Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma
Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma
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DOI：
10.3109/0284186x.2012.682628
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发表时间：
2012-09-01
期刊：
影响因子：
3.1
通讯作者：
Kim, Myung-Hwan
中科院分区：
文献类型：
--
作者：
Kang, Myoung Joo;Lee, Jae-Lyun;Kim, Myung-Hwan
背景资料。我们评价了S-1联合顺铂(SP)和吉西他滨联合顺铂(GP)作为一线方案治疗晚期胆道腺癌的疗效和安全性。材料和方法。随机分为两组，顺铂60 mg/m(2)，静脉滴注，第1天；S-1，40 mg/m(2)，每日2次，口服，第1~14天；吉西他滨1000 mg/m(2)，静脉滴注，10 mg/m(2)/min，第1、8天。主要终点是6个月的无进展生存期(PFS)。结果。在96名符合条件的患者中，49人被随机分成GP组，47人被随机分为SP组。中位随访时间14.2个月，6个月PFS发生率分别为43.8%和34.7%[未调整HR(GP/SP)=0.85，95%CI 0.52~1.36]。GP组和SP组的中位OS值分别为10.1个月和9.9个月[未调整HR(GP/SP)=0.72，95%可信区间0.45~1.17]。GP组和SP组的3-4级毒副反应包括中性粒细胞减少(49.0%比31.8%)、贫血(22.4%比2.3%)、血小板减少(22.4%比4.5%)和乏力(4.1%比2.1%)。结论。作为ABTA的一线治疗，GP和SP都具有相似的疗效和良好的安全性。(ClinicalTrials.gov编号nct 01375972)。
Background. We evaluated the efficacy and safety of a combination of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first-line therapy for advanced biliary tract adenocarcinoma (ABTA). Material and methods. Patients were randomized to receive cisplatin (60 mg/m(2) intravenously [IV] on Day 1) plus S-1 (40 mg/m(2) bid orally on Days 1-14) or gemcitabine (1000 mg/m(2) IV at 10 mg/m(2)/min on Days 1 and 8) every three weeks. The primary end point was six-month progression-free survival (PFS). Results. Of 96 eligible patients, 49 were randomized to GP and 47 to SP. At a median follow-up time of 14.2 months, the six-month PFS rates were 43.8% and 34.7%, respectively [unadjusted HR (GP/SP) = 0.85, 95% CI 0.52-1.36]. The median OS values in the GP and SP groups were 10.1 months and 9.9 months, respectively [unadjusted HR (GP/SP) = 0.72, 95% CI 0.45-1.17]. Grade 3-4 toxicities in the GP and SP groups included neutropenia (49.0% vs. 31.8%), anemia (22.4% vs. 2.3%), thrombocytopenia (22.4% vs. 4.5%), and asthenia (4.1% vs. 2.1%). Conclusion. Both GP and SP has comparable efficacy with favorable safety profile as first-line treatment for ABTA. (ClinicalTrials.gov number NCT 01375972).