title: The use of a sequential high dose recombinant interleukin 2 regimen after autologous bone marrow transplantation does not improve the disease free survival of patients with acute leukemia transplanted in first complete remission.
abstract: We report the outcome of 50 consecutive patients with CR1 acute leukemia (AML = 22; ALL = 28) treated with autologous BMT, after cyclophosphamide and TBI, followed with a sequential high dose rIL2 regimen. rIL-2 (RU 49637 from Roussel-Uclaf, Romainville, France) was started after hematological reconstitution an average of 72 +/- 22 days post transplant. The schedule consisted of a continuous infusion over 5 cycles (Cycle 1: 5 days starting on day 1; cycle 2-5: 2 days starting on day 15, 29, 43 and 57). Patients were treated at 4 different dosages (12 (N = 40), 16 (N = 3), 20 (N = 2), 24 (N = 5) x 10(6) IU/m2/day). Toxicities were mainly related to capillary leak syndrome and thrombocytopenia. Patients received an average of 122 +/- 49 10(6) IU/m2. Two patients with AML died from toxicity. rIL-2 infusion was associated with very a high level of immune stimu-lation of both T-cells (P < 0.05) and natural killer (NK) cells (P < 0.05) and associated cytolytic functions (P < 0.05). With a minimal and median follow-up of 21 and 46 months, 3 year leukemia free survival is 41 +/- 6% overall, 39 +/- 10% and 43 +/- 8% for AML and ALL respectively. Relapse probabilities at 3 years are 59 +/- 11% for AML and 57 +/- 8% for ALL. We conclude that this short infusion of rIL-2 over 2 months, resulting in an increased immune stimulation, is not associated with a better leukemic control for patients with acute leukemia transplanted early after reaching first complete remission.
authors.affiliation: The Transplant Units of Institut Paoli Calmettes, Marseille, France.
authors.forename: D
authors.initials: D
authors.lastname: Blaise
authors.forename: M
authors.initials: M
authors.lastname: Attal
authors.forename: J L
authors.initials: JL
authors.lastname: Pico
authors.forename: J
authors.initials: J
authors.lastname: Reiffers
authors.forename: A M
authors.initials: AM
authors.lastname: Stoppa
authors.forename: C
authors.initials: C
authors.lastname: Bellanger
authors.forename: L
authors.initials: L
authors.lastname: Molina
authors.forename: G
authors.initials: G
authors.lastname: Nedellec
authors.forename: J P
authors.initials: JP
authors.lastname: Vernant
authors.forename: M
authors.initials: M
authors.lastname: Legros
authors.forename: R
authors.initials: R
authors.lastname: Gabus
authors.forename: F
authors.initials: F
authors.lastname: Huguet
authors.forename: M
authors.initials: M
authors.lastname: Brandely
authors.forename: T
authors.initials: T
authors.lastname: Hercend
authors.forename: D
authors.initials: D
authors.lastname: Olive
authors.forename: D
authors.initials: D
authors.lastname: Maraninchi
mesh_terms: D000208:Acute Disease; D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D007694:Killer Cells, Natural / Q000187:drug effects / Q000276:immunology; D007951:Leukemia, Myeloid / Q000097:blood / Q000628:therapy*; D008213:Lymphocyte Activation / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000097:blood / Q000628:therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use; D013601:T-Lymphocytes / Q000187:drug effects / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D007376:Interleukin-2; D011994:Recombinant Proteins