Nolan: A randomized, phase II study to estimate the effect of prophylactic naproxen (N) or loratadine (L) vs no intervention on bone pain in 600 patients (pts) with early-stage breast cancer receiving chemotherapy (chemo) and pegfilgrastim (PEG).

10021Background: Mild-to-moderate bone pain is the most commonly reported adverse event (AE) associated with PEG. Both N (an NSAID) and L (an antihistamine) are used in the clinic to reduce this AE, but data on the efficacy of these interventions are limited. Methods: In this open-label study (NCT01712009), women ≥ 18 years of age with newly diagnosed stage I–III breast cancer and ECOG performance status ≤ 2 who were planning ≥ 4 cycles of adjuvant or neoadjuvant chemo with PEG support starting in cycle 1 were randomized 1:1:1 to receive prophylactic N, L, or no prophylaxis (NP). Pts received N (500 mg BID) or L (10 mg QD) for 5 days beginning the day of PEG administration in each of the first 4 chemo cycles. PEG (6 mg) was administered in each cycle 24–72 hours after chemo. Primary endpoint: all-grade bone pain in cycle 1 from AE reporting. Results: Pts enrolled: 600. White 83.0%, black 14.1%, Asian 1.2%. Mean (SD) age: 54.2 (11.1) years. Stage I/II/III: 25.6%/50.1%/24.4%. Difference (95% CI) in all-grad...