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DC Field | Value | Language |
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dc.contributor.author | Pavlakis N. | - |
dc.contributor.author | Shitara K. | - |
dc.contributor.author | Sjoquist K. | - |
dc.contributor.author | Martin A. | - |
dc.contributor.author | Jaworski A. | - |
dc.contributor.author | Tebbutt N. | - |
dc.contributor.author | Bang Y.-J. | - |
dc.contributor.author | Alcindor T. | - |
dc.contributor.author | O'Callaghan C. | - |
dc.contributor.author | Strickland A. | - |
dc.contributor.author | Rha S.Y. | - |
dc.contributor.author | Lee K.-W. | - |
dc.contributor.author | Kim J.-S. | - |
dc.contributor.author | Bai L.-Y. | - |
dc.contributor.author | Hara H. | - |
dc.contributor.author | Oh D.-Y. | - |
dc.contributor.author | Yip S. | - |
dc.contributor.author | Zalcberg J. | - |
dc.contributor.author | Price T. | - |
dc.contributor.author | Simes J. | - |
dc.contributor.author | Goldstein D. | - |
dc.date.accessioned | 2024-10-16T01:56:25Z | - |
dc.date.available | 2024-10-16T01:56:25Z | - |
dc.date.copyright | 2024 | - |
dc.date.issued | 2024-10-11 | en |
dc.identifier.citation | Journal of Clinical Oncology. (pp JCO2400055), 2024. Date of Publication: 04 Oct 2024. | - |
dc.identifier.uri | https://repository.monashhealth.org/monashhealthjspui/handle/1/52585 | - |
dc.description.abstract | PURPOSE: Treatment options for refractory advanced gastric and esophagogastric junction cancer (AGOC) are limited. Regorafenib, an oral multikinase inhibitor, prolonged progression-free survival (PFS) versus placebo in the INTEGRATE I phase II trial. INTEGRATE IIa was designed to examine whether regorafenib improved overall survival (OS). METHOD(S): A double-blind placebo-controlled phase III trial compared regorafenib and best supportive care (BSC) versus placebo and BSC for participants with confirmed evaluable metastatic/advanced AGOC who failed >=two prior therapies on a 2:1 random assignment, stratified by tumor location, geographic region (Asia v rest of world), and prior vascular endothelial growth factor inhibitors. The primary end point was OS. Treatment efficacy on OS was first tested in the pooled INTEGRATE I + INTEGRATE IIa cohort and, if significant, then in the INTEGRATE IIa cohort. Secondary end points were PFS, objective response rate, safety, and quality of life (QoL). RESULT(S): INTEGRATE IIa enrolled 251 participants: 157 from Asia and 94 from rest of world and 169 received regorafenib and 82 received placebo. No significant heterogeneity was observed between INTEGRATE I and INTEGRATE IIa studies on OS. Pooled OS analysis hazard ratio (HR) was 0.70 (95% CI, 0.56 to 0.87; P = .001; 361 events). INTEGRATE IIa alone OS HR was 0.68 (95% CI, 0.52 to 0.90; P = .006; 238 events), the median OS was 4.5 months versus 4.0 months, and 12-month survival rates were 19% and 6%, for regorafenib versus placebo, respectively. After a preplanned adjustment for multiplicity, there were no statistically significant differences across regions or other prespecified subgroups. Regorafenib improved PFS (HR, 0.53 [95% CI, 0.40 to 0.70]; P < .0001) and delayed deterioration in global QoL (HR, 0.68 [95% CI, 0.52 to 0.89]; P = .0043). The toxicity profile was consistent with that of previous reports. CONCLUSION(S): Regorafenib improves survival compared with placebo in refractory AGOC. | - |
dc.relation.ispartof | Journal of Clinical Oncology | - |
dc.subject.mesh | gastroesophageal junction | - |
dc.subject.mesh | stomach cancer | - |
dc.title | INTEGRATE IIa phase III study: regorafenib for refractory advanced gastric cancer. | - |
dc.type | Article | - |
dc.identifier.affiliation | Oncology | - |
dc.type.studyortrial | Observational study (cohort, case-control, cross sectional, or survey) | - |
dc.identifier.doi | http://monash.idm.oclc.org/login?url=https://dx.doi.org/10.1200/JCO.24.00055 | - |
dc.publisher.place | United States | - |
dc.identifier.pubmedid | 39365958 [https://www.ncbi.nlm.nih.gov/pubmed/?term=39365958] | - |
dc.identifier.institution | (Pavlakis) Department of Medical Oncology, NSW, Royal North Shore Hospital, Sydney, Australia | - |
dc.identifier.institution | (Pavlakis) University of Sydney, NSW, Sydney, Australia | - |
dc.identifier.institution | (Shitara) Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Japan | - |
dc.identifier.institution | (Sjoquist, Martin, Jaworski, Yip, Simes) NHMRC Clinical Trials Centre, University of Sydney, NSW, Sydney, Australia | - |
dc.identifier.institution | (Sjoquist) Cancer Care Centre, St George Hospital, NSW, Kogarah, Australia | - |
dc.identifier.institution | (Tebbutt) Olivia Newton-John Cancer Wellness & Research Centre, Melbourne, VIC, Australia | - |
dc.identifier.institution | (Bang, Lee) Seoul National University College of Medicine, Seoul, South Korea | - |
dc.identifier.institution | (Alcindor) McGill University Health Centre, Montreal, QC, Canada | - |
dc.identifier.institution | (O'Callaghan) Canadian Cancer Trials Group, Queens University, Kingston, ON, Canada | - |
dc.identifier.institution | (Strickland) Department of Medical Oncology, Monash Health, Monash University, Melbourne, VIC, Australia | - |
dc.identifier.institution | (Rha) Yonsei Cancer Centre, Yonsei University Health System, Seoul, South Korea | - |
dc.identifier.institution | (Lee) Seoul National University Bundang Hospital, Seongnam, South Korea | - |
dc.identifier.institution | (Kim) Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea | - |
dc.identifier.institution | (Bai) Division of Hematology and Oncology, China Medical University Hospital, Taichung, Taiwan (Republic of China) | - |
dc.identifier.institution | (Bai) China Medical University, Taichung, Taiwan (Republic of China) | - |
dc.identifier.institution | (Hara) Saitama Cancer Center, Saitama, Japan | - |
dc.identifier.institution | (Oh) Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Jongno-gu, South Korea | - |
dc.identifier.institution | (Oh) Integrated Major in Innovative Medical Science, Seoul National University Graduate School, Seoul, South Korea | - |
dc.identifier.institution | (Zalcberg) Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia | - |
dc.identifier.institution | (Zalcberg) School of Public Health, Faculty of Medicine Monash University, Melbourne, VIC, Australia | - |
dc.identifier.institution | (Price) Queen Elizabeth Hospital, Adelaide, SA, Australia | - |
dc.identifier.institution | (Goldstein) Nelune Cancer Centre, Prince of Wales Hospital, NSW, Sydney, Australia | - |
dc.identifier.affiliationmh | (Strickland) Department of Medical Oncology, Monash Health, Monash University, Melbourne, VIC, Australia | - |
item.openairetype | Article | - |
item.cerifentitytype | Publications | - |
item.grantfulltext | none | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.fulltext | No Fulltext | - |
Appears in Collections: | Articles |
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