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• W4382799170 abstract "Patients with detectable ctDNA after radical intent treatment of metastatic spread from colorectal cancer (mCRC) have a very high risk of recurrence, which might be prevented with intensified adjuvant chemotherapy (aCTh). In low-stage CRC, a ctDNA-guided approach for aCTh resulted in less use of chemotherapy without compromising outcome. In OPTIMISE, we investigate ctDNA-guided aCTh after radical intent treatment of mCRC. The preplanned interim analysis aimed at testing feasibility at an early time, with the possibility of optimizing study and laboratory setup and sample size calculations, if needed, before continuing in a large-scale phase II, multicenter, randomized controlled trial. OPTIMISE is an open-label 1:1 randomized trial comparing ctDNA-guided aCTh against standard of care (SOC), with a run-in phase investigating feasibility measures. Analyses of plasma samples for ctDNA were done by ddPCR, detecting CRC-specific mutations and methylation of the NPY gene. Key inclusion criteria were radical intent treatment for mCRC and clinically eligible for triple-agent chemotherapy. All included patients underwent a PET/CT scan before randomization. Patients randomized to the standard arm were treated according to SOC. In the ctDNA-guided arm, ctDNA positivity led to an escalation strategy with triple-agent chemotherapy, and ctDNA negativity led to a de-escalation strategy by shared-decision making. Feasibility measures for the run-in phase were; inclusion of 30 patients over 12 months in two Danish hospitals, compliance with randomization >80%, rate of unexpected PET-CT-positive cases 80%. Thirty-two patients were included. The rate of PET-CT-positive cases was 22% (n=7/32). Five of the PET-CT-positive cases underwent radical intent treatment and hereafter randomization. One patient awaits randomization due to ongoing treatment of residual disease. 97% of the patients were randomized (n=30/31). Fourteen patients were randomly assigned to SOC and sixteen to ctDNA-guided adjuvant treatment and follow-up. All analyses of the baseline plasma samples in the ctDNA-guided arm passed the quality control process. The median time to result was 3 working days. 19% (n=3/16) had a ctDNA-positive baseline plasma sample. All ctDNA-positive patients were eligible for triple-agent chemotherapy. The median time from inclusion until the start of aCTh was 22 days. The delay from inclusion to the start of aCTh was primarily due to the study-specific PET/CT scan. To the best of our knowledge, this is the first randomized clinical trial evaluating ctDNA-guided adjuvant treatment after radical intent treatment for mCRC. Hence, there were significant reservations when planning the study, so it was of utmost importance to test feasibility early. When taking into account the low number of patients and the consequent uncertainty in the estimates, the feasibility measures were complied with. Furthermore, the median time to result and the quality of analyses were adequate. A minor modification of the study flow has been made to reduce the delay from inclusion to the start of aCTh; solely ctDNA-positive patients in the experimental arm will undergo a PET/CT scan. In conclusion, the study has proven feasible and continues with an optimized study flow in the planned large-scale phase II, multicenter, randomized controlled trial." @default.
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• W4382799170 date "2023-06-01" @default.
• W4382799170 modified "2023-09-27" @default.
• W4382799170 title "SO-18 ctDNA-guided adjuvant treatment after radical intent treatment of metastatic spread from colorectal cancer is feasible – results from the preplanned interim analysis of the OPTIMISE study" @default.
• W4382799170 doi "https://doi.org/10.1016/j.annonc.2023.04.490" @default.
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