Trastuzumab Deruxtecan in
Adult
Aged
Aged, 80 and over
Camptothecin
/ adverse effects
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Female
Follow-Up Studies
Humans
Immunoconjugates
/ adverse effects
Lung Diseases, Interstitial
/ chemically induced
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Pneumonia
/ chemically induced
Progression-Free Survival
Receptor, ErbB-2
/ genetics
Trastuzumab
/ adverse effects
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
20 01 2022
20 01 2022
Historique:
pubmed:
18
9
2021
medline:
27
1
2022
entrez:
17
9
2021
Statut:
ppublish
Résumé
Human epidermal growth factor receptor 2 (HER2)-targeted therapies have not been approved for patients with non-small-cell lung cancer (NSCLC). The efficacy and safety of trastuzumab deruxtecan (formerly DS-8201), a HER2 antibody-drug conjugate, in patients with We conducted a multicenter, international, phase 2 study in which trastuzumab deruxtecan (6.4 mg per kilogram of body weight) was administered to patients who had metastatic A total of 91 patients were enrolled. The median duration of follow-up was 13.1 months (range, 0.7 to 29.1). Centrally confirmed objective response occurred in 55% of the patients (95% confidence interval [CI], 44 to 65). The median duration of response was 9.3 months (95% CI, 5.7 to 14.7). Median progression-free survival was 8.2 months (95% CI, 6.0 to 11.9), and median overall survival was 17.8 months (95% CI, 13.8 to 22.1). The safety profile was generally consistent with those from previous studies; grade 3 or higher drug-related adverse events occurred in 46% of patients, the most common event being neutropenia (in 19%). Adjudicated drug-related interstitial lung disease occurred in 26% of patients and resulted in death in 2 patients. Responses were observed across different Trastuzumab deruxtecan showed durable anticancer activity in patients with previously treated
Sections du résumé
BACKGROUND
Human epidermal growth factor receptor 2 (HER2)-targeted therapies have not been approved for patients with non-small-cell lung cancer (NSCLC). The efficacy and safety of trastuzumab deruxtecan (formerly DS-8201), a HER2 antibody-drug conjugate, in patients with
METHODS
We conducted a multicenter, international, phase 2 study in which trastuzumab deruxtecan (6.4 mg per kilogram of body weight) was administered to patients who had metastatic
RESULTS
A total of 91 patients were enrolled. The median duration of follow-up was 13.1 months (range, 0.7 to 29.1). Centrally confirmed objective response occurred in 55% of the patients (95% confidence interval [CI], 44 to 65). The median duration of response was 9.3 months (95% CI, 5.7 to 14.7). Median progression-free survival was 8.2 months (95% CI, 6.0 to 11.9), and median overall survival was 17.8 months (95% CI, 13.8 to 22.1). The safety profile was generally consistent with those from previous studies; grade 3 or higher drug-related adverse events occurred in 46% of patients, the most common event being neutropenia (in 19%). Adjudicated drug-related interstitial lung disease occurred in 26% of patients and resulted in death in 2 patients. Responses were observed across different
CONCLUSIONS
Trastuzumab deruxtecan showed durable anticancer activity in patients with previously treated
Identifiants
pubmed: 34534430
doi: 10.1056/NEJMoa2112431
pmc: PMC9066448
mid: NIHMS1781059
doi:
Substances chimiques
Immunoconjugates
0
trastuzumab deruxtecan
5384HK7574
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
Trastuzumab
P188ANX8CK
Camptothecin
XT3Z54Z28A
Banques de données
ClinicalTrials.gov
['NCT03505710']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
241-251Subventions
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA249666
Pays : United States
Investigateurs
Pasi Jänne
(P)
Bob Li
(B)
Gregory Kalemkerian
(G)
Shirish Gadgeel
(S)
Misako Nagasaka
(M)
Christina Baik
(C)
Lyudmila Bazhenova
(L)
Andreas Saltos
(A)
Jose Pacheco
(J)
Saiama Waqar
(S)
Egbert Smit
(E)
Pascale Tomasini
(P)
Fabrice Barlesi
(F)
Julien Mazières
(J)
David Planchard
(D)
Maurice Pérol
(M)
Enriqueta Felip
(E)
Luis Paz-Ares
(L)
Koichi Goto
(K)
Hibiki Udagawa
(H)
Yasushi Goto
(Y)
Yutaka Fujiwara
(Y)
Haruyasu Murakami
(H)
Kazuhiko Nakagawa
(K)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2021 Massachusetts Medical Society.
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