Ohno R, Nakamura H, Kodera Y, Masaoka T, Yamada K
Gan To Kagaku Ryoho. 1986 Apr;13(4 Pt 2):1264-9.
The effect of immunotherapy with Nocardia rubra cell-wall skeleton (N-CWS) on the remission duration and survival of adults with acute myelogenous leukemia (AML) was studied in a prospective randomized controlled study. After having been induced into complete remission and consolidated, 73 patients were randomized either to maintenance chemotherapy or maintenance chemotherapy plus immunotherapy with N-CWS and irradiated allogeneic AML cells. Thirty-four patients in the chemotherapy group and 32 in the chemoimmunotherapy group were evaluable. Six months after the closure of the study, the immunotherapy showed a borderline beneficial effect on remission duration (p = 0.080) and on survival length (p = 0.098). When the data were analyzed at 42 months after entry, there was a borderline significant difference in remission duration (p = 0.066) between the two groups, prolonging the 50% remission period by 120 days, but no significant differences in survival length (p = 0.306), although the 50% survival was 168 days longer in the chemoimmunotherapy group. Thus, immunotherapy with N-CWS and irradiated allogeneic AML cells seems to be active in the treatment of adult AML when used for maintenance therapy in combination with chemotherapy.
在一项前瞻性随机对照研究中,研究了红诺卡氏菌细胞壁骨架(N-CWS)免疫疗法对成人急性髓性白血病(AML)缓解期持续时间和生存率的影响。73例患者诱导完全缓解并巩固治疗后,随机分为维持化疗组或维持化疗加N-CWS及辐照异体AML细胞免疫治疗组。化疗组34例患者和化疗免疫治疗组32例患者可进行评估。研究结束6个月后,免疫疗法对缓解期持续时间(p = 0.080)和生存长度(p = 0.098)显示出临界有益效果。当在入组42个月时分析数据时,两组间缓解期持续时间存在临界显著差异(p = 0.066),50%缓解期延长了120天,但生存长度无显著差异(p = 0.306),尽管化疗免疫治疗组的50%生存期长168天。因此,N-CWS及辐照异体AML细胞免疫疗法与化疗联合用于维持治疗时,似乎对成人AML治疗有效。