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001-es BibID:	BIBFORM130526
Első szerző:	Duska, Linda R.
Cím:	Pembrolizumab with chemoradiotherapy in patients with high-risk locally advanced cervical cancer : final analysis results of the phase 3, randomized, double-blind ENGOT-cx11/GOG-3047/KEYNOTE-A18 study / Duska Linda R., Xiang Yang, Hasegawa Kosei, Ramos-Elias Pier Angelo, Valdez Barreto Paolo Rodolfo, Acevedo Alejandro, Cruz Felipe José Silva Melo, Saevets Valeria, Lampé Rudolf, Helpman Limor, Sehouli Jalid, Zagouri Flora, Kim Yong Man, Liu Peng, Yamada Karin Sayuri, Toker Sarper, Pignata Sandro, Lorusso Domenica, ENGOT-cx11/GOG-3047/KEYNOTE-A18 Investigators
Dátum:	2025
ISSN:	0732-183X 1527-7755
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idézhető absztrakt folyóiratcikk
Megjelenés:	Journal Of Clinical Oncology. - 43 : suppl 17 (2025), p. LBA5504. -
További szerzők:	Xiang, Yang Hasegawa, Kosei Ramos-Elias, Pier Valdez Barreto, Paolo Rodolfo Acevedo, Alejandro Cruz, Felipe José Silva Melo Saevets, Valeriya Lampé Rudolf (1983-) (szülész-nőgyógyász) Helpman, Limor Sehouli, Jalid Zagouri, Flora Kim, Yong Man Liu, Peng Yamada, Karin Sayuri Toker, Sarper Pignata, Sandro Lorusso, Domenica ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators
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001-es BibID:	BIBFORM124199
035-os BibID:	(Scopus)85204696439 (WoS)001331531600001
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) : overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial / Lorusso Domenica, Xiang Yang, Hasegawa Kosei, Scambia Giovanni, Leiva Manuel, Ramos-Elias Pier, Acevedo Alejandro, Cvek Jakub, Randall Leslie, Pereira de Santana Gomes Andrea Juliana, Contreras Mejía Fernando, Helpman Limor, Akıllı Hüseyin, Lee Jung-Yun, Saevets Valeriya, Zagouri Flora, Gilbert Lucy, Sehouli Jalid, Tharavichitkul Ekkasit, Lindemann Kristina, Colombo Nicoletta, Chang Chih-Long, Bednarikova Marketa, Zhu Hong, Oaknin Ana, Christiaens Melissa, Petru Edgar, Usami Tomoka, Liu Peng, Yamada Karin, Toker Sarper, Keefe Stephen M., Pignata Sandro, Duska Linda R., ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators
Dátum:	2024
ISSN:	0140-6736
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Lancet. - 404 : 10460 (2024), p. 1321-1332. -
További szerzők:	Xiang, Yang Hasegawa, Kosei Scambia, Giovanni Leiva, Manuel Ramos-Elias, Pier Acevedo, Alejandro Cvek, Jakub Randall, Leslie Pereira de Santana Gomes, Andrea Juliana Contreras Mejía, Fernando Helpman, Limor Akıllı, Hüseyin Lee, Jung-Yun Saevets, Valeriya Zagouri, Flora Gilbert, Lucy Sehouli, Jalid Tharavichitkul, Ekkasit Lindemann, Kristina Colombo, Nicoletta Chang, Chih-Long Bednarikova, Marketa Zhu, Hong Oaknin, Ana Christiaens, Melissa Petru, Edgar Usami, Tomoka Liu, Peng Yamada, Karin Toker, Sarper Keefe, Stephen M. Pignata, Sandro Duska, Linda R. Lampé Rudolf (1983-) (szülész-nőgyógyász) ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators
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001-es BibID:	BIBFORM119637
035-os BibID:	(Scopus)85188577821 (WoS)001226580700001
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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