Cascinu S, Fedeli A, Luzi Fedeli S, Catalano G
Servizio di Oncologia, Ospedali Riuniti, Pesaro, Italy.
Br J Cancer. 1994 Feb;69(2):392-3. doi: 10.1038/bjc.1994.72.
On the basis of preclinical data suggesting the possibility of maximising the efficacy of 5-fluorouracil and cisplatin by interferon, a pilot clinical trial was initiated in recurrent and/or metastatic head and neck cancer. Thirty-four patients were treated with cisplatin at 100 mg m-2, followed by 5-fluorouracil at 1,000 mg m-2 by continuous infusion for 5 days. Interferon alpha 2b was administered at the dose of 3 million U i.m. daily for 7 days, beginning the day before chemotherapy. Courses were repeated every 3 weeks. Two patients achieved a complete remission, six a partial response, 14 had stable disease and 12 progressed on therapy, for an overall response rate of 23% (95% confidence interval 10-36%). Median survival time was 5 months. Toxicity was severe. Stomatitis, diarrhoea and myelosuppression were the most common side-effects. Because of the poor response rate and the presence of severe toxicity, in our opinion further clinical trials in head and neck cancer should be attempted only after a better definition in preclinical studies of interactions among 5-fluorouracil, cisplatin and interferon.
基于临床前数据提示干扰素可能使5-氟尿嘧啶和顺铂的疗效最大化，针对复发性和/或转移性头颈癌开展了一项临床试验。34例患者接受100mg/m²顺铂治疗，随后连续5天持续输注1000mg/m²的5-氟尿嘧啶。从化疗前一天开始，干扰素α2b以每日300万U的剂量肌肉注射，共7天。每3周重复疗程。2例患者达到完全缓解，6例部分缓解，14例病情稳定，12例在治疗过程中病情进展，总缓解率为23%（95%置信区间10 - 36%）。中位生存时间为5个月。毒性严重。口腔炎、腹泻和骨髓抑制是最常见的副作用。鉴于缓解率低且存在严重毒性，我们认为只有在对5-氟尿嘧啶、顺铂和干扰素之间的相互作用进行更好的临床前研究定义后，才应尝试对头颈癌进行进一步的临床试验。
