Neri B, de Leonardis V, Romano S, Andreoli F, Pernice L M, Bruno L, Borrelli D, Valeri A, Fabbroni S, Intini C, Cini G
Institute of Internal Medicine, Oncological Day Hospital, University of Florence, Italy.
Br J Cancer. 1996 Feb;73(4):549-52. doi: 10.1038/bjc.1996.95.
After curative resection for gastric adenocarcinoma, 103 patients, all with positive nodes, were randomised so that 48 received adjuvant chemotherapy of epidoxorubicin (EPI) 75 mg m-2 on day 1, leucovorin (LV) 200 mg m-2 on days 1-3 and 5-fluorouracil (5-FU) 450 mg m-2 on days 1-3, every 21 days for 7 months, whereas the remaining 55 did not. During the first year of observation, 21 control patients (38%) and five treated patients had recurrences. After a follow-up period of 36 months, 12 of the treated patients (25%) and only seven controls (13%) were still alive. At that point, the median survival was 13.6 months for the 55 untreated patients and 20.4 months for the 48 treated patients, a significant difference. We found a survival advantage for patients treated with the EPI-LV-5-FU regimen and a consistent delay in the appearance of recurrent or metastatic cancer. Acute toxicity was mild and treatment was well accepted by all patients. There was no long-term toxicity or any cardiac toxicity. We conclude that this particular chemotherapy, administered shortly after gastric resection, improves survival rate in node-positive gastric cancer patients, even although final assessment of this particular adjuvant approach must await completion of the trial.
对胃腺癌进行根治性切除术后，103例均有阳性淋巴结的患者被随机分组，48例患者在第1天接受表柔比星（EPI）75mg/m²、在第1 - 3天和第5 - 7天接受亚叶酸钙（LV）200mg/m²、在第1 - 3天接受氟尿嘧啶（5 - FU）450mg/m²的辅助化疗，每21天为一周期，共7个月，而其余55例患者未接受化疗。在观察的第一年，21例对照患者（38%）和5例接受治疗的患者出现复发。经过36个月的随访期，12例接受治疗的患者（25%）仍存活，而对照患者只有7例（13%）仍存活。此时，55例未治疗患者的中位生存期为13.6个月，48例接受治疗患者的中位生存期为20.4个月，差异显著。我们发现接受EPI - LV - 5 - FU方案治疗的患者有生存优势，且复发或转移性癌症出现的时间持续延迟。急性毒性较轻，所有患者对治疗的接受度良好。没有长期毒性或任何心脏毒性。我们得出结论，这种特定的化疗在胃切除术后不久进行，可提高淋巴结阳性胃癌患者的生存率，尽管对这种特定辅助治疗方法的最终评估必须等待试验完成。
