4 research outputs found
Phase II randomised discontinuation trial of brivanib in patients with advanced solid tumours
- Author
- Abdul Razak A.R. (Albiruni R.)
- Awada A. (Ahmad)
- Baurain J.F.
- Bedard P.L. (Philippe L.)
- Brockstein B. (Bruce)
- D'Adamo D. (David)
- de Vos-Geelen J. (Judith)
- DeGreve J. (Jacques)
- DeJonge M.J.A. (Maja J.)
- Dickson M.A. (Mark A.)
- Evans T.R.J. (Jeffry)
- Geary D. (David)
- Janisch L. (Linda)
- Jassem J.
- Jones R.L. (Robin L.)
- Kaye S.B. (Stan B.)
- Khayat D. (David)
- Kristeleit R.S. (R.)
- Maki R.G. (Robert G.)
- Medioni J. (Jacques)
- O'Dwyer P.J. (Peter J.)
- Obel J. (Jennifer)
- Ratain M.J. (Mark)
- Rudin C.M. (Charles)
- Sawyer M. (Michael)
- Schwartz G. (Gary)
- Siu R.K. (Ronald)
- Undevia S. (Samir)
- Vitfell-Rasmussen J. (Joanna)
- Walters I. (Ian)
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/10/2019
- Field of study
Background: Brivanib is a selective inhibitor of vascular endothelial growth factor and fibroblast growth factor (FGF) signalling. We performed a phase II randomised discontinuation trial of brivanib in 7 tumour types (soft-tissue sarcomas [STS], ovarian cancer, breast cancer, pancreatic cancer, non-small-cell lung cancer [NSCLC], gastric/esophageal cancer and transitional cell carcinoma [TCC]). Patients and methods: During a 12-week open-label lead-in period, patients received brivanib 800 mg daily and were evaluated for FGF2 status by immunohistochemistry. Patients with stable disease at week 12 were randomised to brivanib or placebo. A study steering committee evaluated week 12 response to determine if enrolment in a tumour type would continue. The primary objective was progression-free survival (PFS) for brivanib versus placebo in patients with FGF2-positive tumours. Results: A total of 595 patients were treated, and stable disease was observed at the week 12 randomisation point in all tumour types. Closure decisions were made for breast cancer, pancreatic cancer, NSCLC, gastric cancer and TCC. Criteria for expansion were met for STS and ovarian cancer. In 53 randomised patients with STS and FGF2-positive tumours, the median PFS was 2.8 months for brivanib and 1.4 months for placebo (hazard ratio [HR]: 0.58, p = 0.08). For all randomised patients with sarcomas, the median PFS was 2.8 months (95% confidence interval [CI]: 1.4–4.0) for those treated with brivanib compared with 1.4 months (95% CI: 1.3–1.6) for placebo (HR = 0.64, 95% CI: 0.38–1.07; p = 0.09). In the 36 randomised patients with ovarian cancer and FGF2-positive tumours, the median PFS was 4.0 (95% CI: 2.6–4.2) months for brivanib and 2.0 months (95% CI: 1.2–2.7) for placebo (HR: 0.56, 95% CI: 0.26–1.22). For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6–4.2) and was 2.0 months (95% CI: 1.2–2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25–1.17; p = 0.11). Conclusion: Brivanib demonstrated activity in STS and ovarian cancer with an acceptable safety profile. FGF2 expression, as defined in the protocol, is not a predictive biomarker of the efficacy of brivanib
Predicting the difficult laparoscopic cholecystectomy: development and validation of a pre-operative risk score using an objective operative difficulty grading system
- Author
- Aawsaj Y.
- Abayomi M.
- Acharya V.
- Aggarwal S.K.
- Ahmad A.
- Ahmed I.
- Ahmed J.
- Ahmed J.
- Ahmed T.
- Ainley P.
- Akhtar M.
- Al Amari K.
- Al-Abed Y.A.
- Al-Akash M.
- Al-Bahrani A.Z.
- Al-Khyatt W.
- Al-Muhktar A.
- Al-Sarireh B.
- Al-Taan O.
- Alagaratnam S.
- Alam I.
- Alberts J.
- Alderson D.
- Aldridge R.C.
- Aleksandrov D.
- Ali H.
- Ali S.
- Amin K.
- Andrew D.R.
- Appleton S.
- Arhi C.
- Aroori S.
- Aryal K.
- Asad M.
- Aseem R.
- Asprou F.M.
- Awan A.
- Ayaani S.
- Aymon
- Babu B.I.
- Bajwa D.S.
- Bajwa F.M.
- Baker A.L.
- Balfe P.
- Ball W.R.
- Ballance L.
- Banwell V.
- Barnes J.
- Barrie J.
- Bartlett F.
- Basheer M.
- Bashir G.
- Basra M.
- Basu S.
- Basynat P.
- Batt J.
- Bausbacher H.
- Bawa S.
- Beasley W.D.
- Belding R.
- Bellini M.I.
- Bennett S.P.
- Bhandari S.
- Bhattacharya V.
- Blane C.
- Blazeby J.M.
- Boal M.
- Boddy A.
- Boland M.
- Bond-Smith G.
- Booth M.I.
- Borowski D.W.
- Bowen L.
- Boyce K.M.
- Boyd A.T.
- Bradley D.
- Bradley N.
- Brennan S.
- Brett D.
- Broadhurst J.
- Brooke E.
- Brown T.H.
- Bryant A.
- Buchan J.
- Bullen N.
- Bunnell C.
- Bunting D.M.
- Burke P.
- Byrne J.P.
- Byrnes C.K.
- Campbell W.
- Carney K.
- Carney K.
- Carroll P.
- Carter C.R.
- Carter N.C.
- Carty N.
- Cassidy J.T.
- Chambers A.
- Chambers A.
- Chambers A.
- Chan W.M.
- Chang J.
- Charalabopoulos A.
- Chauhan N.
- Cheung M.
- Chhabra A.
- Chishti I.A.
- Chitre V.
- Choy A.
- Cieplucha K.
- Clements J.M.
- Coats M.
- Cockbain A.J.
- Coe P.O.
- Connelly M.
- Cooke F.
- Courtney M.J.
- Cowley J.B.
- Cross K.S.
- Cuming T.
- Cunha P.
- D'Costa C.
- Dalgaty F.
- Dar F.
- Date R.
- Dave R.V.
- Davey P.
- Davies J.
- Dawson S.
- De Marchi J.A.
- de Siqueira J.
- Deguara J.
- Delisle T.G.
- Dennison A.R.
- Derbyshire L.
- Devoto L.
- Dhillon A.
- Diamond T.
- Dickson-Lowe R.
- Digney R.
- Dindyal S.
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- Doe M.
- Dorrian E.
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- Downing J.
- Drake B.
- Driscoll P.J.
- Duke D.
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- Dwerryhouse S.J.
- Ebdewi H.
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- Eisawi A.
- El-Dhuwaib Y.
- El-Hasani S.S.
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- Elmasry M.
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- Fenwick S.
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- Fordham I.J.
- Forouzanfar A.
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- Geogloma I.
- Gerakopoulos S.
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- Manzelli A.
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- Martin J.
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- Marudanayagam R.
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- Mawhinney A.
- Mbuvi J.
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- Mockford J.D.K.A.
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- Monk D.
- Morcous P.
- Morrison T.E.M.
- Mothe B.S.
- Mowbray N.
- Mozolowski K.L.
- Mukherjee D.
- Murphy J.O.
- Murtaza G.
- Nally D.M.
- Napetti S.
- Nassar A.H.
- Nassar A.H.M.
- Naumann D.
- Nedujchelyn Y.
- Needham P.J.
- Newton K.
- Newton R.C.
- Ng H.J.
- Ngu W.S.
- Nicholson G.A.
- Nicholson J.
- Nicholson J.A.
- Nicol L.
- Nicolay C.R.
- Nieto T.
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- Nilsson F.
- Noble F.
- Nofal E.
- Noor N.
- Nunes Q.M.
- O'Dwyer P.
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- O'Reilly D.A.
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- Orchard P.
- Orizu M.N.
- Packer J.R.
- Padwick R.
- Pannu A.
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- Parappally C.P.
- Parmar J.
- Pasquali S.
- Patel A.
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- Pati P.
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- Pearson K.L.
- Peirce C.
- Pellen M.
- Peter M.B.
- Peterson M.
- Pezzuto R.
- Photi E.
- Phull M.
- Pinho-Gomes A.C.
- Pollock S.
- Popplewell M.
- Pore N.
- Porter J.
- Prasad A.R.
- Prasad R.
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- Prince S.
- Psica A.
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- Qandeel H.
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- Sukha A.
- Sutcliffe R.
- Suttie S.
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- Szentpali K.
- Tang C.-B.
- Tanner N.
- Tate S.
- Tayeh S.
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- Taylor G.W.
- Teasdale R.L.
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- Thakkar R.
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- Tilston M.P.
- Toh S.K.C.
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- Tomlinson M.A.
- Trevatt A.E.J.
- Trotter M.
- Tsang A.
- Tsavellas G.
- Tuck L.
- Turner P.
- Tutton M.G.
- Ullah M.F.
- Upchurch E.A.
- Urbonas T.
- Varghase J.
- Vass D.G.
- Vaughan E.M.
- Vijay V.
- Vijayan D.
- Vijayanand D.
- Villatoro E.
- Virupaksha S.
- Vitone L.J.
- Vohra R.S.
- Vohra R.S.
- Wadley M.
- Wainwright D.
- Wajed S.
- Wallace T.
- Wardle S.
- Warren C.
- Watkin H.
- Watson A.J.M.
- Watson N.F.
- Wayman J.
- Weaver S.
- Weber B.
- Weber B.
- Weerasinghe C.
- Welbourn H.
- Wheatley K.
- White T.J.
- Wijetunga I.
- Wild J.R.L.
- Wilkinson M.D.
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- Wilson T.R.
- Winter D.C.
- Winter H.
- Wood C.P.J.
- Wood P.
- Wood S.
- Woodman T.
- Yahya S.
- Yao C.
- Yeldham G.
- Yoganathan T.
- Youssef H.
- Zafar S.
- Zafrani Z.
- Zarsadias P.
- Zeeshan S.
- Zhang C.
- Zino S.
- Ziprin P.
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- 01/10/2020
- Field of study
Background:
The prediction of a difficult cholecystectomy has traditionally been based on certain pre-operative clinical and imaging factors. Most of the previous literature reported small patient cohorts and have not used an objective measure of operative difficulty. The aim of this study was to develop a pre-operative score to predict difficult cholecystectomy, as defined by a validated intra-operative difficulty grading scale.
Method:
Two cohorts from prospectively maintained databases of patients who underwent laparoscopic cholecystectomy were analysed: the CholeS Study (8755 patients) and a single surgeon series (4089 patients). Factors potentially predictive of difficulty were correlated to the Nassar intra-operative difficulty scale. A multivariable binary logistic regression analysis was then used to identify factors that were independently associated with difficult laparoscopic cholecystectomy, defined as operative difficulty grades 3 to 5. The resulting model was then converted to a risk score, and validated on both internal and external datasets.
Result:
Increasing age and ASA classification, male gender, diagnosis of CBD stone or cholecystitis, thick-walled gallbladders, CBD dilation, use of pre-operative ERCP and non-elective operations were found to be significant independent predictors of difficult cases. A risk score based on these factors returned an area under the ROC curve of 0.789 (95% CI 0.773–0.806, p < 0.001) on external validation, with 11.0% versus 80.0% of patients classified as low versus high risk having difficult surgeries.
Conclusion:
We have developed and validated a pre-operative scoring system that uses easily available pre-operative variables to predict difficult laparoscopic cholecystectomies. This scoring system should assist in patient selection for day case surgery, optimising pre-operative surgical planning (e.g. allocation of the procedure to a suitably trained surgeon) and counselling patients during the consent process. The score could also be used to risk adjust outcomes in future research
Safety of hospital discharge before return of bowel function after elective colorectal surgery
- Author
- Aabling R.R.
- Aba M.
- Abad-Motos A.
- Abbasguliyev H.
- Abdelgalil R.
- Abdelhameed F.
- Abdulrahman N.
- Abdulrahman S.M.F.
- Abdulrahman Z.
- Abelevich A.
- AbellĂł D.
- Ablett A.D.
- Ablett A.D.
- Abrisqueta J.
- Acherman Y.I.Z.
- Adam A.H.
- Adamo V.
- Adams S.I.B.
- Adel A.
- Adeleye O.
- Adeusi L.
- Adra M.
- Aftab R.
- Agarwal A.
- Agarwal T.
- Agca M.H.
- Aggiusti A.
- Agresta F.
- Aguilar JF Noguera
- Aguilar-MartĂnez M.M.
- Aguilera M.L.
- Aguilera M.L.
- Aguilera M.L.
- Ahmad H.
- Ahmed A.
- Ahmed H.
- Ahmed K.
- Ahmed M.
- Ahmed M.
- Ahmed S.
- Ahmed W.U.R.
- Ahmeidat A.
- Ahsan S.D.
- Ainsworth P.
- Aitken G.
- Ajmera A.
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- Akin F.A.
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- Akram B.
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- Al Zawawi S.
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- Al-Salihi A.
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- Albayrak D.
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- Albert V.
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- Ali A.
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- Ali Z.
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- Aljohmani L.
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- Allen M.
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- Almeida Almeida
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- Alonso B Campillo
- Alonso E Diego
- Alonso-Poza A.
- Alqethami H.J.
- Alsaif A.
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- Publication venue
- 'Wiley'
- Publication date
- 01/04/2020
- Field of study
© 2020 BJS Society Ltd Published by John Wiley & Sons LtdBackground: Ileus is common after colorectal surgery and is associated with an increased risk of postoperative complications. Identifying features of normal bowel recovery and the appropriateness for hospital discharge is challenging. This study explored the safety of hospital discharge before the return of bowel function. Methods: A prospective, multicentre cohort study was undertaken across an international collaborative network. Adult patients undergoing elective colorectal resection between January and April 2018 were included. The main outcome of interest was readmission to hospital within 30 days of surgery. The impact of discharge timing according to the return of bowel function was explored using multivariable regression analysis. Other outcomes were postoperative complications within 30 days of surgery, measured using the Clavien–Dindo classification system. Results: A total of 3288 patients were included in the analysis, of whom 301 (9·2 per cent) were discharged before the return of bowel function. The median duration of hospital stay for patients discharged before and after return of bowel function was 5 (i.q.r. 4–7) and 7 (6–8) days respectively (P < 0·001). There were no significant differences in rates of readmission between these groups (6·6 versus 8·0 per cent; P = 0·499), and this remained the case after multivariable adjustment for baseline differences (odds ratio 0·90, 95 per cent c.i. 0·55 to 1·46; P = 0·659). Rates of postoperative complications were also similar in those discharged before versus after return of bowel function (minor: 34·7 versus 39·5 per cent; major 3·3 versus 3·4 per cent; P = 0·110). Conclusion: Discharge before return of bowel function after elective colorectal surgery appears to be safe in appropriately selected patients
Preoperative risk factors for conversion from laparoscopic to open cholecystectomy: a validated risk score derived from a prospective U.K. database of 8820 patients
- Author
- Abbas Kadhim
- Abdalla Eisawi
- Abdulzahra A. Hussain
- Abheesh R. Prasad
- Abhilasha Patel
- Abi Mawhinney
- Abraham Joel
- Adam Chambers
- Adam Janeczko
- Adam Kimble
- Adeshina S. Fawole
- Adnan Hussain
- Adrian W. O'Sullivan
- Ahmad H. Nassar
- Ahmed Al-Muhktar
- Ahmed K. Mirza
- Ahmed M. Khalil
- Ahmed Z. Al-Bahrani
- Alan J. Grant
- Alan T. Boyd
- Alex Hrycaiczuk
- Alexander E.J. Trevatt
- Alexandros Charalabopoulos
- Alfred Choy
- Ali Majeed
- Alice Bryant
- Alice Chambers
- Alice Chambers
- Alicja Psica
- Alison Kinghorn
- Alistair R. Dennison
- Alistair Reid
- Alok Chhabra
- Alponat
- Altaf Awan
- Amanda Roebuck
- Amarah Khan
- Ambareen Kausar
- Amir Forouzanfar
- Amir Khawaja
- Ana C. Pinho-Gomes
- Andrea R.G. Sheel
- Andreas Luhmann
- Andrew Harris
- Andrew J. Cockbain
- Andrew Jackson
- Andrew L. Baker
- Andrew Macdonald
- Andrew McClarey
- Andrew Tsang
- Andrzej Goscimski
- Angharad Jones
- Angus G.K. McNair
- Angus J.M. Watson
- Anisha Sukha
- Anita Hargreaves
- Ansar Farooq
- Anthony J. Rate
- Antonio Manzelli
- Anwar Ahmad
- Anwar Hussain
- April Nilsen-Nunn
- Arikoge Ogedegbe
- Arnold D.K. Hill
- Arnold D.K. Hill
- Arslan Pannu
- Ashish K. Shrestha
- Ashvina Segaran
- Avgerinos
- Babu Karavadra
- Ballal
- Barry McAree
- Beatrix Weber
- Benjamin Drake
- Benjamin Knight
- Benjamin Z. Starmer
- Benoy I. Babu
- Bhavani S. Mothe
- Brendan L. Skelly
- Brian Dobbins
- Bryony Lovett
- Carla Rengifo
- Caroline Hindley
- Caroline Yao
- Catherine Bunnell
- Catherine Zhang
- Cathy Malcolm
- Chamindri Weerasinghe
- Chanpreet Arhi
- Cherith M.L.R. Sutton
- Cheuk-Bong Tang
- CholeS Study Group
- Chris Kendal
- Christina A.W. Macano
- Christine Blane
- Christopher P.J. Wood
- Christopher R. Nicolay
- Christopher Taylor Santosh Bhandari
- Ciny P. Parappally
- Claire Hall
- Claire Jackson
- Claire Jones
- Claire L. Rutherford
- Clare Jelley
- Colin H. Richards
- Colin McIlmunn
- Colin Peirce
- Colman K. Byrnes
- Connor
- Conor J. Magee
- Conor Warren
- Conrad D'Costa
- Constantine Halkias
- Corinna Slawinski
- Craig R. Forrest
- Dalvir S. Bajwa
- Damian McKay
- Damien Durkin
- Dan Rodriguez
- Daniel Brett
- Daniel J. Puntis
- Daniel U. Rodriguez
- Darius Mirza
- David A. Longbotham
- David Finch
- David G. Vass
- David Hou
- David I. Hunter
- David J. Holroyd
- David Kennedy
- David Larkin
- David Lindsay
- David Lloyd
- David M. Bunting
- David M. Rae
- David Monk
- David Naumann
- David R. Andrew
- David Shier
- David W. Borowski
- Deep Malde
- Deepak Vijayan
- Deirdre M. Nally
- Denise Mason
- Derek A. O'Reilly
- Des C. Winter
- Dhakshinamoorthy Vijayanand
- Dhivya Subramanium
- Diana Duke
- Dimitrios Kyriakidis
- Dipankar Mukherjee
- Donal Bradley
- Donal Maguire
- Donald Menzies
- Dorothy Johnston
- Duncan J. Simpson
- Duncan J. Stewart
- Edrin Iskandar
- Eduardo Villatoro
- Edward Read
- Eleanor Brooke
- Elinor Jones
- Elizabeth M. Vaughan
- Elmoataz Khogali
- Emir Hoti
- Emma A. Upchurch
- Emma Hamilton
- Emma M. Lyons
- Emma Nofal
- Emma R. McGlone
- Emmet Dorrian
- Essam Ghareeb
- Euan Stirland
- Evangelos Photi
- Ewen A. Griffiths
- Ewen Harrison
- Eyad Issa
- Faith Dalgaty
- Farooq Dar
- Farrukh M. Bajwa
- Fergus Noble
- Fiachra Cooke
- Fotini M. Asprou
- Francesco Giovinazzo
- Francis Bartlett
- Frida Nilsson
- Fried
- Gareth Bashir
- Gareth H. Jones
- Gareth Hooks
- Gary A. Nicholson
- Gary Spence
- Geoffrey P. Roberts
- Geoffrey Yeldham
- George Thomas
- George Tsavellas
- Gerry P. McEntee
- Geta Maharaj
- Ghulam Murtaza
- Gianpiero Gravante
- Giles Bond-Smith
- Giorgios Galanopoulos
- Giuseppe Garcea
- Giuseppe Preziosi
- Glenn Bonney
- Goonawardena
- Gourab Sen
- Graeme Ferguson
- Graeme J.K. Guthrie
- Greg W. Taylor
- Guiseppe Fusai
- Guy M. Shingler
- Haitham Qandeel
- Hamdi Ebdewi
- Haney Youssef
- Hannah Lennon
- Hannah Welbourn
- Hannah Winter
- Harald Bausbacher
- Haythem Ali
- Helen Hawkins
- Helen M. Mohan
- Helen Watkin
- Hema Sekhar
- Henry C.C. Lim
- Hrishikesh Shenoy
- Hugh
- Husam Ebied
- Iain J.D. McCallum
- Ian Finlay
- Ileana Geogloma
- Imeshi Wijetunga
- Imogen J. Fordham
- Imran A. Chishti
- Imran Alam
- Irfan Ahmed
- Ishizaki
- Ivan Ivanovski
- J.Guy Finch
- Jack Broadhurst
- Jack Martin
- Jake Sloane
- James A. Gossage
- James Barnes
- James C. Hewes
- James Davies
- James Francombe
- James Gardner-Thorpe
- James Hewes
- James Hodson
- James Kynaston
- James Mbuvi
- James Milburn
- James Nicholson
- James O. Murphy
- James P. Byrne
- Jamil Ahmed
- Janahan Sarveswaran
- Jane Hornsby
- Jane M. Blazeby
- Javed Ahmed
- Jean Deguara
- Jenifer Barrie
- Jennifer Law
- Jennifer R. Hoban
- Jeremy Batt
- Jessica Chang
- Jessica R. Packer
- Jitesh Parmar
- Joanna Buchan
- Joanna Reed
- John P. Slavin
- John Spearman
- John T. Cassidy
- John Wayman
- Jonathan B. Cowley
- Jonathan de Siqueira
- Jonathan G. Finch
- Jonathan Heath
- Jonathan Porter
- Jonathan R.L. Wild
- Joseph Varghase
- Joshil Lodhia
- Joshua M. Clements
- Justin Alberts
- Justin G. Geoghegan
- Justine Downing
- Kaafarani
- Kabita Gurung
- Kam W.J. Mok
- Kama
- Kamal Aryal
- Karoly Szentpali
- Kas Sarvananthan
- Kate Carney
- Kate Carney
- Kate Hancorn
- Katherine A. Mockford
- Katherine L. Pearson
- Kathryn A. Hodgkins
- Kathryn Lee
- Kathryn M. Boyce
- Kathryn M. O'shea
- Katie Fleming
- Katrina Knight
- Katy Newton
- Keerthika Sampat
- Keith S. Cross
- Keith Seymour
- Ken Keogh
- Ken McCune
- Ken Mealy
- Kenneth B. Hosie
- Kenneth B. Hosie
- Keus
- Kevin Wheatley
- Khalid Al Amari
- Khalid Amin
- Khaliel Madbak
- Kirsty L. Mozolowski
- Koch
- Kologlu
- Krashna Patel
- Krzysztos Cieplucha
- Kushik Lalla
- Laura Ballance
- Laura Bowen
- Laura Derbyshire
- Laura Fothergill
- Laura Gould
- Laura Gould
- Laura Nicol
- Laurence Devoto
- Lawen Karim
- Lipman
- Livingston
- Liz Tuck
- Lola Giwa
- Louis J. Vitone
- Lucinda Frank
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