Overview
This is a prospective observational study designed to observe and evaluate the safety and efficacy of mecapegfilgrastim in the treatment of moderate-to-severe myelosuppression associated with concurrent chemoradiotherapy. The project will provide more robust evidence-based medical support for the use of long-acting granulocyte-stimulating agents in patients undergoing concurrent chemoradiotherapy.
Description
Group 1: Monitor the changes in neutrophil levels during the first follow-up cycle after enrollment in this study. When the neutrophil level falls below 1.5×10⁹/L, the investigator will communicate with the patient to determine whether to use conventional leukocyte-increasing drugs such as Licorice tablets. If so, the patient will be assigned to Group 1.
Group 2: After enrollment in this study, the investigator will communicate with the patient to determine whether to use Sulfated PEG-Interferon injection to prevent and treat neutropenia. If so, 24 hours after the end of the chemotherapy cycle, the patient will receive a subcutaneous injection of Sulfated PEG-Interferon once. The recommended dose is a fixed dose of 6 mg per injection; or, based on the patient's weight, an individualized treatment dose of 100 μg/kg. The patient will then be assigned to Group 2.
Eligibility
Inclusion Criteria:
- 1: Subjects are 18-75 years old when signing the informed consent form, and both males and females are eligible. Thoracic tumors (including esophageal cancer and lung cancer) confirmed by pathology or cytology. The investigator determines that the patient can receive treatment with Thiotepa or Licorice tablets. The expected survival time is greater than 3 months. The patient signs the informed consent form, voluntarily joins this study, and is able to comply with the relevant visits as required by the protocol. The patient has indications for concurrent chemoradiotherapy and meets one of the following conditions: The patient is currently undergoing or will undergo a chemotherapy regimen with a high risk of febrile neutropenia (FN risk ≥20%), see Table 1. The patient is currently undergoing or will undergo a chemotherapy regimen with a moderate risk of febrile neutropenia (FN risk 10%-20%),2: and meets one of the following conditions: Age >65 years and receiving full-dose intensity chemotherapy Previous chemotherapy or radiotherapy Persistent neutropenia Tumor involvement of the bone marrow Recent surgical procedure and/or open injury Hepatic dysfunction (bilirubin >2.0 mg/dl) Renal dysfunction (creatinine clearance <50 ml/min) Previous occurrence of FN Chronic immunosuppression, such as HIV Poor nutritional/physical status
Exclusion Criteria:
- 1: Pregnant or breastfeeding women. Individuals allergic to Thiotepa, polyethylene glycol recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF), recombinant human granulocyte colony-stimulating factor (rhG-CSF), or other preparations expressed by Escherichia coli. Other concomitant diseases that, in the investigator's judgment, pose a serious risk to the patient's safety or affect the patient's ability to complete the study. Other situations that, in the investigator's judgment, may affect the conduct of the clinical study and the determination of the study results, and are not suitable for inclusion in the study.