Prophylactic PEG-rhG-CSF During cCRT in LA-NSCLC

Efficacy and Safety of Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor During Definitive Concurrent Chemoradiotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer: A Prospective Cohort Study

Objective: To evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) during definitive concurrent chemoradiotherapy (cCRT) in patients with inoperable stage II-III non-small cell lung cancer (NSCLC).

Methods: A prospective observational cohort study was conducted on patients receiving definitive cCRT. The radiation therapy technique uses intensity modulated radiation therapy (IMRT) and involves field irradiation. It protects more normal tissue from exposure.Chemotherapy regimens included platinum-based doublet combinations: etoposide plus cisplatin (every 28 days), pemetrexed plus platinum (every 21 days), or paclitaxel plus platinum (weekly, only for control group) .

Patients were followed up at one month post-treatment, then every three months for the two year, and every six months thereafter until disease progression.

In the study group, patients received subcutaneous injections of PEG-rhG-CSF (6 mg for patients weighing ≥45 kg, 3 mg for patients <45 kg) 48 hours after each chemotherapy cycle during cCRT. In the control group, patients received guideline-based supportive treatment. Radiotherapy was halted or chemotherapy was delayed when grade 3 or more (G3+) toxicities happened.

Endpoints:Primary endpoint was incidence of G3+ neutropenia during radiotherapy and one month post-radiotherapy. Complete blood counts were monitored weekly during cCRT and for one month post-treatment or as deemed necessary by the physician.

Following the completion of cCRT and the resolution of acute side effects, patients were followed up at one month post-treatment, then every three months for the first year, and every six months thereafter until disease progression.

Statistical Analysis:The inverse probability of treatment weighting (IPTW) algorithm was applied to balance differences between groups in terms of age, gender, smoking, clinical stage, KPS score, induction therapy received or not, ensuring the reliability of the study results. Statistical analysis was performed using R software (version 4.4.1). All tests were two-sided, with a P-value <0.05 considered statistically significant.

Study Overview

• Status: Completed
• Conditions: Conditions Influencing Health Status; Stage II-III Non-small Cell Lung Cancer; Concurrent Chemotherapy
• Intervention / Treatment: Drug: Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor

• Study Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Definitive Concurrent Chemoradiotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer，Patients received prophylactic PEG-rhG-CSF 48 hours after chemotherapy.

Description

Inclusion Criteria:

1. Diagnosis

   • Histologically confirmed stage II-III non-small cell lung cancer (NSCLC)

2. Treatment Plan

   • Planned to receive concurrent platinum-based chemotherapy with radiotherapy (cCRT)

3. Demographics

   • Age 18-80 years

4. Performance Status

   • Karnofsky Performance Status (KPS) ≥70

5. Organ Function

   • Renal function: Creatinine clearance ≥60 mL/min
   • Hepatic function: Total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN
   • Absolute neutrophil count ≥2.0×10⁹/L
   • Platelets ≥100×10⁹/L
   • Hemoglobin ≥10 g/dL

Exclusion Criteria:

1. Active Malignancies

   • Concurrent diagnosis of active malignancies (excluding: non-melanoma skin cancer, carcinoma in situ, or malignancies in complete remission for ≥5 years)

2. Infectious/Immunological Conditions

   • Active systemic infection requiring intravenous antimicrobial therapy
   • Uncontrolled autoimmune diseases (defined as requiring systemic immunosuppressants at doses >10 mg/day prednisone equivalent within 30 days prior to screening)

3. Hypersensitivity Reactions

   • Allergy to PEG-rhG-CSF or other biological products derived from genetically engineered Escherichia coli

4. Neuropsychiatric Impairments

   • Severe psychiatric disorders (e.g., schizophrenia, major depressive disorder with suicidal ideation) requiring hospitalization within 6 months)

5. Prior Radiotherapy

   • History of thoracic radiotherapy involving >30% lung parenchyma or mean heart dose >20 Gy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 3 or more (G3+) neutropenia	According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale	From the first day of radiotherapy to one month after the end of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment delays	Chemotherapy delay	Chemotherapy delay was defined as a delay of ≥7 days
interruptions	Radiotherapy interruption	Break in radiotherapy of ≥3 days
G3+ thrombocytopenia and anemia	According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale	From the first day of radiotherapy to one month after the end of radiotherapy
G2+ acute radiation esophagitis (RE) and pneumonitis (RP)	According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale	From the first day of radiotherapy to six month after the end of radiotherapy
progression-free survival (PFS)	the time from the start of cCRT to the first event of disease progression	assessed up to 72 months
overall survival (OS)	the time from the start of cCRT to death from any cause	assessed up to 72 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): November 7, 2024
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 27, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer; concurrent chemoradiotherapy; Pegylated recombinant human granulocyte colony-stimulating factor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Immunologic Factors; Physiological Effects of Drugs; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: 19/216-2000

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No