患者的选择在一期研究中至关重要，而在治疗经过重度治疗的患者中，预后难以估计。以前的预后模型，如皇家玛斯登医院（RMH）评分或使用中性粒细胞-淋巴细胞比值（NLR），在目前的新型疗法或亚洲一期人群中尚未得到验证。我们对2013年10月至2020年12月在我们中心参加一期研究的414名实体瘤患者进行了回顾性研究。RMH模型显示随着评分的增加，预后越来越差[RMH评分1，HR 1.28（95％CI：0.96-1.70）；RMH评分2，HR 2.27（95％CI：1.62-3.17）；RMH评分3，HR 4.14（95％CI：2.62-6.53）]。NLR未改善模型的AUC。较差的ECOG状况（ECOG 1比0：HR = 1.59（95％CI = 1.24-2.04），P <0.001）和原发肿瘤部位（GI vs.乳腺癌：HR = 3.06，95％CI = 2.16-4.35，P <0.001）具有预后意义。我们开发了一种NCIS预后评分，对于短期和长期生存具有出色的预后能力（iAUC：0.71 [95％CI 0.65-0.76]），并在迄今为止亚洲最大的一项研究中验证了RMH模型。 ©2023年作者（S）。

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.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.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.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.© 2023. The Author(s).