HEALTH PROFESSIONAL · SOURCE READING
Oxaliplatin
Source: Colon Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 12, 2025 · Captured 2026-09-09.
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Randomized phase III trials have addressed the equivalence of substituting capecitabine for infusional 5-FU. Two phase III studies have evaluated 5-FU/oxaliplatin (FUOX) versus capecitabine/oxaliplatin (CAPOX).[61,62]
Evidence (oxaliplatin):
The AIO Colorectal Study Group randomly assigned 474 patients to either 5-FU/LV/oxaliplatin (FUFOX) or CAPOX.
The AIO Colorectal Study Group randomly assigned 474 patients to either 5-FU/LV/oxaliplatin (FUFOX) or CAPOX.
The median PFS was 7.1 months for the CAPOX arm and 8.0 months for the FUFOX arm (HR, 1.17; 95% CI, 0.96–1.43; P = .117), and the HR was in the prespecified equivalence range.
The Spanish Grupo de Tratamiento de los Tumores Digestivos randomly assigned 348 patients to CAPOX or FUOX.[61][Level of evidence B1]
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The Spanish Grupo de Tratamiento de los Tumores Digestivos randomly assigned 348 patients to CAPOX or FUOX.[61][Level of evidence B1]
The TTP was 8.9 months versus 9.5 months (P = .153) and met the prespecified range for noninferiority.
When using an oxaliplatin-based regimen as first-line treatment of metastatic colorectal cancer, a CAPOX regimen is not inferior to a FUOX regimen.
Before the availability of cetuximab, panitumumab, bevacizumab, and ziv-aflibercept as second-line therapy, second-line chemotherapy with irinotecan in patients treated with 5-FU/LV as first-line therapy demonstrated improved OS when compared with either infusional 5-FU or supportive care.[63-66]
Similarly, a phase III trial randomly assigned patients who progressed on irinotecan and 5-FU/LV to bolus and infusional 5-FU/LV (LV5FU2), single-agent oxaliplatin, or FOLFOX-4. The median TTP for FOLFOX-4 versus LV5FU2 was 4.6 months versus 2.7 months (stratified log-rank test, 2-sided P < .001).[67][Level of evidence B1]
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