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M. Redman
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MS13 - Statistics of Personalised Medicine (ID 30)
- Event: WCLC 2013
- Type: Mini Symposia
- Track: Statistics
- Presentations: 4
- Moderators:M. Redman, J. Crowley
- Coordinates: 10/29/2013, 14:00 - 15:30, Parkside 110 A+B, Level 1
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MS13.1 - A Review of Randomised Trials in Lung Cancer (ID 516)
14:05 - 14:25 | Author(s): R. Stephens
- Abstract
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Abstract
There is a long and distinguished history of clinical trials investigating the treatment of lung cancer dating back to the 1950’s. One of the first such trials to be published looked at the use of nitrogen mustard and DON (6-diazo-5-oxo-L-norleucine) in patients with various cancers including bronchogenic carcinoma[1], and probably the first published randomized trial specifically for lung cancer patients compared surgery and supervoltage radiotherapy[2]. Continued progress in treatment relies on randomized clinical trials and meta-analyses, and a review was undertaken in 2003 to assess the quality and quantity of all published randomized lung cancer treatment trials[3]. This showed that, of nearly 1000 trials, only 4 accrued more than 1000 patients, and that clinicians (and patients) could only rely on a few meta-analyses to guide treatment decision making. The review called for greater global collaboration to design and run large trials to improve the survival rates and quality of life of lung cancer patients. Ten years on, an update and extension of the 2003 review has been undertaken, to see what changes have occurred, what patterns have emerged, and whether the data will help the design of future trials. The Cochrane Library was used as the e-library, as it contains some abstracts from major meetings, as Song et al[4] estimate that up to 50% of all trials are not fully published. In addition to sample size, information was collected regarding the histological subgroup studied, the treatment modality investigated, the trial design, the outcome and the country of affiliation of the first author. A search of ‘(lung OR bronchus) AND (cancer OR carcinoma)’ in Sept 2012 produced 7130 reports (5218 full papers and 1912 meeting abstracts) classified by the Cochrane Library as ‘trials’. However, as the inclusion of meeting abstracts was found to be inconsistent, the results presented here are based only on the full publications. A total of 1792 randomized clinical trials of lung cancer were identified, of which 1677 included the sample size in the title or abstract, 49 did not, and in the remaining 66 the abstract could be accessed. An analysis of the 1677 trials with sample size stated showed that: There was an increasing number of randomized trials, mainly due to an increasing number of randomized phase II trials[5] Only 20 trials included >1000 patients, and 48% had less than 100. The median sample size has remained unchanged for 40 years (~100 patients) although the median sample size for those designated as randomized phase III trials has increased from ~200 to ~400 patients over the last 10 years In nearly half of the trials the primary research question addressed chemotherapy, 15% supportive care, 8% radiotherapy and only 1% surgery Of those that indicated the histology, trials of NSCLC cancer accounted for 73% The country producing the most trials (397) was the USA, but China is now the second country, and published the most trials over the last 10 years. Although there are limitations of this review (it is necessarily several years out of date, is only looking at the title and abstract of trials on the Cochrane Library, is complicated by multiple reporting of trials, etc), its strengths are the longitudinal overview and comprehensive inclusion criteria which substantially extend the results reported by Subramanian et al[6] who compared ongoing trials of medical treatment for NSCLC in 2012 with those in 2009. The need to improve the quantity and quality of trials in lung cancer has been highlighted for more than 20 years[7-10 ]as trials have not been sufficiently large, or poorly designed, or unnecessarily duplicated previous work[11-12]. In contrast, well designed trials make best use of researchers’ time, funders’ money and patients’ goodwill[13], and may inform future work. The results of the current review suggest that greater global collaboration is still required to run large trials that will produce reliable results and influence practice worldwide. Updated and more detailed results will be presented. References 1. Krantz S, et al for the Veterans Administration Cancer Chemotherapy Study Group. A Clinical Study of the Comparative Effect of Nitrogen Mustard and DON in Patients With Bronchogenic Carcinoma, Hodgkin's Disease, Lymphosarcoma, and Melanoma. JNCI 1959, 22, 433-9 2. Morrison R. The treatment of carcinoma of the bronchus. A clinical trial to compare surgery and supervoltage radiotherapy. Lancet 1963, 1, 683-4 3. Stephens R. The need for a world strategy for clinical trials. Lung Ca 2003, 41 (suppl 3), S96 (abs E-77) 4. Song F, et al. Dissemination and publication of research findings: an updated review of related biases. Health technology Assessment 2010, 14, No. 8 5. Turrisi AT. Creeping phase II-ism and the Medical Pharmaceutical Complex: Weapons of Mass Distraction in the War against Lung Cancer. JCO 2005, 23, 4827-9 6. Subramanian J, et al. Review of Ongoing Clinical Trials in NSCLC - a status report from the CinicalTrials.gov Web Site. J Thorac Oncol 2013, 8, 860-5 7. Nicolucci A, et al. Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A lost opportunity for meta-analysis. JAMA 1989, 262, 2101-7 8. Brundage MD, Mackillop WJ. Locally advanced non-small cell lung cancer: Do we know the questions? A survey of randomized trials from 1966-1993. J Clin Epidemiol 1996, 49, 183-92 9. Breathnach OS, et al. Twenty-two Years of Phase III trials for Patients With Advanced Non-Small Cell Lung Cancer: Sobering Results. J Clin Oncol 2001, 19, 1734-42 10. Macbeth F, et al. An open letter to all members of the IASLC. Lung Cancer 2004, 45, 119-20 11. Chalmers I. The lethal consequences of failing to make full use of all relevant evidence about the effects of medical treatments: the importance of systematic reviews. Rothwell P, ed. Treating individuals: from randomised trials to personalised medicine. London: Lancet, 2007: 37-58. 12. Young C, Horton R. Putting clinical trials into context. Lancet 2005, 366, 107-8 13. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009, 374, 86-9Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MS13.2 - Clinical Trial Designs for Biomarker Driven Therapies in Advanced Disease (ID 517)
14:25 - 14:45 | Author(s): R. Herbst
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Abstract not provided
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MS13.3 - Clinical Trial Designs for Biomarker Driven Therapies in Early Disease (Adjuvant) (ID 518)
14:45 - 15:05 | Author(s): G. Scagliotti
- Abstract
- Presentation
Abstract not provided
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MS13.4 - The Future of RCTs in the Molecular Era? (ID 519)
15:05 - 15:25 | Author(s): D. Gandara
- Abstract
- Presentation
Abstract not provided
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PC01 - Clinical Trial Design for Drug Development (ID 70)
- Event: WCLC 2013
- Type: Pro/Con Session
- Track: Statistics
- Presentations: 1
- Moderators:N. Yamaguchi, M. Stockler
- Coordinates: 10/28/2013, 14:00 - 15:30, Parkside Ballroom B, Level 1
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PC01.1 - Case Introduction (ID 624)
14:00 - 14:10 | Author(s): M. Redman
- Abstract
- Presentation
Abstract not provided
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