{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Meltzer S"],"funding":["Ministry of Health and Care Services | Helse Sør-Øst RHF (Southern and Eastern Norway Regional Health Authority)","Bristol-Myers Squibb","Ministry of Health and Care Services | Helse Sør-Øst RHF","Kreftforeningen","Kreftforeningen (Norwegian Cancer Society)"],"pagination":["2227-2233"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9726864"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["127(12)"],"pubmed_abstract":["<h4>Background</h4>Immune checkpoint blockade (ICB) results in radiologic tumour response dynamics that differ from chemotherapy efficacy measures and require an early signal of clinical utility.<h4>Methods</h4>Previously untreated, unresectable microsatellite-stable (MSS)/mismatch repair-proficient (pMMR) colorectal cancer (CRC) patients were randomly assigned to the oxaliplatin-based Nordic FLOX regimen (control arm) or repeat sequential two FLOX cycles and two ICB cycles (experimental arm). The radiologic response was assessed every 8 weeks. In this post hoc analysis, we explored early target lesion (TL) dynamics as indicator of ICB responsiveness. Progression-free survival (PFS) was the primary endpoint.<h4>Results</h4>Using a landmark analysis approach, we categorised experimental-arm patients into ≥10% (N = 19) or <10% (N = 16) TL reduction at the first post-baseline response assessment. Median PFS for the groups was 16.0 (95% confidence interval (CI), 12.3-19.7) and 3.9 months (95% CI, 2.3-5.5), respectively, superior and inferior (both P < 0.01) to the median PFS of 9.8 months (95% CI, 4.9-14.7) for control arm patients (N = 31).<h4>Conclusions</h4>Radiologic TL reduction of ≥10% at the first post-baseline response assessment identified patients with ICB-responsive metastatic MSS/pMMR-CRC. This pragmatic measure may be used to monitor patients in investigational ICB schedules, enabling early treatment adaptation for unresponsive cases.<h4>Trial registration</h4>ClinicalTrials.gov number, NCT03388190 (02/01/2018)."],"journal":["British journal of cancer"],"pubmed_title":["Early radiologic signal of responsiveness to immune checkpoint blockade in microsatellite-stable/mismatch repair-proficient metastatic colorectal cancer."],"pmcid":["PMC9726864"],"funding_grant_id":["18054","215613"],"pubmed_authors":["Negard A","Flatmark K","Hamre HM","Hofsli E","Guren MG","Sorbye H","Meltzer S","Kersten C","Bakke KM","Ree AH"],"additional_accession":[]},"is_claimable":false,"name":"Early radiologic signal of responsiveness to immune checkpoint blockade in microsatellite-stable/mismatch repair-proficient metastatic colorectal cancer.","description":"<h4>Background</h4>Immune checkpoint blockade (ICB) results in radiologic tumour response dynamics that differ from chemotherapy efficacy measures and require an early signal of clinical utility.<h4>Methods</h4>Previously untreated, unresectable microsatellite-stable (MSS)/mismatch repair-proficient (pMMR) colorectal cancer (CRC) patients were randomly assigned to the oxaliplatin-based Nordic FLOX regimen (control arm) or repeat sequential two FLOX cycles and two ICB cycles (experimental arm). The radiologic response was assessed every 8 weeks. In this post hoc analysis, we explored early target lesion (TL) dynamics as indicator of ICB responsiveness. Progression-free survival (PFS) was the primary endpoint.<h4>Results</h4>Using a landmark analysis approach, we categorised experimental-arm patients into ≥10% (N = 19) or <10% (N = 16) TL reduction at the first post-baseline response assessment. Median PFS for the groups was 16.0 (95% confidence interval (CI), 12.3-19.7) and 3.9 months (95% CI, 2.3-5.5), respectively, superior and inferior (both P < 0.01) to the median PFS of 9.8 months (95% CI, 4.9-14.7) for control arm patients (N = 31).<h4>Conclusions</h4>Radiologic TL reduction of ≥10% at the first post-baseline response assessment identified patients with ICB-responsive metastatic MSS/pMMR-CRC. This pragmatic measure may be used to monitor patients in investigational ICB schedules, enabling early treatment adaptation for unresponsive cases.<h4>Trial registration</h4>ClinicalTrials.gov number, NCT03388190 (02/01/2018).","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Dec","modification":"2026-05-28T00:39:08.034Z","creation":"2025-04-04T23:36:43.876Z"},"accession":"S-EPMC9726864","cross_references":{"pubmed":["36229579"],"doi":["10.1038/s41416-022-02004-0"]}}