• Masaya Okada, Yoshihiro Fujimori, Mahito Misawa, Shunro Kai, Toshiyuki Nakajima, Yoshiko Okikawa, Atsushi Satake, Hisayuki Itoi, Hiroyuki Takatsuka, Takeyoshi Itsukuma, Keisuke Nishioka, Hiroya Tamaki, Kazuhiro Ikegame, Hiroshi Hara, and Hiroyasu Ogawa.
• Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
• Biol. Blood Marrow Transplant. 2008 Aug 1; 14 (8): 896-903.

AbstractA 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.

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