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1. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial.
作者: Nicholas D James.;Matthew R Sydes.;Noel W Clarke.;Malcolm D Mason.;David P Dearnaley.;Melissa R Spears.;Alastair W S Ritchie.;Christopher C Parker.;J Martin Russell.;Gerhardt Attard.;Johann de Bono.;William Cross.;Rob J Jones.;George Thalmann.;Claire Amos.;David Matheson.;Robin Millman.;Mymoona Alzouebi.;Sharon Beesley.;Alison J Birtle.;Susannah Brock.;Richard Cathomas.;Prabir Chakraborti.;Simon Chowdhury.;Audrey Cook.;Tony Elliott.;Joanna Gale.;Stephanie Gibbs.;John D Graham.;John Hetherington.;Robert Hughes.;Robert Laing.;Fiona McKinna.;Duncan B McLaren.;Joe M O'Sullivan.;Omi Parikh.;Clive Peedell.;Andrew Protheroe.;Angus J Robinson.;Narayanan Srihari.;Rajaguru Srinivasan.;John Staffurth.;Santhanam Sundar.;Shaun Tolan.;David Tsang.;John Wagstaff.;Mahesh K B Parmar.; .
来源: Lancet. 2016年387卷10024期1163-77页
Long-term hormone therapy has been the standard of care for advanced prostate cancer since the 1940s. STAMPEDE is a randomised controlled trial using a multiarm, multistage platform design. It recruits men with high-risk, locally advanced, metastatic or recurrent prostate cancer who are starting first-line long-term hormone therapy. We report primary survival results for three research comparisons testing the addition of zoledronic acid, docetaxel, or their combination to standard of care versus standard of care alone.
2. Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial.
作者: Gérard Zalcman.;Julien Mazieres.;Jacques Margery.;Laurent Greillier.;Clarisse Audigier-Valette.;Denis Moro-Sibilot.;Olivier Molinier.;Romain Corre.;Isabelle Monnet.;Valérie Gounant.;Frédéric Rivière.;Henri Janicot.;Radj Gervais.;Chrystèle Locher.;Bernard Milleron.;Quan Tran.;Marie-Paule Lebitasy.;Franck Morin.;Christian Creveuil.;Jean-Jacques Parienti.;Arnaud Scherpereel.; .
来源: Lancet. 2016年387卷10026期1405-1414页
Malignant pleural mesothelioma is an aggressive cancer with poor prognosis, linked to occupational asbestos exposure. Vascular endothelial growth factor is a key mitogen for malignant pleural mesothelioma cells, therefore targeting of vascular endothelial growth factor might prove effective. We aimed to assess the effect on survival of bevacizumab when added to the present standard of care, cisplatin plus pemetrexed, as first-line treatment of advanced malignant pleural mesothelioma.
3. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial.
作者: Roy S Herbst.;Paul Baas.;Dong-Wan Kim.;Enriqueta Felip.;José L Pérez-Gracia.;Ji-Youn Han.;Julian Molina.;Joo-Hang Kim.;Catherine Dubos Arvis.;Myung-Ju Ahn.;Margarita Majem.;Mary J Fidler.;Gilberto de Castro.;Marcelo Garrido.;Gregory M Lubiniecki.;Yue Shentu.;Ellie Im.;Marisa Dolled-Filhart.;Edward B Garon.
来源: Lancet. 2016年387卷10027期1540-1550页
Despite recent advances in the treatment of advanced non-small-cell lung cancer, there remains a need for effective treatments for progressive disease. We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer.
4. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial.
作者: Ian J Jacobs.;Usha Menon.;Andy Ryan.;Aleksandra Gentry-Maharaj.;Matthew Burnell.;Jatinderpal K Kalsi.;Nazar N Amso.;Sophia Apostolidou.;Elizabeth Benjamin.;Derek Cruickshank.;Danielle N Crump.;Susan K Davies.;Anne Dawnay.;Stephen Dobbs.;Gwendolen Fletcher.;Jeremy Ford.;Keith Godfrey.;Richard Gunu.;Mariam Habib.;Rachel Hallett.;Jonathan Herod.;Howard Jenkins.;Chloe Karpinskyj.;Simon Leeson.;Sara J Lewis.;William R Liston.;Alberto Lopes.;Tim Mould.;John Murdoch.;David Oram.;Dustin J Rabideau.;Karina Reynolds.;Ian Scott.;Mourad W Seif.;Aarti Sharma.;Naveena Singh.;Julie Taylor.;Fiona Warburton.;Martin Widschwendter.;Karin Williamson.;Robert Woolas.;Lesley Fallowfield.;Alistair J McGuire.;Stuart Campbell.;Mahesh Parmar.;Steven J Skates.
来源: Lancet. 2016年387卷10022期945-956页
Ovarian cancer has a poor prognosis, with just 40% of patients surviving 5 years. We designed this trial to establish the effect of early detection by screening on ovarian cancer mortality.
5. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study.
作者: James C Yao.;Nicola Fazio.;Simron Singh.;Roberto Buzzoni.;Carlo Carnaghi.;Edward Wolin.;Jiri Tomasek.;Markus Raderer.;Harald Lahner.;Maurizio Voi.;Lida Bubuteishvili Pacaud.;Nicolas Rouyrre.;Carolin Sachs.;Juan W Valle.;Gianfranco Delle Fave.;Eric Van Cutsem.;Margot Tesselaar.;Yasuhiro Shimada.;Do-Youn Oh.;Jonathan Strosberg.;Matthew H Kulke.;Marianne E Pavel.; .
来源: Lancet. 2016年387卷10022期968-977页
Effective systemic therapies for patients with advanced, progressive neuroendocrine tumours of the lung or gastrointestinal tract are scarce. We aimed to assess the efficacy and safety of everolimus compared with placebo in this patient population.
6. Patient-reported outcomes with anastrozole versus tamoxifen for postmenopausal patients with ductal carcinoma in situ treated with lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial.
作者: Patricia A Ganz.;Reena S Cecchini.;Thomas B Julian.;Richard G Margolese.;Joseph P Costantino.;Laura A Vallow.;Kathy S Albain.;Patrick W Whitworth.;Mary E Cianfrocca.;Adam M Brufsky.;Howard M Gross.;Gamini S Soori.;Judith O Hopkins.;Louis Fehrenbacher.;Keren Sturtz.;Timothy F Wozniak.;Thomas E Seay.;Eleftherios P Mamounas.;Norman Wolmark.
来源: Lancet. 2016年387卷10021期857-65页
The NSABP B-35 trial compared 5 years of treatment with anastrozole versus tamoxifen for reducing subsequent occurrence of breast cancer in postmenopausal patients with ductal carcinoma in situ. This report assesses the effect of these drugs on quality of life and symptoms.
7. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial.
作者: Richard G Margolese.;Reena S Cecchini.;Thomas B Julian.;Patricia A Ganz.;Joseph P Costantino.;Laura A Vallow.;Kathy S Albain.;Patrick W Whitworth.;Mary E Cianfrocca.;Adam M Brufsky.;Howard M Gross.;Gamini S Soori.;Judith O Hopkins.;Louis Fehrenbacher.;Keren Sturtz.;Timothy F Wozniak.;Thomas E Seay.;Eleftherios P Mamounas.;Norman Wolmark.
来源: Lancet. 2016年387卷10021期849-56页
Ductal carcinoma in situ is currently managed with excision, radiotherapy, and adjuvant hormone therapy, usually tamoxifen. We postulated that an aromatase inhibitor would be safer and more effective. We therefore undertook this trial to compare anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy.
8. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial.
作者: John F Forbes.;Ivana Sestak.;Anthony Howell.;Bernardo Bonanni.;Nigel Bundred.;Christelle Levy.;Gunter von Minckwitz.;Wolfgang Eiermann.;Patrick Neven.;Michael Stierer.;Chris Holcombe.;Robert E Coleman.;Louise Jones.;Ian Ellis.;Jack Cuzick.; .
来源: Lancet. 2016年387卷10021期866-73页
Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-receptor-positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole with that of tamoxifen in postmenopausal women with hormone-receptor-positive DCIS.
9. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial.
作者: Johan A Maertens.;Issam I Raad.;Kieren A Marr.;Thomas F Patterson.;Dimitrios P Kontoyiannis.;Oliver A Cornely.;Eric J Bow.;Galia Rahav.;Dionysios Neofytos.;Mickael Aoun.;John W Baddley.;Michael Giladi.;Werner J Heinz.;Raoul Herbrecht.;William Hope.;Meinolf Karthaus.;Dong-Gun Lee.;Olivier Lortholary.;Vicki A Morrison.;Ilana Oren.;Dominik Selleslag.;Shmuel Shoham.;George R Thompson.;Misun Lee.;Rochelle M Maher.;Anne-Hortense Schmitt-Hoffmann.;Bernhardt Zeiher.;Andrew J Ullmann.
来源: Lancet. 2016年387卷10020期760-9页
Isavuconazole is a novel triazole with broad-spectrum antifungal activity. The SECURE trial assessed efficacy and safety of isavuconazole versus voriconazole in patients with invasive mould disease.
10. Effects of evidence-based strategies to reduce the socioeconomic gradient of uptake in the English NHS Bowel Cancer Screening Programme (ASCEND): four cluster-randomised controlled trials.
作者: Jane Wardle.;Christian von Wagner.;Ines Kralj-Hans.;Stephen P Halloran.;Samuel G Smith.;Lesley M McGregor.;Gemma Vart.;Rosemary Howe.;Julia Snowball.;Graham Handley.;Richard F Logan.;Sandra Rainbow.;Steve Smith.;Mary C Thomas.;Nicholas Counsell.;Steve Morris.;Stephen W Duffy.;Allan Hackshaw.;Sue Moss.;Wendy Atkin.;Rosalind Raine.
来源: Lancet. 2016年387卷10020期751-9页
Uptake in the national colorectal cancer screening programme in England varies by socioeconomic status. We assessed four interventions aimed at reducing this gradient, with the intention of improving the health benefits of screening.
11. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study.
作者: Martin Dreyling.;Wojciech Jurczak.;Mats Jerkeman.;Rodrigo Santucci Silva.;Chiara Rusconi.;Marek Trneny.;Fritz Offner.;Dolores Caballero.;Cristina Joao.;Mathias Witzens-Harig.;Georg Hess.;Isabelle Bence-Bruckler.;Seok-Goo Cho.;John Bothos.;Jenna D Goldberg.;Christopher Enny.;Shana Traina.;Sriram Balasubramanian.;Nibedita Bandyopadhyay.;Steven Sun.;Jessica Vermeulen.;Aleksandra Rizo.;Simon Rule.
来源: Lancet. 2016年387卷10020期770-8页
Mantle-cell lymphoma is an aggressive B-cell lymphoma with a poor prognosis. Both ibrutinib and temsirolimus have shown single-agent activity in patients with relapsed or refractory mantle-cell lymphoma. We undertook a phase 3 study to assess the efficacy and safety of ibrutinib versus temsirolimus in relapsed or refractory mantle-cell lymphoma.
12. Hydroxycarbamide versus chronic transfusion for maintenance of transcranial doppler flow velocities in children with sickle cell anaemia-TCD With Transfusions Changing to Hydroxyurea (TWiTCH): a multicentre, open-label, phase 3, non-inferiority trial.
作者: Russell E Ware.;Barry R Davis.;William H Schultz.;R Clark Brown.;Banu Aygun.;Sharada Sarnaik.;Isaac Odame.;Beng Fuh.;Alex George.;William Owen.;Lori Luchtman-Jones.;Zora R Rogers.;Lee Hilliard.;Cynthia Gauger.;Connie Piccone.;Margaret T Lee.;Janet L Kwiatkowski.;Sherron Jackson.;Scott T Miller.;Carla Roberts.;Matthew M Heeney.;Theodosia A Kalfa.;Stephen Nelson.;Hamayun Imran.;Kerri Nottage.;Ofelia Alvarez.;Melissa Rhodes.;Alexis A Thompson.;Jennifer A Rothman.;Kathleen J Helton.;Donna Roberts.;Jamie Coleman.;Melanie J Bonner.;Abdullah Kutlar.;Niren Patel.;John Wood.;Linda Piller.;Peng Wei.;Judy Luden.;Nicole A Mortier.;Susan E Stuber.;Naomi L C Luban.;Alan R Cohen.;Sara Pressel.;Robert J Adams.
来源: Lancet. 2016年387卷10019期661-670页
For children with sickle cell anaemia and high transcranial doppler (TCD) flow velocities, regular blood transfusions can effectively prevent primary stroke, but must be continued indefinitely. The efficacy of hydroxycarbamide (hydroxyurea) in this setting is unknown; we performed the TWiTCH trial to compare hydroxyurea with standard transfusions.
13. Prednisone versus prednisone plus ciclosporin versus prednisone plus methotrexate in new-onset juvenile dermatomyositis: a randomised trial.
作者: Nicolino Ruperto.;Angela Pistorio.;Sheila Oliveira.;Francesco Zulian.;Ruben Cuttica.;Angelo Ravelli.;Michel Fischbach.;Bo Magnusson.;Gary Sterba.;Tadej Avcin.;Karine Brochard.;Fabrizia Corona.;Frank Dressler.;Valeria Gerloni.;Maria T Apaz.;Claudia Bracaglia.;Adriana Cespedes-Cruz.;Rolando Cimaz.;Gerard Couillault.;Rik Joos.;Pierre Quartier.;Ricardo Russo.;Marc Tardieu.;Nico Wulffraat.;Blanca Bica.;Pavla Dolezalova.;Virginia Ferriani.;Berit Flato.;Ana G Bernard-Medina.;Troels Herlin.;Maria Trachana.;Antonella Meini.;Emma Allain-Launay.;Clarissa Pilkington.;Veronika Vargova.;Carine Wouters.;Simona Angioloni.;Alberto Martini.; .
来源: Lancet. 2016年387卷10019期671-678页
Most data for treatment of dermatomyositis and juvenile dermatomyositis are from anecdotal, non-randomised case series. We aimed to compare, in a randomised trial, the efficacy and safety of prednisone alone with that of prednisone plus either methotrexate or ciclosporin in children with new-onset juvenile dermatomyositis.
14. Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial.
作者: Kate Costeloe.;Pollyanna Hardy.;Edmund Juszczak.;Mark Wilks.;Michael R Millar.; .
来源: Lancet. 2016年387卷10019期649-660页
Probiotics may reduce necrotising enterocolitis and late-onset sepsis after preterm birth. However, there has been concern about the rigour and generalisability of some trials and there is no agreement about whether or not they should be used routinely. We aimed to test the effectiveness of the probiotic Bifidobacterium breve BBG-001 to reduce necrotising enterocolitis, late-onset sepsis, and death in preterm infants.
15. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial.
作者: Andrea Wang-Gillam.;Chung-Pin Li.;György Bodoky.;Andrew Dean.;Yan-Shen Shan.;Gayle Jameson.;Teresa Macarulla.;Kyung-Hun Lee.;David Cunningham.;Jean F Blanc.;Richard A Hubner.;Chang-Fang Chiu.;Gilberto Schwartsmann.;Jens T Siveke.;Fadi Braiteh.;Victor Moyo.;Bruce Belanger.;Navreet Dhindsa.;Eliel Bayever.;Daniel D Von Hoff.;Li-Tzong Chen.; .
来源: Lancet. 2016年387卷10018期545-557页
Nanoliposomal irinotecan showed activity in a phase 2 study in patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapies. We assessed the effect of nanoliposomal irinotecan alone or combined with fluorouracil and folinic acid in a phase 3 trial in this population.
16. Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study.
作者: Matthew James Armstrong.;Piers Gaunt.;Guruprasad P Aithal.;Darren Barton.;Diana Hull.;Richard Parker.;Jonathan M Hazlehurst.;Kathy Guo.; .;George Abouda.;Mark A Aldersley.;Deborah Stocken.;Stephen C Gough.;Jeremy W Tomlinson.;Rachel M Brown.;Stefan G Hübscher.;Philip N Newsome.
来源: Lancet. 2016年387卷10019期679-690页
Glucagon-like peptide-1 (GLP-1) analogues reduce hepatic steatosis, concentrations of liver enzymes, and insulin resistance in murine models of fatty liver disease. These analogues are licensed for type 2 diabetes, but their efficacy in patients with non-alcoholic steatohepatitis is unknown. We assessed the safety and efficacy of the long-acting GLP-1 analogue, liraglutide, in patients with non-alcoholic steatohepatitis.
17. Extended pre-exposure prophylaxis with lopinavir-ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial.
作者: Nicolas Nagot.;Chipepo Kankasa.;James K Tumwine.;Nicolas Meda.;G Justus Hofmeyr.;Roselyne Vallo.;Mwiya Mwiya.;Mary Kwagala.;Hugues Traore.;Amwe Sunday.;Mandisa Singata.;Chafye Siuluta.;Eric Some.;David Rutagwera.;Desire Neboua.;Grace Ndeezi.;Debra Jackson.;Valérie Maréchal.;Dorine Neveu.;Ingunn M S Engebretsen.;Carl Lombard.;Stéphane Blanche.;Halvor Sommerfelt.;Claire Rekacewicz.;Thorkild Tylleskär.;Philippe Van de Perre.; .
来源: Lancet. 2016年387卷10018期566-573页
Strategies to prevent postnatal mother-to-child transmission of HIV-1 in Africa, including infant prophylaxis, have never been assessed past 6 months of breastfeeding, despite breastfeeding being recommended up to 12 months after birth. We aimed to compare the efficacy and safety of infant prophylaxis with the two drug regimens (lamivudine or lopinavir-ritonavir) to prevent postnatal HIV-1 transmission up to 50 weeks of breastfeeding.
18. Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial.
作者: Jonathan M Morris.;Christine L Roberts.;Jennifer R Bowen.;Jillian A Patterson.;Diana M Bond.;Charles S Algert.;Jim G Thornton.;Caroline A Crowther.; .
来源: Lancet. 2016年387卷10017期444-52页
Preterm pre-labour ruptured membranes close to term is associated with increased risk of neonatal infection, but immediate delivery is associated with risks of prematurity. The balance of risks is unclear. We aimed to establish whether immediate birth in singleton pregnancies with ruptured membranes close to term reduces neonatal infection without increasing other morbidity.
19. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial.
作者: William T Abraham.;Lynne W Stevenson.;Robert C Bourge.;Jo Ann Lindenfeld.;Jordan G Bauman.;Philip B Adamson.; .
来源: Lancet. 2016年387卷10017期453-61页
In the CHAMPION trial, significant reductions in admissions to hospital for heart failure were seen after 6 months of pulmonary artery pressure guided management compared with usual care. We examine the extended efficacy of this strategy over 18 months of randomised follow-up and the clinical effect of open access to pressure information for an additional 13 months in patients formerly in the control group.
20. Sensitivity and specificity of mammography and adjunctive ultrasonography to screen for breast cancer in the Japan Strategic Anti-cancer Randomized Trial (J-START): a randomised controlled trial.
作者: Noriaki Ohuchi.;Akihiko Suzuki.;Tomotaka Sobue.;Masaaki Kawai.;Seiichiro Yamamoto.;Ying-Fang Zheng.;Yoko Narikawa Shiono.;Hiroshi Saito.;Shinichi Kuriyama.;Eriko Tohno.;Tokiko Endo.;Akira Fukao.;Ichiro Tsuji.;Takuhiro Yamaguchi.;Yasuo Ohashi.;Mamoru Fukuda.;Takanori Ishida.; .
来源: Lancet. 2016年387卷10016期341-348页
Mammography is the only proven method for breast cancer screening that reduces mortality, although it is inaccurate in young women or women with dense breasts. We investigated the efficacy of adjunctive ultrasonography.
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