Joly Florence, McAlpine Jessica, Nout Remi, Åvall-Lundqvist Elisabeth, Shash Emad, Friedlander Michael
*Medical Oncology Department, Clinical Research Department, Centre Francois Baclesse, CHU Côte de Nacre, Inserm "cancer&preventions", University of Basse Normandie, Caen, France; †Department of Gynecology and Obstetrics, Division of Gynecologic Oncology, University of British Columbia, Vancouver, British Columbia, Canada; ‡Department of Clinical Oncology, University Medical Center, Leiden, the Netherlands; §Department of Gynaecologic Oncology, Karolinska University Hospital, Stockholm, Sweden; ∥EORTC, Brussells, Belgium; and ¶Department of Medical Oncology, The Prince of Wales Hospital, University of New South Wales Clinical School, Sydney, Australia.
Int J Gynecol Cancer. 2014 Nov;24(9):1693-9. doi: 10.1097/IGC.0000000000000299.
There is increasing recognition that quality of life (QoL) and patient-reported outcomes (PROs) are of fundamental importance and particularly relevant given the relatively high likelihood of long-term survival in most women with endometrial cancer (EC). However, there has been relatively little research focused on this topic. Our objective was to analyze our current knowledge and identify research questions to be included in the design of next clinical trials.
Analyze and critically assess reported clinical trials in EC that have included QoL and PROs as primary or secondary end points.
Surgery has a significant impact on physical and functional domains of QoL particularly in the first 6 months after diagnosis. Minimally invasive surgery is associated with less acute morbidity than open procedures and this persists over time. Lymphadenectomy is associated with increased incidence of lymphedema, important late effect. Adjuvant external irradiation may cause gastrointestinal and genitourinary symptoms that impact on physical functioning and which can persist over time. In contrast, vaginal brachytherapy has less toxicity and fewer late effects than external irradiation. The impact of treatment on sexuality has been poorly evaluated in EC survivors. There are few published data on QoL and PROs in patients treated with chemotherapy and the long-term impact has not been addressed. There is no evidence that palliative chemotherapy reduces symptoms and improves QoL. There are very few longitudinal studies on survivorship that is an important concern in EC survivors.
Although there have been some studies addressing QoL and PROs in EC, we have identified deficiencies and gaps in our knowledge. Careful consideration of QoL and PROs end points and how to include them in clinical trials will result in a better appreciation of how treatments can impact on patients QoL and lead to conduct interventions to reduce late effects.
人们越来越认识到生活质量（QoL）和患者报告结局（PROs）至关重要，鉴于大多数子宫内膜癌（EC）女性长期生存的可能性相对较高，这一点尤为相关。然而，针对该主题的研究相对较少。我们的目标是分析我们目前的知识，并确定纳入下一轮临床试验设计的研究问题。
分析并严格评估已报道的将QoL和PROs作为主要或次要终点的EC临床试验。
手术对QoL的身体和功能领域有重大影响，尤其是在诊断后的前6个月。微创手术与开放性手术相比，急性发病率较低，且这种情况会持续一段时间。淋巴结清扫术与淋巴水肿发病率增加有关，这是一种重要的晚期效应。辅助外照射可能会导致影响身体功能且可持续一段时间的胃肠道和泌尿生殖系统症状。相比之下，阴道近距离放疗的毒性较小，晚期效应较少。治疗对EC幸存者性功能的影响评估不足。关于化疗患者QoL和PROs的已发表数据很少，且长期影响尚未得到解决。没有证据表明姑息化疗能减轻症状并改善QoL。关于生存的纵向研究非常少，而这是EC幸存者的一个重要问题。
尽管已经有一些关于EC中QoL和PROs的研究，但我们已经确定了知识上的不足和差距。仔细考虑QoL和PROs终点以及如何将它们纳入临床试验，将有助于更好地理解治疗如何影响患者的QoL，并促使开展干预措施以减少晚期效应。
