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. 2021 Oct 28;2(4):e103.
doi: 10.1097/AS9.0000000000000103. eCollection 2021 Dec.

The Prognostic Value of Total Tumor Volume Response Compared With RECIST1.1 in Patients With Initially Unresectable Colorectal Liver Metastases Undergoing Systemic Treatment

Affiliations

The Prognostic Value of Total Tumor Volume Response Compared With RECIST1.1 in Patients With Initially Unresectable Colorectal Liver Metastases Undergoing Systemic Treatment

Nina J Wesdorp et al. Ann Surg Open. .

Abstract

Objectives: Compare total tumor volume (TTV) response after systemic treatment to Response Evaluation Criteria in Solid Tumors (RECIST1.1) and assess the prognostic value of TTV change and RECIST1.1 for recurrence-free survival (RFS) in patients with colorectal liver-only metastases (CRLM).

Background: RECIST1.1 provides unidimensional criteria to evaluate tumor response to systemic therapy. Those criteria are accepted worldwide but are limited by interobserver variability and ignore potentially valuable information about TTV.

Methods: Patients with initially unresectable CRLM receiving systemic treatment from the randomized, controlled CAIRO5 trial (NCT02162563) were included. TTV response was assessed using software specifically developed together with SAS analytics. Baseline and follow-up computed tomography (CT) scans were used to calculate RECIST1.1 and TTV response to systemic therapy. Different thresholds (10%, 20%, 40%) were used to define response of TTV as no standard currently exists. RFS was assessed in a subgroup of patients with secondarily resectable CRLM after induction treatment.

Results: A total of 420 CT scans comprising 7820 CRLM in 210 patients were evaluated. In 30% to 50% (depending on chosen TTV threshold) of patients, discordance was observed between RECIST1.1 and TTV change. A TTV decrease of >40% was observed in 47 (22%) patients who had stable disease according to RECIST1.1. In 118 patients with secondarily resectable CRLM, RFS was shorter for patients with less than 10% TTV decrease compared with patients with more than 10% TTV decrease (P = 0.015), while RECIST1.1 was not prognostic (P = 0.821).

Conclusions: TTV response assessment shows prognostic potential in the evaluation of systemic therapy response in patients with CRLM.

Keywords: RECIST; colorectal cancer; liver metastases; resection; systemic therapy; tumor response assessment; tumor volume.

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Conflict of interest statement

C.J.A.P. has an advisory role for Nordic Pharma. This funding is not related to the current research. The remaining authors declare no potential conflicts of interest. The CAIRO5 study is supported by unrestricted scientific grants from Roche and Amgen. The funders had no role in the design, conduct, and submission of the study, or in the decision to submit the manuscript for publication.

Figures

FIGURE 1.
FIGURE 1.
Flow diagram of patient inclusion. PET indicates positron emission tomography; RFA, radio-frequency ablation.
FIGURE 2.
FIGURE 2.
Change in TTV and in sum of diameters (RECIST1.1). The percentual change in sum of diameters is depicted on the y axis for the individual patients on the x axis (A). In the same manner, the percentual change in TTV is depicted on the y axis for the individual patients on the x axis (B). Patients are classified according to RECIST1.1 as response, stable, and progression. One patient classified as progression by RECIST1.1 experienced a TTV increase of 658%, which is depicted as 300% TTV increase in (B).
FIGURE 3.
FIGURE 3.
Kaplan Meier analysis of recurrence-free survival of patients with secondarily resectable CRLM according to TTV change and RECIST1.1. Survival curves and life tables of patients with: (A) response (equal to and more than 10% TTV decrease) versus stable/progressive (less than 10% TTV decrease), (B) response (equal to and more than 20% TTV decrease) versus stable/progressive (less than 20% TTV decrease), (C) response (equal to and more than 40% TTV decrease) versus stable/progressive (than 40% TTV decrease), (D) RECIST1.1 response versus RECIST1.1 stable/progression.

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