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吉西他滨与S-1诱导治疗后序贯放化疗及使用S-1进行全身化疗用于局部晚期胰腺癌的II期研究

Phase II study of induction gemcitabine and S-1 followed by chemoradiotherapy and systemic chemotherapy using S-1 for locally advanced pancreatic cancer.

作者信息

Sudo Kentaro, Hara Ryusuke, Nakamura Kazuyoshi, Kita Emiri, Tsujimoto Akiko, Yamaguchi Taketo

机构信息

Department of Gastroenterology, Chiba Cancer Center, 666-2 Nitona-cho, Chuo-ku, Chiba, 260-8717, Japan.

Department of Radiation Oncology, Chiba Cancer Center, Chiba, Japan.

出版信息

Cancer Chemother Pharmacol. 2017 Jul;80(1):195-202. doi: 10.1007/s00280-017-3350-5. Epub 2017 Jun 8.

DOI:10.1007/s00280-017-3350-5
PMID:28597040
Abstract

PURPOSE

S-1 has systemic activity for locally advanced pancreatic cancer (LAPC). Here, the efficacy and safety of induction gemcitabine (GEM) and S-1 (GS) followed by chemoradiotherapy (CRT) and systemic chemotherapy using S-1 for LAPC were assessed.

METHODS

The treatment consisted of four cycles of induction GS (S-1 60, 80, or 100 mg/day based on body surface area for 14 days every 3 weeks plus GEM 1000 mg/m on days 8 and 15), followed by S-1 (80, 100, or 120 mg/day based on body surface area on days 1-14 and 22-35) and concurrent radiotherapy (50.4 Gy in 28 fractions). Maintenance chemotherapy with S-1 was started 1-4 weeks after CRT until disease progression or unacceptable toxicity was observed. The primary endpoint was 1-year survival.

RESULTS

A total of 30 patients with LAPC were enrolled. The median survival and progression-free survival were 21.3 and 12.7 months, respectively. Overall survival rates at 1, 2, 3, and 4 years were 73.3, 36.7, 23.3, and 16.7%, respectively. The median survival of 23 patients who received CRT was 22.9 months, with a 3-year survival rate of 30.4%. The two most common grade 3 or 4 adverse events during induction GS were neutropenia (63.3%) and biliary tract infection (20%). Toxicities during CRT or maintenance chemotherapy were generally mild.

CONCLUSIONS

This regimen was feasible and highly active resulting in encouraging survival in patients with LAPC. Further investigations are warranted to elucidate the effectiveness of this treatment strategy in future studies. Clinical trials information: UMIN000006332.

摘要

目的

S-1对局部晚期胰腺癌(LAPC)具有全身活性。在此,评估了诱导吉西他滨(GEM)和S-1(GS)序贯放化疗(CRT)以及使用S-1进行全身化疗对LAPC的疗效和安全性。

方法

治疗包括四个周期的诱导GS(根据体表面积,S-1剂量为60、80或100mg/天,每3周服用14天,加第8天和第15天的GEM 1000mg/m),随后是S-1(根据体表面积,剂量为80、100或120mg/天,第1 - 14天和第22 - 35天服用)及同步放疗(28次分割,共50.4Gy)。CRT结束后1 - 4周开始用S-1进行维持化疗,直至疾病进展或出现不可接受的毒性。主要终点为1年生存率。

结果

共纳入30例LAPC患者。中位生存期和无进展生存期分别为21.3个月和12.7个月。1年、2年、3年和4年的总生存率分别为73.3%、36.7%、23.3%和16.7%。接受CRT的23例患者的中位生存期为22.9个月,3年生存率为30.4%。诱导GS期间最常见的两种3级或4级不良事件是中性粒细胞减少(63.3%)和胆道感染(20%)。CRT或维持化疗期间的毒性一般较轻。

结论

该方案可行且活性高,可使LAPC患者获得令人鼓舞的生存期。有必要在未来研究中进一步研究以阐明该治疗策略的有效性。临床试验信息:UMIN000006332。

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