Lipton Jeffrey H, Khoroshko Nina, Golenkov Anatoly, Abdulkadyrov Kudrat, Nair Krishnan, Raghunadharao Digumarti, Brummendorf Tim, Yoo Kisook, Bergstrom Bengt
Department of Medical Oncology, Princess Margaret Hospital, Toronto, ON, Canada.
Leuk Lymphoma. 2007 Mar;48(3):497-505. doi: 10.1080/10428190601175393.
The efficacy and safety of peginterferon-alpha-2a (40 kD) (PEG-IFNalpha-2a), 450 microg once weekly, versus IFNalpha-2a, 9 MIU once daily, for 12 months, was evaluated in a Phase II study in IFN-naïve patients with chronic-phase, Philadelphia-chromosome-positive CML. At the end of the treatment, complete hematological response was observed in 66.2% (47/71) and 45.2% (33/73) of the PEG-IFNalpha-2a group and IFNalpha-2a groups, respectively (p = 0.009), and major cytogenetic response occurred in 35.2% and 17.8%, respectively (p = 0.016). PEG-IFNalpha-2a was at least as effective as IFNalpha-2a overall, including progression-free survival at the end of treatment, and overall survival after 30 months of follow-up. Adverse events necessitated fewer withdrawals but more dose adjustments in the PEG-IFNalpha-2a group compared with the IFNalpha-2a group (11%versus 23%, and 84.5%versus 65.8%, respectively). In conclusion, PEG-IFNalpha-2a (40 kD), 450 microg once weekly, compared with IFNalpha-2a, 9 MIU once daily, resulted in higher rates of hematologic and cytogenetic response and greater overall survival.
在一项针对初治的慢性期、费城染色体阳性慢性髓性白血病（CML）患者的II期研究中，评估了聚乙二醇化干扰素α-2a（40 kD）（PEG-IFNα-2a）每周一次450微克与干扰素α-2a每日一次9百万国际单位，治疗12个月的疗效和安全性。治疗结束时，PEG-IFNα-2a组和干扰素α-2a组的完全血液学缓解率分别为66.2%（47/71）和45.2%（33/73）（p = 0.009），主要细胞遗传学缓解率分别为35.2%和17.8%（p = 0.016）。总体而言，PEG-IFNα-2a至少与干扰素α-2a一样有效，包括治疗结束时的无进展生存期以及随访30个月后的总生存期。与干扰素α-2a组相比，PEG-IFNα-2a组因不良事件导致的停药较少，但剂量调整较多（分别为11%对23%，84.5%对65.8%）。总之，与每日一次9百万国际单位的干扰素α-2a相比，每周一次450微克的PEG-IFNα-2a（40 kD）导致更高的血液学和细胞遗传学缓解率以及更长的总生存期。
