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V.F. Surmont



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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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      O27.06 - Resistance training in patients with radically treated respiratory cancer: mature results of a multi-centre randomised phase 3 trial (REINFORCE) (ID 678)

      16:15 - 17:45  |  Author(s): V.F. Surmont

      • Abstract
      • Presentation
      • Slides

      Background
      There is a lack of data on the effect of conventional resistance training (CRT) on exercise capacity, muscle strenght and quality of life (QoL) in patients with lung cancer. Whole body vibration (WBV) is proposed as an alternative to CRT. We investigated the effect of a radical treatment and of two post-treatment resistance training programmes on the 6-minutes walking distance (6MWD).

      Methods
      Selected patients with clinical stage I-IIIB (non-) small cell lung cancer or I-II mesothelioma were evaluated before (M1) and at completion (M2) of their radical treatment, and thereafter randomised to either control (CON), CRT or WBV. 6MWD was measured at M1, M2 and at least 12 weeks (w) after randomisation (M3) considering a minimal clinically important difference (MCID) of 54 m. Assuming that this MCID would occur in 10% of the CON-group and aiming for an increase to at least 50% in the combined intervention groups (CRT and WBV), a sample size of 25 participants in each arm was required for a power of 90%. Secondary endpoints were estimated by appropriate MCID's for maximal exercise capacity (Wmax), muscle strenght (Quadriceps Force (QF)) and QoL (physical functioning (PF), fatigue (F), pain (P) and dyspnea D)). Multiple imputation was used to correct for patients not finishing the intervention.

      Results
      Of the 86 patients completing radical treatment, 70 were randomised: 24 to CON, 24 to CRT and 22 to WBV. Characteristics at M1 were well balanced. Radical treatment significantly decreased 6MWD, Wmax, QF, PF and increased P, F and D at M2. At M3, 20 of 37 (54%) patients in the combined CRT-WBV-group reached the MCID for 6MWD vs. 5 of 21 CON (24%) patients (p=0·031). 6MWD increased with 95 m (58–132) in CRT (p<0·0001), 37 m (-1–76) in WBV (p=0·06) and 1 m (-33–36) in CON (CRT vs. CON p=0·0006 and WBV vs. CON p=0·16). CRT and WBV patients recovered and exceeded their M16MWD, albeit not significantly. A significant mean increase in Wmax occurred in both CRT and WBV but not in CON, while QF increased only significantly in CRT. The mean score for PF at M3 improved in CON and WBV but only significantly with WBV. The mean score for P and F at M3 did not change significantly, however the MCID for F was reached in 37% of CRT, 44% of WBV and 30% of CON-patients. The mean score for D at M3 decreased significantly after WBV only. Multivariate analysis showed that there was no significant interaction between rehabilitation and surgery with regard to the MCID in 6MWD (p=0.96).

      Conclusion
      Radical treatment significantly impairs exercise capacity, muscle strength and QoL. CRT significantly improves and restores functional exercise capacity, whilst WBV does not fully substitute for CRT. Resistance training by CRT should be offered to radically treated lung cancer and mesothelioma patients. Supported by research grant 070708 of the Belgian Government Agency of Innovation by Science and Technology for applied Biomedical Research (NCT: 00752700)

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    P3.13 - Poster Session 3 - SCLC (ID 202)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.13-005 - CONVERT - the challenges of opening centres and recruiting patients to an international multi-centre chemo-radiotherapy trial in limited-stage small cell lung cancer (ID 1366)

      09:30 - 16:30  |  Author(s): V.F. Surmont

      • Abstract

      Background
      CONVERT is a multicentre, randomised, phase III trial open in Europe and Canada in limited-stage small cell lung cancer. Patients are randomised to twice (45 Gy in 30 fractions) or once-daily radiotherapy (66 Gy in 33 fractions) given concurrently with 4-6 cycles of chemotherapy. This study is funded by Cancer Research UK and involves centres from the UK NCRI, the ‘Groupe Francais de Pneumo-Cancerologie’, the Spanish Lung Cancer Group, the EORTC and NCIC CTG.

      Methods
      To identify and review the challenges in site set-up. To review time taken from site initiation to first patient randomised, number of centres opened that included 0-2 patients and number of centres that recruited the majority of all patients.

      Results
      In June 2013, 519/532 patients had been recruited in 9 countries; 299 from 32 UK centres, 100 from 17 French centres, 39 from 9 Canadian centres, 27 from 6 Spanish centres, 26 from 3 Belgian centres, 13 patients from 1 centre in Slovenia, 9 from 2 centres in The Netherlands and 6 patients from 1 centre in Poland. Figure 1 shows the number of centres open and patients recruited. 96 sites are currently open to recruitment (5 sites opened in 2008, 34 in 2009, 31 in 2010, 17 in 2011, 8 in 2012 & 3 in 2013, 2 sites subsequently closed early) of which 74 (77%) have randomised at least 1 patient. 24 sites (25%) recruited only 1 or 2 patients. 10 sites have recruited 49% of the total number of patients with a single site recruiting 18.5% of all patients randomised. Time taken from site initiation to 1[st] patient randomised ranged from 0–1029 days with a median of 144 days. Time taken to complete the QA exercise from initial information sent to site ranged from 14-1181 days with a median of 290.5 days. Figure 1

      Conclusion
      Recruitment to an academic trial in LS-SCLC is a challenge but accrual has improved considerably since 2008. This can be directly related to the increasing number of sites opened to recruitment. Duration of site set-up and completion of the QA exercise are factors explaining slower than anticipated accrual rates particularly between 2008 and 2010. We anticipate that the study will close to recruitment in July 2013. International participation has been a key factor to the success of the trial and the experience gained will be of value to the design of future radiotherapy studies to ensure target accrual.

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    P3.24 - Poster Session 3 - Supportive Care (ID 160)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P3.24-032 - Second opinion for thoracic cancer and its impact on diagnosis and treatment strategy: a single institutional series (ID 1950)

      09:30 - 16:30  |  Author(s): V.F. Surmont

      • Abstract

      Background
      Lung cancer patients increasingly seek a second opinion in order to make sure they are receiving an exact diagnosis and an optimal treatment. A second opinion is more likely to be comprehensive when performed in centers with high level of expertise and within a multidisciplinary team.

      Methods
      A dedicated second opinion outpatient clinic was started within the Thoracic Oncology Unit of Ghent University Hospital, in March 2012, aiming at a quick access and evaluating its impact on diagnosis and treatment decisions. Second opinion was defined as a review of the cancer diagnosis and/or the treatment recommendations by another independent oncologist and/or multidisciplinary team. Patients had to be referred by either their general practitioner or the treating specialist. Prior to the consultation relevant investigations (medical history, pathology and imaging) had to be provided.

      Results
      Between March 2012 and June 2013, 79 pts were referred: 31 women and 48 men with a median age of 64 years [17-81 yrs]. Of these, 17 (22%) were never smokers, 18 (23%) smokers and 40 (51%) ex-smokers. Median interval was 3 working days [0-15 days] after first referral. Eighteen percent of patients were referred by their GP’s versus 80% by their treating specialist. Medical information including imaging was available in all pts at the moment of the consultation. Diagnosis included: adenocarcinoma (n=43 - 54%), squamous cell carcinoma (n=8 - 10%), NSCLC, NOS (n=1 large cell neuroendocrine carcinoma (n=3 - 4%), small cell lung cancer (n=4 - 5%), mesothelioma (n=6 - 8%), thymoma (n=2 - 3%), carcinoid tumor (n= 4 - 5%). In 4 patients no diagnosis had been established. Eleven patients were referred for confirmation of diagnosis and treatment, 11 for staging and 57 for treatment advice. Median consultation duration was 35 minutes [15-60 min], median time of multidisciplinary counseling 15 minutes [5-60 min]. In 43% of the referrals, diagnosis and treatment was confirmed, in 21% other diagnostic examinations were advised and in 29% a substantial change in treatment was proposed. Six percent of patients entered into a clinical trial. Almost 50% of patients continued their treatment at our center (26% on request of the referring physician, 23% on patient's request). Patient's satisfaction on waiting time and quality of the advice was high.

      Conclusion
      This dedicated second opinion outpatient clinic confirms the need for an academic second medical advice and provided a quick access. In 50% of cases a substantial change in diagnostic procedure or treatment was proposed.