Feasibility of oral administration of S-1 as adjuvant chemotherapy in gastric cancer: 4-week S-1 administration followed by 2-week rest vs. 2-week administration followed by 1-week rest
Feasibility of oral administration of S-1 as adjuvant chemotherapy in gastric cancer: 4-week S-1 administration followed by 2-week rest vs. 2-week administration followed by 1-week rest
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DOI：
10.3892/mco.2015.500
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发表时间：
2015-05-01
影响因子：
1.2
通讯作者：
Naomoto, Yoshio
中科院分区：
文献类型：
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作者：
Yamatsuji, Tomoki;Fujiwara, Yasuhiro;Naomoto, Yoshio
2006年，S-1胃癌辅助化疗试验（ACTS-GC）证实S-1是一种有效的胃癌辅助治疗药物。在该研究之后，S-1在日本被用作胃癌的标准辅助治疗。然而，ACTS-GC研究的1年完成率仅为65.8%，可行性仍然是一个关键问题。我们进行了一项研究，以评估2周给药S-1作为胃癌辅助化疗方案的可行性。入选标准包括组织学证实的II期（不包括T1期）、IIIA期或IIIB期伴有D2淋巴结清扫的胃癌。患者被随机分配到A组（S-1给药4周后休息2周）或B组（S-1给药2周后休息1周）。在每组中，治疗持续12个月，除非观察到复发或严重不良事件。主要终点是可行性（方案治疗完成率）。次要终点是安全性、无复发生存期和总生存期。在2008年5月至2010年2月期间，共有47名患者被分配到A组或B组。在第一次中期分析中，A组和B组的方案治疗完成率在6个月时分别为83%和100%，在12个月时分别为49%和89% （P=0.0046）。因此，S-1给药2周后休息1周作为胃癌辅助化疗更为可行。A组3级不良事件包括疲劳（8.0%）、厌食（8.0%）、恶心（4.0%）、呕吐（4.0%）和手足综合征（4.0%），而b组未观察到任何不良事件。两组均未报告4级不良事件。综上所述，2周S-1给药后1周休息方案似乎是S-1作为胃癌辅助化疗更可行的口服给药方案。
In 2006, the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer (ACTS-GC) demonstrated that S-1 is an effective adjuvant therapy for gastric cancer. Following that study, S-1 has been used as the standard adjuvant therapy for gastric cancer in Japan. However, the 1-year completion rate was only 65.8% in the ACTS-GC study and feasibility remains a critical issue. We conducted a study to evaluate the feasibility of 2 weekly administration regimens of S-1 as adjuvant chemotherapy in gastric cancer. The criteria for eligibility included histologically proven stage II (excluding T1), IIIA or IIIB gastric cancer with D2 lymph-node dissection. The patients were randomly assigned to either arm A (S-1 administration for 4 weeks followed by 2 weeks of rest) or arm B (S-1 administration for 2 weeks followed by 1 week of rest). In each arm, treatment was continued for 12 months unless recurrence or severe adverse events were observed. The primary endpoint was feasibility (protocol treatment completion rate). The secondary endpoints were safety, relapse-free survival and overall survival. A total of 47 patients were assigned to arms A or B between May, 2008 and February, 2010. During the first interim analysis, the protocol treatment completion rates in arms A and B were 83 and 100%, respectively, at 6 months and 49 and 89%, respectively, at 12 months (P=0.0046). Therefore, S-1 administration for 2 weeks followed by 1 week rest was more feasible as adjuvant chemotherapy in gastric cancer. Grade 3 adverse events in arm A included fatigue (8.0%), anorexia (8.0%), nausea (4.0%), vomiting (4.0%) and hand-foot syndrome (4.0%), whereas none were observed in arm B. There were no reported grade 4 adverse events in either arm. In conclusion, the 2-week S-1 administration followed by 1-week rest regimen appears to be a more feasible oral administration regimen for S-1 as adjuvant chemotherapy in gastric cancer.