Preoperative Cetuximab, Irinotecan, Cisplatin, and Radiation Therapy for Patients With Locally Advanced Esophageal Cancer. (21st February 2013)

• Record Type: Journal Article
• Authors: Lee, Michael S.; Mamon, Harvey J.; Hong, Theodore S.; Choi, Noah C.; Fidias, Panagiotis M.; Kwak, Eunice L.; Meyerhardt, Jeffrey A.; Ryan, David P.; Bueno, Raphael; Donahue, Dean M.; Jaklitsch, Michael T.; Lanuti, Michael; Rattner, David W.; Fuchs, Charles S.; Enzinger, Peter C.
• Is Part Of: Oncologist. Volume 18:Number 3(2013)
• Page Start: 281
• Page End: 287
• Publication Date: 2013-02-21
• Subjects: Cetuximab -- Esophageal cancer -- EGFR -- Chemoradiation; Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1634/theoncologist.2012-0208
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract : Purpose: To determine the efficacy and toxicity of weekly neoadjuvant cetuximab combined with irinotecan, cisplatin, and radiation therapy in patients with locally advanced esophageal or gastroesophageal junction cancer. Methods and Materials: Patients with stage IIA–IVA esophageal or gastroesophageal junction cancer were enrolled in a Simon's two‐stage phase II study. Patients received weekly cetuximab on weeks 0–8 and irinotecan and cisplatin on weeks 1, 2, 4, and 5, with concurrent radiotherapy (50.4 Gy on weeks 1–6), followed by surgical resection. Results: In the first stage, 17 patients were enrolled, 16 of whom had adenocarcinoma. Because of a low pathologic complete response (pCR) rate in this cohort, the trial was discontinued for patients with adenocarcinoma but squamous cell carcinoma patients continued to be enrolled; two additional patients were enrolled before the study was closed as a result of poor accrual. Of the 19 patients enrolled, 18 patients proceeded to surgery, and 16 patients underwent an R0 resection. Three patients (16%) had a pCR. The median progression‐free survival interval was 10 months, and the median overall survival duration was 31 months. Severe neutropenia occurred in 47% of patients, and severe diarrhea occurred in 47% of patients. One patient died preoperatively from sepsis, and one patient died prior to hospital discharge following surgical resection. Conclusions: This schedule of cetuximab in combination with irinotecan, cisplatin, and radiation therapy was toxic and did not achieve a sufficient pCR rate in patients with localized esophageal adenocarcinoma to undergo further evaluation. Abstract : The efficacy and toxicity of weekly neoadjuvant cetuximab combined with irinotecan, cisplatin, and radiation therapy in patients with locally advanced esophageal or gastroesophageal junction cancer were evaluated. This schedule was toxic and did not achieve a sufficient pathologic complete response rate in patients with localized esophageal adenocarcinoma to undergo further evaluation. Abstract : 摘要 目的 . 明确每周一次西妥昔单抗、伊立替康、顺铂新辅助化疗联合放疗用于局部晚期食管癌或胃食管交界癌患者的疗效与毒性反应。 材料与方法 . Simon II期研究分两阶段进行，纳入IIA ∼ IVA期食管癌或胃食管交界癌患者。患者接受每周一次西妥昔单抗（第0 ∼ 8周）、伊立替康与顺铂（第1、2、4、5周），以及同步放疗（50.4 Gy，第1 ∼ 6周），继以手术切除。 结果 . 在第一阶段，17例患者入组，其中16例为腺癌。由于这一队列的病理学完全缓解（pCR）率较低，对腺癌患者的试验中止，仍继续纳入鳞癌患者；最终研究因受试者招募速度过慢而停止，之前又多纳入2例患者。19例患者中，18例患者进行了手术，16例为R0切除。3例患者（16%）获得pCR。中位无进展生存时间为10个月，中位总生存时间为31个月。47%的患者发生重度中性粒细胞减少，47%的患者发生重度腹泻。1例患者术前因败血症死亡，1例患者在手术切除后尚未出院之前死亡。 结论 . 对于局部食管腺癌患者，西妥昔单抗、伊立替康、顺铂以及放疗的联合治疗方案具有毒性，且并未达到足够的pCR率，因而未能按照研究计划开展进一步的评估。