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301. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study.
作者: Arvind Dasari.;Sara Lonardi.;Rocio Garcia-Carbonero.;Elena Elez.;Takayuki Yoshino.;Alberto Sobrero.;James Yao.;Pilar García-Alfonso.;Judit Kocsis.;Antonio Cubillo Gracian.;Andrea Sartore-Bianchi.;Taroh Satoh.;Violaine Randrian.;Jiri Tomasek.;Geoff Chong.;Andrew Scott Paulson.;Toshiki Masuishi.;Jeremy Jones.;Tibor Csőszi.;Chiara Cremolini.;Francois Ghiringhelli.;Ardaman Shergill.;Howard S Hochster.;John Krauss.;Ali Bassam.;Michel Ducreux.;Anneli Elme.;Laurence Faugeras.;Stefan Kasper.;Eric Van Cutsem.;Dirk Arnold.;Shivani Nanda.;Zhao Yang.;William R Schelman.;Marek Kania.;Josep Tabernero.;Cathy Eng.; .
来源: Lancet. 2023年402卷10395期41-53页
There is a paucity of effective systemic therapy options for patients with advanced, chemotherapy-refractory colorectal cancer. We aimed to evaluate the efficacy and safety of fruquintinib, a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (VEGFRs) 1, 2, and 3, in patients with heavily pretreated metastatic colorectal cancer.
302. Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial.
作者: Bruce S Stambler.;A John Camm.;Marco Alings.;Paul Dorian.;Hein Heidbuchel.;Jaco Houtgraaf.;Peter R Kowey.;Jose L Merino.;Blandine Mondésert.;Jonathan P Piccini.;Sean D Pokorney.;Philip T Sager.;Atul Verma.;J Marcus Wharton.;David B Bharucha.;Francis Plat.;Silvia Shardonofsky.;Michael Chen.;James E Ip.; .
来源: Lancet. 2023年402卷10396期118-128页
Etripamil is a fast-acting, intranasally administered calcium-channel blocker in development for on-demand therapy outside a health-care setting for paroxysmal supraventricular tachycardia. We aimed to evaluate the efficacy and safety of etripamil 70 mg nasal spray using a symptom-prompted, repeat-dose regimen for acute conversion of atrioventricular-nodal-dependent paroxysmal supraventricular tachycardia to sinus rhythm within 30 min.
303. Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial.
作者: Martina Schneider.;Marivic Narciso-Abraham.;Sandra Hadl.;Robert McMahon.;Sebastian Toepfer.;Ulrike Fuchs.;Romana Hochreiter.;Annegret Bitzer.;Karin Kosulin.;Julian Larcher-Senn.;Robert Mader.;Katrin Dubischar.;Oliver Zoihsl.;Juan-Carlos Jaramillo.;Susanne Eder-Lingelbach.;Vera Buerger.;Nina Wressnigg.
来源: Lancet. 2023年401卷10394期2138-2147页
VLA1553 is a live-attenuated vaccine candidate for active immunisation and prevention of disease caused by chikungunya virus. We report safety and immunogenicity data up to day 180 after vaccination with VLA1553.
304. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial.
作者: Uwe Platzbecker.;Matteo Giovanni Della Porta.;Valeria Santini.;Amer M Zeidan.;Rami S Komrokji.;Jake Shortt.;David Valcarcel.;Anna Jonasova.;Sophie Dimicoli-Salazar.;Ing Soo Tiong.;Chien-Chin Lin.;Jiahui Li.;Jennie Zhang.;Ana Carolina Giuseppi.;Sandra Kreitz.;Veronika Pozharskaya.;Karen L Keeperman.;Shelonitda Rose.;Jeevan K Shetty.;Sheida Hayati.;Sadanand Vodala.;Thomas Prebet.;Andrius Degulys.;Stefania Paolini.;Thomas Cluzeau.;Pierre Fenaux.;Guillermo Garcia-Manero.
来源: Lancet. 2023年402卷10399期373-385页
Erythropoiesis-stimulating agents (ESAs) are the standard-of-care treatment for anaemia in most patients with lower-risk myelodysplastic syndromes but responses are limited and transient. Luspatercept promotes late-stage erythroid maturation and has shown durable clinical efficacy in patients with lower-risk myelodysplastic syndromes. In this study, we report the results of a prespecified interim analysis of luspatercept versus epoetin alfa for the treatment of anaemia due to lower-risk myelodysplastic syndromes in the phase 3 COMMANDS trial.
305. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial.
作者: Charlotte E Coles.;Joanne S Haviland.;Anna M Kirby.;Clare L Griffin.;Mark A Sydenham.;Jenny C Titley.;Indrani Bhattacharya.;A Murray Brunt.;H Y Charlie Chan.;Ellen M Donovan.;David J Eaton.;Marie Emson.;Penny Hopwood.;Monica L Jefford.;Sara V Lightowlers.;Elinor J Sawyer.;Isabel Syndikus.;Yat M Tsang.;Nicola I Twyman.;John R Yarnold.;Judith M Bliss.; .
来源: Lancet. 2023年401卷10394期2124-2137页
A tumour-bed boost delivered after whole-breast radiotherapy increases local cancer-control rates but requires more patient visits and can increase breast hardness. IMPORT HIGH tested simultaneous integrated boost against sequential boost with the aim of reducing treatment duration while maintaining excellent local control and similar or reduced toxicity.
306. Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): a multicentre, randomised, open-label, phase 3 trial.
作者: Sumanta Kumar Pal.;Laurence Albiges.;Piotr Tomczak.;Cristina Suárez.;Martin H Voss.;Guillermo de Velasco.;Jad Chahoud.;Anastasia Mochalova.;Giuseppe Procopio.;Hakim Mahammedi.;Friedemann Zengerling.;Chan Kim.;Takahiro Osawa.;Martín Angel.;Suyasha Gupta.;Omara Khan.;Guillaume Bergthold.;Bo Liu.;Melania Kalaitzidou.;Mahrukh Huseni.;Christian Scheffold.;Thomas Powles.;Toni K Choueiri.
来源: Lancet. 2023年402卷10397期185-195页
Immune checkpoint inhibitors are the standard of care for first-line treatment of patients with metastatic renal cell carcinoma, yet optimised treatment of patients whose disease progresses after these therapies is unknown. The aim of this study was to determine whether adding atezolizumab to cabozantinib delayed disease progression and prolonged survival in patients with disease progression on or after previous immune checkpoint inhibitor treatment.
307. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial.
作者: Neeraj Agarwal.;Arun A Azad.;Joan Carles.;Andre P Fay.;Nobuaki Matsubara.;Daniel Heinrich.;Cezary Szczylik.;Ugo De Giorgi.;Jae Young Joung.;Peter C C Fong.;Eric Voog.;Robert J Jones.;Neal D Shore.;Curtis Dunshee.;Stefanie Zschäbitz.;Jan Oldenburg.;Xun Lin.;Cynthia G Healy.;Nicola Di Santo.;Fabian Zohren.;Karim Fizazi.
来源: Lancet. 2023年402卷10398期291-303页
Co-inhibition of poly(ADP-ribose) polymerase (PARP) and androgen receptor activity might result in antitumour efficacy irrespective of alterations in DNA damage repair genes involved in homologous recombination repair (HRR). We aimed to compare the efficacy and safety of talazoparib (a PARP inhibitor) plus enzalutamide (an androgen receptor blocker) versus enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC).
308. Heparin for women with recurrent miscarriage and inherited thrombophilia (ALIFE2): an international open-label, randomised controlled trial.
作者: Siobhan Quenby.;Katie Booth.;Louise Hiller.;Arri Coomarasamy.;Paulien G de Jong.;Eva N Hamulyák.;Luuk J Scheres.;Thijs F van Haaps.;Lauren Ewington.;Shreeya Tewary.;Mariëtte Goddijn.;Saskia Middeldorp.; .; .
来源: Lancet. 2023年402卷10395期54-61页
Anticoagulant therapy might reduce the number of miscarriages and adverse pregnancy outcomes in women with recurrent pregnancy loss and inherited thrombophilia. We aimed to assess use of low-molecular-weight heparin (LMWH) versus standard care in this population.
309. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial.
作者: Lu Ma.;Xin Hu.;Lili Song.;Xiaoying Chen.;Menglu Ouyang.;Laurent Billot.;Qiang Li.;Alejandra Malavera.;Xi Li.;Paula Muñoz-Venturelli.;Asita de Silva.;Nguyen Huy Thang.;Kolawole W Wahab.;Jeyaraj D Pandian.;Mohammad Wasay.;Octavio M Pontes-Neto.;Carlos Abanto.;Antonio Arauz.;Haiping Shi.;Guanghai Tang.;Sheng Zhu.;Xiaochun She.;Leibo Liu.;Yuki Sakamoto.;Shoujiang You.;Qiao Han.;Bernard Crutzen.;Emily Cheung.;Yunke Li.;Xia Wang.;Chen Chen.;Feifeng Liu.;Yang Zhao.;Hao Li.;Yi Liu.;Yan Jiang.;Lei Chen.;Bo Wu.;Ming Liu.;Jianguo Xu.;Chao You.;Craig S Anderson.; .
来源: Lancet. 2023年402卷10395期27-40页
Early control of elevated blood pressure is the most promising treatment for acute intracerebral haemorrhage. We aimed to establish whether implementing a goal-directed care bundle incorporating protocols for early intensive blood pressure lowering and management algorithms for hyperglycaemia, pyrexia, and abnormal anticoagulation, implemented in a hospital setting, could improve outcomes for patients with acute spontaneous intracerebral haemorrhage.
310. Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial.
作者: Jasper J Brugts.;Sumant P Radhoe.;Pascal R D Clephas.;Dilan Aydin.;Marco W F van Gent.;Mariusz K Szymanski.;Michiel Rienstra.;Mieke H van den Heuvel.;Carlos A da Fonseca.;Gerard C M Linssen.;C Jan Willem Borleffs.;Eric Boersma.;Folkert W Asselbergs.;Arend Mosterd.;Hans-Peter Brunner-La Rocca.;Rudolf A de Boer.; .
来源: Lancet. 2023年401卷10394期2113-2123页
The effect of haemodynamic monitoring of pulmonary artery pressure has predominantly been studied in the USA. There is a clear need for randomised trial data from patients treated with contemporary guideline-directed-medical-therapy with long-term follow-up in a different health-care system.
311. Conservative management versus tonsillectomy in adults with recurrent acute tonsillitis in the UK (NATTINA): a multicentre, open-label, randomised controlled trial.
作者: Janet A Wilson.;James O'Hara.;Tony Fouweather.;Tara Homer.;Deborah D Stocken.;Luke Vale.;Catherine Haighton.;Nikki Rousseau.;Rebecca Wilson.;Lorraine McSweeney.;Scott Wilkes.;Jill Morrison.;Kenneth MacKenzie.;Kim Ah-See.;Sean Carrie.;Claire Hopkins.;Nicola Howe.;Musheer Hussain.;Hisham Mehanna.;Christopher Raine.;Frank Sullivan.;Alexander von Wilamowitz-Moellendorff.;M Dawn Teare.
来源: Lancet. 2023年401卷10393期2051-2059页
Tonsillectomy is regularly performed in adults with acute tonsillitis, but with scarce evidence. A reduction in tonsillectomies has coincided with an increase in acute adult hospitalisation for tonsillitis complications. We aimed to assess the clinical effectiveness and cost-effectiveness of conservative management versus tonsillectomy in patients with recurrent acute tonsillitis.
312. Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial.
作者: Lindsay Spekreijse.;Rob Simons.;Bjorn Winkens.;Frank van den Biggelaar.;Carmen Dirksen.;Marjolijn Bartels.;Ronald de Crom.;Oege Goslings.;Maurits Joosse.;Jocelyn Kasanardjo.;Peter Lansink.;Theodorus Ponsioen.;Nic Reus.;Jan Schouten.;Rudy Nuijts.
来源: Lancet. 2023年401卷10392期1951-1962页
In an ageing population, efficiency improvements are required to assure future accessibility of cataract care. We aim to address remaining knowledge gaps by evaluating the safety, effectiveness, and cost-effectiveness of immediate sequential bilateral cataract surgery (ISBCS) versus delayed sequential bilateral cataract surgery (DSBCS). We hypothesised that ISBCS is non-inferior to DSBCS, regarding safety and effectiveness, and being superior in cost-effectiveness.
313. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial.
作者: Chantal Mathieu.;Björg Ásbjörnsdóttir.;Harpreet S Bajaj.;Wendy Lane.;Ana Laura S A Matos.;Sreenivasa Murthy.;Karolina Stachlewska.;Julio Rosenstock.
来源: Lancet. 2023年401卷10392期1929-1940页
Insulin icodec (icodec) is a basal insulin analogue suitable for once-weekly dosing. ONWARDS 4 aimed to assess the efficacy and safety of once-weekly icodec compared with once-daily insulin glargine U100 (glargine U100) in individuals with long-standing type 2 diabetes on a basal-bolus regimen.
314. Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial.
作者: Peter Kent.;Terry Haines.;Peter O'Sullivan.;Anne Smith.;Amity Campbell.;Robert Schutze.;Stephanie Attwell.;J P Caneiro.;Robert Laird.;Kieran O'Sullivan.;Alison McGregor.;Jan Hartvigsen.;Den-Ching A Lee.;Alistair Vickery.;Mark Hancock.; .
来源: Lancet. 2023年401卷10391期1866-1877页
Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualised approach that targets unhelpful pain-related cognitions, emotions, and behaviours that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects. We aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain.
315. A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial.
作者: Andrew W Bradbury.;Catherine A Moakes.;Matthew Popplewell.;Lewis Meecham.;Gareth R Bate.;Lisa Kelly.;Ian Chetter.;Athanasios Diamantopoulos.;Arul Ganeshan.;Jack Hall.;Simon Hobbs.;Kim Houlind.;Hugh Jarrett.;Suzanne Lockyer.;Jonas Malmstedt.;Jai V Patel.;Smitaa Patel.;S Tawqeer Rashid.;Athanasios Saratzis.;Gemma Slinn.;D Julian A Scott.;Hany Zayed.;Jonathan J Deeks.; .
来源: Lancet. 2023年401卷10390期1798-1809页
Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion.
316. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Harry P Erba.;Pau Montesinos.;Hee-Je Kim.;Elżbieta Patkowska.;Radovan Vrhovac.;Pavel Žák.;Po-Nan Wang.;Tsvetomir Mitov.;James Hanyok.;Yasser Mostafa Kamel.;Jaime E Connolly Rohrbach.;Li Liu.;Aziz Benzohra.;Arnaud Lesegretain.;Jorge Cortes.;Alexander E Perl.;Mikkael A Sekeres.;Hervé Dombret.;Sergio Amadori.;Jianxiang Wang.;Mark J Levis.;Richard F Schlenk.; .
来源: Lancet. 2023年401卷10388期1571-1583页
Patients with acute myeloid leukaemia (AML) positive for internal tandem duplication (ITD) mutations of FLT3 have poor outcomes. Quizartinib, an oral, highly potent, selective, type 2 FLT3 inhibitor, plus chemotherapy showed antitumour activity with an acceptable safety profile in patients with FLT3-ITD-positive newly diagnosed AML. The aim of the study was to compare the effect of quizartinib versus placebo on overall survival in patients with FLT3-ITD-positive newly diagnosed AML aged 18-75 years.
317. Bariatric-metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial.
作者: Ornella Verrastro.;Simona Panunzi.;Lidia Castagneto-Gissey.;Andrea De Gaetano.;Erminia Lembo.;Esmeralda Capristo.;Caterina Guidone.;Giulia Angelini.;Francesco Pennestrì.;Luca Sessa.;Fabio Maria Vecchio.;Laura Riccardi.;Maria Assunta Zocco.;Ivo Boskoski.;James R Casella-Mariolo.;Pierluigi Marini.;Maurizio Pompili.;Giovanni Casella.;Enrico Fiori.;Francesco Rubino.;Stefan R Bornstein.;Marco Raffaelli.;Geltrude Mingrone.
来源: Lancet. 2023年401卷10390期1786-1797页
Observational studies suggest that bariatric-metabolic surgery might greatly improve non-alcoholic steatohepatitis (NASH). However, the efficacy of surgery on NASH has not yet been compared with the effects of lifestyle interventions and medical therapy in a randomised trial.
318. Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial.
作者: Sant-Rayn Pasricha.;Martin N Mwangi.;Ernest Moya.;Ricardo Ataide.;Glory Mzembe.;Rebecca Harding.;Truwah Zinenani.;Leila M Larson.;Ayse Y Demir.;William Nkhono.;Jobiba Chinkhumba.;Julie A Simpson.;Danielle Clucas.;William Stones.;Sabine Braat.;Kamija S Phiri.
来源: Lancet. 2023年401卷10388期1595-1609页
Anaemia affects 46% of pregnancies in Africa; oral iron is recommended by WHO but uptake and adherence are suboptimal. We tested a single dose of a modern intravenous iron formulation, ferric carboxymaltose, for anaemia treatment in Malawian pregnant women.
320. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial.
作者: Fabrice André.;Yeon Hee Park.;Sung-Bae Kim.;Toshimi Takano.;Seock-Ah Im.;Giuliano Borges.;Joao Paulo Lima.;Sercan Aksoy.;Joaquin Gavila Gregori.;Michelino De Laurentiis.;Giampaolo Bianchini.;Rebecca Roylance.;Yasuo Miyoshi.;Anne Armstrong.;Rajni Sinha.;Manuel Ruiz Borrego.;Elgene Lim.;Johannes Ettl.;Rinat Yerushalmi.;Flora Zagouri.;Francois P Duhoux.;Tanja Fehm.;Dhiraj Gambhire.;Jillian Cathcart.;Cai Wu.;Changan Chu.;Anton Egorov.;Ian Krop.
来源: Lancet. 2023年401卷10390期1773-1785页
In the single-arm, phase 2 DESTINY-Breast01 trial, trastuzumab deruxtecan showed robust activity in patients with HER2-positive metastatic breast cancer who were refractory or resistant to trastuzumab emtansine; a population with scarce effective treatments. In DESTINY-Breast02, we aimed to compare the efficacy and safety of trastuzumab deruxtecan with treatment of physician's choice in this patient population.
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