Li Jiarui, Cheng Yuejuan, Bai Chunmei, Xu Jianming, Shen Lin, Li Jie, Zhou Zhiwei, Li Zhiping, Chi Yihebali, Yu Xianjun, Li Enxiao, Xu Nong, Liu Tianshu, Lou Wenhui, Bai Yuxian, Yuan Xianglin, Wang Xiuwen, Yuan Ying, Chen Jia, Guan Sha, Fan Songhua, Su Weiguo
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Eur J Cancer. 2022 Jul;169:1-9. doi: 10.1016/j.ejca.2022.03.027. Epub 2022 Apr 28.
AIM: To investigate the health-related quality of life (HRQoL) of patients who had neuroendocrine tumors (NETs) from SANET trials. METHODS: Eligible patients were randomized in a 2:1 ratio to receive surufatinib or placebo. HRQoL questionnaires, including the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-G.I.NET21, were collected. The prespecified HRQoL outcome was the mean change of scores from baseline to the last available visit for each domain. Time until definitive deterioration (TUDD) was defined as the time from randomization to deterioration of ≥10 points from baseline in domain score, disease progression, or death. RESULTS: 370 patients were enrolled and randomly assigned to surufatinib (n = 242) or placebo (n = 128). No significant difference in mean scores change from baseline to the last available visit was observed for QLQ-C30 and QLQ- G.I.NET21 domains, with the exception of diarrhea. The mean score of diarrhea increased 11.7 points from baseline in the surufatinib arm and decreased 1.2 points in the placebo arm, and the between-group difference was 12.9 points. Compared with placebo, surufatinib treated patients had a significantly longer TUDD for dyspnea (hazard ratio [HR] 0.58; 95% confidence interval [CI], 0.39-0.86; P = 0.0058) and a significantly shorter TUDD for diarrhea (HR 2.91; 95% CI, 1.66-5.10; P < 0.0001). There were no significant differences in TUDD for the remaining domains of QLQ-C30 and G.I.NET-21. CONCLUSIONS: HRQoL was similar in patients treated with surufatinib and placebo except for diarrhea. The preservation of HRQoL supports surufatinib as a treatment option for NETs. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov: NCT02589821, NCT02588170.
目的：通过SANET试验研究神经内分泌肿瘤（NET）患者的健康相关生活质量（HRQoL）。 方法：符合条件的患者按2:1比例随机分组，接受苏尼替尼或安慰剂治疗。收集HRQoL问卷，包括欧洲癌症研究与治疗组织QLQ-C30和QLQ-G.I.NET21。预先设定的HRQoL结局是每个领域从基线到最后一次可获得访视的得分平均变化。明确恶化时间（TUDD）定义为从随机分组到领域得分从基线恶化≥10分、疾病进展或死亡的时间。 结果：370例患者入组并随机分配至苏尼替尼组（n = 242）或安慰剂组（n = 128）。除腹泻外，QLQ-C30和QLQ-G.I.NET21领域从基线到最后一次可获得访视的平均得分变化无显著差异。腹泻的平均得分在苏尼替尼组较基线增加11.7分，在安慰剂组下降1.2分，组间差异为12.9分。与安慰剂相比，苏尼替尼治疗的患者呼吸困难的TUDD显著更长（风险比[HR] 0.58；95%置信区间[CI]，0.39 - 0.86；P = 0.0058），腹泻的TUDD显著更短（HR 2.91；95% CI，1.66 - 5.10；P < 0.0001）。QLQ-C30和G.I.NET-21其余领域的TUDD无显著差异。 结论：除腹泻外，接受苏尼替尼和安慰剂治疗的患者HRQoL相似。HRQoL的维持支持苏尼替尼作为NET的一种治疗选择。 临床试验信息：ClinicalTrials.gov：NCT02589821，NCT02588170。
Front Immunol. 2025-2-3
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