*US Oncology Research, McKesson Specialty Health, The Woodlands, Texas, and Texas Oncology-Baylor Sammons Cancer Center, Dallas, Texas; †Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana; ‡Community Oncology Center, Kokomo, Indiana; §University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; and ‖Indiana University School of Medicine, Indianapolis, Indiana.
J Thorac Oncol. 2013 Nov;8(11):1425-9. doi: 10.1097/JTO.0b013e3182a46c3b.
On the basis of the promising activity of cetuximab and radiation therapy for head and neck cancers, we evaluated the efficacy of this regimen followed by surgery in patients with resectable esophageal cancer. This was a phase II, open-label, single-arm, multicenter study of patients with potentially resectable esophageal cancer.
Patients received two weekly doses of cetuximab followed by weekly cetuximab combined with radiation therapy for 6 weeks. After a 6- to 8-week rest, patients' primary tumor was resected. The main objective was to evaluate pathologic complete response (pCR) rate in the primary tumor after cetuximab and radiation therapy.
Thirty-nine patients completed the study. Most patients were men (93%), median age was 64 years, performance status was 0 to 1 (95%), patients had a histology of adenocarcinoma (78%), and tumors were located in the esophagus (63%). Grade 3 toxicities in more than 5% of patients included dysphagia (17%), anorexia and dehydration (7%), and dyspnea, fatigue, hypernatremia (5%). Grade 5 aspiration occurred in 2% (1 patient). Four patients died, two from disease progression, one from aspiration pneumonia postsurgery, and one from septic shock. Thirty-one patients (76%) underwent esophagectomy. The pCR rate was 36.6% by intention-to-treat and 48% for patients who underwent esophagectomy. The pCR by histology was 6 of 9 (67%) for squamous cell carcinomas and 9 of 32 (28%) for adenocarcinoma. Earlier-stage disease was associated with increased pCR (IIA 70%, IIB 29%, III 28%).
Cetuximab and radiation therapy results in a pCR rate that seems at least comparable with that of chemotherapy and radiation therapy. This regimen may be better tolerated than preoperative chemotherapy and radiation therapy in patients with resectable esophageal cancers.
基于西妥昔单抗联合放疗对头颈部癌症的良好疗效，我们评估了该方案在可切除食管癌患者中的疗效。这是一项Ⅱ期、开放性、单臂、多中心研究，纳入了潜在可切除食管癌患者。
患者接受每周两次的西妥昔单抗治疗，随后每周联合西妥昔单抗和放疗共 6 周。在 6-8 周的休息期后，患者的原发肿瘤被切除。主要终点是评估西妥昔单抗联合放疗后原发肿瘤的病理完全缓解（pCR）率。
39 例患者完成了研究。大多数患者为男性（93%），中位年龄为 64 岁，体力状态为 0-1 级（95%），组织学类型为腺癌（78%），肿瘤位于食管（63%）。超过 5%的患者出现 3 级毒性包括吞咽困难（17%）、厌食和脱水（7%）以及呼吸困难、乏力、高钠血症（5%）。2%（1 例）的患者发生 5 级吸入性肺炎。4 例患者死亡，2 例死于疾病进展，1 例死于术后吸入性肺炎，1 例死于感染性休克。31 例（76%）患者接受了食管切除术。根据意向治疗分析，pCR 率为 36.6%，接受食管切除术的患者为 48%。组织学 pCR 率为 9 例（67%）鳞癌和 32 例（28%）腺癌。早期疾病与更高的 pCR 率相关（ⅡA 期 70%，ⅡB 期 29%，Ⅲ期 28%）。
西妥昔单抗联合放疗的 pCR 率似乎至少与化疗联合放疗相当。与可切除食管癌患者的术前化疗和放疗相比，该方案的耐受性可能更好。
