TREATMENT OF LOCALLY UNRESECTABLE CANCER OF THE STOMACH AND PANCREAS - A RANDOMIZED COMPARISON OF 5-FLUOROURACIL ALONE WITH RADIATION PLUS CONCURRENT AND MAINTENANCE 5-FLUOROURACIL - AN EASTERN-COOPERATIVE-ONCOLOGY-GROUP STUDY
TREATMENT OF LOCALLY UNRESECTABLE CANCER OF THE STOMACH AND PANCREAS - A RANDOMIZED COMPARISON OF 5-FLUOROURACIL ALONE WITH RADIATION PLUS CONCURRENT AND MAINTENANCE 5-FLUOROURACIL - AN EASTERN-COOPERATIVE-ONCOLOGY-GROUP STUDY
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DOI：
10.1200/jco.1985.3.3.373
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发表时间：
1985-01-01
影响因子：
45.3
通讯作者：
MOERTEL, CG
中科院分区：
文献类型：
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作者：
KLAASSEN, DJ;MACINTYRE, JM;MOERTEL, CG
共有191例患者，病理证实为局部不可切除的胃腺癌（57例）和胰腺癌（91例），随机分配至单独使用5-氟尿嘧啶（5-FU）治疗，600 mg/m2静脉注射，每周一次，或接受放射治疗，4000 rad，加辅助5-FU，600 mg/m2静脉注射，放疗的前3天，随访维持5-FU，600 mg/m2，每周一次。43例患者（22%）因不合格或取消而无法分析;因此，148例患者可评价。两种治疗方案和两种原发癌的中位生存时间相似，如下：胃原发癌，5-FU，9.3个月; 5-FU加放疗，8.2个月;原发性胰腺癌，5-FU治疗8.2个月; 5-FU加放疗，8.3个月。与接受5-FU单药治疗的患者相比，接受联合治疗的患者发生的毒性明显更多。5-FU组中重度或更严重的毒性反应发生率为19%，联合用药组为31%。5-FU治疗的胰腺原发性癌患者的毒性为27%，联合治疗组为51%。重要的预后变量包括：胃癌患者的体重减轻、体力状态、间变性程度和胰腺癌患者的食欲下降。
A total of 191 patients, with pathologically confirmed locally unresectable adenocarcinoma of the stomach (57 patients) and pancreas (91 patients), were randomly allocated to therapy with 5-fluorouracil (5-FU) alone, 600 mg/m2 i.v. once weekly, or to radiation therapy, 4000 rad, plus adjuvant 5-FU, 600 mg/m2 i.v., for the first 3 days of radiotherapy, with follow-up maintenance 5-FU, 600 mg/m2, weekly. Forty-three patients (22%) could not be analyzed because of ineligibility or cancellation; thus, 148 patients were evaluable. The median survival time was similar for both treatment programs and for both types of primary carcinoma, and was as follows: gastric primary carcinoma, 5-FU, 9.3 mo.; 5-FU plus radiotherapy, 8.2 mo.; pancreatic primary carcinoma, 5-FU, 8.2 mo.; 5-FU plus radiotherapy, 8.3 mo. Substantially more toxicity was experienced by patients treated with the combined modality arm than by those patients receiving 5-FU alone. Severe or worse toxicity experienced by patients with gastric primary carcinoma treated by 5-FU was 19%, and the combined modality arm was 31%. The toxicity experienced by patients with pancreatic primary carcinoma treated with 5-FU was 27%, and the combined modality arm was 51%. Significant prognostic variables included: wt loss in stomach-cancer patients; performance status; degree of anaplasia, and reduced appetite in pancreas-cancer patients.