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201. Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: an open-label, randomised, phase 2 trial.
作者: Joe Y Chang.;Steven H Lin.;Wenli Dong.;Zhongxing Liao.;Saumil J Gandhi.;Carl M Gay.;Jianjun Zhang.;Stephen G Chun.;Yasir Y Elamin.;Frank V Fossella.;George Blumenschein.;Tina Cascone.;Xiuning Le.;Jenny V Pozadzides.;Anne Tsao.;Vivek Verma.;James W Welsh.;Aileen B Chen.;Mehmet Altan.;Reza J Mehran.;Ara A Vaporciyan.;Stephen G Swisher.;Peter A Balter.;Junya Fujimoto.;Ignacio I Wistuba.;Lei Feng.;J Jack Lee.;John V Heymach.
来源: Lancet. 2023年402卷10405期871-881页
Stereotactic ablative radiotherapy (SABR) is the standard treatment for medically inoperable early-stage non-small-cell lung cancer (NSCLC), but regional or distant relapses, or both, are common. Immunotherapy reduces recurrence and improves survival in people with stage III NSCLC after chemoradiotherapy, but its utility in stage I and II cases is unclear. We therefore conducted a randomised phase 2 trial of SABR alone compared with SABR with immunotherapy (I-SABR) for people with early-stage NSCLC.
202. Adjuvant immunotherapy with nivolumab versus observation in completely resected Merkel cell carcinoma (ADMEC-O): disease-free survival results from a randomised, open-label, phase 2 trial.
作者: Jürgen C Becker.;Selma Ugurel.;Ulrike Leiter.;Friedegund Meier.;Ralf Gutzmer.;Sebastian Haferkamp.;Lisa Zimmer.;Elisabeth Livingstone.;Thomas K Eigentler.;Axel Hauschild.;Felix Kiecker.;Jessica C Hassel.;Peter Mohr.;Michael Fluck.;Ioannis Thomas.;Marlene Garzarolli.;Imke Grimmelmann.;Konstantin Drexler.;Alexandra N Spillner.;Sebastian Eckhardt.;Dirk Schadendorf.; .
来源: Lancet. 2023年402卷10404期798-808页
Merkel cell carcinoma (MCC) is an immunogenic but aggressive skin cancer. Even after complete resection and radiation, relapse rates are high. PD-1 and PD-L1 checkpoint inhibitors showed clinical benefit in advanced MCC. We aimed to assess efficacy and safety of adjuvant immune checkpoint inhibition in completely resected MCC (ie, a setting without an established systemic standard-of-care treatment).
203. Baricitinib in juvenile idiopathic arthritis: an international, phase 3, randomised, double-blind, placebo-controlled, withdrawal, efficacy, and safety trial.
作者: Athimalaipet V Ramanan.;Pierre Quartier.;Nami Okamoto.;Ivan Foeldvari.;Alberto Spindler.;Šárka Fingerhutová.;Jordi Antón.;Zhongkai Wang.;Gabriella Meszaros.;Joana Araújo.;Ran Liao.;Stuart Keller.;Hermine I Brunner.;Nicolino Ruperto.; .; .
来源: Lancet. 2023年402卷10401期555-570页
Juvenile idiopathic arthritis can be refractory to some or all treatment regimens, therefore new medications are needed to treat this population. This trial assessed the efficacy and safety of baricitinib, an oral Janus kinase 1/2-selective inhibitor, versus placebo in patients with juvenile idiopathic arthritis.
204. First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study.
作者: Siow Ming Lee.;Christian Schulz.;Kumar Prabhash.;Dariusz Kowalski.;Aleksandra Szczesna.;Baohui Han.;Achim Rittmeyer.;Toby Talbot.;David Vicente.;Raffaele Califano.;Diego Cortinovis.;Anh Tuan Le.;Dingzhi Huang.;Geoffrey Liu.;Federico Cappuzzo.;Jessica Reyes Contreras.;Martin Reck.;Ramon Palmero.;Milena Perez Mak.;Youyou Hu.;Stefanie Morris.;Elen Höglander.;Mary Connors.;Alice M Biggane.;Hans Kristian Vollan.;Solange Peters.
来源: Lancet. 2023年402卷10400期451-463页
Despite immunotherapy advancements for patients with advanced or metastatic non-small-cell lung cancer (NSCLC), pivotal first-line trials were limited to patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 and a median age of 65 years or younger. We aimed to compare the efficacy and safety of first-line atezolizumab monotherapy with single-agent chemotherapy in patients ineligible for platinum-based chemotherapy.
205. Planned delivery or expectant management for late preterm pre-eclampsia in low-income and middle-income countries (CRADLE-4): a multicentre, open-label, randomised controlled trial.
作者: Alice Beardmore-Gray.;Nicola Vousden.;Paul T Seed.;Bellington Vwalika.;Sebastian Chinkoyo.;Victor Sichone.;Alexander B Kawimbe.;Umesh Charantimath.;Geetanjali Katageri.;Mrutyunjaya B Bellad.;Laxmikant Lokare.;Kasturi Donimath.;Shailaja Bidri.;Shivaprasad Goudar.;Jane Sandall.;Lucy C Chappell.;Andrew H Shennan.; .
来源: Lancet. 2023年402卷10399期386-396页
Pre-eclampsia is a leading cause of maternal and perinatal mortality. Evidence regarding interventions in a low-income or middle-income setting is scarce. We aimed to evaluate whether planned delivery between 34+ 0 and 36+ 6 weeks' gestation can reduce maternal mortality and morbidity without increasing perinatal complications in India and Zambia.
206. Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial.
作者: Caitlin M P Jones.;Richard O Day.;Bart W Koes.;Jane Latimer.;Chris G Maher.;Andrew J McLachlan.;Laurent Billot.;Sana Shan.;Chung-Wei Christine Lin.; .
来源: Lancet. 2023年402卷10398期304-312页
Opioid analgesics are commonly used for acute low back pain and neck pain, but supporting efficacy data are scarce. We aimed to investigate the efficacy and safety of a judicious short course of an opioid analgesic for acute low back pain and neck pain.
207. Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA.
作者: Julio Rosenstock.;Juan Frias.;Ania M Jastreboff.;Yu Du.;Jitong Lou.;Sirel Gurbuz.;Melissa K Thomas.;Mark L Hartman.;Axel Haupt.;Zvonko Milicevic.;Tamer Coskun.
来源: Lancet. 2023年402卷10401期529-544页
According to current consensus guidelines for type 2 diabetes management, bodyweight management is as important as attaining glycaemic targets. Retatrutide, a single peptide with agonist activity at the glucose-dependent insulinotropic polypeptide (GIP), GLP-1, and glucagon receptors, showed clinically meaningful glucose-lowering and bodyweight-lowering efficacy in a phase 1 study. We aimed to examine the efficacy and safety of retatrutide in people with type 2 diabetes across a range of doses.
208. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial.
作者: Vanita R Aroda.;Jens Aberle.;Lars Bardtrum.;Erik Christiansen.;Filip K Knop.;Sanaz Gabery.;Sue D Pedersen.;John B Buse.
来源: Lancet. 2023年402卷10403期693-704页
Once-daily oral semaglutide is an effective type 2 diabetes treatment. We aimed to investigate a new formulation of oral semaglutide at higher investigational doses versus the approved 14 mg dose in adults with inadequately controlled type 2 diabetes.
209. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Filip K Knop.;Vanita R Aroda.;Ruben D do Vale.;Thomas Holst-Hansen.;Peter N Laursen.;Julio Rosenstock.;Domenica M Rubino.;W Timothy Garvey.; .
来源: Lancet. 2023年402卷10403期705-719页
We assessed the efficacy and safety of the oral glucagon-like peptide-1 analogue, semaglutide 50 mg, taken once per day versus placebo for the treatment of overweight or obesity in adults without type 2 diabetes.
210. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.
作者: W Timothy Garvey.;Juan P Frias.;Ania M Jastreboff.;Carel W le Roux.;Naveed Sattar.;Diego Aizenberg.;Huzhang Mao.;Shuyu Zhang.;Nadia N Ahmad.;Mathijs C Bunck.;Imane Benabbad.;Xiaotian M Zhang.; .
来源: Lancet. 2023年402卷10402期613-626页
Weight reduction is essential for improving health outcomes in people with obesity and type 2 diabetes. We assessed the efficacy and safety of tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, versus placebo, for weight management in people living with obesity and type 2 diabetes.
211. Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study.
作者: Juan P Frias.;Stanley Hsia.;Sarah Eyde.;Rong Liu.;Xiaosu Ma.;Manige Konig.;Christof Kazda.;Kieren J Mather.;Axel Haupt.;Edward Pratt.;Deborah Robins.
来源: Lancet. 2023年402卷10400期472-483页
Orforglipron, an oral, non-peptide glucagon-like peptide-1 (GLP-1) receptor agonist, is in development for type 2 diabetes and obesity. We assessed the efficacy and safety of orforglipron versus placebo or dulaglutide in participants with type 2 diabetes.
212. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.
作者: Juan P Frias.;Srikanth Deenadayalan.;Lars Erichsen.;Filip K Knop.;Ildiko Lingvay.;Stanislava Macura.;Chantal Mathieu.;Sue D Pedersen.;Melanie Davies.
来源: Lancet. 2023年402卷10403期720-730页
Combining the GLP-1 receptor agonist semaglutide with the long-acting amylin analogue cagrilintide has weight-loss benefits; the impact on glycated haemoglobin (HbA1c) is unknown. This trial assessed the efficacy and safety of co-administered semaglutide with cagrilintide (CagriSema) in participants with type 2 diabetes.
213. High-dose dual-antibiotic loaded cement for hip hemiarthroplasty in the UK (WHiTE 8): a randomised controlled trial.
作者: Nickil R Agni.;Matthew L Costa.;Juul Achten.;Nicholas Peckham.;Susan J Dutton.;May Ee Png.;Mike R Reed.; .
来源: Lancet. 2023年402卷10397期196-202页
Hip fracture is the most common injury requiring treatment in hospital. Controversy exists regarding the use of antibiotic loaded bone cement in hip fractures treated with hemiarthroplasty. We aimed to compare the rate of deep surgical site infection in patients receiving high-dose dual-antibiotic loaded cement versus standard care single-antibiotic loaded cement.
214. Balanced crystalloid solution versus saline in deceased donor kidney transplantation (BEST-Fluids): a pragmatic, double-blind, randomised, controlled trial.
作者: Michael G Collins.;Magid A Fahim.;Elaine M Pascoe.;Carmel M Hawley.;David W Johnson.;Julie Varghese.;Laura E Hickey.;Philip A Clayton.;Kathryn B Dansie.;Rachael C McConnochie.;Liza A Vergara.;Charani Kiriwandeniya.;Donna Reidlinger.;Peter F Mount.;Laurence Weinberg.;Colin J McArthur.;P Toby Coates.;Zoltan H Endre.;David Goodman.;Kirsten Howard.;Martin Howell.;Jagadish S Jamboti.;John Kanellis.;Jerome M Laurence.;Wai H Lim.;Steven J McTaggart.;Philip J O'Connell.;Helen L Pilmore.;Germaine Wong.;Steven J Chadban.; .; .
来源: Lancet. 2023年402卷10396期105-117页
Delayed graft function (DGF) is a major adverse complication of deceased donor kidney transplantation. Intravenous fluids are routinely given to patients receiving a transplant to maintain intravascular volume and optimise graft function. Saline (0·9% sodium chloride) is widely used but might increase the risk of DGF due to its high chloride content. We aimed to test our hypothesis that using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline would reduce the incidence of DGF.
215. 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.
216. 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.
217. 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.
218. 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.
219. 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.
220. 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.
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