Castro J E, James D F, Sandoval-Sus J D, Jain S, Bole J, Rassenti L, Kipps T J
Moores UCSD Cancer Center, University of California, La Jolla, CA 92093-0820, USA.
Leukemia. 2009 Oct;23(10):1779-89. doi: 10.1038/leu.2009.133. Epub 2009 Aug 20.
We observed that high-dose methylprednisolone (HDMP) and rituximab was well tolerated and had promising activity when used in combination to treat patients with fludarabine-refractory chronic lymphocytic leukemia (CLL). This prompted us to evaluate the use of these agents in frontline therapy. A total of 28 patients with a median age of 65 years enrolled in this study. Patients received HDMP at 1 g/m(2) each day for 3 days during each of the three 4-week cycles together with rituximab and prophylactic antimicrobial therapy. The treatment was well tolerated with few adverse events of grade III or higher. The overall response rate was 96% (N=27). Nine patients (32%) achieved a complete remission (CR), two of which were without detectable minimal residual disease (MRD). Six patients with MRD received consolidation with alemtuzumab; five of these patients achieved an MRD-negative CR. With over 3 years of follow-up median progression-free survival was 30.3 months with only 39% of patients requiring additional therapy, and an overall survival was 96%. This study demonstrates that HDMP and rituximab is an effective nonmyelosuppressive treatment combination for patients with CLL that warrants consideration particularly for patients with limited myeloid reserve that might not tolerate standard treatment regimens.
我们观察到，高剂量甲泼尼龙（HDMP）与利妥昔单抗联合用于治疗氟达拉滨难治性慢性淋巴细胞白血病（CLL）患者时耐受性良好且具有可观的活性。这促使我们评估这些药物在一线治疗中的应用。共有28名中位年龄为65岁的患者纳入本研究。患者在三个4周疗程的每个疗程中，连续3天每天接受1 g/m²的HDMP，并联合利妥昔单抗及预防性抗菌治疗。治疗耐受性良好，III级或更高级别的不良事件较少。总缓解率为96%（N = 27）。9名患者（32%）达到完全缓解（CR），其中2名患者无可检测的微小残留病（MRD）。6名有MRD的患者接受了阿仑单抗巩固治疗；其中5名患者实现了MRD阴性的CR。经过超过3年的随访，中位无进展生存期为30.3个月，只有39%的患者需要额外治疗，总生存率为96%。这项研究表明，HDMP和利妥昔单抗是一种有效的非骨髓抑制性治疗组合，适用于CLL患者，尤其对于骨髓储备有限、可能无法耐受标准治疗方案的患者值得考虑。
