Clinical Trial Result Information

Title of Study:
Multicenter Open Label Study of NeoRecormon Prevention and Treatment for Anemia in Adult Patients with Solid Tumors and Treated with Platinum-Based Chemotherapy Prone to Induce Anemia.

Fast Facts:

Protocol number:	ML17620
Sponsor:	Shanghai Roche Pharmaceuticals Ltd
Company division:	Pharmaceutical
Product name:	NeoRecormon
Generic name:	epoetin beta
Phase of development:	III
Therapeutic area, approved indication:	Anemia
Date of report:	12/1/2006

Clinical study summary:
This was a multicenter, open-label, two-arm study to investigate the effect of NeoRecormon in patients with solid tumors treated with platinum-based chemotherapy prone to induce anemia. NeoRecormon treatment was compared with standard treatment for anemia.

Study center(s) :
10 sites in China.

Objectives:
To determine the efficacy and safety of NeoRecormon (epoetin beta) in the prevention and treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy.

Methodology:
Eligible patients were randomized to receive either NeoRecormon treatment, at a starting dose of 150 IU/kg s.c. tiw, or standard treatment (supported blood transfusion and iron supplements, as necessary), coinciding with the start of platinum-based chemotherapy. The number and volume of blood transfusions were documented during the study, laboratory parameters and blood pressure were measured at regular intervals, and AEs were recorded continuously.

Number of patients (planned/analyzed):
121 patients enrolled.

Diagnosis and main criteria for inclusion:
Men and women >18 years old, who had anemia with solid tumors and were receiving platinum-based chemotherapy.

Test product, dose and mode of administration or test procedure:
NeoRecormon (epoetin beta). Starting dose: 150 IU/kg body weight s.c. tiw.

Duration of treatment:
12 weeks

Criteria for evaluation (efficacy, safety):
Efficacy. Primary: The percentage of patients with increase in hemoglobin values by ≥2 g/dL compared to baseline without blood transfusion in previous 6 weeks (defined as response rate). Secondary: Increase in hemoglobin; number and volume of blood transfusions per patient; hematocrit; red cell count; reticulocyte count; iron, ferritin, transferrin.
Safety: AEs, laboratory parameters, blood pressure.

Statistical methods:
Efficacy: The 2 treatment arms were compared for response rate and other efficacy parameters at the end of the study. The primary and all secondary efficacy parameters were analyzed using the intent-to-treat population (all randomized patients) and the per protocol population (patients who completed ≥8 weeks of study, with no protocol violations).
Safety: All patients who received at least one dose of the study medication whether withdrawn prematurely or not were included in the safety analysis.

Summary (efficacy, safety, other results):
Efficacy: The response rate of NeoRecormon was 47.5% in the ITT population and 61.7% in the PP population, while the response rate in the control group was 23.3% in the ITT population and 31.8% in the PP population. Hemoglobin levels in the NeoRecormon group were elevated when compared with the baseline value after week 1, and the hemoglobin increase was consistently higher in the NeoRecormon group than the control group after week 2. At the end of treatment, the hemoglobin increase was 21.2±16.4 g/L in the NeoRecormon group and 5.9±18.3 g/L in the control group. At the end of treatment, the increases in hematocrit and red cell count were higher in the NeoRecormon group than in the control group. There were no differences in the number and volume of blood transfusions, reticulocyte counts and serum iron, ferritin and transferrin between the two groups.

Safety: Safety data revealed that the overall incidence of adverse events was comparable between the two groups. A total of 4 patients in the NeoRecormon group died during the study; 3 deaths were unrelated and 1 had an uncertain relationship to study drug. Two AEs in the NeoRecormon group were possibly related to study drug, redness and swelling at the injection site and itching of the whole body. There were no differences between the groups in safety laboratory parameters, and no abnormal laboratory parameters related to the study drug. Blood pressure in both groups remained stable during the entire treatment period.

Conclusions:
In this study, NeoRecormon steadily and consistently increased the hemoglobin level in anemic patients with solid tumors, with good tolerability. It can be concluded that NeoRecormon is an effective and safe drug for anemia in Chinese adult patients with solid tumors treated with platinum-based chemotherapy.

Click here for the protocol registry listing of this trial.