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CAPOX Demonstrates Equivalent Efficacy and Toxicity to FUFOX in First-Line Setting for Patients With Advanced Colorectal Cancer

CAPOX Demonstrates Equivalent Efficacy and Toxicity to FUFOX in First-Line Setting for Patients With Advanced Colorectal Cancer

BREMEN, GERMANY-CAPOX and FUFOX have comparable toxicity profiles and efficacy in the first-line treatment of metastatic colorectal cancer, according to a phase III German study. "Offering the convenience of an oral regimen, CAPOX is a possible alternative to FUFOX," concluded the study's lead investigator, Hendrik-Tobias Arkenau, MD, of Hospital Bremen East in Bremen, Germany (abstract 3507). The study randomized 476 patients to receive one of the two following regimens:

  • CAPOX (capecitabine [Xeloda], 1,000 mg/m2 twice daily on days 1-14; oxaliplatin [Eloxatin], 70 mg/m2 on days 1 and 8) every 3 weeks
  • FUFOX (fluorouracil, 2,000 mg/ m2 as a 24-hour infusion; folinic acid, 500 mg/m2; oxaliplatin, 50 mg/m2 on days 1, 8, 15, and 22) every 5 weeks.
All patients had measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and normal renal and hepatic function. Baseline characteristics were well balanced for the 242 patients in the CAPOX arm and the 234 patients in the FUFOX arm. The median age of patients was 66 years in the CAPOX arm and 64 years in the FUFOX arm. Toxicity and Response The two regimens had comparable toxicity profiles, although there was more hand-foot syndrome, particularly grade 2/3, in the CAPOX arm. The most common grade 3/4 clinical adverse event was neurosensory toxicity. The study was based on a noninferiority design, and CAPOX showed no inferiority compared with FUFOX within the investigators' statistical assumptions. Study results follow for CAPOX vs FUFOX:
  • Overall response rates were 47% for CAPOX (95% CI, 41%-54%) vs 49% for FUFOX (95% CI, 43%-56%), with complete response rates of 2% vs 5%, partial response of 45% vs 44%, and stable disease in 27% vs 24%.
  • Median progression-free survival was 7 vs 8 months (P =.11).
  • Median overall survival was 16.3 vs 17.2 months (P = .72)
"Like the safety analysis, there is no difference in response rates," Dr. Arkenau reported. Caution Advised "Overall, this important study validates capecitabine as an acceptable alternative to infusional 5-FU in combination with oxaliplatin," noted Neal J. Meropol, MD, of Fox Chase Cancer Center in Philadelphia, who served as a discussant for this ASCO presentation. "In interpreting these results, one should note that studies in Europe and North America have been discordant in terms of doses of capecitabine that are tolerable in combination with oxaliplatin," Dr. Meropol said. "Although a mechanism for this discordance has not been elucidated, it suggests that some caution is required in applying the results of this trial to the care of patients worldwide."
 
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