Results from a pivotal clinical trial have supported the use of Revlimid (lenalidomide) as maintenance therapy for patients multiple myeloma. A new analysis from the trial just published in the Journal, Blood raises concerns about the safety of Revlimd maintenance reporting an increased risk of developing secondary cancer.
Doctors from the Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust in London examined the relationship between Revlimid therapy and the development of a new cancer in patients receiving Revlimid maintenance and found they had a significantly higher occurrence.
The study involved 2,732 patients with multiple myeloma; some of who received Revlimid induction and or maintenance therapy, and some who did not. With median follow-up of 34.3 months for patients receiving Revlimid and 24.2 months for those undergoing observation the authors observed a total of 104 new cancers occurring in 96 patients that occurred on average 22.3 months from beginning therapy.
Overall thirteen (.48%) of the new cancers were more serious hematologic malignancies, 55 were solid tumors and 36 were non-melanoma skin cancers. The overall incidence of developing a new cancer was 3.8 percent at three years from treatment and they occurred more frequently in transplant patients (5.2% vs. 2.7%).
Advanced age was the risk factor associated with the highest secondary cancer incidence. Among patients exposed to Revlimid at any time, the researchers observed 73 secondary cancers. Patients receiving Revlimid maintenance had a significantly higher three-year incidence of developing a secondary cancer when compared with patients not treated with Revlimid: 8.9% versus 4%.
The authors concluded that the overall benefit observed in patients receiving maintenance Revlimid for the management of multiple myeloma outweighs the secondary cancer risk with overall trial mortality, as a consequence being only 1 percent. Patients should be informed of the higher incidence of secondary malignancy at three years associated with Revlimid maintenance, but be reassured that more than one-third of all confirmed second malignancies are non-invasive, low-risk skin cancers.
Reference: http://www.ashclinicalnews.org/Revlimid-maintenance-therapy-related-secondary-primary-malignancies-older-adults/ Jones JR, Cairns DA, Gregory WM, et al. Second malignancies in the context of Revlimid treatment: an analysis of 2732 myeloma patients enrolled to the Myeloma XI trial. Blood Cancer J. 2016 December 9.
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