Gootjes E C 1Bakkerus L 1Adhin A A 1张荣欣2
作者信息
- 2. 中山大学肿瘤防治中心结直肠科 广东 广州 510060
- 折叠
摘要
Abstract
Importance Local therapy,including surgery,radiation,and ablation,is increasingly used in patients with multiorgan metastatic colorectal cancer(mCRC).However,prospective evidence for a survival benefit of tumor debulking is lacking.Objective To investigate whether tumor debulking added to palliative chemotherapy improves survival of patients with multiorgan mCRC.Design,Setting,and Participants This investigator-initiated,open-label,multicenter,randomized clinical trial enrolled patients with multiorgan mCRC between May 2013 and May 2023.The last date of follow-up was April 4,2024.Patients were enrolled in 27 hospitals in the Netherlands and 1 in the UK.Adult patients with multiorgan mCRC were considered eligible if more than 80%tumor debulking was deemed feasible by resection,radiotherapy,and/or thermal ablation prior to starting first-line palliative chemotherapy.Interventions After achieving objective tumor response or stable disease after 3 cycles of capecitabine and oxaliplatin or 4 cycles of 5-fluorouracil and oxaliplatin with or without bevacizumab,patients were randomized 1∶1 to receive chemotherapy alone(standard care group)or tumor debulking followed by chemotherapy.Main Outcomes and Measures The primary end point was overall survival.Secondary end points included progression-free survival and serious adverse events.These outcomes were analyzed in the intention-to-treat population,applicable from randomization.A prespecified interim analysis performed after the initial 100 participants were enrolled revealed that the trial was both safe and feasible to proceed.Results A total of 382 of 454 enrolled patients were randomized:192 in the che-motherapy alone group(133[69%]male)and 190 in the chemotherapy plus tumor debulking group(127[67%]male).The median age was 64 years in both groups.After a median follow-up of 32.3 months,median overall survival in the che-motherapy alone group was 27.5 months vs 30.0 months in the chemotherapy plus tumor debulking group(adjusted hazard ratio,0.88[95%CI,0.70-1.10];P=0.26).Median progression-free survival in the chemotherapy alone group was 10.4 months vs 10.5 months in the chemotherapy plus tumor debulking group(adjusted hazard ratio,0.83[95%CI,0.67-1.02];P=0.08).More patients in the chemotherapy plus tumor debulking vs chemotherapy alone group had any serious adverse events(101[53%]vs.74[39%];P=0.006).Conclusions and Relevance Tumor debulking in addition to first-line palliative systemic treatment failed to improve overall survival compared with systemic treatment alone for patients with multiorgan mCRC and should not be considered standard care.关键词
转移性结直肠癌/多器官/肿瘤姑息减瘤/化疗/总生存期Key words
metastatic colorectal cancer/multiorgan/tumor debulking/chemotherapy/overall survival分类
医药卫生
