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BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112
  1. M F Muers1,
  2. R M Rudd2,
  3. M E R O’Brien3,
  4. W Qian4,
  5. A Hodson4,
  6. M K B Parmar4,
  7. D J Girling4,
  8. on behalf of the British Thoracic Society Mesothelioma Group*
  1. 1General Infirmary, Leeds LS1 3EX, UK
  2. 2St Bartholomew’s Hospital, London EC1A 7BE, UK
  3. 3Royal Marsden Hospital, Sutton, Surrey SM2 5PT, UK
  4. 4MRC Clinical Trials Unit, London NW1 2DA, UK
  1. Correspondence to:
    Dr W Qian
    MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK; wendi.qianctu.mrc.ac.uk

Abstract

Background: The incidence of mesothelioma is rising rapidly in the UK. There is no generally accepted standard treatment. The BTS recommends active symptom control (ASC). It is not known whether chemotherapy in addition prolongs survival or provides worthwhile palliation with acceptable toxicity. Palliation as recorded by patients has been fully reported for only two regimens: mitomycin, vinblastine, and cisplatin (MVP), and vinorelbine (N). The BTS and collaborators planned to conduct a phase III randomised trial comparing ASC only, ASC+MVP, and ASC+N in 840 patients with survival as the primary outcome measure. The aim of the present study was to assess the acceptability of the trial design to patients and the suitability of two standard quality of life (QL) questionnaires for mesothelioma.

Methods: Collaborating centres registered all new patients with mesothelioma. Those eligible and giving informed consent completed EORTC QLQ-C30+LC13 and FACT-L QL questionnaires and were randomised between all three or any two of (1) ASC only, (2) ASC+4 cycles of MVP, and (3) ASC+12 weekly doses of N.

Results: During 1 year, 242 patients were registered of whom 109 (45%) were randomised (55% of the 197 eligible patients). Fifty two patients from 20 centres were randomised to an option including ASC only. This translates into a rate of 312 per year from 60 centres interested in collaborating in the phase III trial. The EORTC QL questionnaire was superior to FACT-L in terms of completeness of data and patient preference. Clinically relevant palliation was achieved with ASC.

Conclusion: The planned phase III trial is feasible.

  • mesothelioma
  • randomised trial
  • chemotherapy

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Footnotes

  • * Members of the BTS Mesothelioma Group

    Chairman: M F Muers, Leeds General Infirmary.

    Clinical members: M Britton, St Peter’s Hospital, Chertsey; C M B Higgs, Dorothy House Hospice, Bradford-on-Avon; M Lind, The Princess Royal Hospital, Hull; R Milroy, Stobhill NHS Trust, Glasgow; M Nicolson, Aberdeen Royal Infirmary, Aberdeen; M E R O’Brien, Royal Marsden Hospital, Sutton; M Peake, Glenfield Hospital, Leicester; N Rowell, Royal Marsden Hospital, Sutton; R M Rudd, St Bartholomew’s Hospital, London; I E Smith, Royal Marsden Hospital, Sutton; J P C Steele, St Bartholomew’s Hospital, London.

    Patient advocacy: M Robinson, Patient Mesothelioma Information Line, Cookridge Hospital, Leeds.

    Medical Research Council Clinical Trials Unit staff: D J Girling, M K B Parmar, W Qian, MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA.

    The following consultants and their colleagues entered patients: Bath Royal United Hospital (E D Gilby, A S Malin); Birmingham Heartlands Hospital (D R Ferry); Bristol Oncology Centre (S J Falk, M Tomlinson); Cambridge Addenbrooke’s and Papworth Hospitals (D Gilligan, S Old); Chelmsford Broomfield Hospital (N Davidson); Cheltenham General Hospital (D Farrugia, P J Jenkins); Clatterbridge Centre for Oncology (J Littler, E Marshall, J Maguire, S O’Reilly, A J Slater, A McGuire, J E S Brock, S Myint); Darlington Memorial Hospital (E N Evans); Derbyshire Royal Infirmary (D Guthrie, R B Kulkarni); Dundee Ninewells Hospital (E Rankin); Durham Dryburn Hospital (N Munro); Edinburgh Western General Hospital (A Price); Exeter Royal Devon and Exeter Hospital (P Bliss); Hartlepool (P Sutton); Glan Clwyd Hospital, North Wales (A E Champion); Inverness Raigmore Hospital (D Whillis); Ipswich Hospital (J S Morgan); Leeds General Infirmary and Cookridge Hospitals (M G Bond, M F Muers, D O’Riordan, M P Snee); Leicester Royal Infirmary (K J O’Byrne); Lincoln County Hospital (L D Nuortio); Llandough Hospital and Velindre Hospital (F R Macbeth); London Guy’s and St Thomas’ Cancer Centre and Hammersmith Hospital (P A Ellis, P G Harper); Maidstone Mid-Kent Oncology Centre/Royal Marsden (M E R O’Brien); Manchester Wythenshawe Hospital (H Anderson, N Thatcher); Middlesborough James Cook University Hospital/Northallerton Friarage Hospital (H R Gribbin, J C M Van Der Voet); Newport Chest Clinic (G Williamson); Newport Royal Gwent Hospital (A E Brewster); Peterborough District General Hospital (K Fife); Plymouth Derriford Hospital (C R McGavin); Sheffield Weston Park Hospital (K Dunn, P M Fisher, M Hatton, P Kirkbride, P Lorrigan); Southampton Royal South Hants Hospital (P M W Johnson, A Last, C Ottensmeier); Southend General Hospital (A Lamont, C W L Trask); Stoke-on-Trent North Staffordshire Royal Infirmary (A Cook); Sunderland Royal Infirmary (H Clague); Swansea Singleton Hospital (K Rowley); Torbay Hospital (J M Goldman); Walsall Manor Hospital (A D Chetiyawardana, R Joshi); Wolverhampton New Cross Hospital (C Brammer); York District Hospital (A M Hunter).

    The Clinical Trials Managers were D Lobban, D Andrews, A Hodson, and R Owens.

  • The trial was sponsored by The June Hancock and Anthony Farmer Mesothelioma Research Funds, Pierre Fabre Oncology, and the British Thoracic Society.