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.

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Background: Mild-to-moderate bone pain is the most commonly reported adverse event (AE) associated with pegfilgrastim, but pt education has not been specifically studied in the management of pegfilgrastim-related bone pain. We investigated the effect of pt education on reported bone pain in pts with breast cancer receiving adjuvant or neoadjuvant chemotherapy and pegfilgrastim. Methods: In this single-blind study, female pts ≥ 18 years of age with newly diagnosed stage I–III breast cancer, planning ≥ 4 cycles of neoadjuvant or adjuvant chemotherapy with pegfilgrastim support starting in cycle 1, were randomized 1:1 to view one of two 2-minute educational DVDs: a general educational DVD (GE-DVD) on chemotherapy side effects or a more specific DVD on bone pain following chemotherapy and pegfilgrastim (BP-DVD). Pts were excluded if they were not able to understand English, were scheduled to receive weekly chemotherapy, had ongoing chronic pain requiring treatment, had received chemotherapy for cancer within the last 5 years, or had previously received G-CSF. Pts were required to watch the DVD on 2 separate days during clinic visits up to and including the visit for pegfilgrastim administration in cycle 1. In each of the four cycles of the study period, pts completed a brief bone pain survey once per day for 5 days, beginning the day they received pegfilgrastim; severity of pain was rated on a scale of 0–10. Pts also recorded any medications taken to alleviate bone pain. Pts were asked about AEs at the beginning of each chemotherapy cycle and at the safety follow-up visit. Results: Of the 312 pts screened, 304 were enrolled, and of those, 300 received pegfilgrastim in cycle 1: 149 in the GE-DVD arm and 151 in the BP-DVD arm. Baseline demographics and characteristics were largely balanced between the arms, but fewer pts in the GE-DVD arm were Hispanic/Latino (3.4% vs 7.9%). Fewer pts in the GE-DVD arm were ER positive (59.1% vs 69.5%) and PR positive (46.3% vs 59.6%), while more were HER2 positive (30.2% vs 18.5%). Receipt of taxane-based chemotherapy regimens was balanced between the arms. Pt-reported maximum bone pain was similar in the GE-DVD arm vs the BP-DVD arm (cycle 1, 3.2 vs 3.5, P = .3479; across all cycles, 4.1 vs 4.6, P = .2196). Pt-reported mean bone pain was also similar between arms (cycle 1, 1.6 vs 1.8, P = .3188; across all cycles, 1.5 vs 1.6, P = .5846) as was area under the curve for pt-reported bone pain (cycle 1, 6.7 vs 7.6, P = .3346; across all cycles, 6.3 vs 6.6, P = .6255). All-grade bone pain and grade 3/4 bone pain from AE reporting were similar between the arms. Pt-reported bone pain and bone pain from AE reporting were highest in cycle 1; pain decreased thereafter and remained stable in cycles 2, 3, and 4. Bone pain medication usage was similar between the arms; usage was highest in cycle 1 and decreased with each subsequent cycle. Pain therefore appeared to be truly stable in cycles 2, 3, and 4, not just better medicated. Conclusions: Our bone pain–specific educational program did not improve perceptions of bone pain reported by this pt population. Bone pain was highest in cycle 1, decreased in cycle 2, and then remained stable. Citation Format: Maxwell CL, Guinigundo AS, Vanni L, Morrow PK, Reiner M, Shih A, Klippel Z, Blanchard E. The effect of bone pain–specific education vs general chemotherapy side-effect education on reported bone pain in patients (pts) with breast cancer receiving chemotherapy and pegfilgrastim. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-09-13.