De Andrés L, Brunet J, López-Pousa A, Burgués J, Vega M, Tabernero J M, Mesía R, López J J
Medical Oncology, Otorhinolaryngology, and Radiotherapy Services, Hospital Sant Pau, Barcelona, Spain.
J Clin Oncol. 1995 Jun;13(6):1493-500. doi: 10.1200/JCO.1995.13.6.1493.
A randomized trial was designed to compare cisplatin (CDDP) and fluorouracil (FU) versus carboplatin (CBDCA) and FU as neoadjuvant treatment in stage IV-M0 head and neck cancer to assess whether CBDCA-FU is better than CDDP-FU with regard to response and toxicity.
Patients were randomized to receive CDDP 100 mg/m2 intravenously on day 1 and FU 5,000 mg/m2 over a 120-hour continuous infusion, or CBDCA 400 mg/m2 over a 24-hour continuous infusion on day 1 and FU with the same schedule. Both regimens were repeated every 21 days. The patients received three courses of chemotherapy, excluding those who failed to achieve a partial response (PR) after the second course. Complete responders were treated with radiotherapy. The remaining patients underwent surgery if the tumor was resectable.
Interim analysis was performed when 95 patients were included. The trial was stopped due to significantly better results in the control arm. Differences in response (P = .04) were favorable to CDDP-FU. Hematologic toxicity predominated in the CBDCA-FU arm (P < .001). Mucositis and vomiting predominated in the CDDP-FU arm (P = .03, P < .001, respectively). Favorable outcomes (complete response [CR] plus any grade of toxicity and PR plus grade 0 to 3 toxicity) predominated in the CDDP-FU arm (P = .02). Only the treatment assigned was associated with response (P = .02) and favorable outcomes (P = .009) in the logistic regression analysis. In the CDDP-FU arm, disease-free and overall survival were significantly better. Cox regression analysis showed that only treatment association with disease-free survival remains significant.
Our results indicate that CDDP-FU is more effective than CBDCA-FU as neoadjuvant treatment in stage IV-M0 head and neck cancer.
设计一项随机试验，比较顺铂（CDDP）和氟尿嘧啶（FU）与卡铂（CBDCA）和FU作为IV - M0期头颈癌新辅助治疗的效果，以评估CBDCA - FU在反应和毒性方面是否优于CDDP - FU。
患者被随机分为两组，一组在第1天静脉注射CDDP 100 mg/m²，FU 5000 mg/m²持续输注120小时；另一组在第1天静脉注射CBDCA 400 mg/m²持续输注24小时，FU给药方案相同。两种方案均每21天重复一次。患者接受三个疗程的化疗，第二个疗程后未达到部分缓解（PR）的患者除外。完全缓解者接受放疗。其余患者若肿瘤可切除则接受手术。
纳入95例患者时进行了中期分析。由于对照组结果明显更好，试验提前终止。反应差异（P = 0.04）有利于CDDP - FU组。血液学毒性在CBDCA - FU组占主导（P < 0.001）。黏膜炎和呕吐在CDDP - FU组占主导（分别为P = 0.03，P < 0.001）。CDDP - FU组有利结局（完全缓解[CR]加任何级别的毒性以及PR加0至3级毒性）占主导（P = 0.02）。在逻辑回归分析中，仅分配的治疗与反应（P = 0.02）和有利结局（P = 0.009）相关。在CDDP - FU组，无病生存期和总生存期明显更好。Cox回归分析表明，仅治疗与无病生存期的关联仍然显著。
我们的结果表明，在IV - M0期头颈癌新辅助治疗中，CDDP - FU比CBDCA - FU更有效。
