Langenmayer I, Nerl C, Knauf W, Dempster S, Hallek M, Adorf D, Dietzfelbinger H, Busch R, Ziegler-Heitbrock H W, Thiel E, Emmerich B
Abteilung für Hämatologie und Onkologie, Klinikum Innenstad, Ludwig-Maximilians-Universität München, Germany.
Br J Haematol. 1996 Aug;94(2):362-9. doi: 10.1046/j.1365-2141.1996.d01-1796.x.
The efficacy of interferon-alpha 2b (IFN alpha) to prolong progression-free (PFS) and/or overall survival (OS) in early B-CLL (Binet stage A) was examined in a risk-adapted phase III study. 99 previously untreated B-CLL patients were recruited. 44 patients with expected high risk for disease progression, defined by non-nodular bone marrow infiltration and lymphocyte doubling time < or = 12 months or serum thymidine kinase levels > or = 5 U/I, were randomized to either receive IFN alpha (group 1, n = 21) or not (group 2, n = 23). 55 low-risk patients were observed to evaluate this risk stratification (group 3). During a median observation time of 36 months, four patients in the IFN alpha group achieved a partial remission (PR), no patient had stable disease (SD), and 17 patients experienced progressive disease (PD). The four responders had less extensive disease at study entry and tended to exhibit a rise in serum IgG levels. In group 2, no PR, seven SD and 16 PD, whereas in group 3, no PR, 37 SD and 18 PD occurred. PFS in group 1 (6.7 months) was not different from group 2 (13.3 months, P = 0.22), but PFS of groups 1 and 2 differed from group 3 (37 months, P < or = 0.001). OS was 44.9 months (group 1), 43.1 months (group 2) and 57.9 months (group 3). OS was not significantly different for group 1 v 2, but was significant between groups 1 and 3 (P = 0.023). The higher percentage of PD in group 2 compared to group 3 (70% v 29%) shows that the selected risk factors allow the definition of CLL stage A patients at risk for disease progression within about a year. In conclusion, our data indicate that IFN alpha does not prolong PFS or OS in stage A CLL patients with high risk for disease progression.
在一项风险适应性III期研究中，对干扰素-α 2b（IFNα）延长早期B细胞慢性淋巴细胞白血病（Binet分期A期）患者无进展生存期（PFS）和/或总生存期（OS）的疗效进行了研究。招募了99例既往未接受治疗的B细胞慢性淋巴细胞白血病患者。44例疾病进展风险预期较高的患者，其定义为非结节性骨髓浸润、淋巴细胞倍增时间≤12个月或血清胸苷激酶水平≥5 U/I，被随机分为接受IFNα治疗组（第1组，n = 21）或不接受治疗组（第2组，n = 23）。观察55例低风险患者以评估这种风险分层（第3组）。在中位观察时间36个月期间，IFNα组有4例患者达到部分缓解（PR），无患者病情稳定（SD），17例患者病情进展（PD）。4例缓解者在研究入组时疾病范围较小，且血清IgG水平有升高趋势。在第2组，无PR，7例SD和16例PD，而在第3组，无PR，37例SD和18例PD。第1组的PFS（6.7个月）与第2组（13.3个月，P = 0.22）无差异，但第1组和第2组的PFS与第3组（37个月，P≤0.001）不同。OS分别为44.9个月（第1组）、43.1个月（第2组）和57.9个月（第3组）。第1组与第2组的OS无显著差异，但第1组和第3组之间有显著差异（P = 0.023）。与第3组相比，第2组中PD的百分比更高（70%对29%），这表明所选择的风险因素能够在大约一年内定义有疾病进展风险的A期慢性淋巴细胞白血病患者。总之，我们的数据表明，IFNα不能延长疾病进展风险高的A期慢性淋巴细胞白血病患者的PFS或OS。
