Real-world data on Len/Dex combination at second-line therapy of multiple myeloma: treatment at biochemical relapse is a significant prognostic factor for progression-free survival

Ann Hematol. 2018 Sep;97(9):1671-1682. doi: 10.1007/s00277-018-3361-2. Epub 2018 May 13.

Abstract

We evaluated progression-free survival (PFS) rate of patients treated with lenalidomide/dexamethasone (Len/Dex), the efficacy of the combination, and the prognostic significance of treatment at biochemical vs. clinical relapse on PFS in 207 consecutive myeloma patients treated with Len/Dex in second line, according to routine clinical practice in Greece. First-line treatment included bortezomib-based (63.3%) or immunomodulatory drug-based (34.8%) therapies; 25% of patients underwent autologous stem cell transplantation. Overall response rate was 73.4% (17.8% complete response and 23.7% very good partial response); median time to best response was 6.7 months. Overall, median PFS and 12-month PFS rate was 19.2 months and 67.6%, respectively. 67.5% of patients had biochemical relapse and 32.5% had clinical relapse prior to initiation of Len/Dex. Median PFS was 24 months for patients treated at biochemical relapse vs. 13.2 months for those treated at clinical relapse (HR:0.63, p = 0.006) and the difference remained significant after adjustment for other prognostic factors. Type of relapse was the strongest prognostic factor for PFS in multivariate analysis. These real-world data confirm the efficacy of Len/Dex combination at first relapse; more importantly, it is demonstrated for the first time outside a clinical trial setting that starting therapy with Len/Dex at biochemical, rather than at clinical relapse, is a significant prognostic factor for PFS, inducing a 37% reduction of the probability of disease progression or death.

Keywords: Biochemical relapse; Lenalidomide-dexamethasone; Prognosis; Symptomatic relapse.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Biomarkers, Tumor / analysis
  • Chemotherapy, Adjuvant
  • Combined Modality Therapy
  • Dexamethasone / administration & dosage*
  • Disease-Free Survival
  • Female
  • Humans
  • Lenalidomide
  • Male
  • Middle Aged
  • Multiple Myeloma / diagnosis
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / epidemiology
  • Multiple Myeloma / pathology*
  • Practice Patterns, Physicians' / statistics & numerical data
  • Prognosis
  • Recurrence
  • Retrospective Studies
  • Survival Analysis
  • Thalidomide / administration & dosage
  • Thalidomide / analogs & derivatives*

Substances

  • Biomarkers, Tumor
  • Thalidomide
  • Dexamethasone
  • Lenalidomide