Satake Hironaga, Miki Akira, Kondo Masato, Kotake Takeshi, Okita Yoshihiro, Hatachi Yukimasa, Yasui Hisateru, Imai Yukihiro, Ichikawa Chihiro, Murotani Kenta, Hashida Hiroki, Kobayashi Hiroyuki, Kotaka Masahito, Kato Takeshi, Kaihara Satoshi, Tsuji Akihito
Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Department of Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.
ESMO Open. 2017 Mar 9;2(1):e000130. doi: 10.1136/esmoopen-2016-000130. eCollection 2017.
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/m/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/m/day, twice daily) for 1 year. Escalation of oxaliplatin dose was planned (starting at level 0, oxaliplatin 100 mg/m; level 1, 130 mg/m).
Six patients were enrolled. MTD was not reached at level 1. Oxaliplatin 130 mg/m in combination with S-1 80 mg/m/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/m in combination with S-1 80 mg/m/day, twice daily.
局部晚期胃癌，如临床T4期疾病、大量淋巴结受累、4型和大型3型胃癌，即使采用D2胃切除术并辅以辅助化疗，其预后仍不尽人意。一种有前景的方法是新辅助化疗。S-1与奥沙利铂联合化疗（SOX）被认为是一种对胃癌有潜在前景的方案。然而，尚未有关于采用SOX组成的新辅助化疗用于局部晚期胃癌的报道。本研究的目的是确定术前化疗联合SOX用于局部晚期胃癌的最大耐受剂量（MTD）和推荐剂量。
患者在第1天接受两周期新辅助化疗，使用奥沙利铂，同时S-1（80mg/m²/天，每日两次）给药14天，每3周重复一次。然后他们接受了D2/3根治性淋巴结清扫的胃切除术，随后给予辅助性S-1（80mg/m²/天，每日两次），持续1年。计划逐步增加奥沙利铂剂量（从0级开始，奥沙利铂100mg/m²；1级，130mg/m²）。
入组6例患者。1级时未达到MTD。奥沙利铂130mg/m²联合S-1 80mg/m²/天每日两次给药时毒性可接受。所有患者均观察到周围神经病变，但无功能障碍。未观察到与治疗相关的死亡，手术并发症发生率可耐受。所有患者均进行了根治性切除，5例（83%）为R0切除，1例为R1切除。6例患者中有2例达到病理完全缓解（33%）。
SOX方案新辅助化疗在局部晚期胃癌患者中是可行的。确定的II期推荐剂量为奥沙利铂130mg/m²联合S-1 80mg/m²/天，每日两次。
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