Koo D H, Lee J L, Kim T W, Chang H M, Ryu M H, Yook J H, Oh S T, Kim B S, Lee J S, Kang Y K
Division of Oncology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Pungnap-2dong, Songpa-gu, Seoul 138-736, Republic of Korea.
Eur J Surg Oncol. 2007 Sep;33(7):843-8. doi: 10.1016/j.ejso.2006.11.030. Epub 2007 Jan 5.
This study aimed to evaluate the efficacy and safety of 5-fluorouracil (5-FU), doxorubicin and mitomycin-C (FAM) adjuvant chemotherapy in patients who had undergone curative resection of gastric carcinoma.
From Nov 1999 to Jan 2002, 291 consecutive patients with stage IB-IIIB gastric adenocarcinoma were given FAM adjuvant chemotherapy. Chemotherapy comprised intravenous 5-FU 600 mg/m(2) (days 1, 8, 29 and 36), doxorubicin 30 mg/m(2) (days 1 and 29) and mitomycin-C 10 mg/m(2) (day 1), every 8 weeks for 6 months.
The median follow-up time was 60.6 months, 92 patients died, and 93 patients had recurrent disease. The 5-year overall survival (OS) rates were 85.9% for stage IB, 72.1% for stage II, 58.0% for stage IIIA, and 48.2% for stage IIIB (p=0.002). The 5-year relapse-free survival (RFS) rates were 85.2% for stage IB, 71.2% for stage II, 53.3% for stage IIIA, and 39.2% for stage IIIB (p<0.001). A total of 769 cycles of chemotherapy were delivered, and 15 patients experienced grade 3 or higher leukopenia. The most common grade 3 or higher non-hematologic toxicity was nausea/vomiting (11 patients), followed by stomatitis (3 patients).
Adjuvant chemotherapy with FAM for 6 months for gastric carcinoma indicated comparable RFS and OS with an acceptable toxicity profile.
本研究旨在评估5-氟尿嘧啶（5-FU）、阿霉素和丝裂霉素-C（FAM）辅助化疗对已接受胃癌根治性切除术患者的疗效和安全性。
1999年11月至2002年1月，291例连续的IB-IIIB期胃腺癌患者接受了FAM辅助化疗。化疗方案为静脉注射5-FU 600mg/m²（第1、8、29和36天）、阿霉素30mg/m²（第1和29天）以及丝裂霉素-C 10mg/m²（第1天），每8周进行一次，共6个月。
中位随访时间为60.6个月，92例患者死亡，93例患者出现疾病复发。IB期的5年总生存率（OS）为85.9%，II期为72.1%，IIIA期为58.0%，IIIB期为48.2%（p=0.002）。IB期的5年无复发生存率（RFS）为85.2%，II期为71.2%，IIIA期为53.3%，IIIB期为39.2%（p<0.001）。共进行了769个化疗周期，15例患者出现3级或更高等级的白细胞减少。最常见的3级或更高等级的非血液学毒性是恶心/呕吐（11例患者），其次是口腔炎（3例患者）。
胃癌患者接受FAM辅助化疗6个月，显示出相当的RFS和OS，且毒性可接受。
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