Phase II study of induction gemcitabine and S-1 followed by chemoradiotherapy and systemic chemotherapy using S-1 for locally advanced pancreatic cancer
Phase II study of induction gemcitabine and S-1 followed by chemoradiotherapy and systemic chemotherapy using S-1 for locally advanced pancreatic cancer
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DOI：
10.1007/s00280-017-3350-5
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发表时间：
2017-07-01
影响因子：
3
通讯作者：
Yamaguchi, Taketo
中科院分区：
文献类型：
--
作者：
Sudo, Kentaro;Hara, Ryusuke;Yamaguchi, Taketo
S-1 对局部晚期胰腺癌 (LAPC) 具有全身活性。本研究评估了诱导吉西他滨 (GEM) 和 S-1 (GS) 后进行放化疗 (CRT) 和使用 S-1 进行全身化疗用于 LAPC 的疗效和安全性。治疗包括四个周期的诱导 GS（S-1 60、80 或 100 mg/天，基于体表面积，每 3 周 14 天，加第 8 和 15 天 GEM 1000 mg/m(2)），然后S-1（80、100 或 120 mg/天，根据第 1-14 天和 22-35 天的体表面积）和同步放疗（50.4 Gy，分 28 次）。 CRT 后 1-4 周开始 S-1 维持化疗，直至观察到疾病进展或不可接受的毒性。主要终点是 1 年生存率。共有 30 名 LAPC 患者入组。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%。 23名接受CRT的患者的中位生存期为22.9个月，3年生存率为30.4%。 GS 诱导期间最常见的 3 级或 4 级不良事件是中性粒细胞减少症 (63.3%) 和胆道感染 (20%)。 CRT 或维持化疗期间的毒性通常较轻。该方案可行且高度有效，可提高 LAPC 患者的生存率。在未来的研究中需要进一步的研究来阐明这种治疗策略的有效性。临床试验信息：UMIN000006332。
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.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(2) 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.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.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.