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- Title
Frailty impairs the feasibility of induction therapy but not of maintenance therapy in elderly myeloma patients: final results of the German Maintenance Study (GERMAIN).
- Authors
Brioli, Annamaria; Manz, Kirsi; Pfirrmann, Markus; Hänel, Mathias; Schwarzer, Andreas Christoph; Prange-Krex, Gabriele; Fabisch, Christian; Knop, Stefan; Illmer, Thomas; Krammer-Steiner, Beate; Hochhaus, Andreas; von Lilienfeld-Toal, Marie; Mügge, Lars-Olof
- Abstract
Purpose: The German Maintenance Study (GERMAIN) was designed to evaluate the impact of lenalidomide maintenance after induction therapy with bortezomib, melphalan and prednisolone (VMP) in transplant-ineligible newly diagnosed multiple myeloma (MM) patients. Methods: Due to poor accrual and high dropout rate, only 85 patients (planned 286) entered the trial and 40 (planned 200) were randomized to lenalidomide maintenance (n = 19) vs. observation (n = 21). Results: The primary endpoint, improved progression-free survival, was not met (p = 0.3572). After a median follow-up of 12.9 months, median progression-free survival in the lenalidomide arm was 14.4 months and 11.4 months with placebo. The hazard ratio 0.621 (95% confidence interval: [0.224, 1.725]) was about the same as expected (0.625). However, with only 40 patients randomized, the actual power to detect a difference was 11%. Of patients receiving at least one dose of induction, 54% were frail according to a modified International Myeloma Working Group frailty score. Discontinuations were high during induction (47%), and affected mainly frail patients (54%). Despite a higher rate of adverse events in the lenalidomide arm (p = 0.0061), only 2 patients discontinued lenalidomide due to toxicity. Conclusion: A frailty assessment with appropriate dose modification for induction therapy should be mandatory for all elderly non-transplant-eligible myeloma patients.
- Subjects
OLDER patients; MULTIPLE myeloma; PROGRESSION-free survival; CONFIDENCE intervals; ADVERSE health care events
- Publication
Journal of Cancer Research & Clinical Oncology, 2020, Vol 146, Issue 3, p749
- ISSN
0171-5216
- Publication type
Article
- DOI
10.1007/s00432-019-03101-z