Lawrence Nicola J, Martin Andrew, Davis Ian D, Troon Simon, Sengupta Shomik, Hovey Elizabeth, Coskinas Xanthi, Kaplan Richard, Smith Benjamin, Ritchie Alastair, Meade Angela, Eisen Tim, Blinman Prunella, Stockler Martin R
NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.
Kidney Cancer. 2018 Aug 1;2(2):123-131. doi: 10.3233/KCA-180038.
Decisions about adjuvant therapy involve trade-offs between possible benefits and harms.
We sought to determine the survival benefits that clinical investigators would judge as sufficient to warrant treatment with adjuvant sorafenib in the SORCE trial after nephrectomy for apparently localised renal cell carcinoma (RCC).
A subset of clinical investigators in the SORCE trial completed a validated questionnaire that elicited the minimum survival benefits they judged sufficient to warrant one year of adjuvant sorafenib in scenarios with hypothetical baseline survival times of 5 years and 15 years, and baseline survival rates at 5 years of 65% and 85%.
The 100 participating SORCE investigators had a median age of 42 years, and 74 were male. For one year of sorafenib versus no therapy, the median benefits in survival times the investigators judged sufficient to warrant treatment were an extra nine months beyond five years and an extra 12 months beyond 15 years; the median benefits in survival rates were an extra 5% beyond baseline survival rates of both 65% and 85% at five years. The patients recruited in the SORCE trial by these investigators judged smaller benefits sufficient to warrant adjuvant sorafenib for both survival rate scenarios (≤0.0001). The survival benefits the investigators judged sufficient to warrant one year of adjuvant therapy with sorafenib for RCC were similar to those of other clinicians considering three months of adjuvant chemotherapy for lung cancer, but smaller than those of clinicians considering six months of adjuvant chemotherapy for breast cancer.
SORCE investigators judged larger benefits necessary to warrant adjuvant sorafenib than their patients. The benefits required by the investigators were similar or smaller than those other clinicians considered sufficient to warrant adjuvant chemotherapy for other cancers. Clinicians should recognise that their patients and colleagues may have preferences that differ from their own when considering the potential benefits and harms of adjuvant treatment.
辅助治疗的决策涉及到潜在益处与危害之间的权衡。
我们试图确定在SORCE试验中，对于行肾切除术治疗明显局限性肾细胞癌（RCC）后，临床研究人员认为足以保证使用辅助索拉非尼治疗的生存获益情况。
SORCE试验中的一部分临床研究人员完成了一份经过验证的问卷，该问卷引出了他们在假设基线生存时间为5年和15年，以及5年基线生存率为65%和85%的情况下，认为足以保证使用一年辅助索拉非尼的最小生存获益。
参与SORCE试验的100名研究人员的中位年龄为42岁，其中74名是男性。对于使用一年索拉非尼与不进行治疗相比，研究人员认为足以保证治疗的生存时间的中位获益是在5年后额外延长9个月，在15年后额外延长12个月；生存率的中位获益是在5年时比65%和85%的基线生存率额外提高5%。这些研究人员在SORCE试验中招募的患者在两种生存率情况下都认为较小的获益就足以保证使用辅助索拉非尼（≤0.0001）。研究人员认为足以保证对RCC使用一年辅助索拉非尼治疗的生存获益与其他考虑为肺癌进行三个月辅助化疗的临床医生相似，但小于考虑为乳腺癌进行六个月辅助化疗 的临床医生。
SORCE试验的研究人员认为保证使用辅助索拉非尼需要比他们的患者更大的获益。研究人员要求的获益与其他临床医生认为足以保证对其他癌症进行辅助化疗的获益相似或更小。临床医生应该认识到，在考虑辅助治疗的潜在益处和危害时，他们的患者和同事可能有与他们自己不同的偏好。
