Melphalan and purine analog-containing preparative regimens: reduced-intensity conditioning for patients with hematologic malignancies undergoing allogeneic progenitor cell transplantation

Blood. 2001 Feb 1;97(3):631-7. doi: 10.1182/blood.v97.3.631.

Abstract

A reduced-intensity preparative regimen consisting of melphalan and a purine analog was evaluated for allogeneic transplantation in 86 patients who had a variety of hematologic malignancies and were considered poor candidates for conventional myeloablative therapies because of age or comorbidity. Seventy-eight patients received fludarabine 25 mg/m(2) daily for 5 days in combination with melphalan 180 mg/m(2) (n = 66) or 140 mg/m(2) (n = 12). Eight patients received cladribine 12 mg/m(2) continuous infusion for 5 days with melphalan 180 mg/m(2). The median age was 52 years (range, 22-70 years). Disease status at transplantation was either first remission or first chronic phase in 7 patients, untreated first relapse or subsequent remission in 16 patients, and refractory leukemia or transformed chronic myelogenous leukemia in 63 patients. Nonrelapse mortality rates on day 100 were 37.4% for the fludarabine/melphalan combination and 87.5% for the cladribine/melphalan combination. The median percentage of donor cells at 1 month in 75 patients was 100% (range, 0%-100%). The probability of grade 2-4 and 3-4 acute graft-versus-host disease was 0.49 (95% CI, 0.38-0.60) and 0.29 (95% CI, 0.18-0.41), respectively. Disease-free survival at 1 year was 57% for patients in first remission or chronic phase and 49% for patients with untreated first relapse or in a second or later remission. On multivariate analysis the strongest predictor for disease-free survival was a good or intermediate risk category. In summary, fludarabine/melphalan combinations are feasible in older patients with associated comorbidities, and long-term disease control can be achieved with reduced-intensity conditioning in this population.

Publication types

  • Clinical Trial

MeSH terms

  • Acute Disease
  • Adenosine / adverse effects
  • Adenosine / analogs & derivatives
  • Adenosine / therapeutic use
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chronic Disease
  • Cladribine / administration & dosage
  • Cladribine / adverse effects
  • Cladribine / therapeutic use*
  • Disease-Free Survival
  • Female
  • Graft vs Host Disease / diagnosis
  • Hematologic Neoplasms / diagnosis
  • Hematologic Neoplasms / mortality
  • Hematologic Neoplasms / therapy*
  • Hematopoietic Stem Cell Transplantation* / adverse effects
  • Hematopoietic Stem Cell Transplantation* / mortality
  • Humans
  • Male
  • Melphalan / administration & dosage
  • Melphalan / adverse effects
  • Melphalan / therapeutic use*
  • Middle Aged
  • Survival Rate
  • Transplantation Chimera
  • Transplantation Conditioning
  • Transplantation, Homologous / adverse effects
  • Transplantation, Homologous / mortality
  • Vidarabine / administration & dosage
  • Vidarabine / adverse effects
  • Vidarabine / analogs & derivatives*
  • Vidarabine / therapeutic use*

Substances

  • Cladribine
  • Vidarabine
  • Adenosine
  • fludarabine
  • Melphalan