Evaluation of reported bone pain in cancer patients receiving chemotherapy in pegfilgrastim clinical trials

A retrospective analysis

Stephanie A. Gregory, Lee Schwartzberg, May Mo, Jorge Sierra, Charles Vogel

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Bone pain associated with pegfilgrastim has been perceived to occur at higher frequency and with greater severity than bone pain associated with filgrastim. This retrospective study analyzed patient-level data from randomized controlled trials (RCTs) conducted by Amgen to compare bone pain incidence in patients receiving: (1) once-per-chemotherapy-cycle pegfilgrastim (100 μg/kg or 6-mg fixed dose) versus daily filgrastim (5 μg/kg) in seven studies, and (2) once-per-chemotherapy- cycle pegfilgrastim (100 μg/kg or 6 mg) versus no granulocyte colony-stimulating factor (G-CSF) in five studies. An exploratory analysis that included patients who received once-per-chemotherapy-cycle pegfilgrastim (100 μg/kg or 6 mg) in 23 RCTs, non-RCTs, or single-arm interventional trials was also performed. In RCTs that compared pegfilgrastim versus filgrastim, the incidence (95% CI) of any grade and grade 3/4 bone pain was similar in the pegfilgrastim and filgrastim groups for the first four chemotherapy cycles: any grade, 62% (57%, 67%) and 66% (61%, 71%); grade 3/4, 7% (4%, 10%) and 8% (5%, 11%), respectively. In RCTs that compared pegfilgrastim versus no G-CSF, patients receiving pegfilgrastim appeared to have experienced more bone pain of any grade in the first chemotherapy cycle than patients not receiving G-CSF: 33% (30%, 36%) versus 23% (21%, 26%). Grade 3/4 bone pain was infrequently reported in the first cycle for both treatment arms: 3% (2%, 5%) versus 2% (1%, 3%). Results from subgroup analyses suggest that bone pain may be associated with age, tumor type, and chemotherapy regimen. In this retrospective analysis, bone pain associated with pegfilgrastim did not occur at higher frequency or with greater severity than bone pain associated with filgrastim.

Original languageEnglish (US)
Pages (from-to)297-308
Number of pages12
JournalCommunity Oncology
Volume7
Issue number7
DOIs
StatePublished - Jan 1 2010

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Clinical Trials
Bone and Bones
Drug Therapy
Pain
Granulocyte Colony-Stimulating Factor
Randomized Controlled Trials
Cancer Pain
pegfilgrastim
Incidence
Retrospective Studies
Filgrastim
Neoplasms

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Evaluation of reported bone pain in cancer patients receiving chemotherapy in pegfilgrastim clinical trials : A retrospective analysis. / Gregory, Stephanie A.; Schwartzberg, Lee; Mo, May; Sierra, Jorge; Vogel, Charles.

In: Community Oncology, Vol. 7, No. 7, 01.01.2010, p. 297-308.

Research output: Contribution to journalArticle

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abstract = "Bone pain associated with pegfilgrastim has been perceived to occur at higher frequency and with greater severity than bone pain associated with filgrastim. This retrospective study analyzed patient-level data from randomized controlled trials (RCTs) conducted by Amgen to compare bone pain incidence in patients receiving: (1) once-per-chemotherapy-cycle pegfilgrastim (100 μg/kg or 6-mg fixed dose) versus daily filgrastim (5 μg/kg) in seven studies, and (2) once-per-chemotherapy- cycle pegfilgrastim (100 μg/kg or 6 mg) versus no granulocyte colony-stimulating factor (G-CSF) in five studies. An exploratory analysis that included patients who received once-per-chemotherapy-cycle pegfilgrastim (100 μg/kg or 6 mg) in 23 RCTs, non-RCTs, or single-arm interventional trials was also performed. In RCTs that compared pegfilgrastim versus filgrastim, the incidence (95{\%} CI) of any grade and grade 3/4 bone pain was similar in the pegfilgrastim and filgrastim groups for the first four chemotherapy cycles: any grade, 62{\%} (57{\%}, 67{\%}) and 66{\%} (61{\%}, 71{\%}); grade 3/4, 7{\%} (4{\%}, 10{\%}) and 8{\%} (5{\%}, 11{\%}), respectively. In RCTs that compared pegfilgrastim versus no G-CSF, patients receiving pegfilgrastim appeared to have experienced more bone pain of any grade in the first chemotherapy cycle than patients not receiving G-CSF: 33{\%} (30{\%}, 36{\%}) versus 23{\%} (21{\%}, 26{\%}). Grade 3/4 bone pain was infrequently reported in the first cycle for both treatment arms: 3{\%} (2{\%}, 5{\%}) versus 2{\%} (1{\%}, 3{\%}). Results from subgroup analyses suggest that bone pain may be associated with age, tumor type, and chemotherapy regimen. In this retrospective analysis, bone pain associated with pegfilgrastim did not occur at higher frequency or with greater severity than bone pain associated with filgrastim.",
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