Kinoshita Taira, Nashimoto Atsushi, Yamamura Yoshitaka, Okamura Takeshi, Sasako Mitsuru, Sakamoto Junichi, Kojima Hiroshi, Hiratsuka Masahiro, Arai Kuniyoshi, Sairenji Motonori, Fukushima Norimasa, Kimura Hironobu, Nakajima Toshifusa
Department of Surgical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
Gastric Cancer. 2004;7(2):104-9. doi: 10.1007/s10120-004-0278-3.
We conducted a feasibility study using S-1, a novel oral derivative of 5-fluorouracil, as postoperative adjuvant chemotherapy for curatively resected gastric cancer patients.
Adjuvant chemotherapy consisted of eight courses (4-week administration and 2-week withdrawal) of S-1, at 80-120 mg/body per day. Forty-one patients from 11 institutions were enrolled in this pilot study, from November 1999 to October 2000.
Thirty-five patients were eligible. In 7 patients, S-1 administration was discontinued due to recurrence. Among the 28 patients without recurrence, the planned eight courses of S-1 were administered to 17 patients (60.7%). In 4 patients, S-1 administration was discontinued due to subjective symptoms, such as anorexia, in the first course. Adverse reactions such as neutropenia, leukopenia, elevated total bilirubin, anorexia, general fatigue, diarrhea, nausea, and stomatitis were seen in more than half of the patients. Although grade 3 neutropenia (29.3%), leukopenia (9.8%), and diarrhea (9.8%) were observed, no grade 4 adverse effects appeared. Compared with the treatment of unresectable or recurrent gastric cancer with S-1, the incidence of adverse reactions in the adjuvant setting was slightly higher, probably due to the influence of gastrectomy.
Except for the early development of anorexia, most likely due to adverse effects of surgery, postoperative administration of S-1 for 1 year seems feasible as adjuvant chemotherapy for gastric cancer.
我们开展了一项可行性研究，使用5-氟尿嘧啶的新型口服衍生物S-1作为胃癌根治性切除患者的术后辅助化疗药物。
辅助化疗方案为S-1，每天80 - 120毫克/体质量，共八个疗程（给药4周，停药2周）。1999年11月至2000年10月，来自11家机构的41例患者参与了这项初步研究。
35例患者符合条件。7例患者因复发停止使用S-1。在28例未复发的患者中，17例（60.7%）完成了计划的八个疗程的S-1治疗。4例患者在第一个疗程时因出现如厌食等主观症状而停止使用S-1。超过半数的患者出现了中性粒细胞减少、白细胞减少、总胆红素升高、厌食、全身乏力、腹泻、恶心和口腔炎等不良反应。虽然观察到3级中性粒细胞减少（29.3%）、白细胞减少（9.8%）和腹泻（9.8%），但未出现4级不良反应。与使用S-1治疗不可切除或复发性胃癌相比，辅助治疗中不良反应的发生率略高，这可能是由于胃切除术的影响。
除了厌食症状可能因手术不良反应较早出现外，术后给予S-1进行1年的辅助化疗似乎是可行的。
