The Hammersmith Score Optimises Patient Selection and Predicts for Overall Survival in Early-Phase Cancer Trial Participants Independent of Tumour Burden.
James Alexander Korolewicz, Bernhard Scheiner, Claudia A M Fulgenzi, Antonio D'Alessio, Alessio Cortellini, Chynna Pascual, Aman Mehan, Sarah Partridge, Dorothy M Gujral, Waleed Mohammed, Oreoluwa Mohammed, Aneta Grzesiak, Lauren Booker, Susan Cleator, Tzveta Pokrovska, Waqar Saleem, James Rackie, Yasmine Needham, Jonathan Krell, Iain McNeish, Laura Tookman, Won-Ho Edward Park, Muzamil Asif, Joanne S Evans, David J Pinato
{"title":"The Hammersmith Score Optimises Patient Selection and Predicts for Overall Survival in Early-Phase Cancer Trial Participants Independent of Tumour Burden.","authors":"James Alexander Korolewicz, Bernhard Scheiner, Claudia A M Fulgenzi, Antonio D'Alessio, Alessio Cortellini, Chynna Pascual, Aman Mehan, Sarah Partridge, Dorothy M Gujral, Waleed Mohammed, Oreoluwa Mohammed, Aneta Grzesiak, Lauren Booker, Susan Cleator, Tzveta Pokrovska, Waqar Saleem, James Rackie, Yasmine Needham, Jonathan Krell, Iain McNeish, Laura Tookman, Won-Ho Edward Park, Muzamil Asif, Joanne S Evans, David J Pinato","doi":"10.1159/000539109","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>As tumour response rates are increasingly demonstrated in early-phase cancer trials (EPCT), optimal patient selection and accurate prognostication are paramount. Hammersmith Score (HS), a simple prognostic index derived on routine biochemical measures (albumin <35 g/L, lactate dehydrogenase >450 IU/L, sodium <135 mmol/L), is a validated predictor of response and survival in EPCT participants. HS has not been validated in the cancer immunotherapy era.</p><p><strong>Methods: </strong>We retrospectively analysed characteristics and outcomes of unselected referrals to our early-phase unit (12/2019-12/2022). Independent predictors for overall survival (OS) were identified from univariable and multivariable models. HS was calculated for 66 eligible trial participants and compared with the Royal Marsden Score (RMS) to predict OS. Multivariable logistic regression and C-index was used to compare predictive ability of prognostic models.</p><p><strong>Results: </strong>Of 212 referrals, 147 patients were screened and 82 patients treated in EPCT. Prognostic stratification by HS identifies significant difference in median OS, and HS was confirmed as a multivariable predictor for OS (HR: HS 1 vs. 0 2.51, 95% CI: 1.01-6.24, p = 0.049; HS 2/3 vs. 0: 10.32, 95% CI: 2.15-49.62, p = 0.004; C-index 0.771) with superior multivariable predictive ability than RMS (HR: RMS 2 vs. 0/1 5.46, 95% CI: 1.12-26.57, p = 0.036; RMS 3 vs. 0/1 6.83, 95% CI: 1.15-40.53, p < 0.001; C-index 0.743).</p><p><strong>Conclusions: </strong>HS is a validated prognostic index for patients with advanced cancer treated in the context of modern EPCTs, independent of tumour burden. HS is a simple, inexpensive prognostic tool to optimise referral for EPCT.</p>","PeriodicalId":2,"journal":{"name":"ACS Applied Bio Materials","volume":null,"pages":null},"PeriodicalIF":4.6000,"publicationDate":"2024-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Bio Materials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000539109","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MATERIALS SCIENCE, BIOMATERIALS","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: As tumour response rates are increasingly demonstrated in early-phase cancer trials (EPCT), optimal patient selection and accurate prognostication are paramount. Hammersmith Score (HS), a simple prognostic index derived on routine biochemical measures (albumin <35 g/L, lactate dehydrogenase >450 IU/L, sodium <135 mmol/L), is a validated predictor of response and survival in EPCT participants. HS has not been validated in the cancer immunotherapy era.
Methods: We retrospectively analysed characteristics and outcomes of unselected referrals to our early-phase unit (12/2019-12/2022). Independent predictors for overall survival (OS) were identified from univariable and multivariable models. HS was calculated for 66 eligible trial participants and compared with the Royal Marsden Score (RMS) to predict OS. Multivariable logistic regression and C-index was used to compare predictive ability of prognostic models.
Results: Of 212 referrals, 147 patients were screened and 82 patients treated in EPCT. Prognostic stratification by HS identifies significant difference in median OS, and HS was confirmed as a multivariable predictor for OS (HR: HS 1 vs. 0 2.51, 95% CI: 1.01-6.24, p = 0.049; HS 2/3 vs. 0: 10.32, 95% CI: 2.15-49.62, p = 0.004; C-index 0.771) with superior multivariable predictive ability than RMS (HR: RMS 2 vs. 0/1 5.46, 95% CI: 1.12-26.57, p = 0.036; RMS 3 vs. 0/1 6.83, 95% CI: 1.15-40.53, p < 0.001; C-index 0.743).
Conclusions: HS is a validated prognostic index for patients with advanced cancer treated in the context of modern EPCTs, independent of tumour burden. HS is a simple, inexpensive prognostic tool to optimise referral for EPCT.
简介随着早期癌症试验(EPCT)中肿瘤反应率的不断提高,最佳患者选择和准确预后至关重要。哈默史密斯评分(HS)是根据常规生化指标(白蛋白35克/升、乳酸脱氢酶450 IU/升、钠135毫摩尔/升)得出的简单预后指数,是预测EPCT参与者反应和生存的有效指标。HS尚未在癌症免疫疗法时代得到验证:我们回顾性地分析了我们早期治疗单位(12/2019-12/2022)的非选择性转诊患者的特征和结果。通过单变量和多变量模型确定了总生存期(OS)的独立预测因素。对66名符合条件的试验参与者进行了HS计算,并与皇家马斯登评分(RMS)进行比较,以预测OS。多变量逻辑回归和c指数用于比较预后模型的预测能力:在212名转诊患者中,147名患者接受了筛查,82名患者接受了EPCT治疗。根据HS进行的预后分层确定了中位OS的显著差异,并证实HS是OS的多变量预测因子(HR:HS 1 vs. 0 2.51,95%CI:1.01-6.24,p=0.049;HS 2/3 vs. 0:10.32,95%CI:2.15-49.62,p=0.004;C-指数0.771),其多变量预测能力优于RMS(HR:RMS 2 vs. 0/1 5.0,95%CI:1.01-6.24,p=0.049):HR:RMS 2 vs. 0/1 5.46,95%CI:1.12-26.57,p=0.036;RMS 3 vs. 0/1 6.83,95%CI:1.15-40.53,p<0.001;C-指数0.743):结论:对于接受现代 EPCT 治疗的晚期癌症患者而言,HS 是一个有效的预后指标,与肿瘤负荷无关。HS是一种简单、廉价的预后工具,可用于优化EPCT的转诊。