RESUMO
Cystectomy is a standard treatment for muscle-invasive bladder cancer (MIBC), but it is life-altering. We initiated a phase 2 study in which patients with MIBC received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging. Patients achieving a clinical complete response (cCR) could proceed without cystectomy. The co-primary objectives were to assess the cCR rate and the positive predictive value of cCR for a composite outcome: 2-year metastasis-free survival in patients forgoing immediate cystectomy or Assuntos
Cisplatino
, Neoplasias da Bexiga Urinária
, Humanos
, Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
, Cisplatino/uso terapêutico
, Desoxicitidina/uso terapêutico
, Intervalo Livre de Doença
, Gencitabina
, Músculos
, Terapia Neoadjuvante
, Invasividade Neoplásica
, Nivolumabe/uso terapêutico
, Neoplasias da Bexiga Urinária/tratamento farmacológico
, Neoplasias da Bexiga Urinária/patologia
, Proteína Grupo D do Xeroderma Pigmentoso
RESUMO
In this commentary, we review the timeline of clinical trials and regulatory actions of approved immune checkpoint inhibitors for small cell lung cancer, discuss challenges faced by regulatory agencies, and highlight paradoxical lessons that emerge. Accelerated approvals may fail to expedite drugs to market in this setting and further research on overall survival benefit is needed to prove drug efficacy.