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.

Purpose: The purpose of the Oncology Care Model (OCM) is to improve quality and reduce cost through practice transformation. A foundational tenant is to reduce avoidable emergency room (ER) visits and hospitalizations. In anticipation of being an OCM participant, we instituted a multidimensional campaign designed to meet these objectives. Methods: Prior actions included establishment of phone triage unit, after-hours and weekend calls, and institution of weekend urgent care. Results: On the basis of data from the Chronic Condition Warehouse, as provided by the Centers for Medicare and Medicaid Services, we were successful at reducing the acute care admissions rate by 16%. During the baseline period extending from Jan 2016-Mar 2016, the hospital admission rate was 27 per patient, per quarter, at an average cost per admission event of $11,122, translating to an inpatient cost per patient, per quarter, of $3,003. In the year one reporting period of July 2016-July 2017, the hospital admission rate declined to 22.6 per patient, per quarter, at an average cost per admission event of $11,106, translating to an inpatient cost per patient, per quarter, of $2,505. OCM patient survey scores improved. In addition, at Oncology Hematology Care, we achieved improved results compared with the risk-adjusted national averages for the following measures: readmissions (4.9 v 5.6 per 100 patients, respectively), ER use (17 v 18.6 per 100 patients, respectively), and observation stays (2.7 v 3.6 per 100 patients, respectively). Conclusion: By implementing a cost-efficient, reproducible, and scalable campaign targeting ER avoidance and hospitalizations, we were able to decrease hospital admissions. Reported Medicare savings amounted to nearly $798,000 in inpatient cost per quarter over 1,600 patients.

No abstract