Abstract：
BACKGROUND: This study aimed to assess the prognostic value of total tumor volume (TTV) for early recurrence (within 6 months) and overall survival (OS) in patients with colorectal liver metastases (CRLM), treated with induction systemic therapy followed by complete local treatment.
METHODS: Patients with initially unresectable CRLM from the multicenter randomized phase 3 CAIRO5 trial (NCT02162563) who received induction systemic therapy followed by local treatment were included. Baseline TTV and change in TTV as response to systemic therapy were calculated using the CT scan before and the first after systemic treatment, and were assessed for their added prognostic value. The findings were validated in an external cohort of patients treated at a tertiary center.
RESULTS: In total, 215 CAIRO5 patients were included. Baseline TTV and absolute change in TTV were significantly associated with early recurrence (P = 0.005 and P = 0.040, respectively) and OS in multivariable analyses (P = 0.024 and P = 0.006, respectively), whereas RECIST1.1 was not prognostic for early recurrence (P = 0.88) and OS (P = 0.35). In the validation cohort (n = 85), baseline TTV and absolute change in TTV remained prognostic for early recurrence (P = 0.041 and P = 0.021, respectively) and OS in multivariable analyses (P < 0.0001 and P = 0.012, respectively), and showed added prognostic value over conventional clinicopathological variables (increase C-statistic, 0.06; 95 % CI, 0.02 to 0.14; P = 0.008).
CONCLUSIONS: Total tumor volume is strongly prognostic for early recurrence and OS in patients who underwent complete local treatment of initially unresectable CRLM, both in the CAIRO5 trial and the validation cohort. In contrast, RECIST1.1 did not show prognostic value for neither early recurrence nor OS.
METHODS: Patients with initially unresectable CRLM from the multicenter randomized phase 3 CAIRO5 trial (NCT02162563) who received induction systemic therapy followed by local treatment were included. Baseline TTV and change in TTV as response to systemic therapy were calculated using the CT scan before and the first after systemic treatment, and were assessed for their added prognostic value. The findings were validated in an external cohort of patients treated at a tertiary center.
RESULTS: In total, 215 CAIRO5 patients were included. Baseline TTV and absolute change in TTV were significantly associated with early recurrence (P = 0.005 and P = 0.040, respectively) and OS in multivariable analyses (P = 0.024 and P = 0.006, respectively), whereas RECIST1.1 was not prognostic for early recurrence (P = 0.88) and OS (P = 0.35). In the validation cohort (n = 85), baseline TTV and absolute change in TTV remained prognostic for early recurrence (P = 0.041 and P = 0.021, respectively) and OS in multivariable analyses (P < 0.0001 and P = 0.012, respectively), and showed added prognostic value over conventional clinicopathological variables (increase C-statistic, 0.06; 95 % CI, 0.02 to 0.14; P = 0.008).
CONCLUSIONS: Total tumor volume is strongly prognostic for early recurrence and OS in patients who underwent complete local treatment of initially unresectable CRLM, both in the CAIRO5 trial and the validation cohort. In contrast, RECIST1.1 did not show prognostic value for neither early recurrence nor OS.
摘要：
背景：本研究旨在评估总肿瘤体积（TTV）对结直肠癌肝转移（CRLM）患者早期复发（6个月内）和总生存期（OS）的预后价值，采用诱导全身治疗，然后进行完全局部治疗。
方法：纳入了多中心随机3期CAIRO5试验（NCT02162563）中最初不可切除的CRLM患者，这些患者接受了诱导全身治疗，然后进行了局部治疗。使用全身治疗前后的CT扫描计算基线TTV和对全身治疗反应的TTV变化。并评估其增加的预后价值。这些发现在三级中心接受治疗的患者的外部队列中得到了验证。
结果：总计，包括215例CAIRO5患者。在多变量分析中，基线TTV和TTV的绝对变化与早期复发（分别为P=0.005和P=0.040）和OS显着相关（分别为P=0.024和P=0.006），而RECIST1.1对早期复发(P=0.88)和OS(P=0.35)无预后。在验证队列中（n=85），在多变量分析中，基线TTV和TTV的绝对变化仍然是早期复发的预后（分别为P=0.041和P=0.021）和OS（分别为P<0.0001和P=0.012），并显示出比常规临床病理变量增加的预后价值(增加C统计量，0.06；95%CI，0.02至0.14；P=0.008）。
结论：在接受最初不可切除的CRLM的完全局部治疗的患者中，总肿瘤体积对早期复发和OS具有强烈的预后。在CAIRO5试验和验证队列中。相比之下,RECIST1.1对早期复发和OS均未显示预后价值。
方法：纳入了多中心随机3期CAIRO5试验（NCT02162563）中最初不可切除的CRLM患者，这些患者接受了诱导全身治疗，然后进行了局部治疗。使用全身治疗前后的CT扫描计算基线TTV和对全身治疗反应的TTV变化。并评估其增加的预后价值。这些发现在三级中心接受治疗的患者的外部队列中得到了验证。
结果：总计，包括215例CAIRO5患者。在多变量分析中，基线TTV和TTV的绝对变化与早期复发（分别为P=0.005和P=0.040）和OS显着相关（分别为P=0.024和P=0.006），而RECIST1.1对早期复发(P=0.88)和OS(P=0.35)无预后。在验证队列中（n=85），在多变量分析中，基线TTV和TTV的绝对变化仍然是早期复发的预后（分别为P=0.041和P=0.021）和OS（分别为P<0.0001和P=0.012），并显示出比常规临床病理变量增加的预后价值(增加C统计量，0.06；95%CI，0.02至0.14；P=0.008）。
结论：在接受最初不可切除的CRLM的完全局部治疗的患者中，总肿瘤体积对早期复发和OS具有强烈的预后。在CAIRO5试验和验证队列中。相比之下,RECIST1.1对早期复发和OS均未显示预后价值。
