{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T23:15:26Z","timestamp":1788477326395,"version":"build-2803163510"},"reference-count":43,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T00:00:00Z","timestamp":1765843200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005010","name":"Italian Association for Cancer Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005010","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Critical Reviews in Oncology\/Hematology"],"published-print":{"date-parts":[[2026,2]]},"DOI":"10.1016\/j.critrevonc.2025.105092","type":"journal-article","created":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T16:14:27Z","timestamp":1765901667000},"page":"105092","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":2,"special_numbering":"C","title":["Correlation of ORR and PFS with OS outcomes in phase III trials of immunotherapy in advanced NSCLC: Systematic review and meta-analysis"],"prefix":"10.1016","volume":"218","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7706-1803","authenticated-orcid":false,"given":"Fabio","family":"Salomone","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Di Maio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Viggiano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Liguori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carminia Maria","family":"Della Corte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Viscardi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabiana","family":"Vitiello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabiana","family":"Napolitano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Santaniello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Nuccio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simeone","family":"D\u2019Ambrosio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filippo","family":"Vitale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annarita","family":"Avanzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Bulotta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Formisano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Ferrara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Bianco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valter","family":"Torri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Servetto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.critrevonc.2025.105092_bib1","doi-asserted-by":"crossref","DOI":"10.1155\/2021\/1302811","article-title":"Methods to analyze time-to-event data: the cox regression analysis","volume":"2021","author":"Abd ElHafeez","year":"2021","journal-title":"Oxid. Med Cell Longev."},{"key":"10.1016\/j.critrevonc.2025.105092_bib2","article-title":"Rethinking survival metrics in EGFR-mutated NSCLC: insights from RMST analysis of FLAURA2 and MARIPOSA","author":"Acker","year":"2025","journal-title":"Ann. Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib3","doi-asserted-by":"crossref","DOI":"10.1136\/jitc-2022-005854","article-title":"Changes in circulating tumor DNA and outcomes in solid tumors treated with immune checkpoint inhibitors: a systematic review","volume":"11","author":"Al-Showbaki","year":"2023","journal-title":"J. Immunother. Cancer"},{"key":"10.1016\/j.critrevonc.2025.105092_bib4","doi-asserted-by":"crossref","first-page":"53","DOI":"10.5306\/wjco.v11.i2.53","article-title":"Objective response rate assessment in oncology: Current situation and future expectations","volume":"11","author":"Aykan","year":"2020","journal-title":"World J. Clin. Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib5","doi-asserted-by":"crossref","first-page":"849","DOI":"10.1001\/jamaoncol.2017.5618","article-title":"A 25-year experience of US food and drug administration accelerated approval of malignant hematology and oncology drugs and biologics","volume":"4","author":"Beaver","year":"2018","journal-title":"JAMA Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib6","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1016\/j.lungcan.2023.01.002","article-title":"Primary endpoints to assess the efficacy of novel therapeutic approaches in epidermal growth factor receptor-mutated, surgically resectable non-small cell lung cancer: a review","volume":"177","author":"Blakely","year":"2023","journal-title":"Lung Cancer"},{"key":"10.1016\/j.critrevonc.2025.105092_bib7","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1200\/JCO.2014.59.0489","article-title":"Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses","volume":"33","author":"Blumenthal","year":"2015","journal-title":"J. Clin. Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib8","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1056\/NEJMoa1504627","article-title":"Nivolumab versus docetaxel in advanced squamous-cell non\u2013small-cell lung cancer","volume":"373","author":"Brahmer","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.critrevonc.2025.105092_bib9","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1093\/biostatistics\/1.1.49","article-title":"The validation of surrogate endpoints in meta-analyses of randomized experiments","volume":"1","author":"Buyse","year":"2000","journal-title":"Biostatistics"},{"key":"10.1016\/j.critrevonc.2025.105092_bib10","first-page":"1121","article-title":"Clinical endpoints in oncology - a primer","volume":"11","author":"Delgado","year":"2021","journal-title":"Am. J. Cancer Res"},{"key":"10.1016\/j.critrevonc.2025.105092_bib11","doi-asserted-by":"crossref","first-page":"3001","DOI":"10.1038\/s41467-023-38837-3","article-title":"Towards evidence-based response criteria for cancer immunotherapy","volume":"14","author":"Garralda","year":"2023","journal-title":"Nat. Commun."},{"key":"10.1016\/j.critrevonc.2025.105092_bib12","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1016\/S1470-2045(24)00040-8","article-title":"Correlations of response rate and progression-free survival with overall survival in immunotherapy trials for metastatic non-small-cell lung cancer: an FDA pooled analysis","volume":"25","author":"Goulart","year":"2024","journal-title":"Lancet Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib13","doi-asserted-by":"crossref","first-page":"2020","DOI":"10.1056\/NEJMoa1910231","article-title":"Nivolumab plus Ipilimumab in advanced non\u2013small-cell lung cancer","volume":"381","author":"Hellmann","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.critrevonc.2025.105092_bib14","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1016\/j.lungcan.2012.10.007","article-title":"Progression-free survival and overall survival in phase III trials of molecular-targeted agents in advanced non-small-cell lung cancer","volume":"79","author":"Hotta","year":"2013","journal-title":"Lung Cancer"},{"key":"10.1016\/j.critrevonc.2025.105092_bib15","doi-asserted-by":"crossref","first-page":"1022","DOI":"10.1186\/s12885-022-10046-z","article-title":"Validating ORR and PFS as surrogate endpoints in phase II and III clinical trials for NSCLC patients: difference exists in the strength of surrogacy in various trial settings","volume":"22","author":"Hua","year":"2022","journal-title":"BMC Cancer"},{"key":"10.1016\/j.critrevonc.2025.105092_bib16","doi-asserted-by":"crossref","first-page":"1022","DOI":"10.1186\/s12885-022-10046-z","article-title":"Validating ORR and PFS as surrogate endpoints in phase II and III clinical trials for NSCLC patients: difference exists in the strength of surrogacy in various trial settings","volume":"22","author":"Hua","year":"2022","journal-title":"BMC Cancer"},{"key":"10.1016\/j.critrevonc.2025.105092_bib17","doi-asserted-by":"crossref","first-page":"466","DOI":"10.1080\/02664763.2020.1815673","article-title":"Quantifying treatment differences in confirmatory trials under non-proportional hazards","volume":"49","author":"Jim\u00e9nez","year":"2022","journal-title":"J. Appl. Stat."},{"key":"10.1016\/j.critrevonc.2025.105092_bib18","doi-asserted-by":"crossref","first-page":"1213","DOI":"10.1200\/JCO.22.00975","article-title":"Durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non\u2013small-cell lung cancer: the Phase III POSEIDON study","volume":"41","author":"Johnson","year":"2023","journal-title":"J. Clin. Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib19","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1016\/j.jval.2014.06.006","article-title":"Analyzing overall survival in randomized controlled trials with crossover and implications for economic evaluation","volume":"17","author":"J\u00f6nsson","year":"2014","journal-title":"Value Health"},{"key":"10.1016\/j.critrevonc.2025.105092_bib20","doi-asserted-by":"crossref","first-page":"1351","DOI":"10.1016\/j.jtho.2020.03.028","article-title":"Atezolizumab in combination with carboplatin and nab-paclitaxel in advanced squamous NSCLC (IMpower131): results from a randomized phase III trial","volume":"15","author":"Jotte","year":"2020","journal-title":"J. Thorac. Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib21","doi-asserted-by":"crossref","DOI":"10.1016\/j.mayocp.2016.02.012","article-title":"Strength of validation for surrogate end points used in the US food and drug administration\u2019s approval of oncology drugs","author":"Kim","year":"2016","journal-title":"Mayo Clin. Proc."},{"key":"10.1016\/j.critrevonc.2025.105092_bib22","doi-asserted-by":"crossref","DOI":"10.3390\/life11101029","article-title":"Clinical efficacy and future prospects of immunotherapy in lung cancer","volume":"11","author":"Kinoshita","year":"2021","journal-title":"Life"},{"key":"10.1016\/j.critrevonc.2025.105092_bib23","doi-asserted-by":"crossref","first-page":"1320","DOI":"10.1093\/annonc\/mdy075","article-title":"Treatment effects measured by restricted mean survival time in trials of immune checkpoint inhibitors for cancer","volume":"29","author":"Liang","year":"2018","journal-title":"Ann. Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib24","doi-asserted-by":"crossref","first-page":"3752","DOI":"10.1158\/1078-0432.CCR-22-0741","article-title":"Circulating tumor DNA kinetics predict progression-free and overall survival in EGFR TKI\u2013treated patients with EGFR -Mutant NSCLC (SWOG S1403)","volume":"28","author":"Mack","year":"2022","journal-title":"Clin. Cancer Res."},{"key":"10.1016\/j.critrevonc.2025.105092_bib25","doi-asserted-by":"crossref","DOI":"10.1136\/jitc-2021-003024","article-title":"Defining unique clinical hallmarks for immune checkpoint inhibitor-based therapies","volume":"10","author":"Michielin","year":"2022","journal-title":"J. Immunother. Cancer"},{"key":"10.1016\/j.critrevonc.2025.105092_bib26","doi-asserted-by":"crossref","first-page":"2268","DOI":"10.1158\/1078-0432.CCR-17-1902","article-title":"Evaluation of overall response rate and progression-free survival as potential surrogate endpoints for overall survival in immunotherapy trials","volume":"24","author":"Mushti","year":"2018","journal-title":"Clin. Cancer Res."},{"key":"10.1016\/j.critrevonc.2025.105092_bib27","doi-asserted-by":"crossref","first-page":"3731","DOI":"10.1158\/1078-0432.CCR-11-2859","article-title":"Cure models as a useful statistical tool for analyzing survival","volume":"18","author":"Othus","year":"2012","journal-title":"Clin. Cancer Res."},{"key":"10.1016\/j.critrevonc.2025.105092_bib28","doi-asserted-by":"crossref","first-page":"772","DOI":"10.1001\/jamaoncol.2015.6315","article-title":"Response rate as a regulatory end point in single-arm studies of advanced solid tumors","volume":"2","author":"Oxnard","year":"2016","journal-title":"JAMA Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib29","doi-asserted-by":"crossref","unstructured":"Page, M.J. et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Preprint at https:\/\/doi.org\/10.31222\/osf.io\/v7gm2 (2020).","DOI":"10.31222\/osf.io\/v7gm2"},{"key":"10.1016\/j.critrevonc.2025.105092_bib30","doi-asserted-by":"crossref","first-page":"567","DOI":"10.1001\/jamaoncol.2022.7770","article-title":"Exposure to US cancer drugs with lack of confirmed benefit after US food and drug administration accelerated approval","volume":"9","author":"Parikh","year":"2023","journal-title":"JAMA Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib31","doi-asserted-by":"crossref","first-page":"2873","DOI":"10.1111\/1759-7714.14148","article-title":"Immune checkpoint inhibitors for first-line treatment of advanced non-small-cell lung cancer: a systematic review and network meta-analysis","volume":"12","author":"Peng","year":"2021","journal-title":"Thorac. Cancer"},{"key":"10.1016\/j.critrevonc.2025.105092_bib32","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1016\/j.annonc.2020.02.006","article-title":"ARCTIC: durvalumab with or without tremelimumab as third-line or later treatment of metastatic non-small-cell lung cancer","volume":"31","author":"Planchard","year":"2020","journal-title":"Ann. Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib33","series-title":"Mathematical Statistics with Applications in R","first-page":"531","article-title":"Empirical methods","author":"Ramachandran","year":"2021"},{"key":"10.1016\/j.critrevonc.2025.105092_bib34","doi-asserted-by":"crossref","first-page":"661","DOI":"10.1001\/jamaoncol.2020.0237","article-title":"Durvalumab with or without tremelimumab vs standard chemotherapy in first-line treatment of metastatic non\u2013small cell lung cancer","volume":"6","author":"Rizvi","year":"2020","journal-title":"JAMA Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib35","doi-asserted-by":"crossref","first-page":"e143","DOI":"10.1016\/S1470-2045(17)30074-8","article-title":"iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics","volume":"18","author":"Seymour","year":"2017","journal-title":"Lancet Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib36","doi-asserted-by":"crossref","first-page":"2288","DOI":"10.1056\/NEJMoa1716948","article-title":"Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC","volume":"378","author":"Socinski","year":"2018","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.critrevonc.2025.105092_bib37","doi-asserted-by":"crossref","first-page":"269","DOI":"10.21037\/tlcr.2020.03.17","article-title":"Circulating tumor DNA clearance predicts prognosis across treatment regimen in a large real-world longitudinally monitored advanced non-small cell lung cancer cohort","volume":"9","author":"Song","year":"2020","journal-title":"Transl. Lung Cancer Res."},{"key":"10.1016\/j.critrevonc.2025.105092_bib38","doi-asserted-by":"crossref","first-page":"l4898","DOI":"10.1136\/bmj.l4898","article-title":"RoB 2: a revised tool for assessing risk of bias in randomised trials","author":"Sterne","year":"2019","journal-title":"BMJ"},{"key":"10.1016\/j.critrevonc.2025.105092_bib39","doi-asserted-by":"crossref","first-page":"1137","DOI":"10.1016\/j.annonc.2021.06.004","article-title":"Nivolumab with carboplatin, paclitaxel, and bevacizumab for first-line treatment of advanced nonsquamous non-small-cell lung cancer","volume":"32","author":"Sugawara","year":"2021","journal-title":"Ann. Oncol."},{"key":"10.1016\/j.critrevonc.2025.105092_bib40","doi-asserted-by":"crossref","first-page":"1680","DOI":"10.1016\/j.ccell.2023.08.004","article-title":"Tumor dynamics in patients with solid tumors treated with pembrolizumab beyond disease progression","volume":"41","author":"Topp","year":"2023","journal-title":"Cancer Cell"},{"key":"10.1016\/j.critrevonc.2025.105092_bib41","doi-asserted-by":"crossref","first-page":"2629","DOI":"10.1158\/1078-0432.CCR-12-2935","article-title":"The clinical viewpoint: definitions, limitations of RECIST, practical considerations of measurement","volume":"19","author":"Villaruz","year":"2013","journal-title":"Clin. Cancer Res"},{"key":"10.1016\/j.critrevonc.2025.105092_bib42","doi-asserted-by":"crossref","DOI":"10.1093\/jncics\/pkz002","article-title":"A systematic review and recommendation for reporting of surrogate endpoint evaluation using meta-analyses","volume":"3","author":"Xie","year":"2019","journal-title":"JNCI Cancer Spectr."},{"key":"10.1016\/j.critrevonc.2025.105092_bib43","doi-asserted-by":"crossref","DOI":"10.1093\/jncics\/pkz002","article-title":"A systematic review and recommendation for reporting of surrogate endpoint evaluation using meta-analyses","volume":"3","author":"Xie","year":"2019","journal-title":"JNCI Cancer Spectr."}],"container-title":["Critical Reviews in Oncology\/Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1040842825004809?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1040842825004809?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T12:42:38Z","timestamp":1770036158000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1040842825004809"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2]]},"references-count":43,"alternative-id":["S1040842825004809"],"URL":"https:\/\/doi.org\/10.1016\/j.critrevonc.2025.105092","relation":{},"ISSN":["1040-8428"],"issn-type":[{"value":"1040-8428","type":"print"}],"subject":[],"published":{"date-parts":[[2026,2]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Correlation of ORR and PFS with OS outcomes in phase III trials of immunotherapy in advanced NSCLC: Systematic review and meta-analysis","name":"articletitle","label":"Article Title"},{"value":"Critical Reviews in Oncology\/Hematology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.critrevonc.2025.105092","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"105092"}}