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Additional research on biomarkers in ‘Phase II study of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer (JACCRO CC-09) "

ABSTRACT: Interventions: Collecting blood 16mL at the time of before JACCRO CC-09 protocol treatment, 8 weeks after protocol treatment, and PD. Primary outcome(s): Tumor-related gene variation analysis using plasma free DNA Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2631242 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Additional research on biomarkers in ‘Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer (JACCRO CC-08) &quot

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Phase 2 study of irinotecan plus cetuximab rechallenge as third-line treatment in KRAS wild-type metastatic colorectal cancer: JACCRO CC-08.

Project description:BackgroundRegorafenib or trifluridine/tipiracil as third-line treatment have limited efficacy in metastatic colorectal cancer (mCRC).MethodsThis Phase 2 trial evaluated the efficacy and safety of irinotecan plus cetuximab rechallenge as third-line treatment in KRAS wild-type mCRC patients who achieved clinical benefit with first-line cetuximab-containing therapy. The primary endpoint was 3-month progression-free survival (PFS) rate. A sample size was calculated; 30 patients with a 3-month PFS rate of 45% deemed promising and 15% unacceptable. Patients with greater and less than the cut-off value of cetuximab-free intervals (CFIs) were classified into the long and short CFI groups, respectively, in subgroup analyses.ResultsAmong 34 eligible patients who received treatment at least once, 3-month PFS rate was 44.1% (95% confidence interval, 27.4-60.8%). The median PFS and overall survival (OS) were 2.4 and 8.2 months, respectively. The response and disease control rates were 2.9 and 55.9%, respectively. PFS and OS were significantly longer in the long- than in the short CFI group.ConclusionsIrinotecan plus cetuximab rechallenge as third-line treatment for KRAS wild-type mCRC was safe and had promising activity, especially in those with a long CFI, warranting further investigation in a Phase 3 randomised trial.Clinical trial registrationUMIN000010638.

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