回顾性分析。比较长期缓解者与PFS≤18个月的患者（“其他患者”）的研究持续时间和客观缓解率（ORR）。采用Kaplan-Meier方法总结PFS和总生存期（OS）。
总体而言，898例（15.7%）患者获得长期缓解，4816例（84.3%）患者未获得长期缓解。长期缓解者的研究中位（范围）持续时间为28.6（16.8 - 70.7）个月，其他患者为5.5（0 - 68.8）个月。长期缓解者的ORR为51%，其他患者为14%（P <.0001）。长期缓解者的中位PFS为32.11个月，中位OS未达到。与其他患者相比，长期缓解者在首次扫描时早期肿瘤缩小≥10%的比例更高（67.1%对51.2%；P =.0018），研究期间肿瘤从基线的最大缩小中位数更大（-56.9对-27.1；P <.0001）。白种人、东部肿瘤协作组体能状态0、从诊断到治疗的时间≥1年、透明细胞组织学、无肝转移、乳酸脱氢酶≤正常上限（ULN）的1.5倍、校正钙≤10 mg/dL、血红蛋白高于正常下限、血小板≤ULN、体重指数≥25 kg/m²以及低中性粒细胞与淋巴细胞比值与长期缓解相关。
接受舒尼替尼治疗的mRCC患者中有一部分获得了长期缓解。长期缓解者的ORR、PFS和OS均有所改善。
