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J. Edwards



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    MO09 - Mesothelioma I (ID 120)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track:
    • Presentations: 1
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      MO09.06 - Malignant Pleural Mesothelioma in the UK National Lung Cancer Audit: An analysis of 8503 cases (ID 916)

      16:15 - 17:45  |  Author(s): J. Edwards

      • Abstract
      • Presentation
      • Slides

      Background
      The National Lung Cancer Audit is run jointly by the Royal College of Physicians and The Information Centre for health and social care with the aim of recording outcomes in lung cancer (and mesothelioma) on a population scale, explaining the wide variations seen within the UK and between the UK and other countries and ultimately improving outcomes. This abstract presents results for England only, focusing on mesothelioma.

      Methods
      All patients with mesothelioma seen in in secondary care 2006-2011 were analysed. A hierarchy of diagnosis from surgical histology to non-surgical histology to clinical diagnosis was used to exclude patients with potentially conflicting diagnoses. These records were further analysed to extract data on age/sex distribution, referral source, histological subtype, treatment regime and survival rates.

      Results
      There were 8,503 patients with mean age 72yrs (83% male), representing around 65% of expected incident cases (a substantial number diagnosed at autopsy and not included in the audit). 45% have right-sided disease, 28% were left-sided, and 1% were bilateral (data missing in 26%). The majority of patients (47%) were referred by their primary care physician, but at least 20% present to secondary care as emergencies. Overall, 89% of cases were histo-cytologically confirmed with that figure appearing to rise slowly over the audit period from 81% (2006) to 92% (2011). Survival data is shown below.

      n (%) Median survival (days) 1 year survival (%)
      All patients 8,503 (100%) 278 41
      Survival was slightly better in females (median 304 days vs 274 days HR 0.91, p=0.002)
      Subtype n (%) Median survival (days) 1 year survival (%)
      Unspecified 3,798 276 39.5
      Epithelioid 2,300 388 53.2
      Sarcomatoid 439 123 16.4
      Biphasic 268 274 36.0
      37% of patients received no anti-cancer treatment, but 28%, 26% and 30% of patients received “surgery”, chemotherapy or radiotherapy at any time. Most surgical operations (60%) were pleurodesis. Median survival varied by first treatment modality: surgery 378 days, chemotherapy 399 days, radiotherapy 308 days, no anti-treatment 140 days. Survival was highest in patients having “surgery” and chemotherapy (491 days). Use of chemotherapy varied across 28 regional cancer networks from 14% to 41% of patients, but overall increased over the audit period from 13% to 34%.

      Conclusion
      Mesothelioma is predominantly a cancer of elderly males, with a striking tendency for right-sided disease. Only 11% have no histological confirmation, but where this is obtained, the epithelioid subtype has best prognosis. Low rates of anti-cancer treatment may reflect therapeutic nihilism as well as patient fitness, but there is an encouraging trend towards wider use of chemotherapy which was associated with a greater than doubling in survival compared with no treatment.

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    MS12 - Loco-Regional Management of MPM (ID 29)

    • Event: WCLC 2013
    • Type: Mini Symposia
    • Track: Mesothelioma
    • Presentations: 1
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      MS12.1 - How Has the 'MARS' Trial Affected the Surgical Approach to MPM? (ID 511)

      14:00 - 15:30  |  Author(s): J. Edwards

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    P1.07 - Poster Session 1 - Surgery (ID 184)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 1
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      P1.07-045 - Prognostic Implications of Blood Tests Performed Routinely Prior to Surgical Resection of Non-Small Cell Lung Cancer (ID 3108)

      09:30 - 16:30  |  Author(s): J. Edwards

      • Abstract

      Background
      Routinely performed blood tests may yield important information regarding the risks of post-operative morbidity and survival. Whilst the association between systemic pre-operative inflammatory response and survival in NSCLC chemotherapy patients is recognized, the clinico-pathological correlates in NSCLC surgical patients are less clear.

      Methods
      NSCLC patients undergoing surgery between 29/8/2007 and 30/3/11 were included. Preoperative blood tests were retrieved from laboratory databases and correlated with prospectively collected data held in our surgical database including clinico-pathological factors, pathological TNM stage and survival. Survival analysis was performed on 17/06/13.

      Results
      722 patients underwent surgery for suspected NSCLC. In 563 (78.0%) patients (54.2% males, median age 68.5 (range 37.8 - 90.8) years), complete data for all factors enabled subsequent multivariate analysis. At the time of analysis, 377 (60%) were alive and were censored in survival analyses. In univariate analysis, the following factors were identified as poor prognostic factors; serum fibrinogen >4g/dL (p=0.011), haemoglobin <13.1g/dL (p=0.003), platelet count >370x10[9 ]or<140x10[9 ](p=0.006), ALT >63 IU/L or <17 IU/L (p=0.039), total protein >80g/L or <60g/L (p<0.001), albumin >48g/L or <35g/L (p=0.005), globulin >36g/L or <18g/L (p=0.001), cholesterol <5mmol/L (p=0.011). Other factors identified as poor prognostic factors were, age (p<0.001), male gender (p=0.033), nodal stage (p=0.001), tumour size (p=0.001), completeness of resection p=0.025), and histological grade (p=0.008). In multivariate analysis of the factors identified from the blood tests, total protein (HR 2.263 95% CI 1.357-3.775, p=0.002), globulin (HR 1.507 95% CI 1.015-2.238 p=0.042), and haemoglobin (HR 1.462 95% CI 1.091-1.958 p=0.011) Including stage, age and gender in the model, stage (HR 1.286 95% CI 1.164-1.442 p<0.001), age (HR 1.028 95% CI 1.011-1.046 p=0.001), gender (HR 1.419 95% CI 1.048-1.920 p=0.024), total protein (HR 2.503 95% CI 1.465-4.274 p=0.001) and haemoglobin (HR 1.500 95% CI 1.110-2.026 p=0.008) remained independent prognostic factors.

      Conclusion
      Although survival data are not yet fully mature, pre-operative anaemia and an abnormal serum total protein level are adverse prognostic factors for survival following lung cancer surgery, being independent of other variables including stage, age and gender. Further work is required to determine the clinical implications of these findings.

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    P2.07 - Poster Session 2 - Surgery (ID 190)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 2
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      P2.07-041 - Talc pleurodesis or IPC for malignant pleural effusion. Is it Time to change? (ID 3130)

      09:30 - 16:30  |  Author(s): J. Edwards

      • Abstract

      Background
      Indwelling pleural catheters (IPCs) have a role in the management of pleural effusions. The TIME-2 trial demonstrated equivalence in dyspneoa relief for first time pleurodesis. This single centre study aimed to compare experience of patients receiving talc pleurodesis versus IPC.

      Methods
      A retrospective review of all patients undergoing IPC insertion or talc pleurodesis within a single Trust between October 2007 and September 2012. We had a policy of selective IPC insertion for trapped lung or recurrent pleural effusion, with talc pleurodesis the procedure of choice for expansile lungs. We examined resource utilisation including pre-operative intervention, length of stay (LOS), re-accumulation and re-intervention.

      Results
      130 patients were identified. 61 (47%) patients underwent talc pleurodesis; 69 had an IPC inserted. 13.1% of talc patients and 59.4 % in the IPC group had received a previous pleural intervention (p<0.001). 23.0% of the talc and 29.0% of the IPC group received their procedure on an urgent basis (p=0.44 ). Significantly more patients underwent a general anaesthetic in the talc group (IPC 26 (37.7%), talc 57 (93.4%) p<0.001). Patients treated with IPC had a significantly shorter post-operative stay than those treated with talc (IPC median 2 (range 2-46) days; talc 5 (0-36), p<0.001). Significantly fewer patients experienced re-accumulation following IPC than talc pleurodesis at 30 days (8 (11.6%) vs 19 (31.3%) p=0.006), and overall (12 (17%) vs 27(44%) p<0.001). There were no differences in post-procedure mortality (IPC 3 (4.35%), talc 1 (1.64%) p=0.372); effusion requiring re-admission to hospital (IPC 5(7.25%), talc 7 (11.5%) p=0.406, or re-intervention rates (IPC 6 (8.7%), talc 7 (11.5%) p=0.60).

      Conclusion
      Despite being used in patients with more complicated pleural effusion, IPC placement was associated with a significantly shorter post-operative length of stay and fewer cases of effusion re-accumulation. IPC placement should be considered for the treatment of pleural effusion.

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      P2.07-042 - Is plasma fibrinogen a novel independent prognostic factor in patients undergoing surgery for Non-Small Cell Lung Cancer? (ID 3131)

      09:30 - 16:30  |  Author(s): J. Edwards

      • Abstract

      Background
      Plasma fibrinogen levels have been shown to correlate with outcomes in various extra-thoracic malignancies. In patients with NSCLC, positive associations have been shown between fibrinogen levels and tumour pathology, but the clinical correlates are unclear. We aimed to examine whether pre-operative fibrinogen levels are a prognostic factor in patients undergoing surgical resection for suspected NSCLC.

      Methods
      All NSCLC patients undergoing surgery between 29/8/2007 and 30/3/11 were included. Pre-operative plasma fibrinogen levels were measured and correlated with clinicopathological factors, pathological TNM stage and survival. Survival analysis was performed on 17/06/13.

      Results
      722 patients underwent surgery for suspected NSCLC. In 519 (71.9%) patients (54.5% males, median age 68.5 (range 37.8 - 90.8) years), pTNM stage and preoperative fibrinogen level were available. Median fibrinogen level was 4.1 (range 1.7 - 10.2) g/dL. 330 (63.6%) of patients had fibrinogen level > reference range (2-4g/dL). Fibrinogen correlated with tumour size (p<0.001) and pTNM stage (p<0.001), but not with nodal stage, histological grade or cell type. At the time of analysis, 309 (59.5%) patients were alive. Fibrinogen > 4g/dl (p=0.01), pTNM stage (p<0.001), Nstage (p=0.001) and tumour size (p=0.003) were univariate prognostic factors. In Cox multivariate analysis, fibrinogen level (p=0.02), pTNM stage (p<0.001), age (p<0.001) and gender (p=0.023) were independent predictors of prognosis.

      Fibrinogen <4g/dL Fibrinogen >4g/dL p
      n Median Survival n Median Survival
      StageI 125 Not reached 176 63.0 0.011
      Stage II 45 55.4 97 Not reached 0.677
      Stage III 19 42.3 57 34.5 0.396

      Conclusion
      Fibrinogen is associated with tumour size and pTNM stage. Whilst survival data are not yet mature, pre-operative fibrinogen > 4 g/dl may be a novel independent prognostic factor following surgical resection of NSCLC. Further work is required to determine the clinical implications of high fibrinogen levels, and to investigate the underlying mechanisms.

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    P2.14 - Poster Session 2 - Mesothelioma (ID 196)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P2.14-012 - Oncolytic herpes virus therapy for mesothelioma- a Phase I study of intrapleural oncolytic virus HSV1716 (NCT01721018) (ID 1627)

      09:30 - 16:30  |  Author(s): J. Edwards

      • Abstract

      Background
      Malignant pleural mesothelioma (MPM) remains a major challenge, with limited therapeutic options. Multifocal intrapleural disease can cause disabling symptoms of pain and breathlessness in the absence of distant metastases, so an intrapleural treatment approach is attractive. HSV1716 is a mutant herpes simplex virus type 1 deleted in the RL1 gene which encodes the protein ICP34.5, a specific determinant of virulence. Mutants lacking the RL1 gene are capable of replication in actively dividing cells but not in terminally differentiated cells – a phenotype exploited to selectively kill tumor cells. Activity against mesothelioma has been demonstrated in animal models. Studies in adult patients with high grade glioma, melanoma and squamous cell carcinoma report that HSV1716 is safe and well tolerated when administered by intra-tumoral injection. We have therefore designed a phase I study to determine the safety, tolerability and potential for efficacy of HSV1716 given intrapleurally to patients with MPM.

      Methods
      The study is an open label, dose escalation, phase I/IIa study in a single clinical centre. Patients with a histological diagnosis of MPM and an indwelling pleural catheter are eligible if they have performance status ≤ 2 and adequate hematologic, renal and liver function. Patients will receive 1x10[7]iu HSV1716 through their pleural catheter on one, two or four occasions a week apart, in three separate patient cohorts. The primary objectives are to determine the safety and tolerability of HSV1716 given intrapleurally in patients with inoperable MPM. Detailed safety analyses will be undertaken. The secondary objective is to obtain evidence of HSV1716 replication and lysis of mesothelioma cells through analysis of pleural fluid by determining the number of viral particles on alternate days for one week, after the last Seprehvir administration, then weekly. An exploratory objective will be to assess tumour response by CT using modified RECIST criteria.

      Results
      The study is open and the first two patients have been treated with a single dose of HSV1716 with no dose limiting toxicity (DLT) or serious adverse events (SAEs) reported. HSV1716 DNA has been detected in pleural fluid samples from one of the patients up to one month post treatment.Up to 12 patients will be recruited and, if successful, a randomised phase II study of intrapleural HSV1716 is planned.

      Conclusion
      Not applicable.

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    PL03 - Presidential Symposium Including Top Rated Abstracts (ID 85)

    • Event: WCLC 2013
    • Type: Plenary Session
    • Track:
    • Presentations: 1
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      PL03.03 - MesoVATS: A multi-centre randomised controlled trial of video assisted thoracoscopic pleurectomy versus talc pleurodesis in malignant pleural mesothelioma (ID 2423)

      08:15 - 09:45  |  Author(s): J. Edwards

      • Abstract
      • Slides

      Background
      Malignant pleural mesothelioma (MPM) incidence is increasing and has no known cure. Non randomised studies suggest that video assisted thoracoscopic (VAT) pleurectomy is effective in controlling pleural effusion and may be associated with increased survival compared to talc pleurodesis.

      Methods
      A multicentre randomised controlled trial of VAT pleurectomy versus talc pleurodesis was undertaken for patients > 18 years with any sub-type confirmed or suspected MPM with a pleural effusion who were fit enough to undergo VAT pleurectomy. Exclusion criteria included previous pleurodesis by any approach. Previous malignancy was permitted if there was no evidence of active disease and MPM had been confirmed. Participants were risk stratified using a modified EORTC prognostic scoring system. Talc pleurodesis was performed via tube thoracostomy or by poudrage at thoracoscopy. VAT pleurectomy involved partial parietal pleurectomy and decortication of the visceral pleura, where appropriate, to achieve lung re-expansion. A total of 196 patients was required to show a survival difference at 1 year of 59% (VAT pleurectomy) versus 37% (talc pleurodesis). Ethical approval was granted by Huntingdon, Cambridge (UK) Research Ethics committee: H02/809; ISRCTN: 34321019; ClinicalTrials.gov NCT00821860.

      Results
      Between 2003 and 2012, 196 patients (120 confirmed, 76 suspected) were randomised across 9 UK centres. 21 cases suspected MPM were subsequently found not to have MPM and excluded (pre-planned in protocol), leaving 87 VAT pleurectomy and 88 talc pleurodesis for the main analysis. Baseline characteristics were similar between the two groups; overall mean age 69 years, 86% men and 75% had known asbestos exposure. Eighty four per cent showed epithelioid disease, 78% were IMIG stage 3/4 and 49% were high risk as per EORTC criteria. The allocated procedure was completed for 73 (83%) talc and 78 (90%) VAT pleurectomy patients. One year survival rates (primary outcome measure) were 57% for the talc group and 52% in the pleurectomy group (hazard ratio 1.03 (95% CI: 0.76, 1.42), p=0.83). Of the secondary outcome measures, pleural effusion was controlled in 37% of talc and 59% pleurectomy patients at one month (p=0.008) and in 57% of talc and 76% pleurectomy patients at 6 months (p=0.04). At 9 and 12 months control of pleural effusion was similar between groups. Median hospital stay was longer in pleurectomy patients (8 days (range 1-31) vs. 6 (range 1-15), p<0.001) and this group had significantly more complications, predominantly prolonged air leak (26% vs. 8%, p=0.009). Based on patients with complete data there was a significant benefit in EQ5D quality of life at 6 months (mean difference 0.08 (95%CI 0.003,0.16), p=0.042) and 12 months (mean difference 0.19 (95%CI 0.05,0.32), p=0.006) in favour of the pleurectomy group. Adjusting for bias due to missing data prior to death reduced the difference in 12 month EQ5D to 0.09 (95%CI -0.04,0.22), p=0.16.

      Conclusion
      MesoVATS showed that VAT pleurectomy significantly improved control of pleural effusion versus talc pleurodesis and improved quality of life. However, overall survival was not increased and the pleurectomy group experienced more complications. Subgroup analyses will investigate which patients benefit most from which intervention. Funded by the BUPA Foundation

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