Okada Masaya, Fujimori Yoshihiro, Misawa Mahito, Kai Shunro, Nakajima Toshiyuki, Okikawa Yoshiko, Satake Atsushi, Itoi Hisayuki, Takatsuka Hiroyuki, Itsukuma Takeyoshi, Nishioka Keisuke, Tamaki Hiroya, Ikegame Kazuhiro, Hara Hiroshi, Ogawa Hiroyasu
Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
Biol Blood Marrow Transplant. 2008 Aug;14(8):896-903. doi: 10.1016/j.bbmt.2008.05.020.
A combined chemotherapy regimen comprising fludarabine, cytosine arabinoside, and granulocyte colony-stimulating factor (FLAG) has been used in the treatment of relapsed or refractory leukemias. We here report 38 patients with hematologic malignancies who underwent single-unit cord blood transplantation (CBT) with a conditioning regimen comprising 12-Gy total-body irradiation (TBI) and FLAG therapy (TBI/FLAG). Graft-versus-host disease (GVHD) prophylaxis consisted of tacrolimus or cyclosporin A and/or methotrexate. The median nucleated cell dose was 2.43 x 10(7)/kg (range: 1.96-3.55 x 10(7)/kg). Of 34 evaluable recipients, the cumulative incidence of donor engraftment was 97%. The median time to reach an absolute neutrophil count of 500/microL was 23 days (range: 18-35 days). The median time to an untransfused platelet count of 50,000/microL was 45.5 days (range: 28-208 days). Sixteen patients developed grades II-IV of acute GVHD. Fourteen patients were alive at a median follow-up of 46 months (range: 4-77 months). The estimated event-free survival at 3 years for all patients was 33.5%, with 72.7% in the standard-risk group (n = 11) and 17.7% in the high-risk group (n = 27) (P = .0075). These results showed that this novel regimen was well tolerated by patients and able to establish sustained donor cell engraftment, indicating the feasibility of TBI/FLAG as a conditioning regimen for CBT in adults with hematologic malignancies.
一种包含氟达拉滨、阿糖胞苷和粒细胞集落刺激因子（FLAG）的联合化疗方案已用于治疗复发或难治性白血病。我们在此报告38例血液系统恶性肿瘤患者，他们接受了单单位脐血移植（CBT），预处理方案包括12 Gy全身照射（TBI）和FLAG疗法（TBI/FLAG）。移植物抗宿主病（GVHD）预防措施包括使用他克莫司或环孢素A和/或甲氨蝶呤。中位有核细胞剂量为2.43×10⁷/kg（范围：1.96 - 3.55×10⁷/kg）。在34例可评估的受者中，供者植入的累积发生率为97%。达到绝对中性粒细胞计数500/μL的中位时间为23天（范围：18 - 35天）。未输注血小板计数达到50,000/μL的中位时间为45.5天（范围：28 - 208天）。16例患者发生了II - IV级急性GVHD。14例患者在中位随访46个月（范围：4 - 77个月）时存活。所有患者3年时的无事件生存率估计为33.5%，标准风险组（n = 11）为72.7%，高风险组（n = 27）为17.7%（P = 0.0075）。这些结果表明，这种新方案患者耐受性良好，能够实现供体细胞的持续植入，并表明TBI/FLAG作为成人血液系统恶性肿瘤CBT预处理方案的可行性。
