Kelsen D, Lovett D, Wong J, Saltz L, Buckley M, Murray P, Heelan R, Lightdale C
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
J Clin Oncol. 1992 Feb;10(2):269-74. doi: 10.1200/JCO.1992.10.2.269.
The trial was undertaken to determine the response rate to and toxicities from the combination of interferon alfa-2a (IFN) and fluorouracil (FU) in patients with advanced esophageal cancer.
In this prospective phase II trial conducted at a large tertiary referral cancer center and university hospital, 40 patients with advanced locoregional, metastatic epidermoid, or adenocarcinoma of the esophagus were given FU 750 mg/m2 by 24-hour continuous intravenous infusion days 1 to 5, followed by weekly outpatient bolus FU 750 mg/m2 and IFN 9 x 10(6) U three times per week from day 1. Dose was attenuated for fatigue, neurotoxicity, gastrointestinal toxicity, and myelosuppression.
Complete and partial responses were seen in 10 of 37 assessable patients with esophageal cancer (27%; 95% confidence interval, 0.13 to 0.41). Although substantial, toxicity was tolerable and primarily involved fatigue and mild myelosuppression. The median duration of response was 6.4 months (range, 2.8 to 14+ months).
The combination of IFN and FU is an active regimen in the treatment of advanced esophageal cancer with a response rate similar to that reported for cisplatin-containing combinations in similar patient populations. Further studies based on this combination are indicated.
开展该试验以确定晚期食管癌患者对干扰素α-2a(IFN)与氟尿嘧啶(FU)联合治疗的缓解率及毒性。
在一家大型三级转诊癌症中心和大学医院进行的这项前瞻性II期试验中,40例晚期局部区域、转移性表皮样癌或食管腺癌患者在第1至5天接受24小时持续静脉输注FU 750 mg/m²,随后从第1天起每周门诊推注FU 750 mg/m²,IFN 9×10⁶U,每周3次。根据疲劳、神经毒性、胃肠道毒性和骨髓抑制情况调整剂量。
37例可评估的食管癌患者中有10例出现完全缓解和部分缓解(27%;95%置信区间,0.13至0.41)。尽管毒性较大,但可以耐受,主要表现为疲劳和轻度骨髓抑制。中位缓解持续时间为6.4个月(范围,2.8至14 +个月)。
IFN与FU联合方案是治疗晚期食管癌的一种有效方案,缓解率与在类似患者群体中报道的含顺铂联合方案相似。有必要基于该联合方案开展进一步研究。