CONVERT: An international randomised trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer


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Corinne Faivre-Finn1,Wiebke Appel2,Linda Ashcroft3,Adi Bhatnagar4,Dawn Carnell5,Angel Garcia6,Sam Guglani7,Susan Harden8,Virginia Laurence9,Mike Lind10,Paul Lorigan1,Jonathan McAleese11,Rhona McMenemin12,Nazia Mohammed13,Mary O'Brien14,Clive Peedell15,Anthony Pope16,Allan Price17,Michael Snee18,Paula Wells19,Paula Wilson20,Penella Woll21,Fiona Blackhall1
1The University of Manchester, Institute of Cancer Sciences, Manchester, UK,2Royal Preston Hospital, UK,3MAHSC-CTU, The Christie NHS Foundation Trust, UK,4Southampton General Hospital, UK,5University College London Hospitals NHS Foundation Trust, UK,6Glan Clwyd Hospital and Wrexham Maelor Hospital, UK,7Cheltenham General Hospital & Gloucestershire Royal Hospital, UK,8Addenbrookes Hospital, Cambridge, UK,9Dorset Cancer Centre, Poole, UK,10Castle Hill Hospital, Hull, UK,11Northern Ireland Cancer Centre, Belfast, UK,12Freeman Hospital, Newcastle-upon-Tyne, UK,13Beatson Cancer Centre, Glasgow, UK,14Royal Marsden Hospital, Surrey, UK,15James Cook University Hospital, Middlesbrough, UK,16The Clatterbridge Cancer Centre NHS Foundation Trust, UK,17Edinburgh Cancer Centre, UK,18St James Hospital and Bradford Royal Infirmary, Leeds, UK,19St Bartholomew's Hospital, London, UK,20Bristol Haematology & Oncology Centre, UK,21Weston Park Hospital, Sheffield, UK

Abstract

Background

Concurrent chemo-radiotherapy (cCTRT) is the standard of care for good PS LS-SCLC but there is no international consensus on a standard regimen.  Our aim was to compare overall survival and toxicity of twice-daily (BD) with once-daily (OD) RT using modern conformal RT techniques given concurrently with chemotherapy.

Method

Patients were randomised 1:1 to receive 45Gy in 30 BD fractions over 3 weeks or 66Gy in 33 OD fractions over 6.5 weeks starting on day 22 of cycle 1 chemotherapy (4 to 6 cycles of Cisplatin 25mg/m2 days 1-3 or 75mg/m2 day 1 with Etoposide 100mg/m2 days 1-3), followed by PCI if indicated. RT was planned using 3D conformal or IMRT. Patients were stratified by centre, 4/6 cycles CT and PS 0,1/2. The  primary endpoint was 2-year survival and all analyses were by intention to treat.

Results

547 patients were recruited between 2008-2013 from 88 centres. Patients’ characteristics were well balanced in both arms. At a median follow up of 45 months for those alive; two-year survival was 56% (95% CI 50-61) vs 51% (95% CI 45-57) and  median overall survival was 30 months (95% CI 24-34) versus 25 months (95% CI 21-31) (HR 1.17, 95% CI 0.95-1.45; p=0.15) for BD and OD treatment, respectively. Toxicities were comparable except for significantly more grade 3/4 neutropenia (74% BD vs 65% OD, p=0.03).  There was no statistical difference, between BD and OD respectively, in rates of grade 3/4 oesophagitis (19%, 19%), and grade 3/4 radiation pneumonitis was rare (2.5%, 2.2%).

Conclusion

OD RT did not result in a superior survival or worse toxicity than BD RT, supporting the use of either regimen for standard of care treatment of LS-SCLC with good PS. The survival for both regimens was higher than previously reported and using modern RT techniques radiation toxicities were lower than expected.