Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
Por:
Castellano, D, Maroto, JP, Espinosa, E, Grande, E, Bolos, MV, Llinares, J, Esteban, E, del Alba, AG, Climent, MA, Arranz, JA, Mendez, MJ, Parra, EF, Anton-Aparicio, L, Bayona, C, Gallegos, I, Gallardo, E, Samaniego, L, Donas, JG
Publicada:
1 ene 2018
Resumen:
Background: A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon- in metastatic renal cell carcinoma (mRCC) patients.
Objective: To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice.
Methods: Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals. Tumor response, Progression-free survival (PFS) and overall survival (OS), and main sunitinib-related toxicities were registered.
Results: 224 patients were analyzed. Median PFS 10.6 months (95% CI: 9.02-12.25), median OS 21.9 months (95% CI: 17.2-26.6). Objective response rate (ORR) 43.8% (95% CI: 36.8-50.7). Median time to PR was 3.8 months (95% CI: 3.86-5.99) and to CR 8.2 months (95% CI: 4.75-9.77). The most common >= grade-3 AEs were asthenia/fatigue (18.7%), hand-foot syndrome (6.2%), hypertension (5.8%) and neutropenia (4.8%). Hand-foot syndrome, diarrhea and mucositis were confirmed as independent predictors for PFS and/or OS in a multivariate analysis (p < 0.05)
Conclusions: Outcomes with sunitinib in daily clinical practice resemble those obtained in clinical trials. Long-term benefit with sunitinib is possible in advanced RCC patients but the appropriate management of toxicities is mandatory to enable patients to remain on treatment.
Filiaciones:
Castellano, D:
Hosp Univ 12 Octubre, Madrid, Spain
Maroto, JP:
Hosp Santa Creu & Sant Pau, Med Oncol, Barcelona, Spain
Espinosa, E:
Hosp Univ La Paz, Madrid, Spain
Grande, E:
Ramon y Cajal Univ Hosp, Madrid, Spain
Bolos, MV:
Pfizer, Madrid, Spain
Llinares, J:
Pfizer, Madrid, Spain
Esteban, E:
Gen Univ Hosp Asturias, Asturias, Spain
del Alba, AG:
Hosp Univ Son Espases, Palma De Mallorca, Spain
Climent, MA:
Inst Valenciano Oncol, Valencia, Spain
Arranz, JA:
Hosp Gen Univ Gregorio Maranon, Madrid, Spain
Mendez, MJ:
Hosp Univ Reina Sofia, Med Oncol, Cordoba, Spain
Parra, EF:
Hosp Valme, Seville, Spain
Anton-Aparicio, L:
Hosp Juan Canalejo, La Coruna, Spain
Bayona, C:
Hosp Gen Yague, Burgos, Spain
Gallegos, I:
Hosp Segovia, Segovia, Spain
Gallardo, E:
Parc Tauli Hosp Univ, Sabadell, Spain
Samaniego, L:
Trial Form Support, Madrid, Spain
Donas, JG:
17HM Hosp, Ctr Integral Oncol HM Clara Campal, Madrid, Spain
Green Accepted
|