Colon Cancer Stage IV: Xeloda Side Effects and Capecitabine Trials

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Contents

Capecitabine (Xeloda) is frequently used in combination with other chemotherapies to treat stage IV colon cancer. Multiple controlled trials have compared these combinations — including CapOx, CapIri, FOLFOX, FUFOX and others — to determine both efficacy and toxicity.

Capecitabine Combination Trials

Key trials include:

  • CapOx vs FUFOX
  • FOLFIRI vs XELIRI ± COX II inhibitors
  • Adjuvant Mayo Clinic/RP vs XELOX study
  • German AIO Phase II/III trials
  • Spanish TTD Group randomized phase II study

In the TREE-1 phase II trial, CapIri and CapOx were compared in 161 patients with a day-1 and -8 schedule every 3 weeks. Early dose adjustments in the CapIri arm were required due to severe toxicity, including septic diarrhea and pulmonary embolism, which resulted in a 6% early mortality. CapOx showed lower early mortality (1%) and differing side effect profiles.

Side Effects Comparison

Side effect patterns differ among regimens:

Regimen Diarrhea Neuropathy Hand-Foot Syndrome Other Toxicities
CapIri 23% (Grade 3–4) 1% 9% (Grade 2) Septic diarrhea, pulmonary embolism
CapOx 21.9% 6% 15.6% Nausea, vomiting, dehydration
FOLFOX / FUFOX / bFOL Varies Varies Varies Neutropenia (FOLFOX), withdrawal due to toxicity (bFOL)

Efficacy Outcomes

Response rates (RR) ranged 40–55% depending on the regimen, with median overall survival exceeding 17–18 weeks in TREE-1 trial arms. Large phase III trials including Roche and European Society of Medical Oncology (ESMO) 2006 presentations reported no significant difference in progression-free survival between FOLFOX and XELOX.

Colon Cancer Stage IV: Xeloda Side Effects