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Irinotecan and oxaliplatin
Source: Rectal Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 12, 2025 · Captured 2026-09-09.
Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary. Independent clinical review is pending.
Three randomized studies in patients with metastatic colorectal cancer demonstrated improved response rates, progression-free survival (PFS), and overall survival (OS) when irinotecan or oxaliplatin was combined with 5-FU/LV.[18-20]
Evidence (irinotecan vs. oxaliplatin):
An intergroup study (NCCTG-N9741 [NCT00003594]) compared irinotecan/5-FU/LV (IFL) with oxaliplatin/LV/5-FU (FOLFOX4) in first-line treatment for patients with metastatic colorectal cancer.[21][Level of evidence A1]
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An intergroup study (NCCTG-N9741 [NCT00003594]) compared irinotecan/5-FU/LV (IFL) with oxaliplatin/LV/5-FU (FOLFOX4) in first-line treatment for patients with metastatic colorectal cancer.[21][Level of evidence A1]
Patients assigned to FOLFOX4 experienced an improved PFS compared with patients randomly assigned to IFL (median, 8.7 months vs. 6.9 months; P = .014; hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.61–0.89) and OS (19.5 months vs. 15.0 months; P = .001; HR, 0.66; 95% CI, 0.54–0.82).
Subsequently, two studies compared FOLFOX with LV/5-FU/irinotecan (FOLFIRI), and patients were allowed to cross over after progression on first-line therapy.[22,23][Level of evidence B1]
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Subsequently, two studies compared FOLFOX with LV/5-FU/irinotecan (FOLFIRI), and patients were allowed to cross over after progression on first-line therapy.[22,23][Level of evidence B1]
PFS and OS were identical between the treatment arms in both studies.
The Bolus, Infusional, or Capecitabine with Camptosar-Celecoxib (BICC-C [NCT00094965]) trial evaluated several different irinotecan-based regimens in patients with previously untreated metastatic colorectal cancer: FOLFIRI, irinotecan plus bolus 5-FU/LV (mIFL), and capecitabine/irinotecan (CAPIRI).[24] The study randomly assigned 430 patients and was closed early due to poor accrual.
The Bolus, Infusional, or Capecitabine with Camptosar-Celecoxib (BICC-C [NCT00094965]) trial evaluated several different irinotecan-based regimens in patients with previously untreated metastatic colorectal cancer: FOLFIRI, irinotecan plus bolus 5-FU/LV (mIFL), and capecitabine/irinotecan (CAPIRI).[24] The study randomly assigned 430 patients and was closed early due to poor accrual.
The patients who received FOLFIRI had a better PFS than the patients who received either mIFL (7.6 months vs. 5.9 months; P = .004) or CAPIRI (7.6 months vs. 5.8 months; P = .015).
The Bolus, Infusional, or Capecitabine with Camptosar-Celecoxib (BICC-C [NCT00094965]) trial evaluated several different irinotecan-based regimens in patients with previously untreated metastatic colorectal cancer: FOLFIRI, irinotecan plus bolus 5-FU/LV (mIFL), and capecitabine/irinotecan (CAPIRI).[24] The study randomly assigned 430 patients and was closed early due to poor accrual.
Patients who received CAPIRI had the highest (grade 3 or higher) rates of nausea, vomiting, diarrhea, dehydration, and hand-foot syndrome.
Since the publication of these studies, the use of either FOLFOX or FOLFIRI is considered acceptable for first-line treatment of patients with metastatic colorectal cancer. However, when using an irinotecan-based regimen as first-line treatment of metastatic colorectal cancer, FOLFIRI is preferred.[24][Level of evidence B1]
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Studies cited in this source section
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Preserved source evidence · Independent clinical review pending · Not medical advice