Kelsen D P, Minsky B, Smith M, Beitler J, Niedzwiecki D, Chapman D, Bains M, Burt M, Heelan R, Hilaris B
Department of Medicine, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021.
J Clin Oncol. 1990 Aug;8(8):1352-61. doi: 10.1200/JCO.1990.8.8.1352.
Ninety-six patients with operable epidermoid cancer of the esophagus were entered into a phase III, random assignment study designed to compare the efficacy of two preoperative approaches (chemotherapy [CT] or radiation therapy [RT]). Major study end points were objective response rates, surgical outcome, and recurrence pattern. Patients were randomly assigned to receive either two cycles of cisplatin, vindesine, and bleomycin or 55 Gy of radiation before a planned surgical procedure. Postoperative crossover therapy (radiation to those receiving preoperative CT and vice versa) was given to patients with T3Nany or unresectable tumors. Objective response rates of the primary tumor to preoperative therapy were similar (RT 64%, CT 55%), as were operability rates (RT 77%, CT 75%), resection rates (RT 65%, CT 58%), and operative mortality (RT 13.5%, CT 11.1%). Significantly higher doses of CT could be administered when CT was given as initial therapy, rather than after RT/surgery. Local failure or persistence occurred in 33% of operable patients. The median survival for all patients was 11 months; 20% remain alive without disease (median follow-up, 34 months). Because of the crossover design, it was not possible to analyze survival according to the preoperative therapy arm alone. This study suggests that since CT is as effective in treating local tumor as RT, but can also potentially treat systemic disease, investigational programs using CT before surgery as part of initial treatment for localized esophageal cancer should continue. However, if a significant impact on overall survival is to be achieved, more effective chemotherapy regimens or schedules need to be identified. Outside of carefully designed clinical trials, surgery alone or radiation alone remain standard therapy.
96例可手术切除的食管表皮样癌患者进入一项III期随机分配研究，该研究旨在比较两种术前治疗方法（化疗[CT]或放疗[RT]）的疗效。主要研究终点为客观缓解率、手术结果和复发模式。患者被随机分配在计划手术前接受两个周期的顺铂、长春地辛和博来霉素治疗或55 Gy的放疗。对T3Nany或不可切除肿瘤患者给予术后交叉治疗（对接受术前CT治疗的患者进行放疗，反之亦然）。原发肿瘤对术前治疗的客观缓解率相似（放疗组64%，化疗组55%），可手术切除率（放疗组77%，化疗组75%）、切除率（放疗组65%，化疗组58%）和手术死亡率（放疗组13.5%，化疗组11.1%）也相似。当化疗作为初始治疗而非放疗/手术后给予时，可以给予更高剂量的化疗。33%的可手术患者出现局部失败或肿瘤持续存在。所有患者的中位生存期为11个月；20%的患者无病存活（中位随访34个月）。由于采用了交叉设计，无法单独根据术前治疗组分析生存期。本研究表明，由于化疗在治疗局部肿瘤方面与放疗同样有效，但也可能治疗全身疾病，因此将术前化疗作为局部食管癌初始治疗一部分的研究项目应继续进行。然而，若要对总生存期产生显著影响，则需要确定更有效的化疗方案或疗程。在精心设计的临床试验之外，单纯手术或单纯放疗仍是标准治疗方法。
