Zalupski M M, Baker L H
Wayne State University, Detroit, MI, USA.
J Infus Chemother. 1995 Summer;5(3):129-31.
5-fluorouracil (5-FUra) and etoposide demonstrate relationships between schedule of administration and activity in a number of clinical situations. With limited information regarding 5-FUra and oral etoposide in sarcoma, and informal observations suggesting activity of infusional 5-FUra in sarcomas, a phase II study was performed. This phase II study attempted to evaluate the efficacy of the combination of low-dose continuous infusion 5-FUra (LDCI-5FUra) and oral etoposide administered to patients with advanced sarcomas. Treatment consisted of 5-FUra at 300 mg/m2/day and etoposide at 50 mg/m2/day for 21 days. Cycles were repeated at 28-day intervals or upon recovery from toxicity. Twenty patients received 50 cycles of therapy. No objective responses were seen in 19 evaluable patients (response rate 0%, 95% confidence interval 0-18%). Toxicity was mild and consisted primarily of stomatitis, diarrhea, and leukopenia. Median survival for all patients was 9 months (1.8-30+ months range). The combination of LDCI-5FUra and oral etoposide, at the doses and schedule studied, was inactive in this population with advanced sarcoma.
5-氟尿嘧啶（5-FUra）和依托泊苷在许多临床情况下显示出给药方案与活性之间的关系。鉴于关于5-FUra和口服依托泊苷在肉瘤中的信息有限，且有非正式观察表明持续输注5-FUra对肉瘤有活性，遂开展了一项II期研究。这项II期研究试图评估低剂量持续输注5-FUra（LDCI-5FUra）与口服依托泊苷联合应用于晚期肉瘤患者的疗效。治疗方案为5-FUra 300mg/m²/天和依托泊苷50mg/m²/天，持续21天。每28天为一个周期重复治疗，或在毒性反应恢复后重复。20例患者接受了50个周期的治疗。19例可评估患者中未观察到客观缓解（缓解率0%，95%置信区间0-18%）。毒性反应较轻，主要包括口腔炎、腹泻和白细胞减少。所有患者的中位生存期为9个月（范围1.8-30+个月）。在所研究的剂量和方案下，LDCI-5FUra与口服依托泊苷联合应用于该晚期肉瘤患者群体时无活性。
