Abstract 1451P
Background
Chemotherapy is the mainstay of treatment for advanced inoperable/stage IV gastric carcinoma (AGC). Oral chemotherapy is becoming an increasingly popular treatment strategy for patients with AGC. The aim of this study was to compare the efficacy and tolerability of a cisplatin-capecitabine (XP) regimen with cisplatin-5-fluorouracil (FP) regimen in AGC.
Methods
A total of sixty-two patients (31 patients in each arm), who had biopsy-proven AGC with no history of previous treatment, were included. All patients received cisplatin (80 mg/m2 i.v. day 1). The patients in arm A received 5-FU (800 mg/m2 /day by continuous infusion, days 1–5) (FP) for 6 cycles. Oral capecitabine (1000 mg/m2 b.i.d., days 1–14) (XP) was provided for 6 cycles in Arm B. All patients were followed up according to the set follow-up criteria for up to 6 months after completion of treatment.
Results
At the end of the treatment period, 3.2% patients in Arm B showed complete response (CR). 45.2% and 61.3% patients of Arm A and B showed partial response (PR), respectively. p-value was 0.084 (>0.05). The median progression-free survival (PFS) in Arm A versus Arm B was 5.0 months versus 5.5 months. p-value was 0.19 (>0.05). The most common treatment-related grade 3 or grade 4 toxicities in Arm A versus Arm B were as follows: neutropenia (16.1% versus 16.1%), leukopenia (6.4% versus 3.2%), nausea (3.2% versus 3.2%), vomiting (6.5% versus 6.5%), diarrhoea (3.2% versus 0%), oral mucositis (9.7% versus 3.2%), hand-foot syndrome (0% versus 3.2%). The p-value was not <0.05 for any of these toxicities.
Conclusions
Treatment with a cisplatin-capecitabine regimen is quite effective and more convenient in palliation of symptoms and locoregional control than cisplatin-5-fluorouracil in advanced inoperable gastric cancer.
Clinical trial identification
BSMMU/2017/848(1) - 25/01/2017.
Editorial acknowledgement
Legal entity responsible for the study
Institutional Review Board, Bangabandhu Sheikh Mujib Medical University, Dhaka.
Funding
Bangabandhu Sheikh Mujib Medical University.
Disclosure
All authors have declared no conflicts of interest.