Fisher B, Carbone P, Economou S G, Frelick R, Glass A, Lerner H, Redmond C, Zelen M, Band P, Katrych D L, Wolmark N, Fisher E R
N Engl J Med. 1975 Jan 16;292(3):117-22. doi: 10.1056/NEJM197501162920301.
Prolonged l-phenylalanine mustard (L-PAM) administration as an adjuvant to mastectomy in the management of patients with primary breast cancer and pathologically positive axillary nodes was evaluated by a prospective, randomized, clinical trial. Treatment failures occurred in 22 per cent of 108 patients receiving placebo and 9.7 per cent of 103 women given L-PAM (p = 0.01). A statistically significant difference (p = 0.02) existed in favor of L-PAM relative to disease-free interval. In premenopausal women, the difference with respect to disease-free interval of treated and control groups was highly significant (p = 0.008). A treatment failure occurred in 30 per cent of premenopausal patients receiving placebo and 3 per cent of those treated with L-PAM (p = 0.008). Whereas a similar trend was observed in postmenopausal patients, the difference is not statistically significant. Thus, L-PAM has been demonstrated to be effective in the treatment of women with primary breast cancer, particularly those who are premenopausal. Results were achieved with minimal undesirable side effects.
通过一项前瞻性、随机临床试验,评估了在原发性乳腺癌且腋窝淋巴结病理检查呈阳性的患者中,长期使用左旋苯丙氨酸氮芥(L-PAM)作为乳房切除术辅助治疗的效果。108例接受安慰剂治疗的患者中有22%出现治疗失败,103例接受L-PAM治疗的女性中有9.7%出现治疗失败(p = 0.01)。相对于无病生存期,L-PAM具有统计学显著差异(p = 0.02)。在绝经前女性中,治疗组和对照组的无病生存期差异非常显著(p = 0.008)。接受安慰剂治疗的绝经前患者中有30%出现治疗失败,接受L-PAM治疗的患者中有3%出现治疗失败(p = 0.008)。虽然在绝经后患者中观察到类似趋势,但差异无统计学意义。因此,已证明L-PAM对原发性乳腺癌女性有效,尤其是绝经前女性。该治疗取得了效果,且不良副作用最小。