The safety and efficacy of sunitinib before planned nephrectomy in metastatic clear cell renal cancer.
Ann Oncol
; 22(5): 1041-1047, 2011 May.
Article
en En
| MEDLINE
| ID: mdl-21242586
ABSTRACT
BACKGROUND:
The safety and efficacy of upfront sunitinib, before nephrectomy in metastatic clear cell renal cancer (mCRC), has not been prospectively evaluated.METHODS:
Two prospective single-arm phase II studies investigated either two cycles (study A n = 19) or three cycles (study B n = 33) of sunitinib before nephrectomy in mCRC.RESULTS:
Overall, 38 of 52 (73%) of patients obtained clinical benefit (by RECIST) before surgery. The partial response rate of the primary tumour was 6% [median reduction in longest diameter of 12% (range 8%-35%)]. No patients became ineligible due to local progression of disease. A nephrectomy was carried out in 37 (71%) of patients. Necrosis (>50%) was a prominent feature at nephrectomy in 49%. Surgical complications (Clavien-Dindo classification) occurred in 10 (27%) patients, including one death (3%). The median blood loss and surgical time were 725 (90-4200) ml and 189 (70-420) min, respectively. The median progression-free survival was 8 months (95% confidence interval 6-15 months). A comparison of two versus three pre-surgery cycles showed no significant difference in terms of surgical complications or efficacy.CONCLUSIONS:
Nephrectomy after upfront sunitinib can be carried out safely. It obtains control of disease. Randomised studies are required to address if this approach is beneficial.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Pirroles
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Carcinoma de Células Renales
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Indoles
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Neoplasias Renales
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Antineoplásicos
Tipo de estudio:
Clinical_trials
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Observational_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Ann Oncol
Asunto de la revista:
NEOPLASIAS
Año:
2011
Tipo del documento:
Article