H Xu1, Q Gong2, F D Vogl3, M Reiner4, J H Page5. 1. Center for Observational Research, Amgen Inc., One Amgen Center Drive, Mailstop 24-2-A, Thousand Oaks, CA, 91320, USA. hairongx@amgen.com. 2. Global Biostatistical Science, Amgen Inc., South San Francisco, CA, USA. 3. Hematology/Oncology, Amgen Inc., Thousand Oaks, CA, USA. 4. Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA. 5. Center for Observational Research, Amgen Inc., One Amgen Center Drive, Mailstop 24-2-A, Thousand Oaks, CA, 91320, USA.
Abstract
PURPOSE: The purpose of this study was to evaluate risk factors for bone pain in patients receivingmyelosuppressive chemotherapy and pegfilgrastim. METHODS: Individual patient data from 22 pegfilgrastim clinical trials were analyzed. Multivariable logistic regression models were used to evaluate risk factors associated with grade ≥2 bone pain and any grade bone pain in the first chemotherapy cycle and across cycles 1-6. RESULTS: Of the 1949 patients analyzed, 19 and 36 % had grade ≥2 and anygrade bone pain, respectively, in cycle 1, and 28 and 51 % had grade ≥2 and any grade bone pain, respectively, across cycles 1-6. In cycle 1, history of bone pain (odds ratio (OR), 1.51; 95 % confidence interval (CI), 1.09-2.07) was associated with increased risk of grade ≥2 bone pain; age ≥65 years (versus <45 years; OR, 0.64; 95 % CI, 0.42-0.98), the European Union region (versus the USA region; OR, 0.32; 95 % CI, 0.20-0.52), colorectal cancer (versus breast cancer; OR, 0.14; 95 % CI, 0.05-0.41), and small-cell lung cancer (OR, 0.34; 95 % CI, 0.12-0.98) were associated with reduced risk of grade ≥2 bone pain. CONCLUSIONS: Potential risk factors for bone pain in patients receivingmyelosuppressive chemotherapy and primary prophylactic pegfilgrastim identified in this study are younger age and history of bone pain. No other association with clinical factors and risk of bone pain was detected. Better understanding of risk factors for bone pain would be useful in identifying patients who may benefit from pain prevention strategies.
RCT Entities:
PURPOSE: The purpose of this study was to evaluate risk factors for bone pain in patients receiving myelosuppressive chemotherapy and pegfilgrastim. METHODS: Individual patient data from 22 pegfilgrastim clinical trials were analyzed. Multivariable logistic regression models were used to evaluate risk factors associated with grade ≥2 bone pain and any grade bone pain in the first chemotherapy cycle and across cycles 1-6. RESULTS: Of the 1949 patients analyzed, 19 and 36 % had grade ≥2 and any grade bone pain, respectively, in cycle 1, and 28 and 51 % had grade ≥2 and any grade bone pain, respectively, across cycles 1-6. In cycle 1, history of bone pain (odds ratio (OR), 1.51; 95 % confidence interval (CI), 1.09-2.07) was associated with increased risk of grade ≥2 bone pain; age ≥65 years (versus <45 years; OR, 0.64; 95 % CI, 0.42-0.98), the European Union region (versus the USA region; OR, 0.32; 95 % CI, 0.20-0.52), colorectal cancer (versus breast cancer; OR, 0.14; 95 % CI, 0.05-0.41), and small-cell lung cancer (OR, 0.34; 95 % CI, 0.12-0.98) were associated with reduced risk of grade ≥2 bone pain. CONCLUSIONS: Potential risk factors for bone pain in patients receiving myelosuppressive chemotherapy and primary prophylactic pegfilgrastim identified in this study are younger age and history of bone pain. No other association with clinical factors and risk of bone pain was detected. Better understanding of risk factors for bone pain would be useful in identifying patients who may benefit from pain prevention strategies.
Entities:
Keywords:
Bone pain; Chemotherapy; G-CSF; Pegfilgrastim; Risk factors
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