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999			_c17019 _d17019
003			PC17019
005			20221014122642.0
008			221014b xxu||||| |||| 00| 0 eng d
040			_cH12O
041			_aeng
100			_9882 _aCastellano, Daniel _eOncología Médica
245	0	0	_aFinal results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma. _h[artículo]
260			_bBritish journal of cancer, _c2015
300			_a113(1):12-9.
500			_aFormato Vancouver: Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S et al. Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma. Br J Cancer. 2015 Jun 30;113(1):12-9.
501			_aPMID: 26086878 PMC4647545
504			_aContiene 23 referencias
520			_aBackground: We report final results with extended follow-up from a global, expanded-access trial that pre-regulatory approval provided sunitinib to metastatic renal cell carcinoma (mRCC) patients, ineligible for registration-directed trials. Methods: Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on-2-weeks-off schedule. Safety was assessed regularly. Tumour measurements were scheduled per local practice. Results: A total of 4543 patients received sunitinib. Median treatment duration and follow-up were 7.5 and 13.6 months. Objective response rate was 16% (95% confidence interval (CI): 15-17). Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8-10.0) and 18.7 months (95% CI: 17.5-19.5). Median PFS in subgroups of interest: aged ⩾65 years (33%), 10.1 months; Eastern Cooperative Oncology Group performance status ⩾2 (14%), 3.5 months; non-clear cell histology (12%), 6.0 months; and brain metastases (7%), 5.3 months. OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (n=4065). The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand-foot syndrome (each 7%). Conclusion: Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. Efficacy and safety findings were consistent with previous results.
710			_9303 _aServicio de Oncología Médica
856			_uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4647545/ _yAcceso libre
942			_2ddc _cART _n0