A multicenter, randomized trial comparing efficacy and safety of paclitaxel/capecitabine and cisplatin/capecitabine in advanced gastric cancer.

Abstract

BACKGROUND:

We compared efficacy and safety of paclitaxel/capecitabine therapy followed by capecitabine for maintenance (PACX) versus cisplatin/capecitabine therapy (XP) in advanced gastric cancer.

METHODS:

Multicenter, 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.

RESULTS:

Median 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.

CONCLUSIONS:

First-line chemotherapy with PACX is effective with milder toxicities in advanced gastric cancer, but could not replace XP.

• Authors: Zhihao Lu, Xiaotian Zhang, Wei Liu, Tianshu Liu, Bing Hu, Wei Li, Qingxia Fan, Jianming Xu, Nong Xu, Yuxian Bai, Yueyin Pan, Qing Xu, Wei Bai, Li Xia, Yong Gao, Wenling Wang, Yongqian Shu, Lin Shen
• Journal: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association (Gastric Cancer) Vol. 21 Issue 5 Pg. 782-791 (09 2018) ISSN: 1436-3305 [Electronic] Japan
• PMID: 29488121 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Capecitabine
• Paclitaxel
• Cisplatin

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Capecitabine (administration & dosage)
• Cisplatin (administration & dosage)
• Disease-Free Survival
• Female
• Humans
• Male
• Middle Aged
• Paclitaxel (administration & dosage)
• Quality of Life
• Stomach Neoplasms (drug therapy, mortality, pathology)
• Treatment Outcome