de Andrés L, Brunet J, López-Pousa A, Burgués J, Quer M, León X, Guedea F, Vega M, Mesía R, López J J
Oncology Department Hospital Sant Pau, Barcelona, Spain.
Laryngoscope. 1995 Aug;105(8 Pt 1):822-6. doi: 10.1288/00005537-199508000-00010.
Until recently, standard treatment for stage III laryngeal carcinoma (LC) was total laryngectomy and radiotherapy. Recent data suggest that induction chemotherapy (ICH) plays a role in preserving function in advanced head and neck cancer. No reports to date prospectively evaluate ICH exclusively in stage III LC. The authors designed a sequential phase II trial to assess if ICH allowed a conservative treatment in this disease. The objective of the first part of the study was to rule out a complete response rate with ICH below 30% with P < .05. ICH protocol consisted of three courses of cisplatin 100 mg/M2 on day 1 and 5-fluorouracil 5000 mg/M2 continuous infusion over 120 hours. Radiotherapy was administered to patients who attained a complete response (CR). Functional surgery (FS) was planned for patients with partial response. A total laryngectomy followed by radiotherapy was performed when FS was not feasible. Fifty-two previously untreated patients (all males) with squamous stage III LC were diagnosed in our institution, and 46 were entered in the ICH trial. After 9 patients were included, data showed 7 (78%) CR, ruling out a CR rate of less than 30%. After ICH, a CR was achieved in 29 (63%) of 46 patients. At the end of treatment, 35 patients (76%) had a functioning larynx. With a median follow-up of 3 years, larynx function was preserved in 26 (57%) of 46 patients and in 64% of survivors. Four-year actuarial larynx function preservation, overall survival, and disease-free survival were 55%, 77%, and 67%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
直到最近，III期喉癌（LC）的标准治疗方法仍是全喉切除术和放射治疗。最近的数据表明，诱导化疗（ICH）在晚期头颈癌的功能保留方面发挥着作用。迄今为止，尚无前瞻性评估仅针对III期LC进行ICH治疗的报告。作者设计了一项序贯II期试验，以评估ICH是否能使该病得到保守治疗。该研究第一部分的目的是排除ICH的完全缓解率低于30%且P < 0.05的情况。ICH方案包括在第1天给予顺铂100 mg/M²共三个疗程，以及5-氟尿嘧啶5000 mg/M²在120小时内持续输注。对达到完全缓解（CR）的患者进行放射治疗。对部分缓解的患者计划进行功能性手术（FS）。当FS不可行时，则进行全喉切除术后放疗。在我们机构诊断出52例先前未接受治疗的鳞状III期LC患者（均为男性），其中46例进入ICH试验。纳入9例患者后，数据显示7例（78%）达到CR，排除了CR率低于30%的情况。ICH治疗后，46例患者中有29例（63%）达到CR。治疗结束时，35例患者（76%）的喉部功能正常。中位随访3年时，46例患者中有26例（57%）的喉部功能得以保留，幸存者中这一比例为64%。四年精算的喉部功能保留率、总生存率和无病生存率分别为55%、77%和67%。（摘要截短于250字）
