A phase II study of modified docetaxel, cisplatin, and S-1 (mDCS) chemotherapy for unresectable advanced gastric cancer
A phase II study of modified docetaxel, cisplatin, and S-1 (mDCS) chemotherapy for unresectable advanced gastric cancer
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DOI：
10.1007/s00280-017-3404-8
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发表时间：
2017-10-01
影响因子：
3
通讯作者：
Kato, Junji
中科院分区：
文献类型：
--
作者：
Uemura, Naoki;Kikuchi, Shohei;Kato, Junji
我们以前报道的多西紫杉醇、顺铂和S-1(DCs)三联方案治疗不能切除的胃癌具有很高的临床疗效，总有效率为87.1%，但也显示出较高的3/4度毒性发生率。为了减少毒副反应，我们采用减量的多西紫杉醇方案进行了改良的DCs方案的II期研究，并评价了该方案的临床疗效和不良反应。不能手术切除的胃癌患者接受S-1方案(40 mg/m(2)，tid)第1-14天的化疗，多西紫杉醇(50 mg/m(2))加顺铂(60 mg/m(2))，第8天，每3周一次。主要终点是应答率(RR)。总体(OS)和无进展生存期(PFS)以及毒副作用也被评估。从2011年11月到2014年4月，49名患者入选，其中43人符合条件。总有效率为79.1%，其中完全缓解2例(4.7%)，部分缓解32例(74.4%)。病情稳定者9例(20.9%)，无进展者。43例中15例(34.9%)行根治性中转手术。中位PFS为350天(95%可信区间240-416天)，中位OS为722天(95%可信区间为411天--未达)。有79.1%的患者出现3/4级中性粒细胞减少症，34.9%的患者出现发热中性粒细胞减少症。非血液学3/4级不良反应为食欲不振(25.6%)、恶心(4.7%)和腹泻(9.3%)。改良的DCS疗法显示出很高的临床疗效，足以尝试对不能切除的胃癌进行转化治疗。改良的DCs显示出较少的毒性，但仔细管理这些仍然是必要的。
Triplet therapy using docetaxel, cisplatin, and S-1 (DCS) against unresectable gastric cancer as previously reported by us showed high clinical efficacy, with a 87.1% total response rate; however, it also showed a high incidence of grade 3/4 toxicity. With the aim of reducing toxicities, we conducted a phase II study of modified DCS (mDCS), using a reduced dose of docetaxel, and evaluated the clinical efficacy and adverse events of this regimen.Patients with unresectable gastric cancer received chemotherapy with S-1 (40 mg/m(2) b.i.d) on days 1-14, and docetaxel (50 mg/m(2)) plus cisplatin (60 mg/m(2)) on day 8 every 3 weeks. The primary endpoint was the response rate (RR). Overall (OS) and progression-free survival (PFS), and toxicities were also evaluated.Forty-nine patients were enrolled from November 2011 to April 2014, and 43 were eligible. The overall RR was 79.1%, including two cases of a complete response (4.7%), and 32 cases of a partial response (74.4%). Nine cases had stable disease (20.9%) but none showed progressive disease. Of the 43 cases, 15 cases (34.9%) underwent curative conversion surgery. The median PFS was 350 days (95% CI 240-416 days) and median OS was 722 days (95% CI 411 days-not reached). Grade 3/4 neutropenia developed in 79.1%, and febrile neutropenia in 34.9%, of patients. Non-hematological grade 3/4 adverse events were anorexia (25.6%), nausea (4.7%), and diarrhea (9.3%).Modified DCS therapy showed high clinical efficacy sufficient enough to attempt conversion therapy against unresectable gastric cancer. Modified DCS showed fewer toxicities, but careful management of these is still essential.