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N. O'Rourke



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    C - Inaugural Cochrane Workshop (ID 78)

    • Event: WCLC 2013
    • Type: Other Sessions
    • Track: Other Topics
    • Presentations: 2
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      C.00 - Inaugural Cochrane Workshop (ID 4023)

      07:30 - 12:00  |  Author(s): N. O'Rourke

      • Abstract

      Abstract
      The Cochrane Collaboration is an international, independent, not-for-profit organisation of over 28,000 contributors from more than 100 countries, dedicated to making up-to-date, accurate information about the effects of health care readily available worldwide. Cochrane contributors work together to produce systematic reviews of healthcare interventions, known as Cochrane Reviews, which are published online in The Cochrane Library. Cochrane Reviews are intended to help providers, practitioners and patients make informed decisions about health care, and are the most comprehensive, reliable and relevant source of evidence on which to base these decisions. Over 5,000 Cochrane Reviews have been published so far, online in the Cochrane Database of Systematic Reviews, part of The Cochrane Library. The Collaboration also prepares the largest collection of records of randomised controlled trials in the world, called CENTRAL, published as part of The Cochrane Library. Work from the Cochrane Collaboration is internationally recognised as the benchmark for high quality information about the effectiveness of health care. The Collaboration believes that effective health care is created through equal partnerships between researcher, provider, practitioner and patient. Cochrane Reviews are unique because they are both produced by, and are relevant to, everyone interested in the effects of human health care. Based on the best available evidence, healthcare providers can decide if they should fund production of a particular drug. Practitioners can find out if an intervention is effective in a specific clinical context. Patients and other healthcare consumers can assess the potential risks and benefits of their treatment. The Cochrane Collaboration's contributors are a mix of volunteers and paid staff who are affiliated to the organisation through Cochrane entities: healthcare subject-related review groups, thematic networks (called 'fields'), groups concerned with the methodology of systematic reviews, and regional centres. Many are world leaders in their field of medicine, health policy, research methodology or consumer advocacy, and our entities are situated in some of the world's finest academic and medical institutions. The Cochrane Collaboration is named after Archie Cochrane (1909-1988), a British epidemiologist, who advocated the use of randomised controlled trials as a means of reliably informing healthcare practice. The Collaboration is an independent, not-for-profit organisation, funded by a variety of sources including governments, universities, hospital trusts, charities and personal donations. The Collaboration is registered as a charity in the United Kingdom. To tie the organisation together, there are a number of overarching structures, led by the Steering Group, which provides policy and strategic leadership for the organisation. Members of this group are democratically elected from, and by, contributors. The Cochrane Operations Unit, is based in Oxford, UK, which manages the financial, legal and administrative work of the organisation, led by the Chief Executive Officer of the Collaboration; and a Cochrane Editorial Unit, based in London, UK, which supports Cochrane Review production, editorial processes, and training and methods development, led by the Editor in Chief of The Cochrane Library. There are annual conferences, known as "Colloquia", which are open to everyone. Colloquia are designed to bring people together in one place to discuss, develop and promote our work, and to shape the organisation's future direction In addition to the core mission of producing Cochrane Reviews, contributors are involved in a number of related activities, including advocacy for evidence-based decision-making, providing training in Cochrane Review preparation, developing the methodology for preparing reviews, and translating them from English into a variety of different languages. This session includes providing an introduction to developing a Cochrane Review and is kindly supported by the Cochrane Lung Cancer Review Group, based in Barcelona Spain (website ) and uses high quality training materials developed by the Cochrane Collaboration (grateful acknowledgement of for allowing the use of the training materials) delivered by volunteer Cochrane Collaborators. The session will address topics including; Introduction to systematic reviews, Writing a Cochrane protocol, Searching for studies, Collecting data, Risk of bias, Meta-analysis, Types of data, Heterogeneity, Analysing data and Interpreting results Other training resources include Online Learning Modules as part of a self-directed learning initiative of The Cochrane Collaboration. They provide an introduction to the core skills and methods required for new authors of Cochrane systematic reviews of interventions. The modules are intended to complement other learning opportunities such as face-to-face workshops and webinars, and the guidance provided in the Cochrane Handbook for Systematic Reviews of Interventions.

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      C.02 - Writing a Protocol (ID 801)

      07:30 - 12:00  |  Author(s): N. O'Rourke

      • Abstract
      • Presentation
      • Slides

      Abstract
      The Cochrane Collaboration is an international network of more than 28,000 dedicated people in over 100 countries. Our vision is that healthcare decision-making throughout the world will be informed by high-quality, timely research evidence. We prepare, update and promote the accessibility of Cochrane Systematic Reviews. The Lung Cancer Group editorial team oversees the process of review development from title registration through publishing a protocol to completion of the final systematic review. The scope of topics covered includes prevention, early detection, diagnostic test, all modalities of treatment for both lung cancer and mesothelioma and complementary therapies. The first stage in preparing a review is to identify the topic and register this as a title with the Cochrane group. From this point the authors have a six month time frame to develop a protocol which is essentially the outline plan for the full review. The protocol defines the question to be addressed and specifies the process for identifying, assessing and analysing studies in the review. This will include the inclusion criteria for studies, the search strategy used, the comparisons to be made, any sub-group analyses and their justification and the outcomes to be reported. Once the protocol has been reviewed by the editorial team and confirmed as appropriate for development to a full systematic review, it will be published by Cochrane as a public record of an intended review. This registration helps to minimize bias in the subsequent conduct and reporting of the review and also reduces duplication of effort between groups. This presentation will describe the process of protocol development for a Cochrane review.

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    MO17 - Radiotherapy I: Stereotactic Ablative Body Radiotherapy (ID 106)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      MO17.02 - Radical Radiotherapy for Non-small Cell Lung Cancer - is it the end for 2 Gray per fraction? (ID 2247)

      16:15 - 17:45  |  Author(s): N. O'Rourke

      • Abstract
      • Presentation
      • Slides

      Background
      The standard of care worldwide for radiation dose scheduling in NSCLC has historically been 2Gy per fraction treating once daily over six weeks. The CHART regimen of accelerated hyperfractionated treatment first demonstrated significant survival benefit from a two week radical course, attributed to reduced repopulation and improved local control. A recent individual patient data meta-analysis confirms significant survival benefit from accelerated radiotherapy[1]. Meantime the evolving data on stereotactic radiotherapy treating early stage lung cancer over two weeks or less suggests marked improvement in local control rates compared with historical populations treated with conventional fractionation[2]. The latest challenge to 2Gy per fraction comes from the early stop to the dose escalation arm of RTOG 0617 with 74Gy actually appearing inferior to the 60Gy arm. We postulate that overall treatment time is a key factor in lung cancer radiotherapy outcomes and that standards of care need to be reviewed. This paper examines the current international guidelines on radical radiotherapy schedules, evaluates the supporting evidence and proposes new priorities for research.

      Methods
      Five international guidelines on the management of lung cancer were reviewed. All were published 2010-2013: ESMO Clinical Practice Guideline on early stage and locally advanced lung cancer 2010, NICE guideline (England and Wales) 2011, Australian Government Clinical Practice Guideline for treatment of lung cancer 2012, Cancer Care Ontario evidence based series lung cancer guideline 2013, National Comprehensive Cancer Network (NCCN) Lung Cancer guideline v2.2013. Recommendations on radical radiotherapy dose and fractionation for NSCLC were collated from each guideline together with the references cited in support of these recommendations to assess levels of evidence.

      Results
      Two guidelines specifically recommended hypofractionated SBRT for early stage inoperable disease -NICE and NCCN. The Australian guideline stated uncertainty over relative benefit SBRT versus conventional fractionation in stage I disease. England, Ontario and Australia all included CHART regimen as treatment of choice for stage II/III radical patients not receiving chemotherapy. Cancer Care Ontario undertook specific review of altered fractionation schedules identifying lack of evidence for hyperfractionation but suggesting possible benefit for hypofractionation. All five guidelines specified standard care, if given with chemotherapy, of conventional fraction size 2Gy: Ontario, ESMO and Australian guidance was a minimum of 60Gy in 30 fractions. NCCN offered a range of 60-74Gy at 2Gy/fraction. NICE alone proposed alternative standard of 55Gy in 20 fractions, a common UK schedule, or the option of 64-66Gy at 2Gy/fraction

      Conclusion
      International guidelines lag behind the emerging evidence for lack of benefit from dose escalation at 2Gy/fraction and apparent benefit from shorter treatment courses . We propose that accelerating treatment with hypofractionation and shorter overall treatment times should be the priority for radiotherapy development. We discuss current and pending trials examining this approach. 1. Mauguen A, Le Pechoux C, Saunders M et al: Hyperfractionated or accelerated radiotherapy in lung cancer: an individual patient data meta-analysis. J Clin Oncol 30:2788-2797, 2012 2. Timmerman R, Paulus R, Gavin J et al: Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA 303:1070-1076, 2010

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-040 - Optimal Duration of Chemotherapy for Advanced Non-small Cell Lung Cancer. A prospective population-based audit. (ID 2256)

      09:30 - 16:30  |  Author(s): N. O'Rourke

      • Abstract

      Background
      Chemotherapy trials for stage IIIB/IV NSCLC have established that 3 cycles was better than 6. International guidelines stipulate 4-6 cycles but recent studies addressing maintenance or switch therapy suggest benefits with prolongation of treatment. Our regional protocol for chemotherapy in stage IIIB/IV NSCLC recommends platinum doublet chemotherapy first line to a total of four cycles with interim CT scan after two to assess response. This audit was undertaken to establish what additional benefit in response was achieved by cycles three and four. Our primary outcomes were response rate to chemotherapy after two cycles and change in response between interim imaging and end of treatment scan after four cycles.

      Methods
      During 2011/2012 all advanced non-small cell lung cancer patients referred for chemotherapy to our regional centre had treatment and outcomes recorded. We excluded from our audit any patients receiving non-first line chemotherapy, oral TKIs or clinical trial agents. We included patients who had received minimum two cycles, recording at baseline: age, gender, pathology, ECOG performance status and chemo regimen. Interim CT scans were classed as stable disease SD, partial response PR, mixed response MR( response at one site of disease with either stable or progressive disease at other sites) or progressive disease PD. CT following four cycles was compared to interim imaging and categorised as stable disease, increased response relative to interim scan, mixed response or progressive disease.

      Results
      188 patients fulfilled audit entry criteria: 96 men, 92 women: age range 36-83 years (median 67y). There were 107 adenocarcinoma (57%), 53 squamous carcinoma (28%) and 21 undifferentiated/ not otherwise specified (11%). ECOG: PS0-1 44%, PS2 6%, PS3 1% but 49% not recorded. Most common chemo regimens were cisplatin/pemetrexed (22%), carboplatin/pemetrexed (20%), gemcitabine/carboplatin (22%) and carboplatin/paclitaxel (14%). After 2 cycles chemotherapy 25 patients (13%) had progressive disease but 66(35%) PR, 72(38%) SD and 15(8%) MR. 25 patients stopped or changed therapy following 2 cycles with a further 25 stopping after 3 cycles. Of the 138 completing 4 cycles 26(19%) had PD on end of treatment scan. 62(45%) had stable disease compared to interim scan and 25(18%) had minor improvement relative to interim scan. Of those showing continuing response most (84%) had had initial PR.

      Conclusion
      Our response rates to chemotherapy after two cycles compare well with published series. Evaluation of interim and end of treatment scans has demonstrated that most of the radiological response to chemotherapy is achieved by the first two cycles. The number of patients responding after 2, if SD at 2, was low and the additional benefit in the minority of PR patients who did continue to respond was marginal. Our audit is limited by lack of quality of life data but if patients experience increased fatigue and toxicity with third and fourth cycles then our data would suggest that early stopping of platinum chemotherapy may not be detrimental to overall response rates. The optimal number of cycles of platinum based chemotherapy remains uncertain and worthy of further research.

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    P3.14 - Poster Session 3 - Mesothelioma (ID 197)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P3.14-006 - Radiotherapy for the treatment of pain in Malignant Pleural Mesothelioma: A Systematic Review (ID 1586)

      09:30 - 16:30  |  Author(s): N. O'Rourke

      • Abstract

      Background
      To examine the evidence base for radiotherapy in the treatment of pain in malignant pleural mesothelioma.

      Methods
      A systematic search of the Medline (1946-2013), Embase (1974-2013) and Central (The Cochrane Library Issue 9, 2012) databases was performed looking for studies which evaluated the role of radiotherapy for pain relief in people with malignant pleural mesothelioma (MPM). Studies were included if MPM was radiologically or histologically diagnosed, radiotherapy was given with the intent of improving pain and response rates to radiotherapy were reported. Documentation of the dose and fractionation of radiotherapy that was given was required. Finally, the study must have explored the relationship between radiotherapy and pain response. Systematic reviews were ineligible.

      Results
      Nine studies were eligible. There was marked heterogeneity among studies so quantitative synthesis of results was not possible. The most recent study reported a clinical response rate of 54% two weeks after radiotherapy given at a dose of 36 Gray (Gy) in 12 fractions. This was targeted at the area of MPM that was felt to be causing the pain. However, this assessment was performed retrospectively. A radiological response of 43% measured via CT scanning two months after irradiation was also reported in this study. Another study reported a superior response rate (50%) for those treated with a 4 Gy fraction size compared with those treated with a fraction size of less than 4 Gy (39%). However, this was not randomised and reflected a change in policy to treat sites of symptomatic disease only rather than covering the entire volume of disease. A further study suggested a benefit to hemi-thoracic irradiation at a dose of 30 Gy in 10 fractions. However, Cobalt machines were used in this study. Another study suggested no benefit to hemi-thoracic irradiation at a dose of 40 Gy in 20 fractions. However, 27 of the 47 patients in this study had no pain at study baseline. The other studies in this review report varying response rates, primarily reported in a retrospective fashion.

      Conclusion
      There are no high quality data to support the use of radiotherapy for pain management in MPM. Studies focusing on clear pain endpoints, improving target delineation and delivering higher equivalent doses using modern day radiotherapy are needed. Biomarkers which may predict response in a proportion of patients should be sought.