title: [Sunitinib in clinical practice: the expanded access program for metastatic renal cell carcinoma].
abstract: The preferential application of Sunitinib in the first-line therapy of metastatic renal cell carcinoma (mRCC) is based on data of a phase III study documenting a doubling of progression-free survival (PFS) with the multi-kinase inhibitor compared to Interferon- alpha. Data from clinical studies were then supplemented and supported by comprehensive experiences in everyday practice. Sunitinib was offered to a large group of patients in an expanded access program with more than 4,500 participants. Patients with no access to Sunitinib treatment due to their country-specific approval situation or patients unable to participate in the approval study on the basis of exclusion criteria could thus be included. The cohorte also encompassed patients with an unfavorable prognosis due to metastases of the brain, non-clear cell RCC, or an ECOG performance status > or =2. Priority was given to questions regarding the safety and long-term tolerability of Sunitinib in clinical practice. Regarding tolerability, these subgroups in the expanded access program did not differ from the total population. New or cumulative toxicities did not occur. In addition, even subgroups with an unfavorable prognosis were able to profit from treatment with Sunitinib. A synopsis of phase III data and the results of the expanded access program confirm the evidence for Sunitinib in all patient populations.
authors.affiliation: Praxis für interdisziplinäre Onkologie und Hämatologie, Freiburg i.Br.
authors.forename: Norbert
authors.initials: N
authors.lastname: Marschner
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D017326:Clinical Trials, Phase III as Topic; D057176:Compassionate Use Trials; D018450:Disease Progression; D017277:Drug Approval; D016503:Drug Delivery Systems; D015507:Drugs, Investigational / Q000627:therapeutic use*; D005858:Germany; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality; D011758:Pyrroles / Q000627:therapeutic use*; D000077210:Sunitinib; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib