Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Boston University and Boston Medical Center, Boston, MA, USA.
Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.
Sunitinib prolonged progression-free survival (PFS) versus placebo in patients with metastatic pancreatic neuroendocrine tumors (panNETs) in a phase III trial. The efficacy and safety of sunitinib in patients with panNETs were confirmed in an open-label phase IV trial.
To assess the clinical benefit with sunitinib using the combined data from these trials.
An updated overall survival (OS) in patients with panNETs for the phase IV trial was provided, and an analysis of results from the sunitinib-treated combined cohort from the phase III and IV trials (combined cohort) was conducted to assess PFS, OS, and objective response rate (ORR).
The updated median OS for the phase IV trial was 54.1 months (95% CI 37.9-not reached). Investigator-assessed median PFS for the combined cohort (n = 102) was 12.9 months (95% CI 7.4-16.7) with a significant benefit versus placebo in the phase III trial (n = 35) (HR 0.429; 95% CI 0.245-0.752; p = 0.001). Median OS could not be calculated for the combined cohort or placebo group due to the high number of patients censored; however, the estimated HR of 0.303 (CI 0.100-0.921; p = 0.013) favored sunitinib. ORR for the combined cohort was 16.7% (95% CI 10.0-25.3). Sunitinib was well tolerated in both trials with a safety profile similar to previously seen in other studies.
The combined analysis of these studies confirms the objective tumor responses and improvements in PFS observed in the initial phase III trial, providing further support for the clinical benefit of sunitinib in patients with advanced panNETs. CLINICALTRIALS.
NCT00428597 and NCT01525550.
舒尼替尼在一项 III 期临床试验中延长了转移性胰腺神经内分泌肿瘤（panNETs）患者的无进展生存期（PFS），优于安慰剂。在一项开放标签的 IV 期临床试验中证实了舒尼替尼在 panNETs 患者中的疗效和安全性。
使用这两项试验的合并数据评估舒尼替尼的临床获益。
提供了一项 IV 期试验中 panNETs 患者的更新总生存期（OS），并对 III 期和 IV 期试验中舒尼替尼治疗的合并队列（合并队列）的结果进行了分析，以评估 PFS、OS 和客观缓解率（ORR）。
IV 期试验的更新中位 OS 为 54.1 个月（95%CI 37.9-未达到）。合并队列（n=102）的研究者评估中位 PFS 为 12.9 个月（95%CI 7.4-16.7），与 III 期试验（n=35）中的安慰剂相比有显著获益（HR 0.429；95%CI 0.245-0.752；p=0.001）。由于大量患者被删失，合并队列或安慰剂组的中位 OS 无法计算；然而，舒尼替尼的估计 HR 为 0.303（CI 0.100-0.921；p=0.013），这有利于舒尼替尼。合并队列的 ORR 为 16.7%（95%CI 10.0-25.3）。舒尼替尼在两项试验中均耐受良好，安全性与先前在其他研究中观察到的相似。
对这两项研究的合并分析证实了初始 III 期试验中观察到的客观肿瘤反应和 PFS 的改善，进一步支持舒尼替尼在晚期 panNETs 患者中的临床获益。临床试验。
NCT00428597 和 NCT01525550。
