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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24h group | Other | Pegfilgrastim is administrated 24 hours after completing the chemotherapy in the 24-hour group. |
|
| 48h group | Other | Pegfilgrastim is administrated 48hours after completing the chemotherapy in the 48-hour group. |
|
| 72h group | Other | Pegfilgrastim is administrated 72 hours after completing the chemotherapy in the 72-hour group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of pegfilgrastim administration | Other | Timing of pegfilgrastim administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured by Brief Pain Inventory-Short Form | Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bone pain | Measured by Brief Pain Inventory-Short Form | Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration). |
| Incidence of severe bone pain | Measured by Brief Pain Inventory-Short Form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun Wang, professor | Contact | 13922118086 | gzwangkun@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Kun Wang, professor | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41871353 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration). |
| Duration of bone pain and severe bone pain | Measured by Brief Pain Inventory-Short Form | Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration). |
| Impact of bone pain on daily life and other aspects. | Measured by Brief Pain Inventory-Short Form | 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. | The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement. | 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. | The EORTC QLQ-BR23 is a questionnaire to assess quality of life (QoL), it is composed of 23 questions (items) resulting in 4 functional scales (Body Image, Future Perspective, Sexual Functioning, Sexual Enjoyment) and 4 symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms, Breast Symptoms). All of the scales measures range in score from 0 to 100. Higher score for the functioning scales indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom scales indicate a better quality of life; a negative change from baseline indicates improvement. | 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. | The EQ-5D-5L consists of a descriptive system that defines health in terms of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analog scale (VAS) for respondents to rate their current health status from 0 (worst health) to 100 (best imaginable health). A unique EQ-5D-5L health state (or profile) for each patient was generated by combining the results for the dimensions, consisting of a five-digit code. The health states were then converted to a preference-weighted summary score (weights derived from the general population), or EQ-5D-5L health utility index, with higher scores indicating better outcomes, and a positive change from baseline indicates improvement. | Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration. |
| Analgesic use | According to the diary written by the patient about the use of the analgesic. | 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. | Measured by Brief Pain Inventory-Short Form | Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration). |
| Leukocyte count | Measured by blood routine tests. | 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 | Measured by thermometer and blood routine tests. | 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 | Measured by blood routine tests. | 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. |
| Absolute neutrophil count | Measured by blood routine tests. | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |