Treatment of Myelodysplastic Syndromes With Retinoic Acid and 1 Alpha-Hydroxy-Vitamin D3 in Combination With Low-Dose ara-C Is Not Superior to ara-C Alone. Results From a Randomized Study. The Scandinavian Myelodysplasia Group (SMG)

Eur J Haematol. 1990 Nov;45(5):255-61. doi: 10.1111/j.1600-0609.1990.tb00470.x.

Abstract

63 evaluable patients with myelodysplastic syndromes (MDS) and 15 with acute myelogenous leukemia (AML) were randomized between low-dose ara-C (arm A) and low dose ara-C in combination with 13-cis-retinoic acid (13-CRA) and 1 alpha-hydroxy-vitamin D3 (1 alpha D3) (arm B). 69 patients were evaluable and 18 (26.1%) responded to therapy. The addition of 13-CRA and 1 alpha D3 had no positive influence on survival of the patients, remission rates or duration of remissions. 12/27 patients in arm A and 6/29 patients in arm B progressed from MDS to AML during the course of the study (p = 0.0527). Arm B gave significantly more side-effects than arm A (p = 0.005). Therapeutic effects of 13-CRA and 1 alpha D3 on MDS is not supported by this study. However, an inhibiting effect on AML development in some MDS subgroups cannot be excluded.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cytarabine / administration & dosage
  • Cytarabine / adverse effects
  • Cytarabine / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hydroxycholecalciferols / administration & dosage
  • Hydroxycholecalciferols / adverse effects
  • Hydroxycholecalciferols / therapeutic use*
  • Leukemia, Myeloid, Acute / etiology
  • Male
  • Middle Aged
  • Myelodysplastic Syndromes / complications
  • Myelodysplastic Syndromes / drug therapy*
  • Tretinoin / administration & dosage
  • Tretinoin / adverse effects
  • Tretinoin / therapeutic use*

Substances

  • Hydroxycholecalciferols
  • Cytarabine
  • Tretinoin
  • alfacalcidol