Correlation of Timing of Pegfilgrastim Administration and PIBP.

Официальное название

Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)

Обзор

According to the National Comprehensive Cancer Network (NCCN) guidelines, patients receiving high-risk or moderate-risk febrile neutropenia (FN) chemotherapy with at least one risk factor should receive prophylactic granulocyte colony-stimulating factors (G-CSFs). However, pegfilgrastim-induced bone pain (PIBP) remains a common and significant clinical issue without a satisfactory solution. Studies have reported that the incidence rate of PIBP is 71.3%, with severe bone pain occurring in 27.0% of cases. Currently, the available data on PIBP treatment are limited to case reports, reviews, and small randomized controlled trials. The NCCN guidelines recommend preventive oral non-steroidal anti-inflammatory drugs or antihistamines as the treatment for PIBP. However, even with these preventive measures, the incidence rate of PIBP remains high at 61.1%, with severe bone pain occurring in 19.2% of cases. Severe bone pain can significantly impact the patient's health-related quality of life (HRQol), leading to potential refusal of pegfilgrastim administration and subsequent dose reduction in effective chemotherapy. Ultimately, this may have negative implications for tumor cure rates and patient survival. Based on previous literature, it appears that delaying the administration of pegfilgrastim may be associated with a lower incidence of PIBP. Therefore, our study aims to investigate the correlation between the timing of pegfilgrastim administration and the occurrence of PIBP.

Вмешательства

• Другое Timing of pegfilgrastim administration
  Timing of pegfilgrastim administration

Первичные конечные точки

• The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in cycle 1. [Срок оценки: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]

Вторичные конечные точки (12)

• Incidence of bone pain [Срок оценки: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
• Incidence of severe bone pain [Срок оценки: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
• Duration of bone pain and severe bone pain [Срок оценки: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
• Impact of bone pain on daily life and other aspects. [Срок оценки: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
• Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score. [Срок оценки: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.]
• Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Breast Cancer-23 (EORTC QLQ-BR23) Score. [Срок оценки: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.]
• Change From Baseline in European Quality of Life-Five Dimension-Five Level Scale (EQ-5D-5L) Score. [Срок оценки: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.]
• Analgesic use [Срок оценки: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
• The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in every cycle. [Срок оценки: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).]
• Leukocyte count [Срок оценки: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.]
• Incidence of febrile neutropenia [Срок оценки: Patients monitor their oral temperature daily, and do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.]
• Incidence of neutropenia [Срок оценки: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.]

Критерии участия

Критерии включения

• Age greater than or equal to 18 years and less than or equal to 70 years.
• Pathologically or histologically confirmed diagnosis of primary breast cancer.
• Able to receive the chemotherapy regimen as scheduled.
• Able to understand Chinese and fill out the study-related questionnaires independently.
• Given written informed consent.
• There is no need to use prescription or over-the-counter drugs regularly because of pre-existing chronic pain.

Критерии исключения

• Suffering from bone pain due to other diseases currently.
• Allergy or contraindication to chemotherapeutic agents or pegfilgrastim.
• Previous use of pegfilgrastim.
• Previous received chemotherapy.
• Pregnancy or breastfeeding.
• Concurrently accompanied by other primary malignant tumors.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of — Гуанчжоу

Публикации

• Li P, Chen Y, Lin Y, Zhang X, Cheng M, Zhu T, Gao HF, Zhang L, Li J, Huang N, Chen Y, Liang M, Zhang Y, Huang S, Zheng J, Wu C, Yang C, Wang K. Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain : A Prospective, Randomized, Phase 3 Trial. Ann Intern Med. 2026 May;179(5):656-665. doi: 10.7326/ANNALS-25-02600. Epub 2026 Mar 24. PMID 41871353

Идентификаторы

NCT: NCT05841186 · KY-Q-2022-474-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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