Patient Summary: Randomized phase III trial of capecitabine/cisplatin (XP) vs. continuous infusion of 5FU/cisplatin (FP) as first line therapy in patients (pts) with advanced gastric cancer (AGC): Efficacy and safety results
Randomized phase III trial of capecitabine/cisplatin (XP) vs. continuous infusion of 5FU/cisplatin (FP) as first line therapy in patients (pts) with advanced gastric cancer (AGC): Efficacy and safety results.
This study looked to prove that Xeloda (a newer oral chemotherapy) and cisplatin (XP) are as effective as intravenous therapy with 5-FU and cisplatin (FP). The XP regimen would allow the patient to take the drug at home and avoid the need for a central venous catheter. Patients with advanced gastric cancers were randomized to receive either IV cisplatin with capecitabine given every 3 weeks, or IV cisplatin with continuous infusion 5FU (5 day infusion) given every 3 weeks.
The two groups had similar overall survival (with or without disease progression); XP median survival of 10.5 months and FP median survival of 9.3 months. The XP patients had improved response rates and improved progression free survival compared to the FP patients (although not statistically significant). Both regimens were well tolerated with few side effects. The XP patients had a higher rate of hand-foot syndrome (5% vs. 0%), and the FP patients had a higher rate of stomatitis (6% vs. 2%).
This trial proved the two regimens to be comparable. One issue not addressed is cost, as Xeloda is more costly and may have to be paid by the patient depending on their insurance coverage. A second issue is compliance. Numerous studies have shown that patients frequently do not take medication as prescribed. The XP regimen leaves this responsibility to the patient, where as the FP regimen gives control to the physician. An interesting follow up would be to monitor compliance with the oral regimen.