Amrein P C, Fabian R L
Department of Medicine, Massachusetts General Hospital, Boston 02114.
Laryngoscope. 1992 Aug;102(8):901-6. doi: 10.1288/00005537-199208000-00010.
A prospective randomized trial of 62 patients with recurrent squamous cell carcinoma of the head and neck was conducted to compare the effectiveness of our standard chemotherapy program with that of our test regimen. The standard chemotherapy regimen consisted of cisplatin 80 mg/M2 on day 1 followed by 5-fluorouracil 800 mg/M2 days 2 through 6. Our test regimen consisted of the same two drugs plus 15 U bleomycin on day 1 and methotrexate 100 mg/M2 on day 16 followed in 24 hours with 15 mg leucovorin every 6 hours for six doses. One patient in each arm of the study was not evaluated. Among 29 patients receiving the two-drug regimen, there was 1 complete response and 10 partial responses (38% response rate). Among 31 patients receiving the four-drug regimen, there were 3 complete responses and 16 partial responses (61% response rate; two vs. four-drug regimen, P = .06). The failure-free survival in the four-drug group was better than the two-drug group, median 4.5 vs. 2.3 months (P = .02). The overall survival for both groups was the same (median of 7.8 months). A detailed analysis of toxicity did not reveal any important differences between the two regimens. The addition of bleomycin and methotrexate to our cisplatin and 5-fluorouracil regimen resulted in an increase in effectiveness without adding toxicity.
对62例复发性头颈部鳞状细胞癌患者进行了一项前瞻性随机试验，以比较我们的标准化疗方案与试验方案的有效性。标准化疗方案包括第1天给予顺铂80mg/M²，随后第2至6天给予5-氟尿嘧啶800mg/M²。我们的试验方案由相同的两种药物加上第1天的15U博来霉素和第16天的甲氨蝶呤100mg/M²组成，24小时后每6小时给予15mg亚叶酸，共6剂。研究的每组中有1例患者未进行评估。在接受两药方案的29例患者中，有1例完全缓解和10例部分缓解（缓解率38%）。在接受四药方案的31例患者中，有3例完全缓解和16例部分缓解（缓解率61%；两药方案与四药方案相比，P = 0.06）。四药组的无失败生存期优于两药组，中位数分别为4.5个月和2.3个月（P = 0.02）。两组的总生存期相同（中位数为7.8个月）。对毒性的详细分析未发现两种方案之间有任何重要差异。在我们的顺铂和5-氟尿嘧啶方案中加入博来霉素和甲氨蝶呤可提高有效性，且不增加毒性。
