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Patients' preferences for adjuvant sorafenib after resection of renal cell carcinoma in the SORCE trial: what makes it worthwhile?
Annals of Oncology ( IF 50.5 ) Pub Date : 2018-02-01 , DOI: 10.1093/annonc/mdx715
P L Blinman 1 , I D Davis 2 , A Martin 3 , S Troon 4 , S Sengupta 5 , E Hovey 6 , X Coskinas 7 , R Kaplan 8 , A Ritchie 9 , A Meade 8 , T Eisen 10 , M R Stockler 11
Affiliation  

Background We sought to determine the survival benefits that patients judged sufficient to warrant adjuvant therapy with sorafenib for 1 year, or for 3 years after resection of renal cell carcinoma in the SORCE trial. Methods SORCE participants from all sites in Australia and New Zealand, and selected sites in the UK, completed a validated preferences questionnaire at months 0, 3, 15, and 42 to elicit the minimum survival benefits they judged sufficient to warrant adjuvant sorafenib for 1 year (versus observation), or for 3 years (versus 1 year). The questionnaires used reference survival times of 5 and 15 years; and reference survival rates at 5 years of 65% and 85%. Results The 233 participants had a median age of 57 years (range 29-78) and 71% were male. For 1 year of sorafenib versus no adjuvant therapy, the median benefits in survival times judged sufficient to warrant treatment were an extra 9 months beyond 5 years and an extra 1 year beyond 15 years; the median benefit in survival rates were an extra 4% beyond 65% and an extra 3% beyond 85% at 5 years. For 3 years of sorafenib versus 1 year of sorafenib, the median benefit in survival time judged sufficient to warrant extended treatment was an extra 1 year beyond both 5 and 15 years. Participants randomly allocated to treatment with sorafenib judged larger benefits necessary than those allocated to placebo. Participants' preferences were not associated with their baseline characteristics or the interval from randomisation. Conclusion Most participants judged an extra year of survival necessary to warrant 1 year of adjuvant sorafenib worthwhile, and an additional year of survival to warrant extending the duration of sorafenib from 1 to 3 years. Patients' preferences are important in shared decision making. SORCE trial clinical trials number NCT00492258.

中文翻译:

SORCE 试验中肾细胞癌切除术后患者对索拉非尼辅助治疗的偏好:是什么让它值得?

背景 我们试图确定 SORCE 试验中患者判断足以保证索拉非尼辅助治疗 1 年或肾细胞癌切除后 3 年的生存获益。方法 来自澳大利亚和新西兰所有中心以及英国选定中心的 SORCE 参与者在第 0、3、15 和 42 个月完成了经过验证的偏好调查问卷,以得出他们认为足以保证索拉非尼辅助治疗 1 年的最低生存获益(相对于观察),或 3 年(相对于 1 年)。问卷使用的参考生存时间为 5 年和 15 年;5 年参考生存率分别为 65% 和 85%。结果 233 名参与者的中位年龄为 57 岁(范围 29-78 岁),其中 71% 为男性。对于 1 年索拉非尼与无辅助治疗相比,被认为足以保证治疗的生存时间的中位获益是比 5 年多出 9 个月,比 15 年多出 1 年;5 年生存率的中位获益比 65% 额外增加 4%,比 85% 额外增加 3%。对于 3 年索拉非尼与 ​​1 年索拉非尼相比,被认为足以保证延长治疗的生存时间中位获益比 5 年和 15 年多了 1 年。随机分配接受索拉非尼治疗的参与者认为,比分配给安慰剂的参与者有更大的益处。参与者的偏好与其基线特征或随机化间隔无关。结论 大多数参与者认为,需要额外生存一年才能保证索拉非尼辅助治疗 1 年是值得的,并且需要额外生存一年才能将索拉非尼疗程从 1 年延长至 3 年。患者的偏好对于共同决策非常重要。SORCE 试验临床试验编号 NCT00492258。
更新日期:2017-11-21
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