Abstract
BackgroundWe compared efficacy and safety of paclitaxel/capecitabine therapy followed by capecitabine for maintenance (PACX) versus cisplatin/capecitabine therapy (XP) in advanced gastric cancer.MethodsMulticenter, randomized, phase III trial was conducted in China (December 2009–February 2014). Adults (n = 320) with histologically confirmed, untreated metastatic/unresectable gastric or gastroesophageal junction adenocarcinoma; with ≥ 1 measureable lesions according to Response Evaluation Criteria in Solid Tumors 1.0 criteria; Karnofsky performance score ≥ 70 and life expectancy ≥ 3 months were randomized (1:1) to PACX or XP. PACX group received paclitaxel 80 mg/m2 intravenous on days 1 and 8; capecitabine 1000 mg/m2 orally BD on days 1–14, followed by a 7-day rest interval for 4 cycles, followed by maintenance capecitabine at same dosage/schedule until disease progression, unendurable adverse events or death. XP group received cisplatin intravenous 80 mg/m2 on day 1 and capecitabine at same dosage/schedule as PACX group per cycle for 6 cycles.ResultsMedian progression-free survival (5.0 versus 5.3 months; hazard ratio [95% CI]: 0.906; 0.706–1.164; p = 0.44) and overall survival (12.5 versus 11.8 months; hazard ratio: 0.878 [0.685–1.125]; p = 0.30) were not significantly different between PACX and XP groups. Objective response rate was significantly higher (43.1 versus 28.8%; p = 0.012) and disease control rate was similar (77.5 versus 72.5%; p = 0.75) in PACX versus XP, respectively. Quality of life was significantly improved in PACX versus XP after three treatment cycles. Many treatment-related adverse events were significantly lesser in PACX than XP.ConclusionsFirst-line chemotherapy with PACX is effective with milder toxicities in advanced gastric cancer, but could not replace XP.
Highlights
Gastric cancer is the third most common cancer and the second leading cause of cancer deaths globally
The median percentage of actual dose administered relative to the planned dose was > 80% for capecitabine in both groups, 96.8% for paclitaxel in paclitaxel/capecitabine therapy followed by capecitabine for maintenance (PACX) group, and 98% for cisplatin in XP group
Analysis of treatment-related adverse events (AEs) at level III or IV revealed that the incidences of anemia, thrombocytopenia, vomiting and nausea were significantly higher in XP group than PACX group. 6 (3.8%) patients in PACX group and 4 (2.7%) patients in XP group developed treatment-related serious AEs (SAEs) (Table 3). In this randomized phase III study, PACX regimen did not show longer progression-free survival (PFS), overall survival (OS), and disease control rate (DCR), but significantly higher objective response rate (ORR) and quality of life (QoL) compared with XP regimen
Summary
Gastric cancer is the third most common cancer and the second leading cause of cancer deaths globally. The median survival of patients with advanced gastric cancer (AGC) is 7–10 months in a majority of large clinical studies [2]. We compared efficacy and safety of paclitaxel/capecitabine therapy followed by capecitabine for maintenance (PACX) versus cisplatin/capecitabine therapy (XP) in advanced gastric cancer. Adults (n = 320) with histologically confirmed, untreated metastatic/unresectable gastric or gastroesophageal junction adenocarcinoma; with ≥ 1 measureable lesions according to Response Evaluation Criteria in Solid Tumors 1.0 criteria; Karnofsky performance score ≥ 70 and life expectancy ≥ 3 months were randomized (1:1) to PACX or XP. PACX group received paclitaxel 80 mg/ m2 intravenous on days 1 and 8; capecitabine 1000 mg/m2 orally BD on days 1–14, followed by a 7-day rest interval for 4 cycles, followed by maintenance capecitabine at same dosage/schedule until disease progression, unendurable adverse events or death. Quality of life was significantly improved in PACX versus XP after three treatment cycles. Conclusions First-line chemotherapy with PACX is effective with milder toxicities in advanced gastric cancer, but could not replace XP
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