Clinical outcome and prognostic factors for Asian patients in Phase I clinical trials.
Br J Cancer
; 128(8): 1514-1520, 2023 04.
Article
em En
| MEDLINE
| ID: mdl-36797357
ABSTRACT
BACKGROUND:
Patient selection is key in Phase I studies, and prognosis can be difficult to estimate in heavily pre-treated patients. Previous prognostic models like the Royal Marsden Hospital (RMH) score or using the neutrophil-lymphocyte ratio (NLR) have not been validated in current novel therapies nor in the Asian Phase I population.METHODS:
We conducted a retrospective review of 414 patients with solid tumours participating in Phase I studies at our centre between October 2013 and December 2020.RESULTS:
The RMH model showed poorer prognosis with increasing scores [RMH score 1, HR 1.28 (95% CI 0.96-1.70); RMH score 2, HR 2.27 (95% CI 1.62-3.17); RMH score 3, HR 4.14 (95% CI 2.62-6.53)]. NLR did not improve the AUC of the model. Poorer ECOG status (ECOG 1 vs. 0 HR = 1.59 (95% CI = 1.24-2.04), P < 0.001) and primary tumour site (GI vs. breast cancer HR = 3.06, 95% CI = 2.16-4.35, P < 0.001) were prognostic.CONCLUSIONS:
We developed a NCIS prognostic score with excellent prognostic ability for both short-term and longer-term survival (iAUC 0.71 [95% CI 0.65-0.76]), and validated the RMH model in the largest Asian study to date.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
Tipo de estudo:
Observational_studies
/
Prognostic_studies
Limite:
Female
/
Humans
Idioma:
En
Revista:
Br J Cancer
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Singapura