- Email: [email protected]
182: RESPECT-Meso: a multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma
Poster abstracts, 13th Annual British Thoracic Oncology Group Conference, 2015: Trials in Progress 181 Resection rates in non-small cell lung cancer: how are we doing? K. Bunclark *, C. Caprario, T. Win. Respiratory Medicine, East and North Herts NHS Trust, Stevenage, United Kingdom Introduction: Surgical resection is the gold standard for limited stage non-small cell lung cancer (NSCLC) with low resection rates inversely proportional to lung cancer mortality. The objective of this study was to determine whether NSCLC resection rates for East and North Herts (E&NH) NHS trust were in line with our own and other local networks and to determine the causes of non-operative intervention in those with potentially resectable disease. Methods: The Lung Cancer Audit Data Set (LUCADA) was used to identify patients within the E&NH NHS trust diagnosed with stage 1 or 2 NSCLC during 2012. Case notes of those patients not receiving surgical intervention were subsequently reviewed to establish why a non-operative approach was undertaken. Results: A total of 28 patients with a diagnosis of Stage 1 or 2 NSCLC in the E&NH NHS trust were identified for 2012. Of these 46.4% underwent operative intervention compared to a rate of 35.4% for the Local Cancer Network (N20) and 50.4% nationally. Of the 15 patients who did not undergo surgical resection; 47% were nonoperable due to advanced performance status (Level 3 or 4) and 13% due to upstaging following PET-CT. One further patient actually had a histological diagnosis of small cell lung cancer. For the 5 remaining patients; CT guided biopsy was not performed in two patients (one due to patient discomfort and one patient declined), co-morbidities were deemed to outweigh surgical benefit in two patients and a further patient declined operative intervention.
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Trials in Progress 182 RESPECT-Meso: a multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma S. Gunatilake1 *, L. Marshall2 , A. Chauhan1 . 1 Respiratory, Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom, 2 Research and Development, Portsmouth, United Kingdom Introduction: Malignant pleural mesothelioma (MPM) is an incurable cancer and best supportive care remains the mainstay of treatment for the majority. Patients with MPM frequently have significant physical symptoms at presentation which can impact on quality of life (QOL) [1]. The purpose of this study is to examine if early specialist palliative care involvement in MPM patients can improve patient’s and carer’s quality of life during their illness. Methods: 174 patients diagnosed with MPM and their carers will be invited to participate. Participant’s symptoms, healthcare use will be recorded and QOL and mood questionnaires will be administered. Participants will be randomised to receive regular early specialist symptom control treatment (RESSCT) at 4-weekly intervals or standard treatment. All participants will receive 4 weekly follow-up. Primary outcome: • To assess the impact of RESSCT on global QOL in patients with MPM 12 weeks from randomisation Secondary outcomes: • Patient QOL at 24 weeks • Patient mood at 12 and 24 weeks • Primary caregiver QOL and mood at 12 and 24 weeks, and 24 weeks after patient death • Survival between the 2 groups • Healthcare utilisation and costs • The cost-effectiveness of RESSCT when compared to usual practice • Sub-group analyses of QOL at 12 and 24 weeks for patients based on biological criteria and radiological staging at time of diagnosis. Results: Recruitment: see the figure.
Figure: Rates of surgery in Stage I & II NSCLC.
Conclusion: This audit established surgical resection rates at E&NH NHS trust to be higher than local network as a whole and in line with the national average. Indeed, resection rates may be underestimated due to inaccuracies in LUCADA data entry (eg. inclusion of small cell diagnoses). After retrospective review of data, all 15 patients were assessed and managed appropriately. Disclosure: All authors have declared no conflicts of interest. Figure: RESPECT-Meso cumulative recruitment, March September 2014.
Sites open to recruitment: • Queen Alexandra Hospital, Portsmouth • Norfolk and Norwich University Hospital • University Hospital North Durham • North Manchester General Hospital • South Tyneside District Hospital • New Cross Hospital, Wolverhampton Strategies to improve recruitment: • Increase number of recruitment centres to 15
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Poster abstracts, 13th Annual British Thoracic Oncology Group Conference, 2015: Trials in Progress
• Explore the possibility of opening Perth, Australia as a recruiting site • Regular contact with recruitment centres via telephone and monthly newsletter • Trial promoted in ‘Mesothelioma UK’ newsletter, ‘Cancer UK’ website and at BTOG • Dedicated trial website www.respect-meso.org Reference(s) [1] Hollen PJ, Gralla RJ, Liepa AM, Symanowski JT, Rusthoven JJ. Adapting the Lung Cancer Symptom Scale (LCSS) to mesothelioma: using the LCSS-Meso conceptual model for validation. Cancer 2004; 101: 587 95. Disclosure: All authors have declared no conflicts of interest. 183 PIT: a phase III trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention N. Bayman1 *, D. Ardron2 , L. Ashcroft3 , D.R. Baldwin4 , R. Booton5 , L. Darlison6 , J. Edwards7 , L. Lang-Lazdunski8 , J.F. Lester9 , M. Peake6 , R.C. Rintoul10 , M. Snee11 , P. Taylor5 , C. Lunt3 , C. Faivre-Finn1 . 1 Department of Radiation Related Research, The Christie NHS Foundation Trust, Manchester, United Kingdom, 2 Consumer Liaison Group, National Cancer Research Institute, Barnsley, United Kingdom, 3 R&D, The Christie NHS Foundation Trust, Manchester, United Kingdom, 4 City Hospital Campus, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom, 5 North West Lung Centre, University Hospital South Manchester, Manchester, United Kingdom, 6 Osborne Building, University Hospital of Leicester, Leicester, United Kingdom, 7 Weston Park Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom, 8 Thoracic Surgery, London Bridge Hospital, London, United Kingdom, 9 Clinical Oncology, Velindre Cancer Centre, Cardiff, United Kingdom, 10 Papworth Hospital, Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom, 11 Clinical Oncology, St James’s University Hospital, Leeds, United Kingdom Introduction: Trial Design: PIT is a National Institute of Health Research funded, phase III multicentre, 2 arm randomised trial open in the UK. A total of 374 patients are required to determine the efficacy of Prophylactic Irradiation of (portal) Tracts (PIT) as assessed by incidence of chest wall metastasis in patients with malignant pleural mesothelioma that have undergone a diagnostic or therapeutic invasive chest wall procedure. Methods: Key eligibility: Diagnosed Mesothelioma; ECOG PS 0 2; inoperable disease/patients unsuitable for surgery; invention with VATS, open surgical biopsy, local anaesthetic thoracoscopy or chest drain; able to start radiotherapy within 42 days of intervention; scar visible; radiotherapy target volume accepted by local radiologist; no previous radiotherapy to chest wall; no indwelling catheter in-situ at the intervention site; patient not currently receiving chemotherapy.
Figure: PIT accrual snapshot, September 2014.
Results: Trial Interventions & assessments: Patients are randomised to receive PIT or no PIT. Radiotherapy consists of 21 Gy in 3 fractions once daily over 3 consecutive days, using a single electron field. Patients considered for palliative chemotherapy should have completed the radiotherapy at least 1 week before starting the first chemotherapy cycle. The follow-up period is for two years with regular outpatient visits in the first year and regular telephone follow-up in both years. Conclusion: Current status (September 2014): There are currently 237 patients randomised to the study. 59 research sites are open to PIT, 47 have recruited one patient or more and recruitment is due to end in June 2015. To meet our target we need the recruitment rate to continue to increase in the next 9 months. The Trial Management Group for PIT met in May 2014. There are no safety concerns about safety or the conduct of the study. http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12213 Chief Investigator: Dr Corinne Faivre-Finn, corinne.fi[email protected] Co-chief Investigator: Dr Neil Bayman, [email protected] Trial Manager: Colin Lunt, [email protected] Tel +44 (0)161 918 7492. Disclosure: All authors have declared no conflicts of interest. 184 Quality assurance programme for the isotoxic intensity modulated radiotherapy feasibility study N. Groom1 *, Y. Tsang2 , M.Q. Hatton3 , G. Hanna4 , K. Franks5 , S. Harden6 , F. McDonald7 , S. Harrow8 , C. Faivre-Finn9 . 1 Radiotherapy Physics, Mount Vernon Cancer Centre, Northwood, United Kingdom, 2 Radiotherapy Trials QA, Mount Vernon Cancer Centre, London, United Kingdom, 3 Clinical Oncology, Weston Park Hospital, Sheffield, United Kingdom, 4 Centre for Cancer Research and Cell Biology, Queen’s University, Belfast, United Kingdom, 5 Clinical Oncology, St James’s University Hospital, Leeds, United Kingdom, 6 Clinical Oncology, Addenbrooke’s Hospital, Cambridge, United Kingdom, 7 Clinical Oncology, The Royal Marsden NHS Foundation Trust, Surrey, United Kingdom, 8 Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, 9 MAHSC-CTU, The Christie NHS Foundation Trust, Manchester, United Kingdom Introduction: Isotoxic IMRT is a multicentre feasibility study recruiting patients with stage III non small cell lung cancer, not suitable for concurrent chemo-radiotherapy. Patients recruited will be treated with individualised doses of radiation based on prespecified normal tissue doses. Radiotherapy will be delivered twicedaily over a maximum period of 4.5 weeks using IMRT and the radiation dose will be increased until one or more of the OAR tolerance or the maximum dose of 79.2 Gy is reached. As part of the quality assurance programme (QA) a comparison of the conformity of organ at risk (OAR) outlining and planning technique has been undertaken. Methods: Centres were asked to complete an outlining benchmark case (assessing OAR outlining) and a planning benchmark case (assessing treatment planning technique). The outlining results presented are from 5 centres (A to E) as the outlines from the sixth centre (F) were used as the gold standard (GS) outlines for the exercise. DICE similarity coefficient (DSC) was defined as (2×UNION of Vol_GS and Vol_centre)/(Vol_GS + Vol_centre). DSC values range from 0 to 1, with1 denoting complete conformity to the gold standard and levels above 0.6 considered good for this case. Results: Outlining benchmark case: Figure 1 shows DSC for centres A to E for the OAR outlining. Planning benchmark case: 4 out of the 6 centres were able to achieve the maximum dose/number of fractions. The most common limitation to dose escalation was dose to the 1cc mediastinal envelope.
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Trials in Progress 182 RESPECT-Meso: a multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma S. Gunatilake1 *, L. Marshall2 , A. Chauhan1 . 1 Respiratory, Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom, 2 Research and Development, Portsmouth, United Kingdom Introduction: Malignant pleural mesothelioma (MPM) is an incurable cancer and best supportive care remains the mainstay of treatment for the majority. Patients with MPM frequently have significant physical symptoms at presentation which can impact on quality of life (QOL) [1]. The purpose of this study is to examine if early specialist palliative care involvement in MPM patients can improve patient’s and carer’s quality of life during their illness. Methods: 174 patients diagnosed with MPM and their carers will be invited to participate. Participant’s symptoms, healthcare use will be recorded and QOL and mood questionnaires will be administered. Participants will be randomised to receive regular early specialist symptom control treatment (RESSCT) at 4-weekly intervals or standard treatment. All participants will receive 4 weekly follow-up. Primary outcome: • To assess the impact of RESSCT on global QOL in patients with MPM 12 weeks from randomisation Secondary outcomes: • Patient QOL at 24 weeks • Patient mood at 12 and 24 weeks • Primary caregiver QOL and mood at 12 and 24 weeks, and 24 weeks after patient death • Survival between the 2 groups • Healthcare utilisation and costs • The cost-effectiveness of RESSCT when compared to usual practice • Sub-group analyses of QOL at 12 and 24 weeks for patients based on biological criteria and radiological staging at time of diagnosis. Results: Recruitment: see the figure.
Figure: Rates of surgery in Stage I & II NSCLC.
Conclusion: This audit established surgical resection rates at E&NH NHS trust to be higher than local network as a whole and in line with the national average. Indeed, resection rates may be underestimated due to inaccuracies in LUCADA data entry (eg. inclusion of small cell diagnoses). After retrospective review of data, all 15 patients were assessed and managed appropriately. Disclosure: All authors have declared no conflicts of interest. Figure: RESPECT-Meso cumulative recruitment, March September 2014.
Sites open to recruitment: • Queen Alexandra Hospital, Portsmouth • Norfolk and Norwich University Hospital • University Hospital North Durham • North Manchester General Hospital • South Tyneside District Hospital • New Cross Hospital, Wolverhampton Strategies to improve recruitment: • Increase number of recruitment centres to 15
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Poster abstracts, 13th Annual British Thoracic Oncology Group Conference, 2015: Trials in Progress
• Explore the possibility of opening Perth, Australia as a recruiting site • Regular contact with recruitment centres via telephone and monthly newsletter • Trial promoted in ‘Mesothelioma UK’ newsletter, ‘Cancer UK’ website and at BTOG • Dedicated trial website www.respect-meso.org Reference(s) [1] Hollen PJ, Gralla RJ, Liepa AM, Symanowski JT, Rusthoven JJ. Adapting the Lung Cancer Symptom Scale (LCSS) to mesothelioma: using the LCSS-Meso conceptual model for validation. Cancer 2004; 101: 587 95. Disclosure: All authors have declared no conflicts of interest. 183 PIT: a phase III trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention N. Bayman1 *, D. Ardron2 , L. Ashcroft3 , D.R. Baldwin4 , R. Booton5 , L. Darlison6 , J. Edwards7 , L. Lang-Lazdunski8 , J.F. Lester9 , M. Peake6 , R.C. Rintoul10 , M. Snee11 , P. Taylor5 , C. Lunt3 , C. Faivre-Finn1 . 1 Department of Radiation Related Research, The Christie NHS Foundation Trust, Manchester, United Kingdom, 2 Consumer Liaison Group, National Cancer Research Institute, Barnsley, United Kingdom, 3 R&D, The Christie NHS Foundation Trust, Manchester, United Kingdom, 4 City Hospital Campus, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom, 5 North West Lung Centre, University Hospital South Manchester, Manchester, United Kingdom, 6 Osborne Building, University Hospital of Leicester, Leicester, United Kingdom, 7 Weston Park Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom, 8 Thoracic Surgery, London Bridge Hospital, London, United Kingdom, 9 Clinical Oncology, Velindre Cancer Centre, Cardiff, United Kingdom, 10 Papworth Hospital, Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom, 11 Clinical Oncology, St James’s University Hospital, Leeds, United Kingdom Introduction: Trial Design: PIT is a National Institute of Health Research funded, phase III multicentre, 2 arm randomised trial open in the UK. A total of 374 patients are required to determine the efficacy of Prophylactic Irradiation of (portal) Tracts (PIT) as assessed by incidence of chest wall metastasis in patients with malignant pleural mesothelioma that have undergone a diagnostic or therapeutic invasive chest wall procedure. Methods: Key eligibility: Diagnosed Mesothelioma; ECOG PS 0 2; inoperable disease/patients unsuitable for surgery; invention with VATS, open surgical biopsy, local anaesthetic thoracoscopy or chest drain; able to start radiotherapy within 42 days of intervention; scar visible; radiotherapy target volume accepted by local radiologist; no previous radiotherapy to chest wall; no indwelling catheter in-situ at the intervention site; patient not currently receiving chemotherapy.
Figure: PIT accrual snapshot, September 2014.
Results: Trial Interventions & assessments: Patients are randomised to receive PIT or no PIT. Radiotherapy consists of 21 Gy in 3 fractions once daily over 3 consecutive days, using a single electron field. Patients considered for palliative chemotherapy should have completed the radiotherapy at least 1 week before starting the first chemotherapy cycle. The follow-up period is for two years with regular outpatient visits in the first year and regular telephone follow-up in both years. Conclusion: Current status (September 2014): There are currently 237 patients randomised to the study. 59 research sites are open to PIT, 47 have recruited one patient or more and recruitment is due to end in June 2015. To meet our target we need the recruitment rate to continue to increase in the next 9 months. The Trial Management Group for PIT met in May 2014. There are no safety concerns about safety or the conduct of the study. http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12213 Chief Investigator: Dr Corinne Faivre-Finn, corinne.fi[email protected] Co-chief Investigator: Dr Neil Bayman, [email protected] Trial Manager: Colin Lunt, [email protected] Tel +44 (0)161 918 7492. Disclosure: All authors have declared no conflicts of interest. 184 Quality assurance programme for the isotoxic intensity modulated radiotherapy feasibility study N. Groom1 *, Y. Tsang2 , M.Q. Hatton3 , G. Hanna4 , K. Franks5 , S. Harden6 , F. McDonald7 , S. Harrow8 , C. Faivre-Finn9 . 1 Radiotherapy Physics, Mount Vernon Cancer Centre, Northwood, United Kingdom, 2 Radiotherapy Trials QA, Mount Vernon Cancer Centre, London, United Kingdom, 3 Clinical Oncology, Weston Park Hospital, Sheffield, United Kingdom, 4 Centre for Cancer Research and Cell Biology, Queen’s University, Belfast, United Kingdom, 5 Clinical Oncology, St James’s University Hospital, Leeds, United Kingdom, 6 Clinical Oncology, Addenbrooke’s Hospital, Cambridge, United Kingdom, 7 Clinical Oncology, The Royal Marsden NHS Foundation Trust, Surrey, United Kingdom, 8 Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, 9 MAHSC-CTU, The Christie NHS Foundation Trust, Manchester, United Kingdom Introduction: Isotoxic IMRT is a multicentre feasibility study recruiting patients with stage III non small cell lung cancer, not suitable for concurrent chemo-radiotherapy. Patients recruited will be treated with individualised doses of radiation based on prespecified normal tissue doses. Radiotherapy will be delivered twicedaily over a maximum period of 4.5 weeks using IMRT and the radiation dose will be increased until one or more of the OAR tolerance or the maximum dose of 79.2 Gy is reached. As part of the quality assurance programme (QA) a comparison of the conformity of organ at risk (OAR) outlining and planning technique has been undertaken. Methods: Centres were asked to complete an outlining benchmark case (assessing OAR outlining) and a planning benchmark case (assessing treatment planning technique). The outlining results presented are from 5 centres (A to E) as the outlines from the sixth centre (F) were used as the gold standard (GS) outlines for the exercise. DICE similarity coefficient (DSC) was defined as (2×UNION of Vol_GS and Vol_centre)/(Vol_GS + Vol_centre). DSC values range from 0 to 1, with1 denoting complete conformity to the gold standard and levels above 0.6 considered good for this case. Results: Outlining benchmark case: Figure 1 shows DSC for centres A to E for the OAR outlining. Planning benchmark case: 4 out of the 6 centres were able to achieve the maximum dose/number of fractions. The most common limitation to dose escalation was dose to the 1cc mediastinal envelope.