Head and Neck Cancer Department, Centre Oscar Lambret, Lille, France.
Surgery Department, Institut Jules Bordet, Brussels, Belgium.
Ann Oncol. 2012 Oct;23(10):2708-2714. doi: 10.1093/annonc/mds065. Epub 2012 Apr 6.
We report the 10-year results of the EORTC trial 24891 comparing a larynx-preservation approach to immediate surgery in hypopharynx and lateral epilarynx squamous cell carcinoma.
Two hundred and two patients were randomized to either the surgical approach (total laryngectomy with partial pharyngectomy and neck dissection, followed by irradiation) or to the chemotherapy arm up to three cycles of induction chemotherapy (cisplatin 100 mg/m(2) day 1 + 5-FU 1000 mg/m(2) day 1-5) followed for complete responders by irradiation and otherwise by conventional treatment. The end points were overall survival [OS, noninferiority: hazard ratio (preservation/surgery) ≤ 1.428, one-sided α = 0.05], progression-free survival (PFS) and survival with a functional larynx (SFL).
At a median follow-up of 10.5 years on 194 eligible patients, disease evolution was seen in 54 and 49 patients in the surgery and chemotherapy arm, respectively, and 81 and 83 patients had died. The 10-year OS rate was 13.8% in the surgery arm and 13.1% in the chemotherapy arm. The 10-year PFS rates were 8.5% and 10.8%, respectively. In the chemotherapy arm, the 10-year SFL rate was 8.7%.
This strategy did not compromise disease control or survival (that remained poor) and allowed more than half of the survivors to retain their larynx.
我们报告了 EORTC 试验 24891 的 10 年结果，该试验比较了喉保留方法与下咽和侧咽鳞状细胞癌的即刻手术。
202 例患者被随机分为手术组（全喉切除术伴部分咽切除术和颈部清扫术，继以放疗）或化疗组，接受三个周期的诱导化疗（顺铂 100mg/m²，第 1 天+5-FU 1000mg/m²，第 1-5 天），完全缓解者行放疗，否则行常规治疗。终点为总生存期[OS，非劣效性：风险比（保留/手术）≤1.428，单侧α=0.05]、无进展生存期（PFS）和有功能喉的生存期（SFL）。
在 194 例合格患者中，中位随访 10.5 年，手术组和化疗组分别有 54 例和 49 例出现疾病进展，81 例和 83 例患者死亡。手术组 10 年 OS 率为 13.8%，化疗组为 13.1%。10 年 PFS 率分别为 8.5%和 10.8%。在化疗组，10 年 SFL 率为 8.7%。
该策略并未损害疾病控制或生存（仍然很差），并使超过一半的幸存者保留了他们的喉。
