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HEALTH PROFESSIONAL · SOURCE READING

Capecitabine

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.

Context: Treatment of Stage IV and Recurrent Rectal Cancer / Treatment Options for Stage IV and Recurrent Rectal Cancer / Systemic therapy

Before the advent of multiagent chemotherapy, two randomized studies demonstrated that capecitabine was associated with equivalent efficacy when compared with the Mayo Clinic regimen of 5-FU/LV.[25,26][Level of evidence A1]

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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 capecitabine/oxaliplatin (CAPOX) versus 5-FU/oxaliplatin regimens (FUOX or FUFOX).[27,28]

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Evidence (oxaliplatin vs. capecitabine):

The Arbeitsgemeinschaft Internische Onkologie (AIO) Colorectal Study Group randomly assigned 474 patients to either CAPOX or FUFOX.

The Arbeitsgemeinschaft Internische Onkologie (AIO) Colorectal Study Group randomly assigned 474 patients to either CAPOX or FUFOX.

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.[28]

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The Spanish Cooperative Group randomly assigned 348 patients to CAPOX or FUOX.[27][Level of evidence B1]

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The Spanish Cooperative Group randomly assigned 348 patients to CAPOX or FUOX.[27][Level of evidence B1]

The TTP was 8.9 months for CAPOX versus 9.5 months for FUOX (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 5-FU/oxaliplatin regimen.

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Preserved source evidence · Independent clinical review pending · Not medical advice