Multicenter Randomized Study on the Efficacy of Intravenous Iron Injection in Cancer Patients with Anemia
- Conditions
- Not Applicable
- Registration Number
- KCT0004311
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
333 patients were randomly assigned to the Ferinject group (222 patients) and the control group (111 patients). The mean age was 60.8 ± 13.2 years, and 58.9% were female. The main cancer types were gastric cancer (n=106, 32%), lung cancer (n=87, 26%), and breast cancer (n=74, 22%). The palliative and neoadjuvant treatments were 75% and 15%, respectively. In Visit 4, Hb responder was 86 patients in the Ferinject group vs. 28 patients in the control group (38.7% vs. 25.2%) p=0.0039). In Visit 4, the Hb level was significantly higher in the Ferinject group at 10.36 ± 1.67 g/dL vs. 9.84 ± 1.46 g/dL (p=0.0015) in the Ferinject group. The Hb level increase in the ferinject group continued from visit 2 to visit 4, while the Hb level was maintained at visit 2 to 4 in the control group. As a result, the average Hb increase from Baseline during the study period was also significantly different between the two groups (1.04 ± 1.61 g/dL vs. 0.42 ± 1.36 g/dL (p=0.0027 in the control group). There was a significant difference between sTfR and hepcidin(Anemia related biochemical variable) in the amount of change in visit4 compared to baseline (Ferrinject: -0.13±0.44 VS SoC: 0.14±0.37, p<0.0001 / Ferinject: 20.56±22.81 VS SoC: -3.03±18.17, p<0.0001). In addition, there was no significant difference between the two groups in the amount of change in vis4 compared to baseline in the measured WBC, PLT, ANC, and Reticulocyte count (%) and corrected reticulocyte count (%). (Ferrinject: 0.06±2.22 VS SoC: 0.62±6.65, p=0.4549 / Ferinject: -7.40±94.57 VS SoC -4.98±123.45, p=0.8742 / Ferinject: 0.16±2.12 VS SoC: 0.42±6.16, p=0.6973 / 0.01±2.10 VS -0.05±1.66, p=0.8022 / Ferinject: 0.13±1.44 VS 0.04±1.07, p=0.5785). In CIA patients, IV ferric carboxymaltose (1,000 mg) monotherapy generates more Hb responder compared to standard therapy, and significantly increases mean Hb without serious treatment-related adverse events. During the study period, adverse events and significant adverse events occurred in a total of 8 patients, of which 1 (weakness, myalgia) had side effects that could be associated with Ferinject administration. IV ferric carboxymaltose (1,000 mg) monotherapy in patients with Chemotherapy-Independent Anemia results in more Hb responder compared to standard therapy and significantly increases the mean Hb without serious treatment-related side effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 333
? The subject should be diagnosed with solid cancer or lymphoma.
? Adults over 19
?The test subjects must have a history of or have undergone chemotherapy (named chemotherapy, chemotherapy + radiotherapy, target agent, etc.) within 2 months prior to study participation.
? Hemoglobin level of test subject should be in the range of 8.0-10.5g / dL, or he / she has experienced hemoglobin reduction of 2g / dL or more during chemotherapy.
? Subjects should have the ability to prepare / submit informed consent before participating in the study.
? The patients have a history of iron (oral or intravenous), hematopoietic stimulating agents (ESA), and dialysis within 4 weeks of study enrollment.
? The patients have a history of uncontrolled infection within 4 weeks of study enrollment.
? At the time of study enrollment, subjects have bleeding (ongoing bleeding).
? Deteriorated organ function
? Patients correspond to ECOG performance 3-4 in whole body performance evaluation.
? There is evidence that the patient's disease is a bone marrow invasion.
? There is a hypersensitivity reaction to ferinject or the components of ferinject.
? There is a significant hypersensitivity to other parenteral iron preparations.
? Patients with anemia other than iron deficiency (eg, small red blood anemia)
Patients with excessive iron or iron use disorder
Patients with advanced bacteremia
? Pregnant or lactating women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemoglobin
- Secondary Outcome Measures
Name Time Method Mean Hemoglobin Change;anemia related biochemical variables;Identification of variables predictive for hemoglobin response CBC;adverse events associated with the use of ferric injectables;Evaluate the quality of life with EORTC QLQ-C30.