A randomized phase II trial of interleukin-2 and interferon-α plus bevacizumab versus interleukin-2 and interferon-α in metastatic renal-cell carcinoma (mRCC): results from the Danish Renal Cancer Group (DaRenCa) study-1

Autor: Torben Smidt-Hansen, Niels Viggo Jensen, Frede Donskov, Poul F. Geertsen, Line Brøndum
Rok vydání: 2018
Předmět:
0301 basic medicine
Oncology
Male
Recombinant Proteins/administration & dosage
medicine.medical_treatment
Phases of clinical research
Kaplan-Meier Estimate
0302 clinical medicine
Renal cell carcinoma
Interferon
Antineoplastic Combined Chemotherapy Protocols
Medicine
Bevacizumab/administration & dosage
Hematology
General Medicine
Middle Aged
Kidney Neoplasms
Recombinant Proteins
Bevacizumab
Kidney Neoplasms/drug therapy
Treatment Outcome
030220 oncology & carcinogenesis
Female
medicine.drug
Interleukin 2
Adult
medicine.medical_specialty
Interferon-alpha/administration & dosage
Disease-Free Survival
03 medical and health sciences
Internal medicine
Carcinoma
Humans
Radiology
Nuclear Medicine and imaging
Carcinoma
Renal Cell
Aged
business.industry
Interleukin-2/administration & dosage
Cancer
Interferon-alpha
Immunotherapy
medicine.disease
030104 developmental biology
Carcinoma
Renal Cell/drug therapy
Interleukin-2
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
business
Zdroj: Donskov, F, Jensen, N V, Smidt-Hansen, T, Brøndum, L & Geertsen, P 2018, ' A randomized phase II trial of interleukin-2 and interferon-α plus bevacizumab versus interleukin-2 and interferon-α in metastatic renal-cell carcinoma (mRCC): results from the Danish Renal Cancer Group (DaRenCa) study-1 ', Acta Oncologica, vol. 57, no. 5, pp. 589-594 . https://doi.org/10.1080/0284186X.2018.1433324
Donskov, F, Jensen, N V, Smidt-Hansen, T, Brøndum, L & Geertsen, P 2018, ' A randomized phase II trial of interleukin-2 and interferon-α plus bevacizumab versus interleukin-2 and interferon-α in metastatic renal-cell carcinoma (mRCC) : results from the Danish Renal Cancer Group (DaRenCa) study-1 ', Acta Oncologica, vol. 57, no. 5, pp. 589-594 . https://doi.org/10.1080/0284186X.2018.1433324
ISSN: 1651-226X
DOI: 10.1080/0284186X.2018.1433324
Popis: BACKGROUND: Interleukin-2 (IL2)-based immunotherapy is curative for a small subset of patients with metastatic renal-cell carcinoma (mRCC). Preclinical data suggests that bevacizumab (BEV), a humanized anti-VEGF monoclonal antibody, has potential immunomodulatory effects by permitting efficient natural killer (NK) cell-mediated killing and by reverting immune suppression.PATIENT AND METHODS: We performed a randomized phase II study comparing IL2/IFN (interferon)/BEV with IL2/IFN in favourable/intermediate-risk mRCC patients. One hundred and eighteen patients received IFN 3 MIU subcutaneously (sc) daily and IL2 2.4 MIU/m2 sc twice daily, 5 days per week for two consecutive weeks every 28-day-cycle, for 9 months; or supplemented with BEV 10 mg/kg, every 2 weeks intravenously (iv) until progression, unacceptable toxicity, or 1 year following no evidence of disease (NED). Primary end point was progression-free survival (PFS).RESULTS: Baseline characteristics were well-balanced between the two arms; metastasis-free interval CONCLUSIONS: The addition of BEV to IL-2/IFN did not add efficacy in mRCC. (ClinicalTrials.gov, NCT01274273.).
Databáze: OpenAIRE
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