Boni C, Moretti G, Savoldi L, Armaroli L, Barbieri W, Bisagni G, Caroggio A, Iotti C, Pedroni C, Manenti A L, Rondini E, Sassi M, Zadro A
Servizio di Oncologia Medica, Azienda Ospedaliera di Reggio Emilia, Italy.
Tumori. 1996 Nov-Dec;82(6):567-72. doi: 10.1177/030089169608200610.
The aim of the study was to assess the activity and the toxicity of cisplatin (DDP) and fluorouracil (FU) administered by continuous infusion as neoadjuvant chemotherapy for patients with stage II-IV, M0 squamous cell carcinoma of the head and neck.
Thirty previously untreated patients were submitted to chemotherapy with DDP (20 mg/m2) and FU (1000 mg/m2), both in continuous infusion for 5 days, repeated every 21 days, for a maximum of 5 cycles. Following completion of chemotherapy, the patients underwent radiotherapy; in some patients surgery was performed immediately after chemotherapy. All patients were monitored for response, time to failure, survival, treatment-related events and toxicity.
All patients were evaluated for response; after chemotherapy the complete response rate was 27% and the partial response rate 33%. Twenty-four patients underwent radiotherapy: the overall response rate was 83% (complete response 79%). After a median follow-up of 34 months, the median survival time was 22 months with a median time to failure of 15 months. Acute vascular accidents were the main and unexpected adverse events, with 2 deaths for pulmonary embolism and 1 for stroke. The response rate to the regimen does not seem to be better than that obtained with the standard combination of cisplatin bolus and fluorouracil continuous infusion. The disadvantage of the regimen is that it causes more discomfort for the patient in that it requires hospitalization.
For this reason, we believe that there are no elements for recommending the schedule as neoadjuvant treatment of patients with squamous cell carcinoma of the head and neck or as an experimental arm in a randomized trial.
本研究旨在评估顺铂（DDP）和氟尿嘧啶（FU）持续输注作为II-IV期、M0头颈部鳞状细胞癌患者新辅助化疗的活性和毒性。
30例既往未接受过治疗的患者接受DDP（20mg/m²）和FU（1000mg/m²）化疗，均持续输注5天，每21天重复一次，最多进行5个周期。化疗完成后，患者接受放疗；部分患者在化疗后立即进行手术。所有患者均监测疗效、失败时间、生存率、治疗相关事件和毒性。
所有患者均评估疗效；化疗后完全缓解率为27%，部分缓解率为33%。24例患者接受放疗：总缓解率为83%（完全缓解79%）。中位随访34个月后，中位生存时间为22个月，中位失败时间为15个月。急性血管意外是主要且意外的不良事件，2例死于肺栓塞，1例死于中风。该方案的缓解率似乎并不优于顺铂大剂量推注与氟尿嘧啶持续输注的标准联合方案。该方案的缺点是需要住院，给患者带来更多不适。
因此，我们认为没有理由推荐该方案作为头颈部鳞状细胞癌患者的新辅助治疗或作为随机试验的试验组。
