Department of Medical Oncology, Cancer Center Amsterdam.
Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam.
Ann Oncol. 2017 Mar 1;28(3):478-486. doi: 10.1093/annonc/mdw617.
New palliative systemic treatment regimens in patients with metastatic colorectal cancer (mCRC) have significantly improved overall survival and prognosis. These treatment regimens are often accompanied by increased toxicity, which may impair patients' quality of life (QOL). We systematically reviewed whether severe toxicity affects global QOL in patients with mCRC receiving palliative systemic treatment in recent published randomized controlled trials (RCTs).
Phase III RCTs evaluating palliative systemic treatments in patients with mCRC and published between 2004 and 2016 were considered. Studies were evaluated on the basis of global QOL scores, toxicity during treatment (assessed by scoring relevant adverse events) and primary outcomes (POs).
A total of 30 studies were identified in which 19863 patients were included. In 25 out of these 30 trials (83%), no difference in global QOL between treatment arms was observed. In contrast, 22 out of 30 trials (73%) showed increased toxicity during treatment in the experimental arm as compared with the control arm. In 19 out of 22 trials with higher toxicity (86%) global QOL outcomes remained unaffected or improved. In ten out of eleven studies with a better PO, no improvement in global QOL was seen.
Global QOL of patients with mCRC included in phase III RCTs evaluating palliative systemic treatment did not differ across treatment arms despite consistently higher toxicity during treatment of the experimental compared with the standard treatment arms. Based on these findings we conclude that the use of global QOL for comparing treatment arms in RCTs for patients with mCRC does not provide information of clinical relevance. Further consideration of how to better assess the net effect of new agents on patients' QOL is urgently needed.
新型姑息性系统治疗方案在转移性结直肠癌（mCRC）患者中的应用显著改善了总体生存率和预后。这些治疗方案通常伴随着毒性增加，可能会损害患者的生活质量（QOL）。我们系统地回顾了最近发表的随机对照试验（RCT）中，接受姑息性系统治疗的 mCRC 患者中严重毒性是否会影响总体 QOL。
评估 mCRC 患者姑息性系统治疗的 III 期 RCT，并于 2004 年至 2016 年期间发表。研究根据总体 QOL 评分、治疗期间的毒性（通过相关不良事件评分评估）和主要结局（POs）进行评估。
共确定了 30 项研究，其中纳入了 19863 例患者。在这 30 项试验中的 25 项（83%）中，治疗组之间的总体 QOL 没有差异。相比之下，30 项试验中的 22 项（73%）显示实验组的治疗毒性较对照组增加。在 22 项毒性较高的试验中的 19 项（86%）中，总体 QOL 结果保持不变或改善。在 11 项具有更好 PO 的研究中的 10 项中，未观察到总体 QOL 的改善。
纳入评估姑息性系统治疗的 III 期 RCT 的 mCRC 患者的总体 QOL 在治疗组之间没有差异，尽管实验组的治疗毒性始终高于标准治疗组。基于这些发现，我们得出结论，使用总体 QOL 比较 mCRC 患者 RCT 中的治疗组不能提供临床相关信息。迫切需要进一步考虑如何更好地评估新药物对患者 QOL 的净效应。
