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161. Standard-of-care systemic therapy with or without stereotactic body radiotherapy in patients with oligoprogressive breast cancer or non-small-cell lung cancer (Consolidative Use of Radiotherapy to Block [CURB] oligoprogression): an open-label, randomised, controlled, phase 2 study.
作者: Chiaojung Jillian Tsai.;Jonathan T Yang.;Narek Shaverdian.;Juber Patel.;Annemarie F Shepherd.;Juliana Eng.;David Guttmann.;Randy Yeh.;Daphna Y Gelblum.;Azadeh Namakydoust.;Isabel Preeshagul.;Shanu Modi.;Andrew Seidman.;Tiffany Traina.;Pamela Drullinsky.;Jessica Flynn.;Zhigang Zhang.;Andreas Rimner.;Erin F Gillespie.;Daniel R Gomez.;Nancy Y Lee.;Michael Berger.;Mark E Robson.;Jorge S Reis-Filho.;Nadeem Riaz.;Charles M Rudin.;Simon N Powell.; .
来源: Lancet. 2024年403卷10422期171-182页
Most patients with metastatic cancer eventually develop resistance to systemic therapy, with some having limited disease progression (ie, oligoprogression). We aimed to assess whether stereotactic body radiotherapy (SBRT) targeting oligoprogressive sites could improve patient outcomes.
162. Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial.
作者: Inder Kaul.;Sharon Sawchak.;Christoph U Correll.;Rishi Kakar.;Alan Breier.;Haiyuan Zhu.;Andrew C Miller.;Steven M Paul.;Stephen K Brannan.
来源: Lancet. 2024年403卷10422期160-170页
New treatments with new mechanisms are urgently needed for people with schizophrenia. Xanomeline is a dual M1 and M4-preferring muscarinic receptor agonist that does not block D2 dopamine receptors, unlike all currently approved treatments for schizophrenia. Xanomeline-trospium (KarXT) combines xanomeline with the peripherally restricted muscarinic receptor antagonist trospium chloride with the goal of ameliorating xanomeline-related adverse events associated with peripheral muscarinic receptors. The EMERGENT-2 trial aimed to assess the efficacy and safety of KarXT in people with schizophrenia experiencing acute psychosis.
163. Perinatal morbidity among women with a previous caesarean delivery (PRISMA trial): a cluster-randomised trial.
作者: Nils Chaillet.;Benoît Mâsse.;William A Grobman.;Allison Shorten.;Robert Gauthier.;Patrick Rozenberg.;Marylène Dugas.;Jean-Charles Pasquier.;François Audibert.;Haim A Abenhaim.;Suzanne Demers.;Bruno Piedboeuf.;William D Fraser.;Robert Gagnon.;Guy-Paul Gagné.;Diane Francoeur.;Isabelle Girard.;Louise Duperron.;Marie-Josée Bédard.;Mira Johri.;Eric Dubé.;Simon Blouin.;Thierry Ducruet.;Mario Girard.;Emmanuel Bujold.; .
来源: Lancet. 2024年403卷10421期44-54页
Women with a previous caesarean delivery face a difficult choice in their next pregnancy: planning another caesarean or attempting vaginal delivery, both of which are associated with potential maternal and perinatal complications. This trial aimed to assess whether a multifaceted intervention, which promoted person-centred decision making and best practices, would reduce the risk of major perinatal morbidity among women with one previous caesarean delivery.
164. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study.
作者: David J Jackson.;Liam G Heaney.;Marc Humbert.;Brian D Kent.;Anat Shavit.;Lina Hiljemark.;Lynda Olinger.;David Cohen.;Andrew Menzies-Gow.;Stephanie Korn.; .
来源: Lancet. 2024年403卷10423期271-281页
Stepwise intensification of inhaled corticosteroids (ICS) is routine for severe eosinophilic asthma, despite some poor responses to high-dose ICS. Dose reductions are recommended in patients responding to biologics, but little supporting safety evidence exists.
165. Postoperative radiotherapy omission in selected patients with early breast cancer following preoperative breast MRI (PROSPECT): primary results of a prospective two-arm study.
作者: Gregory Bruce Mann.;Anita Rohini Skandarajah.;Nicholas Zdenkowski.;Janemary Hughes.;Allan Park.;Dennis Petrie.;Karinna Saxby.;Sean M Grimmond.;Anand Murugasu.;Andrew J Spillane.;Boon H Chua.;Heath Badger.;Helen Braggett.;Val Gebski.;Arlene Mou.;John P Collins.;Allison K Rose.
来源: Lancet. 2024年403卷10423期261-270页
Adjuvant breast radiotherapy as a standard component of breast-conserving treatment for early cancer can overtreat many women. Breast MRI is the most sensitive modality to assess local tumour burden. The aim of this study was to determine whether a combination of MRI and pathology findings can identify women with truly localised breast cancer who can safely avoid radiotherapy.
166. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial.
作者: Ana Oaknin.;Laurence Gladieff.;Jerónimo Martínez-García.;Guillermo Villacampa.;Munetaka Takekuma.;Ugo De Giorgi.;Kristina Lindemann.;Linn Woelber.;Nicoletta Colombo.;Linda Duska.;Alexandra Leary.;Ana Godoy-Ortiz.;Shin Nishio.;Antoine Angelergues.;Maria Jesús Rubio.;Lorena Fariñas-Madrid.;Satoshi Yamaguchi.;Domenica Lorusso.;Isabelle Ray-Coquard.;Luis Manso.;Florence Joly.;Jesús Alarcón.;Philippe Follana.;Ignacio Romero.;Coriolan Lebreton.;J Alejandro Pérez-Fidalgo.;Mayu Yunokawa.;Hanna Dahlstrand.;Véronique D'Hondt.;Leslie M Randall.; .
来源: Lancet. 2024年403卷10421期31-43页
The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone.
167. Conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): a UK multicentre, open, parallel-group, randomised clinical trial.
作者: Mark J Peters.;Doug W Gould.;Samiran Ray.;Karen Thomas.;Irene Chang.;Marzena Orzol.;Lauran O'Neill.;Rachel Agbeko.;Carly Au.;Elizabeth Draper.;Lee Elliot-Major.;Elisa Giallongo.;Gareth A L Jones.;Lamprini Lampro.;Jon Lillie.;Jon Pappachan.;Sam Peters.;Padmanabhan Ramnarayan.;Zia Sadique.;Kathryn M Rowan.;David A Harrison.;Paul R Mouncey.; .
来源: Lancet. 2024年403卷10424期355-364页
The optimal target for systemic oxygenation in critically ill children is unknown. Liberal oxygenation is widely practiced, but has been associated with harm in paediatric patients. We aimed to evaluate whether conservative oxygenation would reduce duration of organ support or incidence of death compared to standard care.
168. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Uwe Platzbecker.;Valeria Santini.;Pierre Fenaux.;Mikkael A Sekeres.;Michael R Savona.;Yazan F Madanat.;Maria Díez-Campelo.;David Valcárcel.;Thomas Illmer.;Anna Jonášová.;Petra Bělohlávková.;Laurie J Sherman.;Tymara Berry.;Souria Dougherty.;Sheetal Shah.;Qi Xia.;Libo Sun.;Ying Wan.;Fei Huang.;Annat Ikin.;Shyamala Navada.;Faye Feller.;Rami S Komrokji.;Amer M Zeidan.
来源: Lancet. 2024年403卷10423期249-260页
Unmet medical needs remain in patients with red blood cell transfusion-dependent (RBC-TD) lower-risk myelodysplastic syndromes (LR-MDS) who are not responding to or are ineligible for erythropoiesis-stimulating agents (ESAs). Imetelstat, a competitive telomerase inhibitor, showed promising results in a phase 2 trial. We aimed to compare the RBC transfusion independence (RBC-TI) rate with imetelstat versus placebo in patients with RBC-TD LR-MDS.
169. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials.
作者: Marcus Maurer.;Luis Felipe Ensina.;Ana Maria Gimenez-Arnau.;Gordon Sussman.;Michihiro Hide.;Sarbjit Saini.;Clive Grattan.;Daria Fomina.;Dimitrios Rigopoulos.;Frederic Berard.;Giorgio Walter Canonica.;Heike Rockmann.;Carla Irani.;Jacek C Szepietowski.;Jeffrey Leflein.;Jonathan A Bernstein.;Jonny G Peter.;Kanokvalai Kulthanan.;Kiran Godse.;Ledit Ardusso.;Olga Ukhanova.;Petra Staubach.;Rodney Sinclair.;Shaila Gogate.;Simon Francis Thomsen.;Tonny Tanus.;Young Min Ye.;Alis Burciu.;Avantika Barve.;Darshna Modi.;Emil Scosyrev.;Eva Hua.;Kerstin Letzelter.;Vineeth Varanasi.;Manmath Patekar.;Thomas Severin.; .
来源: Lancet. 2024年403卷10422期147-159页
Many patients with chronic spontaneous urticaria (CSU) do not achieve complete control of their symptoms with current available treatments. In a dose-finding phase 2b study, ligelizumab improved urticaria symptoms in patients with H1-antihistamine (H1-AH) refractory CSU. Here, we report the efficacy and safety outcomes from two ligelizumab phase 3 studies.
170. Type of goals set and progress towards these goals, as part of a behaviour change intervention, in people with mild cognitive impairment: a secondary analysis.
作者: Tasmin Rookes.;Rachael Frost.;Yolanda Barrado-Martin.;Louise Marston.;Claudia Cooper.;Benjamin Gardner.;Megan Armstrong.;Kate Walters.
来源: Lancet. 2023年402 Suppl 1卷S80页
Mild cognitive impairment (MCI) affects 5-20% of older people in the UK, but often goes undiagnosed and is associated with increased risk of dementia. Targeting risk factors such as physical inactivity and social isolation through behaviour-change interventions could reduce this risk. However, it is unclear how MCI impacts engagement with these interventions. We aimed to explore how MCI affects goal-setting priorities and progress towards these goals in a behaviour-change intervention (HomeHealth).
171. A peer-led walking intervention for adolescent girls (the WISH study): a cluster-randomised controlled trial.
作者: Marie H Murphy.;S Maria O'Kane.;Angela Carlin.;Ian M Lahart.;Leanne C Doherty.;Russell Jago.;Gary McDermott.;Maria Faulkner.;Alison M Gallagher.
来源: Lancet. 2023年402 Suppl 1卷S72页
Adolescent girls in the UK and Ireland fail to meet physical activity (PA) guidelines. PA behaviours track from childhood into adulthood. The effects of walking interventions on adult health are known; however, the potential of walking to promote PA in adolescents is less known. This study evaluated the effectiveness of a novel, school-based walking intervention aimed at increasing PA levels of adolescent girls.
172. Enabling health and maintaining independence for older people at home (HomeHealth trial): a multicentre randomised controlled trial.
作者: Rachael Frost.;Christina Avgerinou.;Sarah Kalwarowsky.;Farah Mahmood.;Claire Goodman.;Andrew Clegg.;Jane Hopkins.;Rebecca Gould.;Benjamin Gardner.;Louise Marston.;Rachael Hunter.;Kalpa Kharicha.;Claudia Cooper.;Dawn A Skelton.;Vari Drennan.;Pip Logan.;Kate Walters.
来源: Lancet. 2023年402 Suppl 1卷S42页
NHS frailty services commonly target more severely frail older people, despite evidence suggesting frailty can be prevented or reversed when addressed at an earlier stage. HomeHealth is a new home-based, manualised voluntary sector service supporting older people with mild frailty to maintain their independence through behaviour change. Over six appointments, a trained HomeHealth worker discusses what matters to the older person and supports them to set and achieve goals around mobility, nutrition, socialising and/or psychological wellbeing. The service showed promising effects in a feasibility trial. We aimed to test the clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty compared with treatment as usual.
173. Lessons from the Gateway programme, aimed at improving health and life chances for young people committing low-level offences: a qualitative evaluation.
Young people who commit criminal offences are often affected by mental health issues, including drug and alcohol misuse, with many leading chaotic lifestyles. Gateway was a pioneering court-diversion programme aimed to reduce reoffending and improve the health and wellbeing of people aged 18-24 years who had been questioned for a low-level offence. The Gateway Study consisted of a pragmatic, parallel-group, superiority randomised controlled trial (RCT) of the programme's effectiveness, and its qualitative evaluation. We aimed to determine barriers and enablers for implementation of Gateway and recruitment into the RCT.
174. Evaluation of the impact of letters to GP practices to promote asthma prescription uptake in school-age children during summer (TRAINS study): a pragmatic cluster-randomised controlled trial.
作者: Rami A Alyami.;Rebecca Simpson.;Phillip Oliver.;Steven A Julious.
来源: Lancet. 2023年402 Suppl 1卷S22页
Asthma exacerbations peak in school-aged children after the return to school in September. Previous studies have shown a decline in collections of asthma prescriptions during August. The PLEASANT trial demonstrated that sending a reminder letter to parents increased prescription uptake; reduced unscheduled care, and was cost saving to the health service. We aimed to assess whether informing general practitioner (GP) practices about the PLEASANT trial and its results could lead to its implementation in routine practice.
175. An SMS and animated video intervention to increase uptake of breast cancer screening: a randomised controlled trial.
Breast cancer screening attendance in the UK has fallen, and London has the lowest uptake nationally. This study tested the impact of a behavioural science-informed reminder SMS, and animated video intervention on screening uptake.
176. Goal setting as part of a holistic intervention to promote independence in older people with mild frailty: a process evaluation alongside a randomised controlled trial.
作者: Yolanda Barrado-Martín.;Rachael Frost.;Jessica Catchpole.;Tasmin Rookes.;Sarah Gibson.;Christina Avgerinou.;Benjamin Gardner.;Rebecca Gould.;Paul Chadwick.;Claire Jowett.;Jane Hopkins.;Rashmi Kumar.;Rekha Elaswarapu.;Louise Marston.;Kalpa Kharicha.;Vari M Drennan.;Kate Walters.
来源: Lancet. 2023年402 Suppl 1卷S1页
Frailty is a condition resulting from a decline in physiological reserves caused by an accumulation of several deficits, which progressively impairs the ability to recover from health adverse events. Following a promising feasibility study, the HomeHealth trial assessed a holistic tailored intervention for older adults with mild frailty to promote independence in their own homes, compared with usual care. We aimed to understand how goal setting worked among older people with mild frailty.
177. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA.
作者: David W Dodick.;Peter J Goadsby.;Todd J Schwedt.;Richard B Lipton.;Chengcheng Liu.;Kaifeng Lu.;Sung Yun Yu.;Lawrence Severt.;Michelle Finnegan.;Joel M Trugman.
来源: Lancet. 2023年402卷10419期2307-2316页
Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that is approved for acute treatment of migraine. The prodrome is the earliest phase of a migraine attack and is characterised by non-aura symptoms that precede headache onset. The aim of this trial was to evaluate the efficacy, safety, and tolerability of ubrogepant 100 mg compared with placebo for the acute treatment of migraine when administered during the prodrome.
178. Primaquine radical cure in patients with Plasmodium falciparum malaria in areas co-endemic for P falciparum and Plasmodium vivax (PRIMA): a multicentre, open-label, superiority randomised controlled trial.
作者: Kamala Thriemer.;Tamiru Shibiru Degaga.;Michael Christian.;Mohammad Shafiul Alam.;Megha Rajasekhar.;Benedikt Ley.;Mohammad Sharif Hossain.;Mohammad Golam Kibria.;Tedla Teferi Tego.;Dagamawie Tadesse Abate.;Sophie Weston.;Hellen Mnjala.;Angela Rumaseb.;Ari Winasti Satyagraha.;Arkasha Sadhewa.;Lydia Vista Panggalo.;Lenny L Ekawati.;Grant Lee.;Rodas Temesgen Anose.;Fitsum Getahun Kiros.;Julie A Simpson.;Amalia Karahalios.;Adugna Woyessa.;J Kevin Baird.;Inge Sutanto.;Asrat Hailu.;Ric N Price.
来源: Lancet. 2023年402卷10417期2101-2110页
In areas co-endemic for Plasmodium vivax and Plasmodium falciparum there is an increased risk of P vivax parasitaemia following P falciparum malaria. Radical cure is currently only recommended for patients presenting with P vivax malaria. Expanding the indication for radical cure to patients presenting with P falciparum malaria could reduce their risk of subsequent P vivax parasitaemia.
179. Impact of discontinuing oxytocin in active labour on neonatal morbidity: an open-label, multicentre, randomised trial.
作者: Aude Girault.;Loïc Sentilhes.;Raoul Desbrière.;Paul Berveiller.;Diane Korb.;Charline Bertholdt.;Julie Carrara.;Norbert Winer.;Eric Verspyck.;Eric Boudier.;Tiphaine Barjat.;Gilles Levy.;Georges Emmanuel Roth.;Gilles Kayem.;Mona Massoud.;Caroline Bohec.;Paul Guerby.;Elie Azria.;Julie Blanc.;Hélène Heckenroth.;Jessica Rousseau.;Charles Garabedian.;Camille Le Ray.; .
来源: Lancet. 2023年402卷10417期2091-2100页
Oxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity.
180. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial.
作者: Brad H Rovin.;Jonathan Barratt.;Hiddo J L Heerspink.;Charles E Alpers.;Stewart Bieler.;Dong-Wan Chae.;Ulysses A Diva.;Jürgen Floege.;Loreto Gesualdo.;Jula K Inrig.;Donald E Kohan.;Radko Komers.;Laura Ann Kooienga.;Richard Lafayette.;Bart Maes.;Robert Małecki.;Alex Mercer.;Irene L Noronha.;Se Won Oh.;Chen Au Peh.;Manuel Praga.;Priscila Preciado.;Jai Radhakrishnan.;Michelle N Rheault.;William E Rote.;Sydney C W Tang.;Vladimir Tesar.;Howard Trachtman.;Hernán Trimarchi.;James A Tumlin.;Muh Geot Wong.;Vlado Perkovic.; .
来源: Lancet. 2023年402卷10417期2077-2090页
Sparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.
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