Ten year follow-up results of patients with carcinoma of the breast in a co-operative clinical trial evaluating surgical adjuvant chemotherapy.
Ten year follow-up results of patients with carcinoma of the breast in a co-operative clinical trial evaluating surgical adjuvant chemotherapy.
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一项评估手术辅助化疗的合作临床试验中乳腺癌患者的十年随访结果。
DOI：
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发表时间：
1975
期刊：
影响因子：
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通讯作者：
N. Wolmark
中科院分区：
文献类型：
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作者：
B. Fisher;N. Slack;D. Katrych;N. Wolmark
1958年，一项涉及23家机构的合作临床试验开始，评估短期疗程三乙烯埃塞俄比亚磷酰胺辅助根治性乳房切除术治疗原发性乳腺癌患者的疗效。对826名妇女进行前瞻性随机分组，使她们接受安慰剂或三乙烯埃塞俄比亚磷酰胺，其中99.3%的妇女可进行为期5年的随访研究，95.3%的妇女已观察10年或更长时间。结果表明，标准的手术治疗在大多数患者实现永久无肿瘤状态方面是不够的。尤其令人痛心的是，研究发现，在所有腋窝淋巴结呈阳性的患者中，76%（1 - 3个为65%，大于或等于4个为86%）的患者在10年后都表现出治疗失败，只有24.9%的患者存活下来。1 ~ 3个阳性淋巴结患者的生存率为37.5%，4个以上淋巴结患者的生存率仅为13.4%。同样令人不安的是，观察到四名腋窝淋巴结阴性的患者中有一名治疗失败了十年。这些发现要求立即评估术后可用的全身治疗药物的紧迫性。系统性化疗可以提高至少一些乳腺癌患者的无病状态和生存率，这一发现得到了支持，最初的18个月观察表明，接受三乙烯埃塞俄比亚磷酰胺治疗的绝经前妇女有超过或等于4个阳性淋巴结的优势持续长达10年。当时，三乙烯埃塞俄比亚磷酰胺组治疗失败的患者减少了21%，存活的患者增加了21%，这表明治疗失败的最初延迟反映在患者存活率上。数据表明，有限的化疗在肿瘤较小的患者中更有效，这与辅助治疗可能在肿瘤残余负荷最小的宿主中最有效的概念是一致的。重要的是观察到在10年内发生的80%的治疗失败在5年的观察中是明显的。引人注目的是，在淋巴结呈阳性的患者中，86%的十年治疗失败发生在五年之后。在超过或等于4个阳性淋巴结的患者中，92%的病例是这样。这样的发现倾向于质疑这样一种说法，即乳腺癌的另一种治疗方法的价值只能通过远远超过5年的观察来确定。
In 1958, a co-operative clinical trial, involving 23 institutions, was begun to evaluate the efficacy of a short course of triethylenethiophosphoramide as an adjuvant to radical mastectomy in the treatment of patients with primary carcinoma of the breast. Of 826 women prospectively randomized so that they received either a placebo or triethylenethiophosphoramide, 99.3 per cent were available for five years of follow-up study, and 95.3 per cent have been observed for ten or more years. Results have indicated the inadequacy of standard operative therapy in effecting a permanent tumor-free state in a majority of patients. Particularly distressing was the finding that 76 per cent of all patients with positive axillary nodes--65 per cent with one to three and 86 per cent of those with more than or equal to four positive--demonstrated a treatment failure by ten years and that only 24.9 per cent survived. The survival rate of those with one to three positive nodes was 37.5 per cent and only 13.4 per cent if more than or equal to four nodes contained tumor. Also disturbing was the observation that one of four patients with negative axillary nodes displayed a treatment failure by ten years. Such findings mandate the urgency for immediate evaluation of available systemic therapeutic agents postoperatively. That systemic chemotherapy can enhance the disease-free state as well as survival rate of at least some patients with carcinoma of the breast is supported by the finding that the original observation at 18 months indicating an advantage for premenopausal women with more than or equal to four positive nodes who received triethylenethiophosphoramide persisted for as long as ten years. At that time, 21 per cent fewer patients in the triethylenethiophosphoramide group had treatment failures and 21 per cent more survived, an indication that the initial delay in treatment failure was reflected in patient survival rate. Data suggesting that the limited chemotherapy used was more effective in patients having smaller tumors are in keeping with the concept that adjuvant therapy is likely to be most effective in a host with minimal residual tumor burden. Of importance was the observation that 80 per cent of treatment failures occurring in ten years were apparent by five years of observation. Strikingly, 86 per cent of ten year treatment failures in patients with positive nodes occurred by five years. In patients with more than or equal to four positive nodes, this was so in 92 per cent of the instances. Such findings tend to discredit the claim that the worth of an alternative treatment for carcinoma of the breast can be ascertained only by a period of observation much longer than five years.