Phase II trial of nivolumab monotherapy and biomarker screening in patients with chemo-refractory germ cell tumors.
Int J Urol
; 29(7): 741-747, 2022 07.
Article
em En
| MEDLINE
| ID: mdl-35462438
ABSTRACT
OBJECTIVES:
Germ cell tumors are highly susceptible to chemotherapy; however, there is a lack of established treatments for consistently relapsing germ cell tumor. Therefore, in this phase II study, we evaluated the efficacy and safety of nivolumab for relapsed germ cell tumor.METHODS:
Seventeen adult patients (median age 34 years) with refractory primary germ cell tumor after second-line or higher chemotherapy were enrolled. Nivolumab was administered over 30 min at 240 mg/body every 2 weeks until disease progression or intolerable adverse event occurrence. The primary endpoint was the overall response rate.RESULT:
We performed a biomarker analysis of programmed death ligand-1 expression and genomic sequencing. Tumor histology revealed nonseminoma and seminoma in 14 and three patients, respectively. Patients were pretreated with a median of three chemotherapy lines, and three patients received high-dose chemotherapy. The median number of nivolumab doses was 3 (range 2-46). One patient showed a partial response and three showed stable disease. Responses were durable in one patient with a partial response and one patient with stable disease (median 90 and 68 weeks, respectively). Nivolumab was well-tolerated, with only two Grade 3 adverse events observed. Programmed death ligand-1 expression was not associated with objective responses. Genomic sequencing revealed a high tumor mutation burden in a patient with a durable partial response. While a small subset of chemorefractory germ cell tumors may respond to nivolumab, programmed death ligand-1 is unreliable to measure response.CONCLUSIONS:
Tumor mutation burden is a potential biomarker for future testing of germ cell tumor response.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Embrionárias de Células Germinativas
/
Antineoplásicos Imunológicos
Tipo de estudo:
Diagnostic_studies
/
Screening_studies
Limite:
Adult
/
Humans
/
Male
Idioma:
En
Revista:
Int J Urol
Assunto da revista:
UROLOGIA
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Japão