A study at the Huntsman Cancer Institute seeks to determine whether nicotinamide, a form of vitamin B3, can prevent the recurrence of non-melanoma skin cancers (NMSC).
Patients with chronic lymphocytic leukemia (CLL) are 7 times more likely to develop recurrent NMSC than patients without CLL who develop NMSC. A phase 3 trial demonstrated that oral nicotinamide reduced recurrent NMSC lesions by 23%, but it excluded patients with histories of other malignancies or immunosuppression.
At the 2023 National Comprehensive Cancer Network (NCCN) Annual Meeting, Deborah Stevens, recipient of an NCCN Young Investigator Award, presented a phase 2 trial currently enrolling patients with a history of CLL and NMSC. In the trial, patients will be 1:1 randomized to treatment with nicotinamide or placebo. A dermatologist will examine their skin at 6, 12, 18, and 24 months. At the end of month 12, patients in the placebo group will be switched to the treatment group and continue for 12 months.
The total number of lesions will be tallied for both groups at months 12 and 24. The target enrollment of 86 patients (43 per group) will provide sufficient power for statistical analysis. At the time of presentation, the trial had enrolled 11 patients.
“Planned correlative studies include evaluation of T-cell exhaustion between treatment arms and analysis of B-human papilloma virus (B-HPV) subtypes in CLL cells via whole exome sequencing and skin cancer biopsy samples via polymerase chain reaction,” Stevens added.
The trial is currently in enrollment at Huntsman Cancer Institute, University of Utah (NCT04844528).
Stephens DM, Boucher K, Wada DA, et al. Non-melanoma skin cancer (NMSC) in patients with chronic lymphocytic leukemia (CLL): biology and prevention. Presented at the 2023 National Comprehensive Cancer Network Annual Meeting, Orlando, Florida, March 31-April 2, 2003.