Θεραπευτικές κατηγορίες > Ογκολογία > Καρκίνοι Γαστρεντερικού
KEYTRUDA®, in combination with platinum-and fluoropyrimidine- based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the esophagus in adults whose tumors express PD-L1 with CPS≥10.1
Safety
Treatment-Related AEs With ≥5% Incidence in Either Treatment Arm
(ASaT: n=370 in Each Treatment Arm)2
Selected AE summary (ASaT).
-
Any AEs (ASaT): 370 (100%) patients with KEYTRUDA + cisplatin/5-FU vs 368 (99%) patients with cisplatin/5-FU alone
- Led to discontinuation: 90 (24%) patients with KEYTRUDA + cisplatin/5-FU vs 74 (20%) patients with cisplatin/5-FU alone
-
Treatment-related AEs (ASaT): 364 (98%) patients with KEYTRUDA + cisplatin/5-FU vs 360 (97%) patients with cisplatin/5-FU alone
- Grade ≥3: 266 (72%) patients with KEYTRUDA + cisplatin/5-FU vs 250 (68%) patients with cisplatin/5-FU alone
- Led to death: 9 (2%) patients with KEYTRUDA + cisplatin/5-FU vs 5 (1%) patients with cisplatin/5-FU alone
-
Immune-mediated AEs and infusion reactions (ASaT): 95 (26%) patients with KEYTRUDA + cisplatin/5-FU vs 43 (12%) patients with cisplatin/5-FU alone
- Grade ≥3: 26 (7%) patients with KEYTRUDA + cisplatin/5-FU vs 8 (2%) patients with cisplatin/5-FU alone
achemotherapy = cisplatin/5-FU
5-FU = 5-fluorouracil; AE = adverse event; ASaT = all subjects as treated.
1L=first line; 5-FU=5-fluorouracil; AE=adverse event; Cl=confidence interval; CPS=combined positive score; CR=complete response; DOR= duration of response; ECOG= Eastern Cooperative Oncology Group; ECOG PS= Eastern Cooperative Oncology Group performance status; FU= fluorouracil; GEJ=gastroesophageal junction; HER-2= human epidermal growth factor receptor 2; HR=hazard ratio; ORR=objective response rate; OS=overall survival; PD=progressive disease; PD-L1=programmed death ligand 1; PFS=progression-free survival; QoL=quality of life; RECIST v1.1= Response Evaluation Criteria In Solid Tumors v1.1; TRAE=treatment-related adverse event
- KEYTRUDA® Summary of Product Characteristics, 19th of June 2025.
- Sun J-M, Shen L, Manish AH, et al. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomized, placebo-controlled, phase 3 study. Lancet. 2021;398(10302):759-771.doi:10.1016/S0140-6736(21)01234-4.
- Agilent Technologies, Inc. Instructions for Use: PD-L1 IHC 22C3 pharmDX.
Πριν τη συνταγογράφηση, παρακαλώ συμβουλευτείτε την Περίληψη Χαρακτηριστικών Προϊόντος
KEYTRUDA C/S.SOL.IN 25MG/ML BTx1 VIALx4ML: 2.481,70€ (Χ.Τ) 2.702,95€ (Λ.Τ) 2.231,33€ (Ν.Τ)
GR-KEY-00972-13/10/2025
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