http://bmj.com/cgi/content/abstract/325/7362/465
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Stephen J Falk
a Department of Oncology, Bristol Oncology Centre, Bristol BS2 8ED, b Cancer Division, MRC Clinical Trials Unit, London NW1 2DA, c Department of General Medicine, Frenchay Hospital, Bristol BS16 1LE, d Christie Hospital NHS Trust, Manchester M20 4BX
Correspondence to: R J Stephens
rs@ctu.mrc.ac.uk
Objective: To determine whether patients with locally
advanced non-small cell lung cancer unsuitable for resection or
radical radiotherapy, and with minimal thoracic symptoms, should be
given palliative thoracic radiotherapy immediately or as needed to
treat symptoms.
Design: Multicentre randomised controlled trial.
Setting: 23 centres in the United Kingdom, Ireland, and South
Africa.
Participants: 230 patients with previously untreated, non-small
cell lung cancer that is locally too advanced for resection or
radical radiotherapy with curative intent, with minimal thoracic
symptoms, and with no indication for immediate thoracic radiotherapy.
Interventions: All patients were given supportive treatment
and were randomised to receive palliative thoracic radiotherapy
either immediately or delayed until needed to treat symptoms. The
recommended regimens were 17 Gy in two fractions one week apart or
10 Gy as a single dose.
Main outcome measures: Primary
patients
alive and without moderate or severe cough, chest pain, haemoptysis,
or dyspnoea six months from randomisation, as recorded by clinicians.
Secondary
quality
of life, adverse events, survival.
Results: From December 1992 to May 1999, 230 patients were
randomised. 104/115 of the patients in the immediate treatment group
received thoracic radiotherapy (90 received one of the recommended
regimens). In the delayed treatment group, 48/115 (42%) patients
received thoracic radiotherapy (29 received one of the recommended
regimens); 64 (56%) died without receiving thoracic radiotherapy; the
remaining three (3%) were alive at the end of the study without
having received the treatment. For patients who received thoracic
radiotherapy, the median time to start was 15 days in the immediate
treatment group and 125 days in the delayed treatment group. The
primary outcome measure was achieved in 28% of the immediate treatment
group and 26% of patients from the delayed treatment group (27/97
and 27/103, respectively; absolute difference 1.6%, 95% confidence
interval -10.7% to 13.9%). No evidence of a difference was observed
between the two treatment groups in terms of activity level, anxiety,
depression, and psychological distress, as recorded by the patients.
Adverse events were more common in the immediate treatment group.
Neither group had a survival advantage (hazard ratio 0.95, 0.73 to
1.24; P=0.71). Median survival was 8.3 months and 7.9 months, and the
survival rates were 31% and 29% at 12 months, for the immediate and
delayed treatment groups, respectively.
Conclusion: In minimally symptomatic patients with locally
advanced non-small cell lung cancer, no persuasive evidence was found
to indicate that giving immediate palliative thoracic radiotherapy
improves symptom control, quality of life, or survival when compared
with delaying until symptoms require treatment.
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What is already known on this topic One or two fractions of palliative radiotherapy can control thoracic symptoms What this study adds Compared with immediate, palliative radiotherapy, no evidence exists that such a policy affects patients' survival or levels of activity, anxiety, or depression |
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