Senn H J, Amgwerd R, Jungi W F, Hochuli R, Ammann J, Engelhart G, Heinz C, Wick A, Enderlin F, Creux G, Simon B, Lanz R, Bigler R, Seiler S
Recent Results Cancer Res. 1982;80:177-84. doi: 10.1007/978-3-642-81685-7_29.
A randomized surgical adjuvant trial in 242 evaluable patients with T1-3a, N0-1, and M0 breast cancer was initiated 4 years ago. The well-tolerated, oral combination chemotherapy with six cycles of Leukeran plus methotrexate plus fluorouracil (LMF) plus repeated BCG skin scarifications was used. After 4 years, the following results were seen: (1) significant increase of relapse-free (RFS) and also overall survival (S) in both pre- and postmenopausal node-negative patients versus surgical controls (RFS 91.1 vs. 701%, P = 0.003; S 96 vs. 88%, P = 0.03); (2) no significant increase of RFS or S in pre- and postmenopausal node-positive patients versus surgical controls (RFS 50.1 versus 44%, P = 0.49; S 70 versus 68 %, P = 0.9, respectively); (3) Patients receiving greater than 90% of the planned LMF dose showed significantly better survival after 4 years; and (4) Nonrandomized comparison with concurrent Swiss adjuvant studies with LMF alone indicate no beneficial or harmful effect of BCG skin scarifications in addition to the six-cycle LMF.
4年前启动了一项针对242例可评估的T1-3a、N0-1和M0期乳腺癌患者的随机手术辅助试验。采用了耐受性良好的口服联合化疗方案，即六个周期的苯丁酸氮芥加甲氨蝶呤加氟尿嘧啶（LMF），并重复进行卡介苗皮肤划痕接种。4年后，观察到以下结果：（1）绝经前和绝经后淋巴结阴性患者的无复发生存期（RFS）和总生存期（S）均显著高于手术对照组（RFS：91.1%对70.1%，P = 0.003；S：96%对88%，P = 0.03）；（2）绝经前和绝经后淋巴结阳性患者的RFS或S与手术对照组相比无显著增加（RFS：50.1%对44%，P = 0.49；S：70%对68%，P = 0.9）；（3）接受计划LMF剂量超过90%的患者4年后生存率显著更高；（4）与同期瑞士单独使用LMF的辅助研究进行非随机比较表明，除六个周期的LMF外，卡介苗皮肤划痕接种无有益或有害影响。
