dc.contributor.author | Kato, K | |
dc.contributor.author | Doki, Y | |
dc.contributor.author | Chau, I | |
dc.contributor.author | Xu, J | |
dc.contributor.author | Wyrwicz, L | |
dc.contributor.author | Motoyama, S | |
dc.contributor.author | Ogata, T | |
dc.contributor.author | Kawakami, H | |
dc.contributor.author | Hsu, C-H | |
dc.contributor.author | Adenis, A | |
dc.contributor.author | El Hajbi, F | |
dc.contributor.author | Di Bartolomeo, M | |
dc.contributor.author | Braghiroli, MI | |
dc.contributor.author | Holtved, E | |
dc.contributor.author | Makino, T | |
dc.contributor.author | Blum Murphy, M | |
dc.contributor.author | Amaya-Chanaga, C | |
dc.contributor.author | Patel, A | |
dc.contributor.author | Hu, N | |
dc.contributor.author | Matsumura, Y | |
dc.contributor.author | Kitagawa, Y | |
dc.contributor.author | Ajani, J | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2024-07-30T14:03:29Z | |
dc.date.available | 2024-07-30T14:03:29Z | |
dc.date.issued | 2024-05-01 | |
dc.identifier | ARTN e7235 | |
dc.identifier.citation | Cancer Medicine, 2024, 13 (9), pp. e7235 - | en_US |
dc.identifier.issn | 2045-7634 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/6324 | |
dc.identifier.eissn | 2045-7634 | |
dc.identifier.eissn | 2045-7634 | |
dc.identifier.doi | 10.1002/cam4.7235 | |
dc.identifier.doi | 10.1002/cam4.7235 | |
dc.description.abstract | BACKGROUND: First-line nivolumab plus chemotherapy and nivolumab plus ipilimumab both demonstrated significant overall survival (OS) benefit versus chemotherapy in previously untreated patients with advanced esophageal squamous cell carcinoma (ESCC) in the CheckMate 648 trial, leading to approvals of both nivolumab-containing regimens in many countries. We report longer-term follow-up data. METHODS: This open-label, phase III trial (NCT03143153) enrolled adults with previously untreated, unresectable, advanced, recurrent, or metastatic ESCC. Patients were randomized 1:1:1 to nivolumab plus chemotherapy, nivolumab plus ipilimumab, or chemotherapy. Primary endpoints were OS and progression-free survival (PFS) by blinded independent central review. Hierarchical testing was performed first in patients with tumor cell programmed death ligand 1 (PD-L1) expression of ≥1% and then in the overall population. RESULTS: A total of 970 patients were randomly assigned. After 29 months of minimum follow-up, nivolumab plus chemotherapy continued to demonstrate improvement in OS versus chemotherapy (hazard ratio [HR] = 0.59 [95% CI: 0.46-0.76]) in patients with tumor cell PD-L1 expression of ≥1% and in the overall population (HR = 0.78 [95% CI: 0.65-0.93]) and with nivolumab plus ipilimumab versus chemotherapy (HR = 0.62 [95% CI: 0.48-0.80]) in patients with tumor cell PD-L1 expression of ≥1% and in the overall population (HR = 0.77 [95% CI: 0.65-0.92]). In patients with tumor cell PD-L1 expression of ≥1%, nivolumab plus chemotherapy demonstrated PFS benefit versus chemotherapy (HR = 0.67 [95% CI: 0.51-0.89]); PFS benefit was not observed with nivolumab plus ipilimumab versus chemotherapy (HR = 1.04 [95% CI: 0.79-1.36]). Among all treated patients (n = 936), Grade 3-4 treatment-related adverse events were reported in 151 (49%, nivolumab plus chemotherapy), 105 (32%, nivolumab plus ipilimumab), and 110 (36%, chemotherapy) patients. CONCLUSIONS: Nivolumab plus chemotherapy and nivolumab plus ipilimumab continued to demonstrate clinically meaningful OS benefit versus chemotherapy with no new safety signals identified with longer follow-up, further supporting use as first-line standard treatment options for patients with advanced ESCC. | |
dc.format | Print | |
dc.format.extent | e7235 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | WILEY | en_US |
dc.relation.ispartof | Cancer Medicine | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_US |
dc.subject | cancer management | |
dc.subject | check point control | |
dc.subject | chemotherapy | |
dc.subject | clinical cancer research | |
dc.subject | clinical trials | |
dc.subject | esophageal squamous cell carcinoma | |
dc.subject | Humans | |
dc.subject | Ipilimumab | |
dc.subject | Nivolumab | |
dc.subject | Male | |
dc.subject | Esophageal Squamous Cell Carcinoma | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Female | |
dc.subject | Esophageal Neoplasms | |
dc.subject | Middle Aged | |
dc.subject | Aged | |
dc.subject | Follow-Up Studies | |
dc.subject | Adult | |
dc.subject | Progression-Free Survival | |
dc.subject | B7-H1 Antigen | |
dc.subject | Aged, 80 and over | |
dc.title | Nivolumab plus chemotherapy or ipilimumab versus chemotherapy in patients with advanced esophageal squamous cell carcinoma (CheckMate 648): 29-month follow-up from a randomized, open-label, phase III trial. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2024-04-21 | |
dc.date.updated | 2024-07-30T14:03:01Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1002/cam4.7235 | en_US |
rioxxterms.licenseref.startdate | 2024-05-01 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/38716626 | |
pubs.issue | 9 | |
pubs.organisational-group | ICR | |
pubs.organisational-group | ICR/Primary Group | |
pubs.organisational-group | ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.publisher-url | http://dx.doi.org/10.1002/cam4.7235 | |
pubs.volume | 13 | |
dc.contributor.icrauthor | Chau, Ian | |
icr.provenance | Deposited by Mr Arek Surman on 2024-07-30. Deposit type is initial. No. of files: 1. Files: Nivolumab plus chemotherapy or ipilimumab versus chemotherapy in patients with advanced esophageal squamous cell carcinoma (.pdf | |