Effective chemotherapy with mild toxicity for treatment of advanced gastric cancer is still limited. This study aimed to compare the efficacy and safety of combination therapy of paclitaxel and capecitabine followed by capecitabine monotherapy as maintenance therapy (PACX) versus cisplatin and capecitabine combination therapy (XP) for advanced gastric cancer.
This multicentre, randomised, active-controlled phase III study included 320 patients who were enrolled from 22 clinical sites across different regions of China. Patients were randomly allocated to PACX or XP group in a 1:1 ratio with the following four stratification factors: Karnofsky performance score (≥80/ < 80); resection of primary tumour (yes/no); weight loss within last 3 months (≥5%/ < 5%); and primary tumour site at the gastroesophageal junction (yes/no). The primary endpoint assessed progression-free survival (PFS). The secondary endpoints assessed overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life (QoL), and safety.
Comparison of PACX and XP groups showed that both median PFS (5.1 versus 5.3 months, respectively; p = 0.40) and median OS (12.6 versus 11.9 months, respectively; p = 0.21) were not different. ORR in PACX group was significantly higher versus XP group (45.4% vs. 31.7%, p = 0.0115), while DCR was similar in both groups (81.6% vs. 80.0%, p = 0.75). Patients receiving PACX showed significantly improved QoL compared with those receiving XP after three cycles of the regimens. The incidences of treatment-associated leukopenia, thrombocytopenia, nausea, vomiting, and reduction in food intake were significantly lower in PACX group than those in XP group (all p < 0.05).
These findings suggest that combination therapy of paclitaxel and capecitabine as first-line chemotherapy followed by capecitabine monotherapy as maintenance therapy might be effective and safe in treatment of advanced gastric cancer.
Clinical trial identification
All authors have declared no conflicts of interest.