A multicenter, randomized trial comparing efficacy and safety of paclitaxel/capecitabine and cisplatin/capecitabine in advanced gastric cancer.
A multicenter, randomized trial comparing efficacy and safety of paclitaxel/capecitabine and cisplatin/capecitabine in advanced gastric cancer.
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DOI：
10.1007/s10120-018-0809-y
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发表时间：
2018-09
期刊：
影响因子：
--
通讯作者：
Shen L
中科院分区：
文献类型：
--
作者：
Lu Z;Zhang X;Liu W;Liu T;Hu B;Li W;Fan Q;Xu J;Xu N;Bai Y;Pan Y;Xu Q;Bai W;Xia L;Gao Y;Wang W;Shu Y;Shen L
我们比较了紫杉醇/卡培他滨联合卡培他滨维持治疗（PACX）与顺铂/卡培他滨治疗（XP）在晚期胃癌中的疗效和安全性。在中国进行了多中心、随机、III期试验（2009年12月至2014年2月）。经组织学证实的、未经治疗的转移性/不可切除的胃或胃食管交界处腺癌成人（n = 320）;根据实体瘤疗效评价标准1.0标准，有≥ 1处可测量病灶; Karnofsky体能评分≥ 70且预期寿命≥ 3个月，随机（1：1）接受PACX或XP治疗。PACX组给予紫杉醇80 mg/m2静脉滴注，第1、8天;卡培他滨1000 mg/m2口服，第1-14天，每日一次，停药7天，共4个周期，之后卡培他滨维持治疗，剂量/方案不变，直至疾病进展、出现不能耐受的不良事件或死亡。XP组给予顺铂80 mg/m2静脉滴注，第1天，卡培他滨剂量与方案同PACX组，每周期1次，共6个周期。PACX组和XP组的中位无进展生存期（5.0 vs 5.3个月;风险比[95% CI]：0.906; 0.706-1.164; p = 0.44）和总生存期（12.5 vs 11.8个月;风险比：0.878 [0.685-1.125]; p = 0.30）无显著差异。PACX与XP的客观缓解率显著更高（43.1%与28.8%; p = 0.012），疾病控制率相似（77.5%与72.5%; p = 0.75）。三个治疗周期后，PACX组与XP组相比，生活质量显著改善。PACX组的许多治疗相关不良事件明显少于XP组。PACX一线化疗对进展期胃癌有较好的疗效，但不能取代XP。本文的在线版本（10.1007/s10120-018-0809-y）包含补充材料，可供授权用户使用。
We compared efficacy and safety of paclitaxel/capecitabine therapy followed by capecitabine for maintenance (PACX) versus cisplatin/capecitabine therapy (XP) in advanced gastric cancer. 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. 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. First-line chemotherapy with PACX is effective with milder toxicities in advanced gastric cancer, but could not replace XP. The online version of this article (10.1007/s10120-018-0809-y) contains supplementary material, which is available to authorized users.
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