舒尼替尼治疗晚期进展胰腺神经内分泌瘤临床疗效

Efficiency of Sunitinib in Chinese Patients with Advanced Progressive Pancreatic Neuroendocrine Tumor

目的评估舒尼替尼治疗中国晚期进展胰腺神经内分泌瘤（p NET）患者的临床疗效。方法回顾性分析2009年1月至2015年6月在北京协和医院肿瘤内科采用舒尼替尼治疗的晚期进展p NET患者的临床病理资料、方案及预后等信息。结果 18例p NET患者应用舒尼替尼的总有效率（ORR）和疾病控制率（DCR）分别为27.8%和83.3%,其中,采用舒尼替尼一线治疗9例,二线及二线以上治疗9例,两组患者的中位无进展生存期（m PFS）（12个月比12个月;HR：0.92,95%CI：0.31～2.75,P=0.88）、ORR（22.2%比33.3%;χ2=0.055,P=0.98）和DCR（88.9%比77.8%;χ2=0.4,P=0.98）差异均无统计学意义。Ki-67≥10%患者应用舒尼替尼的m PFS短于Ki-67〈10%患者,但差异无统计学意义（8个月比13个月;HR：1.13,95%CI：0.34～3.77,P=0.845）。舒尼替尼的主要不良反应为骨髓抑制、腹泻、蛋白尿、高血压和皮疹。结论舒尼替尼治疗中国晚期进展p NET的疗效和不良反应与西方数据相似,一线与二线及二线以上应用舒尼替尼的疗效可能无差异。

Objective To explore the efficiency of sunitinib in Chinese pancreatic neuroendocrine tumors （pNET） patients. Methods Advanced pNET patients who had accepted sunitinib treatment in the oncol- ogy department of PUMC Hospital from January 2009 to June 2015 after disease progression were enrolled in this study. Data collection included clinicopathological characteristics, medical therapies and outcomes. Results Eighteen pNET patients were collected. The overall response rate （ORR） was 27.7% and the disease control rate （DCR） was 83.3 %. Nine patients received sunitinib as the first-line therapy and 9 as the second/post-sec- ond line. The median progression-free survival （mPFs） （12 month vs. 12 month; HR： 0. 92, 95% CI： 0. 31- 2. 75, P=0.88）, ORR （22.2% vs. 33.3%; X2=0.055, P=0.98）, andDCR （88.9% vs. 77.8%; X2= 0.4, P = 0. 98） showed no significant difference between first-line therapy and post-second line therapy. The mPFS of Ki-67 I〉 10% and Ki-67 〈 10% group patients was not significantly different （8 months vs. 13 months; HR： 1.13, 95% CI： 0. 34-3.77, P =0. 845） . The commonly reported adverse events included bone marrow suppression, diarrhea, roteinuria, hypertension, and rash. Conclusions First-line or second/post-second line sunitinib treatment has certain antitumor activity in Chinese patients with advanced pNET. The efficiency and commonly reported adverse events of Sunitinib are consistent with the known Western data.