Trial reportJapanese journal of clinical oncology2026
Phase II study of FOLFIRI with low-dose irinotecan plus ramucirumab as second-line treatment in Japanese patients with metastatic colorectal cancer (study rindo).
Trial report in Japanese journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveThis multicenter, single-arm, Phase II study aimed to evaluate the efficacy and safety of fluorouracil, levofolinate, and irinotecan (150 mg/m2, standard dose in Japan) (FOLFIRI) plus ramucirumab (RAM) as second-line treatment for metastatic colorectal cancer (mCRC) in Japanese patients.
methodsOn Day 1 of each 2-week cycle, patients with unresectable mCRC who were refractory to oxaliplatin and fluoropyrimidine in combination with bevacizumab or anti-epidermal growth factor receptor antibodies as first-line treatment received 8 mg/kg RAM, followed by the FOLFIRI regimen with low-dose irinotecan (150 mg/m2). The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), treatment compliance, and safety.
resultsA total of 62 patients were enrolled from 15 institutions between January 2018 and August 2021. The intent-to-treat and safety populations included 61 and 58 patients. Median PFS and OS were 5.9 months (95% CI, 4.8-6.9 months) and 17.0 months (95% CI, 12.0-21.0 months), respectively. The objective response rate and disease control rate were 8.2% and 74%, respectively. The median time to treatment failure was 4.8 months (95% CI, 3.2-5.9 months). The median relative dose intensities of irinotecan, 5-fluorouracil, and RAM were 73.8% (range, 40.3%-102.4%), 58.5% (range, 22.8%-102.4%), and 80.8% (range, 36.1%-102.4%), respectively. Frequencies of Grade ≥ 3 hematologic, non-hematologic, and RAM-associated adverse events were 43%, 24%, and 17%, respectively. The observed Grade ≥ 3 adverse events included neutropenia (40%), diarrhea (8.6%), decreased appetite (10%), hypertension (6.9%), and proteinuria (3.4%).
conclusionFOLFIRI with low-dose irinotecan plus RAM is a feasible second-line treatment in Japanese patients with mCRC.
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