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N. Macleod



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    ORAL 26 - Clinical Trials 2 (ID 127)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
    • Presentations: 1
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      ORAL26.05 - Symptom Study of Radiotherapy in Mesothelioma (SYSTEMS), a Phase II Study (ID 390)

      11:28 - 11:39  |  Author(s): N. Macleod

      • Abstract
      • Presentation
      • Slides

      Background:
      There is little evidence to support the use of radiotherapy in treating pain in malignant pleural mesothelioma (MPM), however it is widely used. The aim of the present study was to assess the role of radiotherapy in palliating pain in MPM.

      Methods:
      A multi-centre, single arm, phase II study was conducted in the UK. Eligible patients met the following criteria: a diagnosis of MPM; worst pain score of > 4/10; performance status 0-2; CT scan within eight weeks of radiotherapy; due to receive radiotherapy for pain. Patients who had received anti-cancer therapy in the previous 6 weeks were ineligible. The following key assessments were performed at study baseline: pain (Brief Pain Inventory), Quality of Life (EORTC QLQ-C30) and inflammation (CRP). Following this, all patients were treated with 20 Gray in five fractions to the area of tumour felt to be responsible for the pain. The primary endpoint was a 30% drop in the BPI score five weeks after radiotherapy. Patients were followed up for 12 weeks after radiotherapy.

      Results:
      Forty patients were recruited between June 2012 and December 2013. Mean age was 71 with a male to female ratio of 7 : 1. Histological diagnosis was present in 85% of patients; 52.5% epithelioid, 25% sarcomatoid, 7.5% biphasic and 15% unspecified. The mean response to radiotherapy at five weeks was 35% (95% CI 20.6-51.7%). 37 patients started radiotherapy and 35 patients completed the full course. Fourteen patients had received prior chemotherapy. No association between baseline CRP and response was observed (p=0.958). Only one patient had a radiological response on CT with stable disease seen in a further 13 patients. There was no significant change in quality of life (QoL) score at any timepoint (p=0.680 week 1, p=0.765 week 5, p=0.384 week 12).

      Conclusion:
      Radiotherapy provides effective pain relief in a proportion of patients with MPM and should be considered for all patients with MPM related pain. Randomised dose escalation studies are now warranted and funding has been secured for such a study, SYSTEMS 2.

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