title: Randomized study of recombinant interleukin-2 after autologous bone marrow transplantation for acute leukemia in first complete remission.
abstract: Immunological control of acute leukemia may be achieved after allogeneic transplant. Despite promising preliminary results, the impact of immunotherapy with interleukin-2 (r-IL-2) on patients with acute leukemia (AL), in first complete remission (CR1) remains unclear. We conducted a prospective multicenter randomized trial to compare outcome in patients with AL in CR1, treated with autologous bone marrow transplantation (BMT) with or without postgraft r-IL-2. One hundred and thirty patients with AL in CR1 (myeloblastic (AML): N = 78; lymphoblastic (ALL): N = 52) were randomized at time of BMT to receive (N = 65) or not (N = 65) r-IL-2. r-IL-2 (RU 49637 from Roussel Uclaf) was started after hematological recovery, as a five cycle regimen (12 M IU/m2/day continuous infusion on day 1-5, 15-17, 29-31,43-45 and 57-59). The two groups were balanced for patient and transplant characteristics. Analysis was based on an intent to treat. Thirty-eight (59%) of the 65 patients randomized into the study group started r-IL-2 at a median of sixty-eight days (23-140) after transplant and received 77% (16-100) of the scheduled dosage. They received a median of 120 x 10(6) IU/m2 (25-156) over 10 (3-13) days during a total median period of 56 (3-78) days. With a median follow-up of 7 years (5.4-8.1 years), 79 patients relapsed (study group: 43 (66%); control group: 36 (55%): p = NS). Survival and leukemia-free survival estimates were 33% (23-45) versus 43% (22-52) and 29% (19-41) versus 36% (24-51) respectively for study and control groups (all p = NS). These results show that leukemic control after autologous BMT is not increased by r-IL-2 therapy. Further studies should investigate more appropriate r-IL-2 schedules and the possibilities offered by better antigen recognition and activated effector cells.
authors.affiliation: Unité de Transplantation et de Thérapie Cellulaire, Université de la Méditerranée, Institut Paoli-Calmettes, 232, bd Sainte-Marguerite, 13273 Marseille Cedex 9 France. blaised@marseille.fnclcc.fr
authors.forename: D
authors.initials: D
authors.lastname: Blaise
authors.forename: M
authors.initials: M
authors.lastname: Attal
authors.forename: J
authors.initials: J
authors.lastname: Reiffers
authors.forename: M
authors.initials: M
authors.lastname: Michallet
authors.forename: C
authors.initials: C
authors.lastname: Bellanger
authors.forename: J L
authors.initials: JL
authors.lastname: Pico
authors.forename: A M
authors.initials: AM
authors.lastname: Stoppa
authors.forename: C
authors.initials: C
authors.lastname: Payen
authors.forename: G
authors.initials: G
authors.lastname: Marit
authors.forename: R
authors.initials: R
authors.lastname: Bouabdallah
authors.forename: J J
authors.initials: JJ
authors.lastname: Sotto
authors.forename: J F
authors.initials: JF
authors.lastname: Rossi
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: Maraninchi
mesh_terms: D000328:Adult; D016026:Bone Marrow Transplantation; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000401:mortality / Q000628:therapy*; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012074:Remission Induction; D015996:Survival Rate; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins