ients. In addition the histological improvement favoured the combination therapy.
Supportive favourable results from a small study in naïve patients were reported using interferon alfa-2a (3 MIU 3 times per week) with ribavirin.
For other information on pharmacodynamic properties please refer to the SmPC for Ribavirin.
Follicular Non-Hodgkin's lymphoma
The efficacy of Roferon-A in addition to cytotoxic chemotherapy (CHOP-like regimen of cyclophosphamide, vincristine, prednisone and doxorubicin) was assessed in 122 patients with clinically aggressive low-grade or intermediate-grade non-Hodgkin's lymphoma and compared with 127 controls receiving the same chemotherapy regimen. The two regimens produced comparable objective responses, but the regimen including Roferon-A had a greater effect in prolonging the time to treatment failure (p<0.001), the duration of complete response (p<0.003).
Renal Cell Carcinoma
1) Combination with vinblastine
The efficacy of Roferon-A, given in combination with vinblastine, was compared with vinblastine alone. The combination of Roferon-A plus vinblastine is superior to vinblastine alone in the treatment of patients with locally advanced or metastatic renal cell carcinoma. Median survival was 67.8 weeks for the 79 patients receiving Roferon-A plus vinblastine and 37.8 weeks for the 81 patients treated with vinblastine (p=.0049). Overall response rates were 16.5% for patients treated Roferon-A plus vinblastine and 2.5% for patients treated with vinblastine alone (p=.0025).
2) Combination with bevacizumab (Avastin)
The pivotal phase III study compared bevacizumab in combination with interferon alfa-2a (N=327) to placebo plus interferon alfa-2a (N=322) as first-line therapy of nephrectomised patients with advanced and/or metastatic renal cell carcinoma.
Table 1: Efficacy results for study BO17705
Parameter
(median value)
Pbo + IFN N = 322
Bv + IFN N = 327
Hazard Ratioα
p-value
Overall survival
21.3 mo.
23.3 mo.
0.91
(0.76 – 1.10)
p = 0.3360 β
Progression-free survival
5.5 mo.
10.2 mo.
0.75
(0.64 – 0.88)
p < 0.0004 β
Overall response rateγ
12.5 %
32.4 %
19.9
p < 0.0001 δ
α - determined with a 95 % CI. For ORR, a difference in rates between study arms is given instead.
β - p-value was obtained using Log-Rank Test
γ - populations for reference are those patients with measurable disease at baseline [ITT N = 289 / 306]
δ - p-value was obtained using χ2 Test
Surgically Resected Malignant Melanoma
The efficacy of Roferon-A in patients with primary cutaneous melanoma thicker than 1.5 mm and without clinically detectable node metastasis was assessed in a large randomised study involving 253 patients receiving Roferon-A at a dose of 3 MIU three times a week for 18 months, compared with 246 untreated controls. After a median follow-up of 4.4 years a significant extension of relapse-free interval (p=0.035) but no statistically significant difference in overall survival (p=0.059) in Roferon-A treated patients compared with controls have been shown. The overall treatment effect was a 25% reduction in the risk of relapse.
5.2 Pharmacokinetic properties
The serum concentrations of interferon alfa |
