Renfro L A, Grothey A, Kerr D, Haller D G, André T, Van Cutsem E, Saltz L, Labianca R, Loprinzi C L, Alberts S R, Schmoll H, Twelves C, Yothers G, Sargent D J
Division of Biomedical Statistics and Informatics.
Department of Oncology, Mayo Clinic, Rochester, USA.
Ann Oncol. 2015 May;26(5):950-958. doi: 10.1093/annonc/mdv073. Epub 2015 Feb 19.
Post-treatment survival experience of early colon cancer (CC) patients is well described in the literature, which states that cure is probable for some patients. However, comparisons of treated patients' survival versus that expected from a matched general population (MGP) are limited.
A total of 32 745 patients from 25 randomized adjuvant trials conducted from 1977 to 2012 in 41 countries were pooled. Observed long-term survival of these patients was compared with expected survival matched on sex, age, country, and year, both overall and by stage (II and III), sex, treatment [surgery, 5-fluorouracil (5-FU), 5-FU + oxaliplatin], age (<70 and 70+), enrollment year (pre/post 2000), and recurrence (yes/no). Comparisons were made at randomization and repeated conditional on survival to 1, 2, 3, and 5 years. CC and MGP equivalence was tested, and observed Kaplan-Meier survival rates compared with expected MGP rates 3 years out from each landmark. Analyses were also repeated in patients without recurrence.
Within most cohorts, long-term survival of CC patients remained statistically worse than the MGP, though conditional survival generally improved over time. Among those surviving 5 years, stage II, oxaliplatin-treated, elderly, and recurrence-free patients achieved subsequent 3-year survival rates within 5% of the MGP, with recurrence-free patients achieving equivalence.
Conditional on survival to 5 years, long-term survival of most CC patients on clinical trials remains modestly poorer than an MGP, but achieves MGP levels in some subgroups. These findings emphasize the need for access to quality care and improved treatment and follow-up strategies.
早期结肠癌(CC)患者治疗后的生存经历在文献中有充分描述,文献指出部分患者有可能治愈。然而,已治疗患者的生存率与匹配的普通人群(MGP)预期生存率的比较却很有限。
汇总了1977年至2012年在41个国家进行的25项随机辅助试验中的32745例患者。将这些患者的观察到的长期生存率与按性别、年龄、国家和年份匹配的预期生存率进行比较,总体比较以及按分期(II期和III期)、性别、治疗方式[手术、5-氟尿嘧啶(5-FU)、5-FU+奥沙利铂]、年龄(<70岁和70岁及以上)、入组年份(2000年前/后)和复发情况(是/否)进行比较。在随机分组时进行比较,并在生存1、2、3和5年时重复进行条件比较。对CC和MGP的等效性进行了检验,并将观察到的Kaplan-Meier生存率与各里程碑事件后3年的预期MGP率进行比较。对无复发患者也重复进行了分析。
在大多数队列中,CC患者的长期生存率在统计学上仍低于MGP,不过条件生存率通常随时间有所改善。在存活5年的患者中,II期、接受奥沙利铂治疗、老年和无复发患者的后续3年生存率在MGP的5%以内,无复发患者实现了等效。
以存活5年为条件,大多数参加临床试验的CC患者的长期生存率仍略低于MGP,但在某些亚组中达到了MGP水平。这些发现强调了获得优质护理以及改进治疗和随访策略的必要性。