Clinical trialPhase 3Colorectal cancer

Capecitabine Plus Oxaliplatin Compared With Fluorouracil and Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer

JCO · 20111886 patients in the intention-to-treat population (944 in the XELOX group and 942 in the FU/FA group)
Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, et al. JCO. 2011. 29:1465-1471
Study type
Clinical trial
Phase
Phase 3
Design
Multicentre randomised trial
Sample size
1886 patients in the intention-to-treat population (944 in the XELOX group and 942 in the FU/FA group)
Source
JCO · 2011

In plain words

In this study, patients with stage III colon cancer received, after surgery, either an oral drug called capecitabine together with oxaliplatin (the XELOX regimen) or standard chemotherapy with fluorouracil and folinic acid. The chance of the disease coming back, a new colon cancer developing, or death was lower in the XELOX group. The difference in overall survival between the two groups was not statistically significant. The best regimen should be chosen with the advice of your treating doctor.

Key results

0.80 (95% CI 0.69 to 0.93)
Disease-free survival (DFS) – hazard ratio
P = 0.0045; after 57 months of follow-up in the primary analysis
31.3% (295 patients) with XELOX vs 37.5% (353 patients) with FU/FA
Relapse, new primary colon cancer or death
70.9% vs 66.5%
3-year disease-free survival
XELOX vs FU/FA
0.87 (95% CI 0.72 to 1.05)
Overall survival (OS) – hazard ratio
P = 0.1486; follow-up ongoing
77.6% vs 74.2%
5-year overall survival
XELOX vs FU/FA

Dose and schedule cards

CAPOX / XELOX

Colorectal cancer (adjuvant and metastatic), gastric cancerCycle length: Every 21 daysOn the page “CAPOX (XELOX): dose, schedule and side effects”

Nivolumab + CAPOX

Advanced HER2-negative gastric cancerCycle length: Every 21 daysOn the page “Nivolumab with CAPOX or FOLFOX in gastric cancer (CheckMate 649)”

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1XELOX (capecitabine + oxaliplatin)

Oxaliplatin 130 mg/m² on day 1 plus capecitabine 1,000 mg/m² twice daily on days 1 to 14 every 3 weeks, for 24 weeks. Number of patients: 944.

2Bolus fluorouracil + folinic acid (FU/FA)

Standard adjuvant bolus fluorouracil and folinic acid regimen: the Mayo Clinic protocol for 24 weeks (664 patients; as this regimen is described in the FDA label for capecitabine: fluorouracil 425 mg/m² and leucovorin 20 mg/m² IV days 1 to 5 every 28 days, 6 cycles) or the Roswell Park protocol for 32 weeks (278 patients; dose not stated in the available sources). Total number of patients: 942.

Source of the regimen details: Abstract of the paper (XELOX doses); Mayo Clinic regimen dose from the FDA label for capecitabine (X-ACT section, the same standard regimen); the Roswell Park regimen dose is not stated in the available sources

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Patients with stage III colon cancer who had undergone surgery with curative intent (complete resection).

Endpoints

Primary endpoint: disease-free survival (DFS). The abstract also reports overall survival (OS).

Safety and side effects

Safety and adverse event data are not reported in the abstract; for grade 3 or higher adverse events, consult the full text.

Clinical significance and place in guidelines

Based on the abstract, XELOX improved disease-free survival compared with bolus FU/FA in stage III colon cancer and was presented as an additional adjuvant treatment option. The improvement in overall survival was not statistically significant. The status of this regimen in current clinical guidelines and drug approvals should be checked separately.

Limitations

The control group received a bolus FU/FA regimen. The difference in overall survival was not statistically significant, and follow-up was ongoing at publication. Safety data are not given in the abstract.

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.