Heath E I, Burtness B A, Heitmiller R F, Salem R, Kleinberg L, Knisely J P, Yang S C, Talamini M A, Kaufman H S, Canto M I, Topazian M, Wu T T, Olukayode K, Forastiere A A
Departments of Oncology, Surgery, Medicine, and Pathology, Johns Hopkins University School of Medicine, Baltimore, MD 21287-8934, USA.
J Clin Oncol. 2000 Feb;18(4):868-76. doi: 10.1200/JCO.2000.18.4.868.
This phase II trial evaluated continuous-infusion cisplatin and fluorouracil (5-FU) with radiotherapy followed by esophagectomy. The objectives of this trial were to determine the complete pathologic response rate, survival rate, toxicity, pattern of failure, and feasibility of administering adjuvant chemotherapy in patients with resectable cancer of the esophagus treated with preoperative chemoradiation.
Patients were staged using computed tomography, endoscopic ultrasound, and laparoscopy. The preoperative treatment plan consisted of continuous intravenous infusion of cisplatin and 5-FU and a total dose of 44 Gy of radiation. Esophagogastrectomy was planned for approximately 4 weeks after the completion of chemoradiotherapy. Paclitaxel and cisplatin were administered as postoperative adjuvant therapy.
Forty-two patients were enrolled onto the trial. Of the 39 patients who proceeded to surgery, 29 responded to preoperative treatment: 11 achieved pathologic complete response (CR) and 18 achieved a lower posttreatment stage. Five patients had no change in stage, whereas eight had progressive disease (four with distant metastases and four with increases in the T and N stages). At a median follow-up of 30.2 months, the median survival time has not been reached and the 2-year survival rate is 62%. The median survival of pathologic complete responders has not been reached, whereas the 2-year survival rate of this group is 91% compared with 51% in patients with complete tumor resection with residual tumor (P =.03).
An excellent survival rate, comparable to that of our prior preoperative trial, was achieved with lower doses of preoperative cisplatin and 5-FU concurrent with radiotherapy.
本II期试验评估了持续输注顺铂和氟尿嘧啶（5-FU）联合放疗后行食管切除术的疗效。本试验的目的是确定可切除食管癌患者在接受术前放化疗后辅助化疗的完全病理缓解率、生存率、毒性、失败模式及可行性。
患者采用计算机断层扫描、内镜超声和腹腔镜进行分期。术前治疗方案包括持续静脉输注顺铂和5-FU以及44 Gy的总放疗剂量。计划在放化疗完成后约4周进行食管胃切除术。紫杉醇和顺铂作为术后辅助治疗。
42例患者入组本试验。在进行手术的39例患者中，29例对术前治疗有反应：11例达到病理完全缓解（CR），18例治疗后分期降低。5例患者分期无变化，而8例出现疾病进展（4例有远处转移，4例T和N分期增加）。中位随访30.2个月时，中位生存时间尚未达到，2年生存率为62%。病理完全缓解者的中位生存时间尚未达到，而该组的2年生存率为91%，相比之下，肿瘤完全切除但有残留肿瘤的患者为51%（P = 0.03）。
术前使用较低剂量的顺铂和5-FU联合放疗可取得与我们之前术前试验相当的优异生存率。
