Glass A, Wieand H S, Fisher B, Redmond C, Lerner H, Wolter J, Shibata H, Plotkin D, Foster R, Margolese R, Wolmark N
Cancer Treat Rep. 1981 May-Jun;65(5-6):363-76.
Since 1972, the National Surgical Adjuvant Breast and Bowel Project (NSABP) has carried out a series of clinical trials evaluating the worth of adjuvant chemotherapy in the management of patients with primary breast cancer. This report provides information concerning (a) protocol compliance relative to drug administration and (b) acute toxicity encountered by patients in three separate trials who were given one-, two- or three-drug chemotherapy within 1 month of operation. The findings are derived from 1548 women who received 20,765 courses of chemotherapy, the most extensively documented experience yet reported. They indicate that despite the large number of physicians and the heterogeneity of the institutions participating, large cooperative efforts can be accomplished with credibility. Only 13 (0.8%) of the women failed to complete all courses of therapy for reasons directly related to nonprotocol compliance by physicians. Only 4.3% failed to complete therapy for miscellaneous reasons other than toxicity, treatment failure, occurrence of a second primary, or death unrelated to tumor. While almost all patients experienced toxic reactions during the therapy, only 3%--4% of recipients of melphalan (L-PAM; P) and 4%--5% of recipients of L-PAM + 5-FU(F)(PF) failed to complete 2 years of therapy because of toxicity. Of those patients receiving PF + methotrexate (MTX; M) (PMF), 15% did not finish their treatment for that reason. While there was little difference in hematologic and nonhematologic toxicity between those patients receiving P or PF, and such toxicity was generally acceptable to both patients and physicians, the addition of MTX (PMF) resulted in greater toxicity (vomiting, stomatitis, and alopecia) which was less readily accepted. Tolerance of any of these regimens was unrelated to patient age, despite the belief that older women are less tolerant of chemotherapy. The earlier toxicity occurred, the greater was the number of subsequent courses associated with toxicity, and the lower was the total amount of drug received. The extent of the toxicity produced by the NSABP regimens and the end results obtained with them, must be compared with the end results and toxicity obtained by other regimens before making a choice of the adjuvant therapy to be used.
自1972年以来，国家乳腺癌和肠道外科辅助治疗项目（NSABP）开展了一系列临床试验，以评估辅助化疗在原发性乳腺癌患者治疗中的价值。本报告提供了有关以下两方面的信息：（a）与药物给药相关的方案依从性，以及（b）在三项独立试验中，术后1个月内接受单药、两药或三药化疗的患者所遭遇的急性毒性反应。这些发现来自1548名接受了20765个疗程化疗的女性，这是迄今报道的记录最为详尽的经验。结果表明，尽管参与的医生数量众多且机构各异，但通过大量合作仍能取得可信的成果。仅有13名（0.8%）女性因医生未遵守方案的直接原因而未能完成所有疗程的治疗。仅有4.3%的女性因毒性、治疗失败、出现第二原发性肿瘤或与肿瘤无关的死亡以外的其他杂项原因而未能完成治疗。虽然几乎所有患者在治疗期间都经历了毒性反应，但因毒性而未能完成2年治疗的苯丙氨酸氮芥（左旋苯丙氨酸氮芥；P）接受者仅为3% - 4%，左旋苯丙氨酸氮芥 + 氟尿嘧啶（F）（PF）接受者为4% - 5%。在接受PF + 甲氨蝶呤（MTX；M）（PMF）的患者中，有15%因此未完成治疗。虽然接受P或PF的患者在血液学和非血液学毒性方面差异不大，且这种毒性通常患者和医生都可接受，但添加MTX（PMF）会导致更大的毒性（呕吐、口腔炎和脱发），且较难被接受。尽管人们认为老年女性对化疗的耐受性较低，但这些方案中任何一种的耐受性都与患者年龄无关。毒性出现得越早，随后与毒性相关的疗程数量就越多，接受的药物总量就越低。在选择使用的辅助治疗方法之前，必须将NSABP方案产生的毒性程度及其最终结果与其他方案获得的最终结果和毒性进行比较。
