Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer
Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer
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DOI：
10.1007/s00280-009-1215-2
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发表时间：
2010-09-01
影响因子：
3
通讯作者：
Kato, Junji
中科院分区：
文献类型：
--
作者：
Sato, Yasushi;Takayama, Tetsuji;Kato, Junji
我们评估了多西他赛、顺铂和S-1（DCS）联合化疗在不可切除的转移性胃癌患者中的活性和毒性。组织学证实的不可切除的转移性胃腺癌患者，体能状态（PS）0-2，既往未接受过化疗。患者接受口服S-1（40 mg/m（2）b.i.d.）顺铂60 mg/m2，多西他赛60 mg/m2，第8天，每3周一次。3例患者被认为不合格，未接受DSC治疗。临床特征如下：中位年龄，63岁（范围，44-77岁）; PS，0/1/2：23/8/0;女性/男性，8/23;高分化/未分化腺癌，10/21。客观缓解率为87.1%，31例可评估患者中1例完全缓解（3.2%），26例部分缓解（83.9%）。4例患者病情稳定（12.9%），但无进展性疾病。在这27例缓解者中，8例（25.8%）实现了降级，7例（22.6%）接受了根治性手术。中位生存期和无进展生存期分别为687天[置信区间（95% CI），600.0- 1，138.1]和226天（95% CI，182.5-379.3）。最常见的3/4级血液学毒性是中性粒细胞减少（77.4%）。最常见的3级非血液学毒性包括厌食（35.5%）和恶心（32.3%）。DCS联合化疗对不能切除的转移性胃癌有高度的活性，在适当处理不良事件的情况下可以安全地给药。这种组合的进一步研究是必要的。
We evaluated the activity and toxicity of docetaxel, cisplatin, and S-1 (DCS) combination chemotherapy in patients with unresectable metastatic gastric cancer.Patients with histologically proven, unresectable metastatic gastric adenocarcinoma, performance status (PS) 0-2, and no prior chemotherapy were eligible. Patients received oral S-1 (40 mg/m(2) b.i.d.) on days 1-14 and intravenous cisplatin (60 mg/m(2)) and docetaxel (60 mg/m(2)) on day 8 every 3 weeks.Thirty-four patients were enrolled between March 2005 and April 2007. Three patients were considered ineligible and did not receive the DSC therapy. Clinical characteristics were as follows: median age, 63 years (range, 44-77); PS, 0/1/2: 23/8/0; women/men, 8/23; and well-differentiated/undifferentiated adenocarcinoma, 10/21. The objective response rate was 87.1% with 1 complete response (3.2%) and 26 partial responses (83.9%) in 31 assessable patients. Four had stable disease (12.9%) but none had progressive disease. Of these 27 responders, 8 (25.8%) achieved downstaging and 7 (22.6%) underwent curative surgery. The median survival time and progression-free survival were 687 days [confidence interval (95% CI), 600.0-1,138.1] and 226 days (95% CI, 182.5-379.3), respectively. Most common grade 3/4 hematologic toxicity was neutropenia (77.4%). Most common grade 3 nonhematologic toxicities included anorexia (35.5%) and nausea (32.3%). All treatment-related toxicities resolved, and no toxic deaths were observed.DCS combination chemotherapy is highly active against unresectable metastatic gastric cancer and can be given safely with proper management of adverse events. Further studies of this combination are warranted.