Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Richtig, E; Hofmann-Wellenhof, R; Pehamberger, H; Forstinger, Ch; Wolff, K; Mischer, P; Raml, J; Fritsch, P; Zelger, B; Ratzinger, G; Koller, J; Lang, A; Konrad, K; Kindermann-Glebowski, E; Seeber, A; Steiner, A; Fialla, R; Pachinger, W; Kos, C; Klein, G; Kehrer, H; Kerl, H; Ulmer, H; Smolle, J.
Temozolomide and interferon alpha 2b in metastatic melanoma stage IV.
BRIT J DERMATOL. 2004; 151(1): 91-98.
Doi: 10.1111/j.1365-2133.2004.06019.x
Web of Science
PubMed
FullText
FullText_MUG
- Führende Autor*innen der Med Uni Graz
- Richtig Erika
- Co-Autor*innen der Med Uni Graz
- Hofmann-Wellenhof Rainer
- Kerl Helmut
- Smolle Josef
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- Abstract:
- BACKGROUND: A multicentre, centrally randomized, open-labelled study with temozolomide and interferon (IFN)-alpha 2b was carried out to study the therapeutic effect in patients with metastatic melanoma stage IV. OBJECTIVES: The response rate, efficacy, side-effects, reasons for discontinuation of therapy and survival rate of 47 patients treated with temozolomide in combination with two different dosing regimens of IFN-alpha 2b were documented. PATIENTS/METHODS: Twenty-nine male and 18 female patients (mean age 57.6 years, range 34-74) were centrally randomized to two different arms: 20 patients received a treatment schedule with temozolomide 150 mg m(-2) on days 1-5 orally every 28 days in combination with IFN-alpha 2b 10 MIU m(-2) every other day and 27 patients received temozolomide 150 mg m(-2) on days 1-5 every 28 days in combination with IFN-alpha 2b in a fixed dose of 10 MIU every other day. RESULTS: We observed an overall response rate of 27.6% comprising five complete remissions (10.6%: one patient group A, four patients group B), in two of these five patients at the last follow-up in the study (4.3%, both in group B); and eight partial remissions (17%: six patients in group A, two patients in group B), in three of these eight patients at the last follow-up in the study (6.4%, two patients in group A, one patient in group B). Three patients showed stable disease (6.4%: one patient in group A, two patients in group B). Mean survival was 14.5 months [95% confidence interval (CI) 10-19] with no significant differences between treatment groups. However, there was a significant correlation with response after three cycles (log rank test, P < 0.03). Within the 32 patients who completed at least three cycles of therapy, seven patients (three in group A and four in group B) with a partial or complete response showed a significantly better mean survival of 30.6 months (95% CI 19.1-42) compared with 25 patients who did not respond (13.7 months 95% CI 9.2-18.3). In total, patients with at least one complete remission showed the longest survival (37.1 months 95% CI 26.3-47.9), followed by patients with at least one partial response (17.4 95% CI 10.9-23.9). Major side-effects of the treatment were nausea, vomiting, headache, leucopenia, thrombopenia, elevation of liver function parameters and neurological symptoms. In five patients, the side-effects led to a discontinuation of treatment: neurological symptoms (two patients), sepsis (one patient), brain haemorrhage (one patient) and exanthema (one patient). There were no treatment-related deaths. CONCLUSIONS: The combination of temozolomide and IFN-alpha 2b can easily be administered and shows tolerable toxicity. When an objective response occurs after three cycles, it indicates a significant survival advantage.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Antineoplastic Combined Chemotherapy Protocols - therapeutic use
- Dacarbazine - administration and dosage
- Drug Administration Schedule - administration and dosage
- Female - administration and dosage
- Follow-Up Studies - administration and dosage
- Humans - administration and dosage
- Interferon Alfa-2b - administration and dosage
- Liver Neoplasms - drug therapy
- Lung Neoplasms - drug therapy
- Male - drug therapy
- Melanoma - drug therapy
- Middle Aged - drug therapy
- Proportional Hazards Models - drug therapy
- Remission Induction - drug therapy
- Skin Neoplasms - drug therapy
- Survival Rate - drug therapy
- Find related publications in this database (Keywords)
- interferon alpha 2b
- metastatic malignant melanoma
- temozolomide