SYSTEMS-2: A randomised phase II study of radiotherapy dose escalation for pain control in malignant pleural mesothelioma

Our plain-English summary of SYSTEMS-2: A randomised phase II study of radiotherapy dose escalation for pain control in malignant pleural mesothelioma, by M. Ashton, N. O'Rourke, N. Macleod, et al (Clinical and Translational Radiation Oncology, 2018).

The study

• Authors: M. Ashton, N. O'Rourke, N. Macleod, B. Laird, J. Stobo, C. Kelly, L. Alexander, K. Franks, K. Moore, S. Currie, R. Valentine, A.J. Chalmers
• Journal: Clinical and Translational Radiation Oncology
• Published: 2018;8:45-49
• Cited by: 13 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

SYSTEMS-2 is a randomised study of radiotherapy dose escalation for pain control in 112 patients with malignant pleural mesothelioma (MPM). Standard palliative (20 Gy/5#) or dose escalated treatment (36 Gy/6#) will be delivered using advanced radiotherapy techniques and pain responses will be compared at week 5. Data will guide optimal palliative radiotherapy in MPM.

In plain English

This short communication described the plan for SYSTEMS-2, a randomised phase II trial in the UK comparing two radiotherapy schedules for pain caused by malignant pleural mesothelioma. It reported no results. The trial planned to enrol 112 patients for whom radiotherapy was clinically indicated for mesothelioma-related pain, 56 per arm. Patients were to receive either standard treatment of 20 Gy in 5 fractions over 1 week or a higher, dose escalated treatment of 36 Gy in 6 fractions over 2 weeks. Doses could be reduced to 30 Gy in 5 fractions if limits on doses to normal organs could not be met. The main measure was the proportion of patients whose 'worst pain score' on the Brief Pain Inventory dropped by at least 2 points between baseline and week 5. The trial was sized to detect a rise in responders from 40% to 60%. Secondary measures were side effects, quality of life, tumour response on scans and survival. The authors anticipated that the trial would provide robust symptom response data and help establish the optimal dose in this setting. The article did not discuss asbestos exposure.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Trial protocol (short communication) for a randomised, phase II, multicentre trial; no results reported
• Who was studied: 112 planned patients with malignant pleural mesothelioma for whom radiotherapy is clinically indicated for pain (56 per arm); developed at the Beatson West of Scotland Cancer Centre, Edinburgh and the Cancer Research UK Clinical Trials Unit Glasgow; ethical approval granted 19 January 2016
• Exposure: Palliative radiotherapy (not asbestos): dose escalated 36 Gy in 6 fractions over 2 weeks versus standard 20 Gy in 5 fractions over 1 week, predominantly using IMRT; dose may be reduced to 30 Gy in 5 fractions over 2 weeks if dose constraints cannot be met
• The authors' conclusion: The authors anticipated that SYSTEMS-2 would provide robust and accurate symptom response data and help establish the optimal dose and fractionation for palliative radiotherapy in this disease

Topics

Medical terms in this study, explained in our Lexicon: Pleural Mesothelioma, Palliative Care.

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