Dr David Cunningham and colleagues from the United Kingdom evaluated capacitabine, an oral fluoropyrimidine, and oxaliplatin, a platinum compound.
The research team investigated the effect of these interventions as alternatives to infused fluorouracil and cisplatin, respectively, for untreated advanced esophagogastric cancer.
In a factorial design, the team randomly assigned 1002 patients.
Patients in Group 1 received triplet therapy with epirubicin and cisplatin plus either fluorouracil
In Group 2, patients received triplet therapy with epirubicin and cisplatin plus capecitabine.
In Group 3, patients received triplet therapy with epirubicin and oxaliplatin plus fluorouracil.
Patients in Group 4 received triplet therapy with oxaliplatin plus capecitabine.
|The survival rates at 1 year was 47% for Group 4|
|New England Journal of Medicine|
The primary end point was noninferiority in overall survival for the triplet therapies containing capecitabine as compared with fluorouracil, and for those containing oxaliplatin as compared with cisplatin.
The team found that for the capecitabine-fluorouracil comparison, the hazard ratio for death in the capecitabine group was 0.86.
For the oxaliplatin-cisplatin comparison, the hazard ratio for the oxaliplatin group was 0.92.
The upper limit of the confidence intervals for both hazard ratios excluded the predefined noninferiority margin of 1.2.
The researchers found that median survival times in Groups 1 and 2 were 10 months.
The researchers found that median survival times in Groups 3 and 4 were 9 and 11 months, respectively.
Survival rates at 1 year were 38%, 41%, 40%, and 47% for Groups 1, 2, 3 and 4, respectively.
In the secondary analysis, overall survival was longer in Group 4 than in Group 1, with a hazard ratio for death of 0.80 in Group 4.
Progression-free survival and response rates did not differ significantly among the regimens.
The team found toxic effects of capecitabine and fluorouracil were similar.
As compared with cisplatin, oxaliplatin was associated with lower incidences of grade 3 or 4 neutropenia, alopecia, renal toxicity, and thromboembolism.
However, as compared with cisplatin, oxaliplatin was associated with slightly higher incidences of diarrhea and neuropathy.
Dr Cunningham's team concluded, "Capecitabine and oxaliplatin are as effective as fluorouracil and cisplatin, respectively, in patients with previously untreated esophagogastric cancer."