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

Abstract

PurposeMild-to-moderate bone pain is a commonly reported adverse event (AE) associated with pegfilgrastim. We evaluated the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on pegfilgrastim-associated bone pain.MethodsIn this open-label study (NCT01712009), women ≥ 18 years of age with newly diagnosed stage I–III breast cancer and an ECOG performance status ≤ 2 who were planning ≥ 4 cycles of adjuvant or neoadjuvant chemotherapy with pegfilgrastim support starting in cycle 1 were randomized 1:1:1 to receive naproxen, loratadine, or no treatment to prevent pegfilgrastim-associated bone pain. The primary endpoint was all-grade bone pain in cycle 1 from AE reporting. Secondary endpoints included bone pain in cycles 2–4 and across all cycles from AE reporting and patient-reported bone pain by cycle and across all cycles.ResultsSix hundred patients were enrolled. Most patients (83.0%) were white, and mean (SD) age was 54.2 (11.1) years. The percentage of patients with all-grade bone pain in cycle 1 from AE reporting in the naproxen, loratadine, and no prophylaxis groups was 40.3, 42.5, and 46.6%, respectively; differences between the treatment groups were not statistically significant. Maximum, mean, and area under the curve for patient-reported bone pain were consistently lower in the naproxen and loratadine groups than in the no prophylaxis group; some of these differences were significant. Loratadine was associated with fewer treatment-related AEs and discontinuations than naproxen.ConclusionsGiven 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.Clinical trial registration ClinicalTrials.gov; NCT01712009Electronic supplementary materialThe online version of this article (10.1007/s00520-017-3959-2) contains supplementary material, which is available to authorized users.

A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy‐induced neutropenia in patients with early‐stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): A Phase 3 study

“…Overall, eflapegrastim was safe in patients receiving TC, and despite higher ANC values with eflapegrastim, eflapegrastim-related AEs occurred at rates consistent with those previously reported for filgrastim and pegfilgrastim, including bone pain and other related musculoskeletal complaints. 12,[15][16][17][18][19] Patients ≥65 years of age accounted for 37% of patients in the Eflapegrastim Arm and 34% of patients in the Pegfilgrastim Arm. This subset of patients is more susceptible to toxicity from chemotherapy regimens than patients <65 years of age, 20,21 and prophylactic use of G-CSF is recommended.…”

Project IDentif.AI: Harnessing Artificial Intelligence to Rapidly Optimize Combination Therapy Development for Infectious Disease Intervention

“…[ 22 ] Recent clinical trials have evaluated its use as abortive therapy in pegfilgrastim‐associated bone pain. [ 23 ] Omeprazole sodium is a proton pump inhibitor (PPI) used to treat gastrointestinal reflux disease and in Helicobacter pylori eradication therapy for gastritis and peptic ulcers. [ 24 ] Omeprazole and other PPIs have recently been investigated for and demonstrated antitumor activity and anti‐inflammatory effects.…”

Construction of Immune-related lncRNA Prognosis Models and Development Related Networks and Drugs in LGG

“…In total, seven compounds have been the subject of cMap identi cation. Among these, loratadine has been used for combination chemotherapy for cancers such as breast cancer [50] , melanoma [51] , and gastrointestinal tumor [52] . However, it has not been used in glioma yet.…”