Lledo Gérard, Huguet Florence, Chibaudel Benoist, Di Fiore Frédéric, Mineur Laurent, Galais Marie-Pierre, Artru Pascal, Blondin Valérie, Dupuis Olivier, Abdiche Menouar Samir, Jovenin Nicolas, Pozet Astrid, Bonnetain Franck, Attia Mohamed, Dahan Laetitia, de Gramont Aimery
Gastroenterology Department, Private Hospital Jean Mermoz, Lyon, France; Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France.
Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France; Radiation Oncology Department, Tenon Universitary Hospital, Assistance Publique - Hôpitaux Universitaires Paris Est, University Pierre and Marie Curie Paris 6, Institut Universitaire de Cancérologie, Paris, France.
Eur J Cancer. 2016 Mar;56:115-121. doi: 10.1016/j.ejca.2015.12.020. Epub 2016 Feb 2.
To determine efficacy and toxicity of radiation therapy combined with oxaliplatin, 5-fluorouracil, and folinic acid (FOLFOX) and cetuximab in patients with locally advanced oesophageal cancer.
Patients with stage III oesophageal or gastro-oesophageal junction cancer were enrolled in a Simon's two-stage phase II study. Patients received FOLFOX and weekly cetuximab on week 1-10 with concurrent radiotherapy (50.4 Gy in 30 fractions) on week 5-10. Primary end-point was clinical overall response rate (ORR). An ORR rate of more than 50% was expected.
Among the 79 included patients, clinical ORR was 77% with 40% complete responses. Median overall survival and progression-free survival were 21.6 and 11.3 months, respectively. The most common grade III-IV toxicities observed during experimental chemoimmunotherapy followed by chemoradiation included neutropenia (28%), oesophagitis (12%), rash (11%), and allergy (9%). There was one treatment-related death due to oesophagitis with gastrointestinal bleeding.
Cetuximab-FOLFOX regimen combined with radiotherapy demonstrated its efficacy and was well tolerated. Unfortunately, these results were not confirmed in two recent phase III studies.
确定放疗联合奥沙利铂、5-氟尿嘧啶和亚叶酸（FOLFOX）以及西妥昔单抗治疗局部晚期食管癌患者的疗效和毒性。
III期食管癌或胃食管交界癌患者纳入一项西蒙两阶段II期研究。患者在第1 - 10周接受FOLFOX和每周一次的西妥昔单抗治疗，在第5 - 10周同时接受放疗（30次分割，共50.4 Gy）。主要终点为临床总缓解率（ORR）。预期ORR率超过50%。
79例纳入患者中，临床ORR为77%，完全缓解率为40%。中位总生存期和无进展生存期分别为21.6个月和11.3个月。实验性化疗免疫治疗后序贯放化疗期间观察到的最常见3 - 4级毒性包括中性粒细胞减少（28%）、食管炎（12%）、皮疹（11%）和过敏（9%）。有1例因食管炎合并胃肠道出血导致的治疗相关死亡。
西妥昔单抗 - FOLFOX方案联合放疗显示出疗效且耐受性良好。遗憾的是，这些结果在最近的两项III期研究中未得到证实。
