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1.
001-es BibID:
BIBFORM119637
035-os BibID:
(Scopus)85188577821
Első szerző:
Lorusso, Domenica
Cím:
Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18) : a randomised, double-blind, phase 3 clinical trial / Domenica Lorusso, Yang Xiang, Kosei Hasegawa, Giovanni Scambia, Manuel Leiva, Pier Ramos-Elias, Alejandro Acevedo, Vladyslav Sukhin, Noelle Cloven, Andrea J. Pereira de Santana Gomes, Fernando Contreras Mejía, Ari Reiss, Ali Ayhan, Jung-Yun Lee, Valeriya Saevets, Flora Zagouri, Lucy Gilbert, Jalid Sehouli, Ekkasit Tharavichitkul, Kristina Lindemann, Roberta Lazzari, Chih-Long Chang, Rudolf Lampé, Hong Zhu, Ana Oaknin, Melissa Christiaens, Stephan Polterauer, Tomoka Usami, Kan Li, Karin Yamada, Sarper Toker, Stephen M. Keefe, Sandro Pignata, Linda R. Duska, ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators
Dátum:
2024
Megjegyzések:
Background Pembrolizumab has shown efficacy in persistent, recurrent, or metastatic cervical cancer. The effect of chemoradiotherapy might be enhanced by immunotherapy. In this phase 3 trial, we assessed the efficacy and safety of adding pembrolizumab to chemoradiotherapy in locally advanced cervical cancer. Methods In this randomised, double-blind, placebo-controlled, phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 clinical trial, adults (age ?18 years) at 176 medical centres in 30 countries with newly diagnosed, high-risk, locally advanced cervical cancer were randomly assigned (1:1) using an interactive voice-response system with integrated web response to receive 5 cycles of pembrolizumab (200 mg) or placebo every 3 weeks plus chemoradiotherapy, followed by 15 cycles of pembrolizumab (400 mg) or placebo every 6 weeks. Randomisation was stratified by planned external beam radiotherapy type (intensity-modulated radiotherapy or volumetric-modulated arc therapy vs non-intensity-modulated radiotherapy or non-volumetric-modulated arc therapy), cervical cancer stage at screening (International Federation of Gynecology and Obstetrics 2014 stage IB2?IIB node positive vs stage III?IVA), and planned total radiotherapy (external beam radiotherapy plus brachytherapy) dose (<70 Gy vs ?70 Gy equivalent dose in 2 Gy fractions). Primary endpoints were progression-free survival per Response Evaluation Criteria in Solid Tumours version 1.1?by investigator or by histopathologic confirmation of suspected disease progression?and overall survival. Primary analysis was conducted in the intention-to-treat population, which included all randomly allocated participants. Safety was assessed in the as-treated population, which included all randomly allocated patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT04221945, and is closed to new participants. Findings Between June 9, 2020, and Dec 15, 2022, 1060 participants were randomly assigned to treatment, with 529 assigned to the pembrolizumab?chemoradiotherapy group and 531 to the placebo?chemoradiotherapy group. At data cutoff (Jan 9, 2023), median follow-up was 17?9 months (IQR 11?3?22?3) in both treatment groups. Median progression-free survival was not reached in either group; rates at 24 months were 68% in the pembrolizumab? chemoradiotherapy group versus 57% in the placebo?chemoradiotherapy group. The hazard ratio (HR) for disease progression or death was 0?70 (95% CI 0?55?0?89, p=0?0020), meeting the protocol-specified primary objective. Overall survival at 24 months was 87% in the pembrolizumab?chemoradiotherapy group and 81% in the placebo? chemoradiotherapy group (information fraction 42?9%). The HR for death was 0?73 (0?49?1?07); these data have not crossed the boundary of statistical significance. Grade 3 or higher adverse event rates were 75% in the pembrolizumab? chemoradiotherapy group and 69% in the placebo?chemoradiotherapy group. Interpretation Pembrolizumab plus chemoradiotherapy significantly improved progression-free survival in patients with newly diagnosed, high-risk, locally advanced cervical cancer
Tárgyszavak:
Orvostudományok
Klinikai orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:
The Lancet. - 403 : 10434 (2024), p. 1341-1350. -
További szerzők:
Xiang, Yang
Hasegawa, Kosei
Scambia, Giovanni
Leiva, Manuel
Ramos-Elias, Pier
Acevedo, Alejandro
Sukhin, Vladyslav
Cloven, Noelle
Santana Gomes, Andrea J. Pereira de
Contreras Mejía, Fernando
Reiss, Ari
Ayhan, Ali
Lee, Jung-Yun
Saevets, Valeriya
Zagouri, Flora
Gilbert, Lucy
Sehouli, Jalid
Tharavichitkul, Ekkasit
Lindemann, Kristina
Lazzari, Roberta
Chang, Chih-Long
Lampé Rudolf (1983-) (szülész-nőgyógyász)
Zhu, Hong
Oaknin, Ana
Christiaens, Melissa
Polterauer, Stephan
Usami, Tomoka
Li, Kan
Yamada, Karin
Toker, Sarper
Keefe, Stephen M.
Pignata, Sandro
Duska, Linda R.
ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators
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