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Bevacizumab plus IFN-alpha-2a in First-line Treatment of Patients With Advanced or Metastatic Renal Cell Carcinoma: A Prospective German Non-interventional Study.
Schultze-Seemann, Wolfgang; Schulz, Holger; Tschechne, Barbara; Häckl, Manuel.
Afiliación
  • Schultze-Seemann W; University Hospital Freiburg (Albert-Ludwigs-University) Urology, Freiburg, Germany wolfgang.schultze-seemann@uniklinik-freiburg.de sekretariat.schultze-seemann@uniklinik-freiburg.de.
  • Schulz H; PIOH Study and Management GbR, Frechen, Germany.
  • Tschechne B; Specialist for Internal Medicine Hematology and Oncology, Neustadt, Germany.
  • Häckl M; Roche Pharma AG Germany, Grenzach-Wyhlen, Germany.
Anticancer Res ; 39(2): 875-882, 2019 Feb.
Article en En | MEDLINE | ID: mdl-30711970
BACKGROUND/AIM: The combination of bevacizumab (BEV) plus interferon alpha-2a (IFN) constitutes an option for first-line treatment of metastatic renal cell carcinoma. Real-world data from routine clinical practice are rare and were, therefore, collected during this non-interventional study (NIS). PATIENTS AND METHODS: A total of 359 patients received at least one dose of BEV (safety set population; SAF), 354 patients had at least one post-dose effectiveness assessment and formed the full analysis set (FAS) of the final analysis. RESULTS: Progression-free survival (10.2 months, 95% CI=8.6-12.6) and overall response rate (27.2%) outcomes match the results from the phase III trials AVOREN and CALGB 90206. Longer overall survival (28.7 months, 95% CI=24.5-38.3) probably is an effect of patient characteristics and follow-up therapies. Safety findings were comparable to the results of the Phase III trials, although comprehensive severity assessments were not provided. CONCLUSION: Overall, efficacy and safety data from BEV plus IFN administered in routine clinical practice in an observational NIS are in line with results from the controlled phase III trials. (NCT02627144).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Células Renales / Interferón-alfa / Bevacizumab / Neoplasias Renales Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Anticancer Res Año: 2019 Tipo del documento: Article Pais de publicación: Grecia

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Células Renales / Interferón-alfa / Bevacizumab / Neoplasias Renales Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Anticancer Res Año: 2019 Tipo del documento: Article Pais de publicación: Grecia