Multicenter randomized controlled trial of the management of unresectable malignant mesothelioma proposed by the British Thoracic Society and the British Medical Research Council

Our plain-English summary of Multicenter randomized controlled trial of the management of unresectable malignant mesothelioma proposed by the British Thoracic Society and the British Medical Research Council, by D.J. Girling, M.F. Muers, W. Qian, et al (Seminars in Oncology, 2002).

The study

• Authors: D.J. Girling, M.F. Muers, W. Qian, D. Lobban
• Journal: Seminars in Oncology
• Published: 2002;29(1):97-101
• Type of article: Randomized trial, Review
• Cited by: 14 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Malignant mesothelioma is almost invariably fatal. The incidence of the disease is rising rapidly in many countries, and there is no generally accepted standard treatment for patients with unresectable disease. According to current British Thoracic Society (BTS) guidelines, patients should be treated with active symptom control (ASC), involving (1) regular follow-up in a specialist clinic; (2) structured assessments of physical, psychological and social problems with appropriate action; (3) rapid involvement of additional specialists; and (4) parallel nursing support. Although many nonrandomized studies have reported tumor responses to anticancer chemotherapy, few have studied palliation and it is not known whether chemotherapy prolongs survival or provides clinically worthwhile palliation with acceptable toxicity when given in addition to ASC. We therefore plan to conduct a multicenter randomized controlled trial comparing (1) ASC alone, (2) ASC plus mitomycin vinblastine and cisplatin (MVP), and (3) ASC plus vinorelbine (N; Navelbine, Pierre Fabre Oncology, Winchester, UK). We chose these chemotherapy regimens because they have been shown in nonrandomized studies to provide good symptom control as recorded by patients. The outcome measures are overall survival, palliation of symptoms, performance status, analgesic usage, toxicity, quality of life, tumor response, and recurrence/progression-free survival. In a preliminary feasibility study, we are assessing the acceptability of the trial design to patients and the suitability of two standard quality-of-life instruments in mesothelioma. Data will help us to decide the final details of the large multicenter trial.

Copyright 2002 by W.B. Saunders Company.

In plain English

This article did not report results. It described a planned multicenter randomized controlled trial, proposed by the British Thoracic Society and the British Medical Research Council, for patients with unresectable malignant mesothelioma, meaning mesothelioma that cannot be removed by surgery. The trial was to compare three approaches. The first was active symptom control alone: regular specialist follow-up, structured assessment of problems, prompt referral to other specialists, and nursing support. The second was active symptom control plus the drug combination mitomycin, vinblastine and cisplatin (MVP). The third was active symptom control plus the single drug vinorelbine. The authors planned to enroll 840 patients, 280 per group, over 4 years. Outcomes included survival, symptom relief, quality of life, side effects and tumor response. A feasibility study was under way to test whether patients would accept the design, after which the design and patient numbers might be reviewed. The authors noted that tumor response is hard to measure in mesothelioma. They concluded that large randomized trials were urgently needed, and that their trial would be uniquely useful because it was large, randomized and included a symptom-control-only group.

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: Description (protocol) of a proposed three-arm multicenter randomized controlled trial, not yet started. Planned outcome measures: overall survival, palliation of symptoms, performance status, analgesic usage, toxicity, quality of life, tumor response, and recurrence/progression-free survival. A preliminary feasibility study was in progress. No trial results are reported.
• Who was studied: Planned enrollment of 840 patients with unresectable malignant mesothelioma, 280 in each of three treatment groups, over 4 years. Eligibility required microscopically and immunohistochemically confirmed malignant mesothelioma and no previous chemotherapy for mesothelioma. The trial was proposed by UK bodies (British Thoracic Society, Medical Research Council).
• Exposure: Not a study of asbestos exposure. The interventions compared were active symptom control (ASC) alone, ASC plus MVP, and ASC plus vinorelbine. ASC meant regular specialist follow-up, structured assessment of physical, psychological and social problems, rapid involvement of other specialists, and nursing support. MVP was four cycles of mitomycin 6 mg/m2, vinblastine 6 mg/m2 and cisplatin 50 mg/m2 every 3 weeks. Vinorelbine was given at 30 mg/m2 weekly in two blocks of six injections separated by a 2-week interval.
• The authors' conclusion: The authors concluded that large randomized trials are urgently needed to define standard treatment of malignant mesothelioma, measuring survival as well as patient-recorded symptom palliation and quality of life. They stated that their proposed trial should prove uniquely useful because it is large, randomized and includes an ASC-only arm.
• Limitations the authors state:
  • Because mesothelioma grows diffusely, tumor response could not be routinely assessed with standard RECIST criteria. It was instead to be judged on CT scan as definitely better, definitely worse or probably unchanged.
  • The trial design and planned number of patients were provisional and might be revised after the feasibility study.

Topics

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

Medical terms in this study, explained in our Lexicon: Unresectable, Malignant Mesothelioma, Chemotherapy, Cisplatin, Vinorelbine, Overall Survival, Performance Status, Quality of Life.

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