Shields T W, Higgins G A, Humphrey E W, Matthews M J, Keehn R J
Cancer. 1982 Nov 1;50(9):1713-21. doi: 10.1002/1097-0142(19821101)50:9<1713::aid-cncr2820500910>3.0.co;2-b.
Eight hundred sixty-five patients with a microscopically curative resection for carcinoma of the lung were accepted for study, none of whom were excluded from analysis. Adjuvant therapy was randomly assigned about the tenth to 14th postoperative day; 432 patients (treated) were to receive CCNU and hydroxyurea for one year, while 433 patients (controls) were to receive no adjuvant therapy. Toxic reactions to therapy were reported, but only 1% were severe enough to require stopping therapy. No evidence of improved survival or delayed recurrence of disease was seen in treated patients as a whole or when examined by cell type and by postsurgical TNM category. On the contrary, survival beyond the second year of follow-up may have been impaired by the drugs when administered to patients without evidence of tumor spread to the lymph nodes.
865例接受了肺癌显微镜下根治性切除术的患者被纳入研究，无一例被排除在分析之外。辅助治疗在术后第10至14天随机分配；432例患者（治疗组）接受洛莫司汀和羟基脲治疗一年，而433例患者（对照组）不接受辅助治疗。报告了治疗的毒性反应，但只有1%严重到需要停止治疗。在整个治疗组患者中，或按细胞类型和术后TNM分类检查时，均未发现生存改善或疾病复发延迟的证据。相反，当给没有肿瘤扩散至淋巴结证据的患者使用这些药物时，随访第二年以后的生存可能受到了损害。
