Show simple item record

dc.contributor.authorKato, K.
dc.contributor.authorSun, J. M.
dc.contributor.authorShah, M. A.
dc.contributor.authorEnzinger, P. C.
dc.contributor.authorAdenis, A.
dc.contributor.authorDoi, T.
dc.contributor.authorKojima, T.
dc.contributor.authorMetges, J. P.
dc.contributor.authorLi, Z.
dc.contributor.authorKim, S. B.
dc.contributor.authorCho, B. C. C.
dc.contributor.authorMansoor, Was
dc.contributor.authorLi, S. H.
dc.contributor.authorSunpaweravong, P.
dc.contributor.authorMaqueda, M. A.
dc.contributor.authorGoekkurt, E.
dc.contributor.authorLiu, Q.
dc.contributor.authorShah, S.
dc.contributor.authorBhagia, P.
dc.contributor.authorShen, L.
dc.date.accessioned2020-12-08T05:36:29Z
dc.date.available2020-12-08T05:36:29Z
dc.date.issued2020en
dc.identifier.citationKato K, Sun JM, Shah MA, Enzinger PC, Adenis A, Doi T, et al. LBA8_PR Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study. Annals of Oncology. 2020;31:S1192-S3.en
dc.identifier.doi10.1016/j.annonc.2020.08.2298en
dc.identifier.urihttp://hdl.handle.net/10541/623480
dc.description.abstractBackground: KEYNOTE-590 (NCT03189719) is a randomized, international, doubleblind study of 1L pembrolizumab (pembro) + chemotherapy (chemo) vs chemo alone in patients (pts) with locally advanced/unresectable or metastatic adenocarcinoma or esophageal squamous cell carcinoma (ESCC) or Siewert type 1 esophagogastric junction adenocarcinoma (EGJ).Methods: Eligible pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2 yr + chemo (cisplatin 80 mg/m2 Q3W [d1; 6 doses] + 5-FU 800 mg/m2 on d1-5 Q3W). Randomization was stratified by Asia vs Rest of World, adenocarcinoma vs ESCC, and ECOG PS 0 vs 1. Treatment continued until progression, unacceptable toxicity, or withdrawal, or 2 yr. No crossover was permitted. Primary end points were OS in pts with ESCC PD-L1 combined positive score (CPS) _10 tumors, and OS and PFS (RECIST v1.1 ; by investigator) in ESCC, PD-L1 CPS _10, and all pts. The secondary end point was ORR (RECIST v1.1; by investigator) in all pts. Data cutoff for interim OS/final PFS analysis was July 2, 2020. Results: At data cutoff, 749 pts (83% male, 73% ESCC) were randomized (373 pembro + chemo; 376 chemo). Median follow-up was 10.8 mo. Pembro + chemo vs chemo was superior for OS in pts with ESCC CPS ≥10 (median 13.9 vs 8.8 mo; HR 0.57; 95% CI, 0.43-0.75; P < 0.0001), ESCC (median 12.6 vs 9.8 mo; HR 0.72; 95% CI, 0.60-0.88; P = 0.0006), CPS ≥10 (median 13.5 vs 9.4 mo; HR 0.62; 95% CI, 0.49-0.78; P < 0.0001), and all pts (median 12.4 vs 9.8 mo; HR, 0.73, 95% CI, 0.62-0.86; P < 0.0001). PFS was superior with pembro + chemo vs chemo in ESCC (median 6.3 vs 5.8 mo; HR 0.65; 95% CI, 0.54-0.78; P < 0.0001), CPS ≥10 (median 7.5 vs 5.5 mo; HR 0.51; 95% CI, 0.41- 0.65; P < 0.0001), and all pts (median 6.3 vs 5.8 mo; HR 0.65; 95% CI, 0.55-0.76; P < 0.0001). Confirmed ORR was 45.0% vs 29.3% (P < 0.0001) in all pts, with median DOR of 8.3 vs 6.0 mo. Grade 3-5 drug-related AE rates were 72% vs 68%. Discontinuation rates from drug-related AEs were 19% vs 12%. Conclusions: Pembro + chemo provided superior OS, PFS, and ORR vs chemo, with a manageable safety profile in pts with untreated, advanced esophageal and EGJ cancer. These data demonstrate that 1L pembro + chemo is a new standard of care in this pt population.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.annonc.2020.08.2298en
dc.titlePembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 studyen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentGastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japanen
dc.identifier.journalAnnals of Oncologyen
dc.description.noteen]
refterms.dateFOA2020-12-08T11:42:58Z


Files in this item

Thumbnail
Name:
Kato.pdf
Size:
110.9Kb
Format:
PDF
Description:
From UNPAYWALL

This item appears in the following Collection(s)

Show simple item record