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Second malignancies in the context of lenalidomide treatment: an analysis of 2732 myeloma patients enrolled to the Myeloma XI trial.

Abstract
We have carried out the largest randomised trial to date of newly diagnosed myeloma patients, in which lenalidomide has been used as an induction and maintenance treatment option and here report its impact on second primary malignancy (SPM) incidence and pathology. After review, 104 SPMs were confirmed in 96 of 2732 trial patients. The cumulative incidence of SPM was 0.7% (95% confidence interval (CI) 0.4-1.0%), 2.3% (95% CI 1.6-2.7%) and 3.8% (95% CI 2.9-4.6%) at 1, 2 and 3 years, respectively. Patients receiving maintenance lenalidomide had a significantly higher SPM incidence overall (P=0.011). Age is a risk factor with the highest SPM incidence observed in transplant non-eligible patients aged >74 years receiving lenalidomide maintenance. The 3-year cumulative incidence in this group was 17.3% (95% CI 8.2-26.4%), compared with 6.5% (95% CI 0.2-12.9%) in observation only patients (P=0.049). There was a low overall incidence of haematological SPM (0.5%). The higher SPM incidence in patients receiving lenalidomide maintenance therapy, especially in advanced age, warrants ongoing monitoring although the benefit on survival is likely to outweigh risk.
AuthorsJ R Jones, D A Cairns, W M Gregory, C Collett, C Pawlyn, R Sigsworth, A Striha, R Henderson, M F Kaiser, M Jenner, G Cook, N H Russell, C Williams, G Pratt, B Kishore, J Lindsay, M T Drayson, F E Davies, K D Boyd, R G Owen, G H Jackson, G J Morgan
JournalBlood cancer journal (Blood Cancer J) Vol. 6 Issue 12 Pg. e506 (12 09 2016) ISSN: 2044-5385 [Electronic] United States
PMID27935580 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
Chemical References
  • Hydroxamic Acids
  • Oligopeptides
  • Thalidomide
  • Vorinostat
  • Bortezomib
  • carfilzomib
  • Lenalidomide
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
  • Bortezomib (administration & dosage)
  • Disease-Free Survival
  • Female
  • Humans
  • Hydroxamic Acids
  • Kaplan-Meier Estimate
  • Lenalidomide
  • Male
  • Middle Aged
  • Multiple Myeloma (drug therapy, epidemiology, pathology)
  • Neoplasms, Second Primary (drug therapy, epidemiology, pathology)
  • Oligopeptides (administration & dosage)
  • Risk Factors
  • Thalidomide (administration & dosage, analogs & derivatives)
  • Vorinostat

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