Vall d'Hebron University Hospital, Department of Medical Oncology, and Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, Barcelona, Spain.
Department of Medical Oncology, H.U. Marqués Valdecilla, Av. Valdecilla, 25, Santander, Spain.
Target Oncol. 2018 Feb;13(1):69-78. doi: 10.1007/s11523-017-0536-z.
Pre-operative chemoradiotherapy using a 5-fluorouracil (5-FU)/cisplatin backbone is widely used to improve surgical outcomes in locoregional oesophageal cancer patients, despite a non-negligible failure rate.
We evaluated intensification of this approach to improve patient outcomes by adding cetuximab to induction 5-FU/cisplatin/docetaxel (TPF) and to chemoradiotherapy in a phase II study.
Between November 2006 and April 2009, 50 patients with stage II-IVa squamous cell carcinoma (SCC) or adenocarcinoma of the oesophagus or gastro-oesophageal junction initiated three TPF/cetuximab cycles. Six weeks later, patients with response or stabilisation initiated 6 weeks of cisplatin/cetuximab/radiotherapy, followed by surgery. The primary objective was the clinical complete response (cCR) rate after induction therapy plus chemoradiotherapy in intent-to-treat patients.
Thirty-eight patients were evaluable after chemoradiotherapy, 84% of whom showed disease control. Six patients (12%) achieved a cCR, with a 54% overall response rate. Twenty-seven patients underwent surgery, 11 of whom (22%; nine SCC, two adenocarcinoma) had a pathological CR (41%). Fifteen patients were alive after a median follow-up of 23.2 months. Median progression-free survival was 12.2 months (95% confidence interval [CI] 1.7-22.8). Median overall survival was 23.4 months (95% CI 12.2-36.6) and was significantly longer among the 22 patients with complete resection than in the five patients without (42.1 vs. 24.9 months; p = 0.02, hazard ratio: 3.6, 95% CI 1.1-11.6). The toxicity profile was acceptable.
Neoadjuvant cetuximab/TPF followed by chemoradiotherapy in locoregional oesophageal carcinoma patients is feasible and offers a modest response rate in this trial. The results of combining trimodality neoadjuvant treatment with cetuximab are consistent with the literature. Registration: The study is registered at ClinicalTrials.gov (NCT00733889).
在局部食管癌患者中，使用氟尿嘧啶（5-FU）/顺铂为基础的术前放化疗可改善手术结果，但失败率不可忽视。
我们评估了通过在诱导 5-FU/顺铂/多西紫杉醇（TPF）和放化疗中加入西妥昔单抗来强化这种方法，以提高患者的治疗效果。
2006 年 11 月至 2009 年 4 月，50 例 II-IVa 期食管鳞状细胞癌（SCC）或腺癌或胃食管交界处腺癌患者接受了三个 TPF/西妥昔单抗周期治疗。6 周后，对有反应或稳定的患者开始进行 6 周的顺铂/西妥昔单抗/放疗，然后进行手术。主要研究终点为意向治疗患者诱导治疗加放化疗后的临床完全缓解（cCR）率。
化疗放疗后可评估 38 例患者，84%的患者显示疾病控制。6 例（12%）患者达到 cCR，总缓解率为 54%。27 例患者接受了手术，其中 11 例（22%；9 例 SCC，2 例腺癌）病理完全缓解（41%）。在中位随访 23.2 个月后，15 例患者存活。中位无进展生存期为 12.2 个月（95%置信区间 [CI] 1.7-22.8）。中位总生存期为 23.4 个月（95%CI 12.2-36.6），完全切除的 22 例患者明显长于未完全切除的 5 例患者（42.1 个月 vs. 24.9 个月；p=0.02，风险比：3.6，95%CI 1.1-11.6）。毒性谱是可以接受的。
新辅助西妥昔单抗/TPF 联合放化疗在局部食管癌患者中是可行的，本试验中反应率适中。三联新辅助治疗联合西妥昔单抗的结果与文献一致。注册：该研究在 ClinicalTrials.gov（NCT00733889）注册。
