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B. Moore



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    O27 - Clinical Trials and Practice (ID 142)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Other Topics
    • Presentations: 1
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      O27.02 - Preliminary results from the FRAGMATIC trial: A randomised Phase III clinical trial investigating the effect of FRAGMin® Added to standard Therapy In patients with lung Cancer. (ID 1799)

      16:15 - 17:45  |  Author(s): B. Moore

      • Abstract
      • Presentation
      • Slides

      Background
      Venous thromboembolism (VTE) is common in lung cancer patients and the incidence is increased by treatments including radiotherapy, surgery and chemotherapy. Research suggests a survival benefit in cancer patients receiving long term low moecular weight heparin (LMWH). LMWH may also have antimetastatic effects through the inhibition of P-selectin. This trial was developed to investigate whether or not adding LMWH to standard treatment increases overall survival. The study is funded by a research grant from Cancer Research UK (C13275/A5323) and free drug and an educational grant from Pfizer. The trial is sponsored by Velindre NHS Trust, and coordinated by the Wales Cancer Trials Unit, Cardiff, UK.

      Methods
      An open label, multi-centre, Phase III randomised controlled trial in patients with lung cancer comparing anticancer treatment according to local practice plus dalteparin (Fragmin®), with anticancer treatment alone. Eligible patients had a histopathological or cytological diagnosis of primary bronchial carcinoma (SCLC or NSCLC) within the previous 7 weeks, performance status 0, 1, 2 or 3 and were willing and able to inject daily subcutaneous injection. The dalteparin was given as a daily 5,000 IU subcutaneous injection for 24 weeks. The primary outcome measure is overall survival and the secondary outcome measures include toxicity, VTE-free survival, metastasis-free survival, quality of life, and cost utility. To detect an advantage of 5% in overall survival at 1 year (to 30%) a total of 2200 patients were required (1100 in each arm).

      Results
      2202 patients were enrolled and randomised in 4 years. The two groups were well balanced for key variables. 60% were men; the median age was 65 years; 82% had NSCLC (5% Stages I and II, 38% Stage III, 57% Stage IV) and 18% SCLC (63% Extensive Disease); 85% had WHO PS 0 or 1; 95% received chemotherapy as first treatment. 56% of those in the dalteparin arm received at least 90 of the 168 planned injections. By 1/8/2013 there had been 1891 deaths recorded and, on advice from the Independent Data Monitoring Committee, the primary results have been released. There was no significant difference in overall survival (HR 0.97; 95% CI 0.89-1.06) nor in metastasis-free survival. Exploratory subgroup analyses do not suggest a significant survival advantage in any subgroup. Dalteparin use was not associated with a significant increase in major bleeding complications. There were 78 (7.1%) confirmed VTEs in the control group and 47 (4.1%) in the treatment group.

      Conclusion
      This large RCT which recruited mainly good PS lung cancer patients having chemotherapy, has confirmed that prophylactic dalteparin reduces the risk of VTE events without a significant increase in major bleeding. The baseline VTE risk of 7% and relative risk reduction of 40% are consistent with previous studies. There was no significant difference in overall survival. These results do not support a policy of routine prophylactic anticoagulation of all lung cancer patients undergoing chemotherapy.

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    P2.24 - Poster Session 2 - Supportive Care (ID 157)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P2.24-025 - Applying the results of the FRAGMATIC trial to real life: longitudinal qualitative study exploring the experiences of patients partcipating in a randomised Phase III clinical trial investigating the effect of FRAGMin Added To standard therapy In lung Cancer (ID 1581)

      09:30 - 16:30  |  Author(s): B. Moore

      • Abstract

      Background
      Clinical data suggests low molecular weight heparin (LMWH) may produce a survival benefit when given to cancer patients. Several studies are being conducted in different cancer primaries to explore this hypothesis including FRAGMATIC, which will be presented at the World Lung Conference. The FRAGMATIC trial is an open label multi-centre Phase III randomised controlled trial in patients with lung cancer comparing anticancer treatment according to local practice plus dalteparin (Fragmin®), with anticancer treatment according to local practice alone. The primary outcome measure is overall survival and the secondary outcome measures include; toxicity, VTE-free survival, metastasis-free survival, quality of life, patient experience and cost utility. 2202 patients have been recruited in order to detect an advantage of 5% in overall survival at 1 year (to 30%). Fragmin is given as a daily subcutaneous injection for six months by the patients themselves or a willing partner/ carer. This may raise practical challenges regarding how applicable the results of the main trial will be to clinical practice especially with regard to quality of life and thus compliance. We conducted a longitudinal quality of life study to explore the experiences of patients participating in the FRAGMATIC trial to better inform the patient journey and practicalities of applying results to clinical practice.

      Methods
      Semi-structured interviews were held at up to three time points, with two groups of patients recruited from the intervention (n=4) and control (n=6) arms of the FRAGMATIC trial.A total of twenty interviews were analysed using Interpretative Phenomenological Analysis to identify emergent themes that reflect participants' lived experience. We report data focusing on participant views and experiences of self injection for six months.

      Results
      No discernable difference in quality of life was identified between patients in the control or intervention arm who reported similar experiences of the cancer journey and its treatments. Patients on the intervention arm found daily Fragmin injections to be acceptable and a small consequence of having additional treatment as they saw it. Patients developed processes in order to administer Fragmin at similar times and described adaptive techniques to reduce discomfort and bruising. Minimal training was required to be able to inject Fragmin and few side effects were reported. The most common side effect was stinging which was short lived and bruising around injection sites. Patients reported these events did not impact upon quality of life. Overall, Fragmin was found to be an acceptable intervention, which did not pose any compliance problems.

      Conclusion
      The FRAGMATIC trail will report the impact of daily subcutaneous LMWH on overall survival in lung cancer. In this trial 1100 patients self injected Fragmin or had it administered to them. Based on qualitative interview data, Fragmin injections were well tolerated and the experiences of patients suggest that it would be relatively simple to introduce self-injecting into standard lung cancer therapy should the results of the FRAGMATIC study demonstrate a survival benefit.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-024 - <strong>QUARTZ</strong><br /><strong>Quality of Life after Treatment for Brain Metastases from Non-Small Cell Lung Cancer: An update on the UK Medical Research Council QUARTZ trial.</strong> (ID 2154)

      09:30 - 16:30  |  Author(s): B. Moore

      • Abstract

      Background
      Approximately one third of all non-small cell lung cancer (NSCLC) patients will develop brain metastases. The majority of such patients are inoperable with a very poor prognosis, and for several decades the standard treatment has been a combination of steroids and whole brain radiotherapy (WBRT). However, little evidence exists to support this approach, and there is continuing debate over the use of WBRT. The diversity of clinical opinion and patient preference makes this a challenging question to address.

      Methods
      The multi-centre randomised QUARTZ trial assesses whether optimal supportive care including steroids (OSC) is a viable alternative to the current standard of OSC plus WBRT, in terms of duration and quality of life (QoL). The primary endpoint of Quality Adjusted Life Years (QALYs) reflects that both quality and duration of survival are important. Disease status, symptoms and QoL data are collected weekly. The impact of the disease and treatment on carers is also being assessed. A total of 534 patients is required to exclude a detriment in terms of QALYs of >1 week with OSC (from 5 weeks with OCS plus WBRT), and the aim was to recruit this number in three years.

      Results
      After four years, only 188 patients had been recruited and a decision was taken to present the interim results to participating clinicians. Interim data (from the first 151 QUARTZ patients)[1] provided no strong evidence that omitting WBRT was detrimental in terms of survival or QoL and there were no clear differences in steroid usage or toxicity. By June 2013 QUARTZ has recruited 438 patients (82%) and 336 carers from 78 UK and Australian centres. Data collection is excellent with 98% of forms returned.

      Conclusion
      Patients with brain metastases (and others approaching end of life) represent a difficult group to study, as they often have different priorities regarding treatment options, but it is vital that we obtain the highest quality evidence possible in order to best guide treatment. QUARTZ has demonstrated that good trial design (weekly phone assessments, using QALYs as the primary endpoint, releasing interim results, etc) makes it possible to conduct successful clinical trials in this challenging patient population in order to answer important clinical questions. The interim results have reassured QUARTZ Investigators that omitting WBRT does not appear to lead to any detrimental effect in terms of either length or QoL, and have proved very useful when discussing the trial with potential patients. Although molecular targeted agents can extend treatment options for some patients, QUARTZ remains an important trial, which will define the use of WBRT and may impact on practice worldwide. We estimate completing recruitment during Summer 2014. Recruitment rates remain constant with many centres demonstrating successful recruitment to QUARTZ. Acknowledgements Thank you to all the patients and their carers for participating in the trial and the recruiting centres for their hard work in recruiting patients and helping to achieve the high standard of data collection. QUARTZ is supported by Cancer Research UK (CRUK/07/001). References 1. Langley RE et al. Clin Oncol (R Coll Radiol) 2013;25(3):e23-30.