Continuous, hyperfractionated, accelerated radiotherapy (CHART) versus conventional radiotherapy in non-small cell lung cancer: mature data from the randomised multicentre trial
Introduction
Continuous hyperfractionated accelerated radiotherapy (CHART) was introduced in January 1985 in an attempt to overcome proliferation of tumour cells during a conventional course of radiotherapy and to minimise long-term normal tissue morbidity by the use of many small fractions [9], [23].
In a pilot study of 76 patients with non-small cell lung cancer (NSCLC), there was improved primary tumour control and survival compared with historical controls [24]. A multicentre randomised trial was designed in 1989 to run in parallel with a similar study in head and neck cancer. In both, CHART was compared with conventional radiotherapy and there was a 2:1 randomisation in favour of CHART in order to facilitate the use of this regimen in groups of patients. Endpoints were: survival, disease-free interval, local tumour control, metastasis-free interval and morbidity. An interim report on both trials was prepared immediately after closure of entry in April 1995 and the definitive results of the trial in NSCLC were published in July 1997 [26], [27]. In this publication, we give further analyses of the data which has matured over two further years.
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Patients and methods
The design, eligibility, radiotherapy and assessments, together with the endpoints and analysis has been described in detail [18], [27]. In summary, eligible patients were those who showed a WHO performance status of 0 or 1, and presented pathologically proven, inoperable NSCLC, considered suitable for radical radiotherapy. During the first phase of radiotherapy a large volume was irradiated which included the mediastinum and the primary tumour together with a 1 cm margin. The ipsilateral hilar
Results
From 1 April 1990 to 31 March 1995, 563 patients with NSCLC were entered by 13 centres–Clatterbridge, Merseyside (122); Beatson, Glasgow (71); Mount Vernon, Northwood (70); Weston Park, Sheffield (52); Nottingham (50); Royal Marsden, London/Surrey (40); Carl Gustav Carus, Dresden (39); Velindre, Cardiff (34); Cookridge, Leeds (33); Bristol (24); Umea, Sweden (14); St Mary's, Portsmouth (11) and Jonkoping, Sweden (3).
The trial profile is shown in Fig. 1. Four patients, two randomised to each
Discussion
This analysis of the mature data shows that improvement in survival and in local tumour control previously reported have been maintained [27]. Considering all patients the estimated benefits with regard to disease free and metastasis free intervals did not reach conventional levels of significance. However in the 81% of patients entered into this trial who had squamous cancer there was not only a reduction of 30% in the relative risk of death (P=0.0007) and 27% in the relative risk of local
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Members of the CHART Steering Committee: A. Barrett (Chairman), D. Coyle, B. Cottier, A.M. Crellin, P. Dawes, S. Dische, M.F. Drummond, C. Gaffney, D. Gibson, A. Harvey, J.M. Henk, T. Herrmann, B. Littbrand, J. Littler, F. Macbeth, D.A.L. Morgan, H. Newman, M.K.B. Parmar, A.G. Robertson, M. Robinson, R.I. Rothwell, M.I. Saunders, R.P. Symonds, J.S. Tobias, M.J. Whipp, H. Yosef.