Loratadine was effective in preventing pegfilgrastim-associated mild-to-moderate bone pain when administered prophylactically to women with breast cancer receiving chemotherapy, a study published in Supportive Care in Cancer has shown.
Bone pain is a commonly occurring adverse event among patients with cancer who receive pegfilgrastim as supportive therapy to chemotherapy and may lead to discontinuation of treatment. This in turn may cause increased rates of infection, hospitalization, and mortality.
For this open-label study, researchers enrolled 600 patients with stage I-III breast cancer planning to undergo at least 4 cycles of adjuvant or neoadjuvant chemotherapy supported by pegfilgrastim starting cycle 1. Patients were randomly assigned to 3 experimental arms and received no treatment, naproxen, or loratadine orally for the first 5 days in each chemotherapy cycle.
After cycle 1, the rate of bone pain of any grade was 46.6% in the no treatment group, 42.5% in the loratadine group, and 40.3% in the naproxen group. Across all cycles in the study, all-grade bone pain was reported by 63.4%, 59.2%, and 61.0% of patients in the no treatment group, naproxen group, and loratadine group, respectively. No differences between the groups were found to be statistically significant.
Surveys that reflected patient-reported maximum bone pain, mean bone pain, and area under the curve bone pain showed primarily nominal improvements for patients receiving naproxen and loratadine.
The rates of adverse events (AE) was 15.5% and 3.5% among patients receiving naproxen compared with loratadine, respectively. Gastrointestinal (GI) AEs were the most commonly cited reason for discontinuation, and 10.9% of patients receiving naproxen reported experiencing GI AE compared with 0.5% of patients in the loratadine arm.
The authors concluded, “[g]iven its tolerability, its ease of administration, and its potential benefit, treatment with loratadine should be considered to help prevent bone pain in patients receiving chemotherapy and pegfilgrastim.”
1. Kirshner JJ, McDonald MC, Kruter F, et al. NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim [published online November 16, 2017]. Support Care Cancer. doi: 10.1007/s00520-017-3959-2