The addition of chemotherapy to active symptom control* (ASC) for mesothelioma patients does not appear to improve their survival or quality of life. These are the conclusions of authors of an Article in this week’s edition of The Lancet.
Malignant pleural mesothelioma (MPM) is a cancer of the protective lining that covers the lungs, and is almost always fatal. The worldwide incidence continues to rise — in the UK, the mortality rate increased 12-fold between 1968 and 2001; nearly 2000 deaths were recorded in 2005. This yearly death rate is expected to increase to a peak of 2200 by 2013. Similar death rates occur in the USA and Western Europe. The incidence of mesothelioma is directly related to the production and use of asbestos — and while peaks in death rates are approaching in the USA and Western Europe, in future decades the epidemic will shift towards countries that still produce or use large quantities of asbestos eg, Russia, China, Canada, Kazakhstan, Brazil, Zimbabwe, India, and Thailand.
Richard Stephens and Professor Mahesh Parmar, Medical Research Council (MRC) Clinical Trials Unit, London, UK, and colleagues did the MS01 study, a Cancer Research UK-funded, randomised trial involving 409 patients with MPM from 76 centres in the UK and two in Australia. Of these, 136 were randomised to ASC alone. A further 137 received ASC plus MVP chemotherapy (four cycles of mitomycin, vinblastine, and cisplatin every three weeks); and the remaining patients (136) received ASC plus vinorelbine chemotherapy (one injection of vinorelbine every week for 12 weeks). Follow-up was every three weeks to 21 weeks after randomisation, and every eight weeks thereafter. Unfortunately insufficient patients could be recruited to allow a separate assessment of the two chemotherapy regimens, so they were combined and compared with ASC alone for the primary outcome of overall survival.
At the time of analysis, 393 (96%) of patients had died – 132 (97%) of the ASC only group; 132 (96%) in the ASC/MVP group; and 129 (95%) in the ASC/vinorelbine group. A small but non-statistically-significant benefit was seen in the ASC plus chemotherapy group versus ASC alone (29% of ASC patients were alive at 1 year compared to 32% of those on ASC plus chemotherapy). Patients in the ASC/vinorelbine showed a trend towards improved survival compared with ASC alone, and 37% of these patients were alive at 1 year, although this was not statistically significant. Quality of life scores (physical functioning, pain, shortness of breath, overall health status) were similar in the three groups.
The authors conclude: “The addition of chemotherapy to ASC offers no significant benefits in terms of overall survival or quality of life. However, exploratory analyses suggested that vinorelbine merits further investigation.”
In an accompanying Comment, Dr Nicholas J Vogelzang, Nevada Cancer Institute, Las Vegas, NV, USA, discusses the evidence around various chemotherapy regimens for mesothelioma. He concludes: “Patients with malignant pleural mesothelioma who wish to be treated should be informed that strong medical evidence establishes the standard as cisplatin and pretrexed. Although cisplatin plus gemcitabine might be equally effective, there have as yet been no randomised comparisons of the two doublet regimens.”
*Notes to editors: Active symptom control (ASC) can include steroids, painkillers, bronchodilators, and palliative radiotherapy,
Laure Thomas, MRC Senior Press Officer T) + 44 (0) 207 670 5139 E) Laure.Thomas@headoffice.mrc.ac.uk
Dr Trish Fisher, Consultant Clinical Oncologist, Weston Park Hospital, Sheffield, UK T) +44 (0) 114 2265248 / + 44 (0) 7739 389850 E) Patricia.Fisher@sth.nhs.uk
Dr Martin Muers, Consultant Respiratory Physician, The General Infirmary at Leeds, Leeds, UK +44 (0) 7720 60 20 62 E) martin.muers@leedsth.nhs.uk
Comment : For Dr Nicholas J Vogelzang, Nevada Cancer Institute, Las Vegas, NV, USA please contact Jennifer McDonnell, NVCI Public Relations and Marketing Director, +1 702-821-0082 E) jmcdonnell@nvcancer.org
http://multimedia.thelancet.com/pdf/press/mesothelioma.pdf
Journal
The Lancet