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1.
Clin. transl. oncol. (Print) ; 24(3): 495-502, marzo 2022.
Artigo em Inglês | IBECS | ID: ibc-203544

RESUMO

PurposeTo review current measures for renal cancer care and develop a comprehensive and updated list of measures for their practical use in Spain.MethodsThe study was developed by Fundación ECO, a Spanish foundation aiming to improve oncology quality of care. A systematic literature review was carried out to identify measures and knowledge gaps. A scientific committee composed of nine experts reviewed the literature findings and added measures. A preliminary list of 42 measures was evaluated with the Delphi method to gather feedback from 47 medical oncology experts in Spain. Experts scored the appropriateness of the measures and ranked their priority in two consecutive online surveys. The scientific committee reviewed the Delphi results and developed the measures. A technical group from Universidad Francisco de Vitoria conducted and oversaw the Delphi method.ResultsThe Delphi method led to consensus on all 42 measures. The scientific committee used a prioritisation matrix to select 25 of these measures for evaluating quality of care in renal cancer. These measures regarded structure, process, and outcome and covered general management, diagnosis, treatment, follow-up, and evaluation of health outcomes. Easy-to-use index cards were developed for all 25 measures, including their definition, formula, acceptable level of attainment, and rationale.ConclusionsThis manuscript aims to provide healthcare professionals with expert- and evidence-based measures that are useful for evaluating quality of care in renal cancer in Spain and cover all aspects and stages.


Assuntos
Neoplasias Renais/terapia , Cuidados Médicos , Qualidade da Assistência à Saúde , Terapêutica , Espanha , Oncologia
2.
Clin Transl Oncol ; 24(3): 495-502, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34482526

RESUMO

PURPOSE: To review current measures for renal cancer care and develop a comprehensive and updated list of measures for their practical use in Spain. METHODS: The study was developed by Fundación ECO, a Spanish foundation aiming to improve oncology quality of care. A systematic literature review was carried out to identify measures and knowledge gaps. A scientific committee composed of nine experts reviewed the literature findings and added measures. A preliminary list of 42 measures was evaluated with the Delphi method to gather feedback from 47 medical oncology experts in Spain. Experts scored the appropriateness of the measures and ranked their priority in two consecutive online surveys. The scientific committee reviewed the Delphi results and developed the measures. A technical group from Universidad Francisco de Vitoria conducted and oversaw the Delphi method. RESULTS: The Delphi method led to consensus on all 42 measures. The scientific committee used a prioritisation matrix to select 25 of these measures for evaluating quality of care in renal cancer. These measures regarded structure, process, and outcome and covered general management, diagnosis, treatment, follow-up, and evaluation of health outcomes. Easy-to-use index cards were developed for all 25 measures, including their definition, formula, acceptable level of attainment, and rationale. CONCLUSIONS: This manuscript aims to provide healthcare professionals with expert- and evidence-based measures that are useful for evaluating quality of care in renal cancer in Spain and cover all aspects and stages.


Assuntos
Técnica Delphi , Neoplasias Renais/terapia , Qualidade da Assistência à Saúde , Humanos , Espanha
3.
J Clin Oncol ; 39(9): 1020-1028, 2021 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-33529051

RESUMO

PURPOSE: Pembrolizumab, a programmed death 1 inhibitor, demonstrated promising single-agent activity in untreated patients with various cancer types. The phase II KEYNOTE-427 study evaluated efficacy and safety of single-agent pembrolizumab in treatment-naive patients with advanced clear cell renal cell carcinoma (ccRCC; cohort A) and advanced non-ccRCC (cohort B). Results of cohort A are reported. METHODS: In this open-label, single-arm phase II study, patients with advanced ccRCC received pembrolizumab 200 mg every 3 weeks for ≤ 24 months. The primary end point was objective response rate by RECIST, version 1.1. RESULTS: In the total population (N = 110), median time from enrollment to data cutoff was 35.9 (range, 29.5-40.3) months. Objective response rate was 36.4% with four (3.6%) complete responses and 36 (32.7%) partial responses; disease control rate was 58.2% (95% CI, 48.4 to 67.5). Most patients (68.2%) had a decrease in target lesions, including 30.9% with a reduction ≥ 60%. Median duration of response was 18.9 (range, 2.3-37.6+) months; 64.1% of responders had a response ≥ 12 months (Kaplan-Meier). Median progression-free survival was 7.1 months (95% CI, 5.6 to 11.0). Median overall survival was not reached; 12-month and 24-month overall survival rates were 88.2% and 70.8%, respectively. Durable responses were observed across all International Metastatic RCC Database Consortium categories. Grade 3-5 treatment-related adverse events were reported in 30.0% of patients, of which colitis and diarrhea were most frequent. CONCLUSION: Single-agent pembrolizumab showed promising antitumor activity as a first-line treatment in patients with advanced ccRCC, with durable responses across International Metastatic RCC Database Consortium categories. Safety and tolerability profile of pembrolizumab monotherapy was comparable to what has been previously described in other tumor types.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos Imunológicos/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Neoplasias Renais/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma de Células Renais/patologia , Feminino , Seguimentos , Humanos , Neoplasias Renais/patologia , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados não Aleatórios como Assunto , Prognóstico , Taxa de Sobrevida
4.
BJU Int ; 128(2): 254-261, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33547860

RESUMO

OBJECTIVE: To assess the efficacy and tolerability of rechallenge with sunitinib and other targeted therapies (TTs) in patitents with relapsed recurrent renal cell carcinoma (RCC) in the advanced setting. METHODS: In this multi-institutional retrospective study, patients with relapsed RCC were rechallenged with sunitinib or other systemic TTs as a first-line therapeutic approach after failed adjuvant sunitinib treatment. Patient characteristics, treatments and clinical outcomes were recorded. The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR) and overall survival (OS). RESULTS: A total of 34 patients with relapses were recorded, and 25 of these (73.5%) were men. Twenty-five patients were treated with systemic TT: 65% of patients received TT against the vascular endothelial growth factor pathway (including sunitinib), 21.7% received mammalian target of rapamycin inhibitors and 13% received immunotherapy. The median (interquartile range) time to relapse was 20.3 (5.2-20.4) months from diagnosis, and 7.5 months (1.0-8.5) from the end of adjuvant suntinib treatment. At a median follow-up of 23.5 months, 24 of the 25 patients had progressed on first-line systemic therapy. The median PFS was 12.0 months (95% confidence interval [CI] 5.78-18.2). There were no statistical differences in PFS between different treatments or sunitinib rechallenge. PFS was not statistically different in patients relapsing on or after adjuvant suntinib treatment (≤ 6 or >6 months after adjuvant suntinib ending). The ORR was 20.5%. The median OS was 29.1 months (95% CI 16.4-41.8). CONCLUSIONS: Rechallenge with sunitinib or other systemic therapies is still a feasible therapeutic option that provides patients with advanced or metastastic RCC with additional clinical benefits with regard to PFS and OS after failed response to adjuvant sunitinib.


Assuntos
Antineoplásicos/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Neoplasias Renais/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Sunitinibe/uso terapêutico , Adulto , Idoso , Quimioterapia Adjuvante , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
5.
Clin Genitourin Cancer ; 18(6): 452-460, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32565133

RESUMO

INTRODUCTION: The MAJA study compared vinflunine (VFL) plus best supportive care (BSC) maintenance therapy versus BSC alone in advanced urothelial carcinoma responsive to first-line chemotherapy. The primary end point of progression-free survival was achieved. We present the final overall survival (OS) and long-term follow-up safety analyses. PATIENTS AND METHODS: Patients were enrolled, and a subsequent post hoc analysis was performed on the basis of radiologic response or stabilization to first-line cisplatin/gemcitabine (CG) chemotherapy (4-6 cycles), according to Response Evaluation Criteria in Solid Tumors (RECIST). VFL + BSC versus BSC alone were randomly assigned until disease progression. RESULTS: At final analysis, 58 patients (66.7%) had died while 29 (33.3%) had survived; the BSC arm had higher mortality (VFL + BSC, n = 26, 59.1% vs. BSC, n = 32, 74.4%). Median follow-up of surviving patients was 38.8 months (interquartile range, 23.8-61.6). Median OS was 16.7 months (95% confidence interval, 0-34.5) in VFL and 13.2 months (95% confidence interval, 6-20.4) in the BSC groups (hazard ratio, 0.736; 95% confidence interval, 0.44-1.24, P = .182). Post hoc group division did not affect median OS in either study arm. CONCLUSION: Final analysis supported a benefit of VFL in maintenance therapy in patients with disease control after first-line treatment with CG, with no unexpected long-term adverse effects. The study was insufficiently powered to show a significant OS advantage.


Assuntos
Carcinoma de Células de Transição , Neoplasias da Bexiga Urinária , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma de Células de Transição/tratamento farmacológico , Humanos , Análise de Sobrevida , Neoplasias da Bexiga Urinária/tratamento farmacológico , Vimblastina/análogos & derivados , Vimblastina/uso terapêutico
6.
Arch Esp Urol ; 68(2): 187-90, 2015 Mar.
Artigo em Espanhol | MEDLINE | ID: mdl-25774827

RESUMO

We present two cases of enterovaginal and enterocutaneous fistulae associated to treatment with pazopanib, which is an angiogenesis inhibitor for the treatment of metastatic renal cancer. The times from drug administration and the first appearance of a fistula were 6 and 16 months, respectively. None of the cases had a history of surgery or radiotherapy in the area where the complication was observed. Enterovaginal and enterocutaneous fistula represent less than 1% of all published complications caused by the use of antiangiogenic drugs. However, they must be taken into account as the reported mortality rate is close to 30%. Given its low incidence, we believe that sharing this data is a great way to help specialists who have to treat these patients to take the necessary precautions and decide on an adequate approach.


Assuntos
Inibidores da Angiogênese/efeitos adversos , Fístula Intestinal/induzido quimicamente , Neoplasias Renais/tratamento farmacológico , Pirimidinas/efeitos adversos , Fístula Retovaginal/induzido quimicamente , Sulfonamidas/efeitos adversos , Inibidores da Angiogênese/uso terapêutico , Feminino , Humanos , Indazóis , Masculino , Pessoa de Meia-Idade , Pirimidinas/uso terapêutico , Sulfonamidas/uso terapêutico
7.
Clin Transl Oncol ; 14(7): 520-7, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22721797

RESUMO

Prostate cancer (PC) is the most common cancer in men. Many patients have prolonged survival and die of other diseases, so treatment decisions are often influenced by age and coexisting comorbidities. The main procedure to diagnose PC is an ultrasound-guided core needle biopsy, which is indicated when a digital rectal examination (DRE) finds nodularity or when PSA is >10 ng/ml, but is also recommended with PSA between 4.0 and 10 ng/ml. Depending on age, PSA, Gleason score and characteristics of the tumour, treatment options for localised PC are active surveillance, radical prostatectomy and radiation therapy. Androgen deprivation treatment (ADT) should be added to radiotherapy for men with intermediate- or high-risk PC. ADT is the current standard first-line treatment for metastatic PC. Castration-resistant PC is a heterogeneous entity. Several treatments such as sipuleucel-T, docetaxel-based chemotherapy, radium 223, cabazitaxel or abiraterone plus prednisone, zoledronic and denosumab, are useful for this situation.


Assuntos
Carcinoma/terapia , Guias de Prática Clínica como Assunto , Neoplasias da Próstata/terapia , Algoritmos , Carcinoma/diagnóstico , Carcinoma/patologia , Humanos , Masculino , Oncologia/legislação & jurisprudência , Metástase Neoplásica , Estadiamento de Neoplasias/métodos , Orquiectomia/estatística & dados numéricos , Prostatectomia/estatística & dados numéricos , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Espanha , Falha de Tratamento
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