PREOPERATIVE THERAPY FOR ESOPHAGEAL CANCER - A RANDOMIZED COMPARISON OF CHEMOTHERAPY VERSUS RADIATION-THERAPY
PREOPERATIVE THERAPY FOR ESOPHAGEAL CANCER - A RANDOMIZED COMPARISON OF CHEMOTHERAPY VERSUS RADIATION-THERAPY
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DOI：
10.1200/jco.1990.8.8.1352
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发表时间：
1990-08-01
影响因子：
45.3
通讯作者：
HILARIS, B
中科院分区：
文献类型：
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作者：
KELSEN, DP;MINSKY, B;HILARIS, B
96例可手术的食管表皮样癌患者进入了一项III期随机分配研究，旨在比较两种术前方法（化疗[CT]或放疗[RT]）的疗效。主要研究终点为客观有效率、手术结果和复发模式。患者被随机分配接受顺铂、长春地西和博来霉素两个周期的治疗，或者在计划的手术前接受55 Gy的放疗。对于T3Nany或不可切除的肿瘤患者，术后交叉治疗（术前行CT者放疗，术前行CT者放疗）。原发肿瘤对术前治疗的客观反应率相似（RT 64%, CT 55%），可操作性（RT 77%, CT 75%），切除率（RT 65%, CT 58%）和手术死亡率（RT 13.5%, CT 11.1%）。当CT作为初始治疗时，而不是在RT/手术后给予明显更高剂量的CT。33%的可手术患者出现局部失败或持续。所有患者的中位生存期为11个月；20%存活无疾病（中位随访34个月）。由于交叉设计，不可能仅根据术前治疗组分析生存率。本研究表明，由于CT在治疗局部肿瘤方面与RT一样有效，但也可能治疗全身性疾病，因此术前使用CT作为局部食管癌初始治疗的一部分的研究项目应继续进行。然而，如果要对总体生存产生重大影响，则需要确定更有效的化疗方案或时间表。在精心设计的临床试验之外，单独手术或单独放疗仍然是标准的治疗方法。
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.