Phase I study of neoadjuvant chemotherapy with S-1 and oxaliplatin for locally advanced gastric cancer (Neo G-SOX PI).
Phase I study of neoadjuvant chemotherapy with S-1 and oxaliplatin for locally advanced gastric cancer (Neo G-SOX PI).
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DOI：
10.1136/esmoopen-2016-000130
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发表时间：
2017
期刊：
影响因子：
7.3
通讯作者：
Tsuji A
中科院分区：
文献类型：
--
作者：
Satake H;Miki A;Kondo M;Kotake T;Okita Y;Hatachi Y;Yasui H;Imai Y;Ichikawa C;Murotani K;Hashida H;Kobayashi H;Kotaka M;Kato T;Kaihara S;Tsuji A
局部进展期胃癌，如临床T4疾病，巨大淋巴结受累，4型和大3型胃癌，预后仍然不令人满意，即使D2胃切除术后辅助化疗。新辅助化疗是一种很有前途的方法。替吉奥联合奥沙利铂（SOX）化疗被认为是治疗胃癌的一种有潜力的方案。然而，使用新辅助化疗组成的SOX局部进展期胃癌还没有报道。本研究的目的是确定术前化疗联合SOX治疗局部晚期胃癌的最大耐受剂量（MTD）和推荐剂量。患者在第1天接受两个周期的奥沙利铂新辅助化疗，以及S-1（80 mg/m2/天，每日两次），持续14天，每3周重复一次。然后，他们接受了胃切除术和根治性D2/3淋巴结清扫术，随后接受了辅助S-1（80 mg/m2/天，每日两次）治疗1年。计划递增奥沙利铂剂量（从水平0开始，奥沙利铂100 mg/m2;水平1，130 mg/m2）。6例患者入组。在1级时未达到MTD。奥沙利铂130 mg/m2联合S-1 80 mg/m2/天每日两次给药的毒性可接受。在所有患者中均观察到周围神经病变，但无功能障碍。未观察到治疗相关死亡，手术并发症的发生率可耐受。所有患者均进行了根治性切除，5例（83%）进行了R 0切除，1例进行了R1切除。6例患者中有2例病理学完全缓解（33%）。SOX方案新辅助化疗对局部进展期胃癌患者是可行的。推荐的II期剂量确定为奥沙利铂130 mg/m2联合S-1 80 mg/m2/天，每日两次。
The prognosis of locally advanced gastric cancer, such as clinical T4 disease, bulky nodal involvement, type 4 and large type 3 gastric cancer, remains unsatisfactory, even with D2 gastrectomy followed by adjuvant chemotherapy. One promising approach is neoadjuvant chemotherapy. Combination chemotherapy with S-1 and oxaliplatin (SOX) is recognised as a potentially promising regimen for gastric cancer. However, the use of neoadjuvant chemotherapy consisting of SOX for locally advanced gastric cancer has not been reported. The aim of this study was to determine the maximum tolerated dose (MTD) and recommended dose of preoperative chemotherapy combined with SOX for locally advanced gastric cancer. Patients received two cycles of neoadjuvant chemotherapy with oxaliplatin on day 1, as well as S-1 (80 mg/m2/day, twice daily) for 14 days, repeated every 3 weeks. They then underwent gastrectomy with curative D2/3 lymph node dissection followed by adjuvant S-1 (80 mg/m2/day, twice daily) for 1 year. Escalation of oxaliplatin dose was planned (starting at level 0, oxaliplatin 100 mg/m2; level 1, 130 mg/m2). Six patients were enrolled. MTD was not reached at level 1. Oxaliplatin 130 mg/m2 in combination with S-1 80 mg/m2/day twice daily could be administered with acceptable toxicity. Peripheral neuropathy was observed in all patients but with no functional disorders. No treatment-related death was observed and the incidence of operative morbidity was tolerable. Resection with curative intent was undertaken in all patients with R0 resection performed in five (83%) and R1 in one. Two of the six patients had a pathological complete response (33%). Neoadjuvant chemotherapy with an SOX regimen was feasible in patients with locally advanced gastric cancer. The recommended phase II dose was determined to be oxaliplatin 130 mg/m2 in combination with S-1 80 mg/m2/day, twice daily.
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DOI：
10.1111/j.1525-1438.2003.13603.x
发表时间：
2003-11-01
影响因子：
4.8
作者：
Calhoun, EA;Welshman, EE;Cella, D
通讯作者：
Cella, D
影响因子：
6.2
作者：
Garland, Sheila N.;Pelletier, Guy;Bathe, Oliver F.
通讯作者：
Bathe, Oliver F.
影响因子：
168.9
作者：
Bang, Yung-Jue;Kim, Young-Woo;Noh, Sung Hoon
通讯作者：
Noh, Sung Hoon
影响因子：
50.5
作者：
Koizumi, W.;Takiuchi, H.;Tsuburaya, A.
通讯作者：
Tsuburaya, A.
影响因子：
8.8
作者：
Yamada, Y.;Tahara, M.;Miya, T.;Satoh, T.;Shirao, K.;Shimada, Y.;Ohtsu, A.;Sasaki, Y.;Tanigawara, Y.
通讯作者：
Tanigawara, Y.