Is Radiotherapy Useful for Treating Pain in Mesothelioma?: A Phase II Trial

Our plain-English summary of Is Radiotherapy Useful for Treating Pain in Mesothelioma?: A Phase II Trial, by N. MacLeod, A. Chalmers, N. O'Rourke, et al (Journal of Thoracic Oncology, 2015).

The study

• Authors: N. MacLeod, A. Chalmers, N. O'Rourke, K. Moore, J. Sheridan, L. McMahon, C. Bray, J. Stobo, A. Price, M. Fallon, B.J. Laird
• Journal: Journal of Thoracic Oncology
• Published: 2015;10(6):944-50
• Cited by: 51 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Introduction: Radiotherapy is often used to treat pain in malignant pleural mesothelioma (MPM), although there is limited evidence to support this. The aim of this trial was to assess the role of radiotherapy for the treatment of pain in MPM.

Methods: A multicentre, single arm phase II trial was conducted. Eligible patients fulfilled the following criteria: pathological or radiological diagnosis of MPM; pain secondary to MPM; radiotherapy indicated for pain control; and more than 18 years of age. Patients had assessments of pain and other symptoms at baseline and then received 20 Gy in five daily fractions. Key follow-up points were 5 and 12 weeks posttreatment. The primary end point measure was assessment of pain at the site of radiotherapy at 5 weeks. Secondary end points included effects on quality of life, breathlessness, fatigue, mood, toxicity, and the radiological response.

Results: Forty patients were recruited from three UK oncology centers. Fourteen patients had a clinically meaningful improvement in their pain 5 weeks post radiotherapy (intention to treat), with five patients having a complete improvement. On the basis of a complete case analysis of the 30 patients assessable at week 5, 47% (confidence intervals, 28.3-65.7) of patients alive at week 5 had an improvement in their pain. There was no improvement in other key symptoms or quality of life.

Conclusions: Radiotherapy for pain control in MPM is an effective treatment in a proportion of patients. Future studies examining differing radiotherapy regimens with a view to improving response rates are warranted.

In plain English

This single-arm phase II trial at three UK cancer centres tested whether radiotherapy relieves pain in malignant pleural mesothelioma. Forty patients consented between June 2012 and December 2013, and 37 started treatment. The planned dose was 20 Gy in five fractions to the painful area. Pain was measured with the Brief Pain Inventory, and a meaningful improvement meant a drop in pain of 30% or more. Five weeks after radiotherapy, 14 of the 40 patients (35%) had such an improvement, and 5 had complete improvement. Among the 30 patients assessable at week 5, 47% (confidence interval 28.3 to 65.7) responded. Overall quality of life did not change. Only night sweats improved significantly on the separate symptom scales. On the quality-of-life questionnaire, breathlessness was significantly lower at week 1, while nausea and vomiting (week 1) and fatigue (week 12) worsened significantly. Median survival from trial entry was 93 days (confidence interval 68 to 118). The authors concluded that palliative radiotherapy can effectively treat pain in a proportion of patients. They noted the small sample, high drop-out, conservative dose and no follow-up beyond 12 weeks.

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: Multicentre, single-arm, phase II clinical trial with no comparison group
• Who was studied: 40 adults with malignant pleural mesothelioma and pain from the disease who consented between June 2012 and December 2013 at three UK regional cancer centres (Glasgow, Edinburgh and Sheffield). 37 started radiotherapy. 35 were male, and the median age was 71.5 years.
• Exposure: Palliative radiotherapy, planned as 20 Gy in five fractions to the painful area (all pain sites were in the chest). The study did not examine asbestos exposure.
• Main results:
  • In the intention-to-treat analysis, 14 of 40 patients (35%) had a clinically meaningful improvement in pain 5 weeks after radiotherapy.
  • Five patients had complete improvement in their pain, reported as 12.5%.
  • Among the 30 patients who could be evaluated at week 5, 47% (CI 28.3 to 65.7) responded.
  • Among patients who could be evaluated, the proportion with a pain response was 36.7% (CI 19.9 to 56.1%) at week 1 and 33.3% (CI 13.3 to 59.0%) at week 12. Only 18 patients were evaluable at week 12.
  • Among responders, mean opioid dose did not differ between baseline and the week 5 end point (p = 0.627).
  • For the group as a whole, global quality of life did not change during the study.
  • On the quality-of-life questionnaire, pain scores were significantly lower at weeks 1 (p = 0.005) and 5 (p = 0.034), and dyspnea (breathlessness) scores were significantly lower at week 1 (p = 0.037).
  • On the quality-of-life questionnaire, fatigue scores at week 12 (p = 0.040) and nausea/vomiting scores at week 1 (p = 0.017) increased significantly.
  • On the separate symptom assessments (Table 2), only night sweats changed significantly, improving by week 5 (p = 0.01).
  • Median survival from trial registration was 93 days (CI 68 to 118) for all patients.
• The authors' conclusion: The authors concluded that palliative radiotherapy can be an effective method for treating pain in malignant pleural mesothelioma. They also concluded that in a proportion of patients it is associated with dramatic improvements in pain.
• Limitations the authors state:
  • Small sample size
  • Very high attrition: only 75% of patients could be evaluated 5 weeks after radiotherapy
  • A rather conservative radiotherapy dose and regimen was chosen because it was widely used at the study centres
  • No information on whether pain improvement lasted beyond 12 weeks, the end of the study

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Mesothelioma, Pleural Mesothelioma, Quality of Life, confidence interval.

Related studies

• Radiotherapy for the treatment of pain in malignant pleural mesothelioma: a systematic review — N. Macleod, A. Price, et al. (2014)
• Prophylactic radiotherapy for the prevention of procedure-tract metastases after surgical and large-bore pleural procedures in malignant pleural mesothelioma (SMART): a multicentre, open-label, phase 3, randomised controlled trial — A.O. Clive, H. Taylor, et al. (2016)
• Anterior cingulotomy improves malignant mesothelioma pain and dyspnoea — E.A. Pereira, M. Paranathala, et al. (2014)
• Re-evaluating the role of palliative radiotherapy in malignant pleural mesothelioma — P. Jenkins, R. Milliner, et al. (2011)
• Cordotomy in mesothelioma-related pain: a systematic review — B.D. France, R.A. Lewis, et al. (2014)
• Chronic pleuritic pain in four patients with asbestos induced pleural fibrosis — A. Miller (1990)

Browse more research in Journal of Thoracic Oncology, or return to medical research.