Randomized study of combination chemotherapy in unresectable gastric cancer
Randomized study of combination chemotherapy in unresectable gastric cancer
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联合化疗治疗不可切除胃癌的随机研究
DOI：
10.1002/1097-0142(19840101)53:1
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发表时间：
1984
期刊：
影响因子：
6.2
通讯作者：
M. O’connell
中科院分区：
文献类型：
--
作者：
M. O’connell
1978年12月至1981年3月期间，241例不可切除的胃腺癌患者入组前瞻性随机比较三种化疗方案，以确定治疗活性并确定患者耐受性：（1）5-氟尿嘧啶+阿霉素（FA）;（2）FA+甲基-CCNU（FAMe）;（3）FA+丝裂霉素C（FAMi）。在随机化前，患者按分期和体能状态分层。治疗组在已知的预后判别因素方面平衡良好。评价治疗效果的主要终点是患者生存率。使用比例风险模型调整分期和体能状态的成对比较证明，与FA相比，FAMe具有显著的生存优势（P < 0.03）。毒性主要是血液学的，在接受FAMe的患者中更常见。FAMe方案在手术辅助治疗和联合放疗治疗局部不可切除胃癌患者的进一步研究正在开发中。Cancer 53：13 - 17，1984.
Two hundred forty‐one patients with unresectable gastric adenocarcinoma were entered between December 1978 and March 1981, into a prospectively randomized comparison of three chemotherapy regimens to identify therapeutic activity and determine patient tolerability: (1) 5‐fluorouracil plus Adriamycin (FA); (2) FA plus methyl‐CCNU (FAMe); and (3) FA plus mitomycin C (FAMi). Patients were stratified by stage and performance status prior to randomization. Treatment groups were well balanced with respect to known prognostic discriminants. The primary endpoint to evaluate treatment effect was patient survival. Pair‐wise comparisions using a proportional hazards model adjusted for stage and performance status documented a significant survival advantage for FAMe compared with FA (P < 0.03). Toxicity was primarily hematologic and was seen more frequently in patients receiving FAMe. Further investigations of the FAMe regimen in the surgical adjuvant setting and combined with radiotherapy for patients with locally unresectable gastric cancer are under development. Cancer 53:13‐17, 1984.