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http://hdl.handle.net/1942/33874
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DC Field | Value | Language |
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dc.contributor.author | Oba, Koji | - |
dc.contributor.author | Paoletto, Xavier | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Bouche, Olivier | - |
dc.contributor.author | Ducreux, Michel | - |
dc.contributor.author | Michiels, Stefan | - |
dc.contributor.author | Moehler, MarkusH | - |
dc.contributor.author | Morita, Satoshi | - |
dc.contributor.author | Ohashi, Yasuo | - |
dc.contributor.author | Sakamoto, Junichi | - |
dc.contributor.author | Sasako, Mitsuru | - |
dc.contributor.author | Shitara, Kohei | - |
dc.contributor.author | Van Cutsem, Eric | - |
dc.contributor.author | BUYSE, Marc | - |
dc.contributor.author | BURZYKOWSKI, Tomasz | - |
dc.date.accessioned | 2021-04-07T10:25:32Z | - |
dc.date.available | 2021-04-07T10:25:32Z | - |
dc.date.issued | 2020 | - |
dc.date.submitted | 2021-03-09T12:56:37Z | - |
dc.identifier.citation | JOURNAL OF CLINICAL ONCOLOGY, 38 (15) (Art N° e16506) | - |
dc.identifier.uri | http://hdl.handle.net/1942/33874 | - |
dc.description.abstract | Background: In 2013, the GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research through International Collaboration) evaluated the surrogacy of PFS based on IPD of 4,069 patients from 20 randomized trials of AGC. Treatment effects on PFS and on OS were only moderately correlated, and we could not validate PFS as a surrogate endpoint for OS. More recent trials, with refined inclusion criteria and higher standards for evaluating progression, may allow for a more accurate estimate of the correlation. The 2nd round of the GASTRIC sought to re-evaluate the surrogacy of PFS for OS in AGC. Methods: The GASTRIC database was updated with trials published after 2010 which used RECIST (Response Evaluation Criteria in Solid Tumors). Since the proportional hazards assumption was questionable for PFS, we primarily used mean-time ratio as a treatment effect measure, estimated by using the log-logistic model. Using the meta-analytic approach, correlations between PFS and OS at the individual level (Rindiv), and between treatment effects on PFS and on OS at the trial level (Rtrial), were estimated using Spearman’s rank-correlation and estimation-error-adjusted regression, respectively. Surrogate threshold effect was estimated as well. Results: We analyzed 10,912 patient data (1st round 4,069 patients from 20 trials and 2nd round 6,843 patients from 17 trials). Overall, moderate correlations were found at the individual level (Rindiv = 0.75, 95%CI = 0.75 to 0.76 in Hougaard copula) and at the trial level (Rtrial = 0.77, 95%CI = 0.32 to 1.00), respectively. Surrogate threshold effect was equal to 1.29, i.e., observing 29% increase in mean PFS time would predict a significant increase of the OS time. In the subgroup of patients with measurable disease in the 2nd round dataset (4,866 patients), Rtrial was higher and equal to 0.93 (95%CI = 0.70 to 1.00), with STE equal to 1.21. These results were same for 1st and 2nd line trials. Conclusions: The meta-analysis indicates a strong correlation between treatment effects (expressed as log-mean-ratios) on PFS and OS in patients with measurable disease. | - |
dc.description.sponsorship | JSPS KAKENHI the Leading Initiative forExcellent Young Researchers of the University of Tokyo | - |
dc.language.iso | en | - |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | - |
dc.title | Progression-free survival (PFS) as a surrogate endpoint for overall survival (OS) in advanced/recurrent gastric cancer (AGC) treatment: Individual-patient-data (IPD) based meta-analysis of randomized trials | - |
dc.type | Journal Contribution | - |
local.bibliographicCitation.conferencedate | MAY 29-31, 2020 | - |
local.bibliographicCitation.conferencename | Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO) | - |
local.bibliographicCitation.conferenceplace | ELECTR NETWORK | - |
dc.identifier.issue | 15 | - |
dc.identifier.volume | 38 | - |
local.format.pages | 2 | - |
local.bibliographicCitation.jcat | M | - |
local.publisher.place | TWO COMMERCE SQ, 2001 MARKET ST, PHILADELPHIA, PA 19103 USA | - |
local.type.refereed | Refereed | - |
local.type.specified | Meeting Abstract | - |
local.bibliographicCitation.artnr | e16506 | - |
dc.identifier.isi | WOS:000560368305504 | - |
local.provider.type | wosris | - |
local.uhasselt.uhpub | yes | - |
local.description.affiliation | Univ Tokyo, Interfac Initiat Informat Studies, Tokyo, Japan. | - |
local.description.affiliation | Inst Curie, Paris, France. | - |
local.description.affiliation | Seoul Natl Univ, Coll Med, Seoul, South Korea. | - |
local.description.affiliation | CHU Robert Debre, Reims, France. | - |
local.description.affiliation | Gustave Roussy Canc Campus Grand Paris, Villejuif, France. | - |
local.description.affiliation | Inst Gustave Roussy, Villejuif, France. | - |
local.description.affiliation | Johannes Gutenberg Univ Clin, Mainz, Germany. | - |
local.description.affiliation | Kyoto Univ, Dept Biomed Stat & Bioinformat, Grad Sch Med, Kyoto, Japan. | - |
local.description.affiliation | Chuo Univ, Integrated Sci & Engn Sustainable Soc, Tokyo, Japan. | - |
local.description.affiliation | Japanese Fdn Multidisciplinary Treatment Canc, Tokyo, Japan. | - |
local.description.affiliation | Hyogo Coll Med, Dept Surg, Div Upper Gastrointestinal Surg, Nishinomiya, Hyogo, Japan. | - |
local.description.affiliation | Natl Canc Ctr Hosp East, Kashiwa, Chiba, Japan. | - |
local.description.affiliation | Katholieke Univ Leuven, Univ Hosp Gasthuisberg Leuven, Leuven, Belgium. | - |
local.description.affiliation | Int Drug Dev Inst, Louvain La Neuve, Belgium. | - |
local.description.affiliation | Hasselt Univ, Ctr Stat, Diepenbeek, Belgium. | - |
local.uhasselt.international | yes | - |
item.contributor | Oba, Koji | - |
item.contributor | Paoletto, Xavier | - |
item.contributor | Bang, Yung-Jue | - |
item.contributor | Bouche, Olivier | - |
item.contributor | Ducreux, Michel | - |
item.contributor | Michiels, Stefan | - |
item.contributor | Moehler, MarkusH | - |
item.contributor | Morita, Satoshi | - |
item.contributor | Ohashi, Yasuo | - |
item.contributor | Sakamoto, Junichi | - |
item.contributor | Sasako, Mitsuru | - |
item.contributor | Shitara, Kohei | - |
item.contributor | Van Cutsem, Eric | - |
item.contributor | BUYSE, Marc | - |
item.contributor | BURZYKOWSKI, Tomasz | - |
item.fulltext | No Fulltext | - |
item.accessRights | Closed Access | - |
item.fullcitation | Oba, Koji; Paoletto, Xavier; Bang, Yung-Jue; Bouche, Olivier; Ducreux, Michel; Michiels, Stefan; Moehler, MarkusH; Morita, Satoshi; Ohashi, Yasuo; Sakamoto, Junichi; Sasako, Mitsuru; Shitara, Kohei; Van Cutsem, Eric; BUYSE, Marc & BURZYKOWSKI, Tomasz (2020) Progression-free survival (PFS) as a surrogate endpoint for overall survival (OS) in advanced/recurrent gastric cancer (AGC) treatment: Individual-patient-data (IPD) based meta-analysis of randomized trials. In: JOURNAL OF CLINICAL ONCOLOGY, 38 (15) (Art N° e16506). | - |
crisitem.journal.issn | 0732-183X | - |
crisitem.journal.eissn | 1527-7755 | - |
Appears in Collections: | Research publications |
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