The pathway study: results of a pilot feasibility study in patients suspected of having lung carcinoma investigated in a conventional chest clinic setting compared to a centralised two-stop pathway
Introduction
The only current hope of cure in non-small cell lung cancer (NSCLC) is treatment at an early stage with either surgery [1] or radical radiotherapy [2]. In the UK, regional surgical resection rates vary, with reported rates between 5 and 10% [3], [4], [5]. This compares to a rate of 25% in the USA and the rest of Europe [6].
There are a number of explanations for such a large discrepancy. Firstly, there is often a delay in diagnosis of lung cancer due to its slow growth [7] with most patients presenting themselves very late once the tumour has begun to cause local symptoms [8]. A second common cause of delay is that after the presentation to a physician time is lost in waiting for both the investigations and the results [9]. Other causes of these lower resection rates include poor awareness on behalf of both primary physicians and patients along with the lack of expert thoracic surgical input at the time of diagnosis with some patients being inappropriately treated with palliative intent.
Currently, there is no evidence that early diagnosis will increase survival. The three seminal studies on lung cancer screening reported in the 1980s showed no apparent true benefit—only lead-time bias—using regular chest X-ray (CXR) and sputum analysis [10], [11], [12]. Once the tumour has been detected, it would seem logical that the earlier definitive treatment is instituted the better. However, a recent study of just over 500 patients with stage IA tumours showed that there is no correlation between size of the tumour at diagnosis and survival. Outcomes were similar when comparing a 3 cm tumour to a tumour less than 1 cm in diameter [13]. This is probably explained by the fact that once tumours are visible on conventional imaging, their metastatic potential may have already been realised.
Presently, there is a resurgence of interest in screening, using low-dose helical CT scanning, in both the USA and Japan [14], [15]. So far, detection rates are promising and follow-up survival data are eagerly awaited.
National guidelines (COIN [16], COG [17], BTS [18]) have focused on the patient pathway from presentation to treatment, and central to this is the setting up of multi-disciplinary meetings (MDMs). The Whitehouse Report in 1994 made recommendations regarding the time frame of investigations in lung cancer, particularly in operable cases, to prevent delay. The recommendations were that the patient must be seen in the specialist outpatients within 14 days of referral from the GP, and that bronchoscopy or other method of biopsy must be performed within 7 days of being seen and subsequent pathology reports should be ready within 7 days after this. Finally, if surgery was possible, it should be carried out within 56 days of first presentation [19]. The National Health Service (NHS) Cancer Plan (2000) sets out a maximum waiting period of 2 months from urgent GP referral to treatment and 1 month from diagnosis to treatment for all cancer patients by 2005 [20].
At Papworth Hospital, a two-stop centralised clinic, with an MDM, has been set up for patients to be diagnosed with lung cancer within a median of 2 weeks and has resulted in an increase in resection rates from 11 to 26% [21]. A similarly high resection rate has been reported in Scotland [22].
More recently, a retrospective study from Norwich has shown no relation between delay in treatment and outcome in nearly 200 NSCLC patients with a 29% radical treatment rate [23]. A similar study in Spain on 1082 patients also showed no correlation between delay in therapy and survival [24].
However, there is no randomised controlled trial that looks at the role of a centralised approach to lung cancer management. In this era of increased service commitment at all levels, practitioners and purchasers need evidence that such strategies will produce true benefits before investing in a major management pathway change.
Thus, we have carried out a randomised pilot study to test the feasibility of a full trial to investigate patients suspected of having lung cancer. We have compared the conventional method of investigation in local chest clinics to a centralised two-stop pathway at The Royal Marsden Hospital in Surrey. The results of such a study would provide a basis to plan appropriate lung cancer management and service requirement in the New Millenium.
Section snippets
Methods
Patients were recruited from the local District General Hospitals of Kingston, St. Helier and The Mayday University Hospitals. The study was approved by both the local and multi-centre research ethics committees. Informed written consent was obtained from all enrolled patients. Eligibility criteria for the study were a possible diagnosis of lung cancer with fitness for a CT scan and biopsy, either percutaneously or by bronchoscopy.
Patients were seen in the local clinics and were randomised to
Results
Eighty-eight patients were recruited from October 1998 to January 2001. At the time of data analysis, 36 patients had died, 20 were in the central arm and 16 in the local arm.
Table 1 summarises the patient demographics in both arms. There was no statistical difference between the two groups in the distribution of lung cancer cell types or diagnostic rate, with 35% of patients found not to have lung cancer. Nearly two-thirds of the overall group had locally advanced or metastatic disease at
Discussion
Recruitment was labour intensive and needed a full time study co-ordinator to organise patient randomisation and investigation in the central arm. Twice as many patients received chemotherapy, mostly with a palliative intent in the central arm than in the conventional arm. All patients who received chemotherapy were treated at the Royal Marsden Hospital. As shown in Table 1, there was no significant difference in the two-patient groups as regards cancer cell type or performance status,
Acknowledgements
The study was supported by the Royal Marsden NHS Trust and the Alan J. Lerner Lung Cancer and Mesothelioma Research Fund.
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