Mesothelioma UK Update July 2008 (extracts)

Chemotherapy in Mesothelioma Project (ChiMP)

It is very encouraging to see the way recruitment to the ChiMP audit has taken off. We are all hopeful that this will provide some really useful data to support the development of services for mesothelioma patients.

Data from the National Lung Cancer Audit in 2006 was patchy on mesothelioma, but only 10% of patients were recorded as having received chemotherapy. ChiMP has recruited 155 patients in less than 5 months which should mean we will reach about 400 within the year, suggesting we have captured a significant proportion of those receiving treatment. Many thanks to all of you who have entered patients! To those who haven’t yet, we hope you appreciate the potential value of this project and will start to put patients in.

Out of the 155 patients registered we have 53 patients with complete data. If you require any help or need further advice either with registration or the data set, please do not hesitate to contact me either by email or telephone through the mesothelioma website.

Don’t forget for every complete set of patient data sent to us £15.00 will be paid into a study/research fund or in book tokens at the end of the audit year. Please ask for details. Jill Lemon – ChiMP Audit Manager Email: jill.lemon@uhl-tr.nhs.uk

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TRIALS UPDATE

Changing routine clinical practice requires reliable evidence from randomised trials, and, for numerous reasons, few such large trials have been conducted in Mesothelioma. Radical surgery is only possible for a tiny minority of patients, radical radiotherapy is inappropriate in this disease, and few chemotherapy drugs have been shown to be active. The MRC MS01 trial which was recently reported in the Lancet (Muers et al, Lancet 2008, 371, 1685-94) was the 2nd largest randomised trial so far reported in this disease, but did not give a clear green light for the use of chemotherapy. It could be argued, of course, that the chemotherapy regimens used had been superseded, but that is the dilemma of large trials, which can take up to 10 years from design to publication. Embarking on such projects therefore requires some belief that the treatments being investigated will be of relevance a decade hence. However, we are now in the era of new agents and molecular markers, and future treatments will almost inevitably be based around attempting to select the best treatment for each individual patient. In Mesothelioma we know that only a small proportion of patients respond to chemotherapy, but if we can identify those patients upfront we can potentially improve the lives of both the patients who then receive that chemotherapy, and those who don’t, who will be spared the burden of pointless chemotherapy. The challenges therefore, perhaps before we embark on another large randomised trial, are to identify some strong predictive biomarkers and subsequently build trials around them. Richard Stephens MRC Clinical Trials Unit –

Email: rs@ctu.mrc.ac.uk

MARS

97 patients have now been recruited to the registration phase of MARS. A big thank you to all of you who have been working hard to recruit these patients. However, we still have some way to go if we are to achieve our goal of randomising 50 patients by September 2008 (when funding for the recruitment phase from Cancer Research UK (CRUK ceases). By the end of May 2008 41 patients have been randomised. There is therefore a need to register as many patients as possible by the end of June, so that their chemotherapy and other investigations are complete prior to eligibility review and randomisation. Email: mars-icrctsu@icr.ac.uk

MALCS/TIPS

A new centre for TIPS (The Inhaled Particles Study) patients (BirminghamHeartlandsHospital) is now active. We are contacting patients. who have had a spontaneous pneumothorax on behalf of the team at BHH.

MALCS (Mesothelioma and Lung Cancer Study) continues to recruit steadily. We have had 157 notifications of cases of Mesothelioma, since March 2007.

The report from the first part of the study is still awaiting publication and peer scrutiny. It is hoped that this will soon be published.

We would like to express our continuing gratitude to all patients who are involved with our research. It is only with the help of patients, that we may be able to understand more about the disease and its epidemiology. We would also like to thank all those involved in recruitment to the study, and to encourage you to continue, your help is invaluable to us.

If you are not recruiting and would like to please contact us at MALCS@icr.ac.uk or phone 0208 722 4298 and ask for the MALCS team in Epidemiology.

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Proposal for a randomised controlled trial investigating the role of prophylactic radiotherapy to intervention sites in malignant mesothelioma

Patients with malignant pleural mesothelioma (MPM), who undergo chest instrumentation, may develop seeding at the site of intervention, leading to subcutaneous tumour.

This is believed to be reduced by the common practice of prophylactic irradiation to intervention tracts (PIT). However, evidence to support PIT is currently inadequate and contentious. Recent studies have thrown this practice into question but have not provided definitive answers due to underpowering. The British Thoracic Society and the French Speaking Society for Chest Medicine advocate the use of PIT, but other organisations recommend against it.

We recently carried out a national survey of PIT in MPM (54 centres). Out of the 45 centres that replied, 76% practiced PIT, yet 70% of respondents wanted a trial to determine PIT efficacy (31 centres). We propose a randomised controlled trial of PIT versus no PIT (21Gy in 3 fractions) for newly diagnosed mesothelioma patients, pre commencement of any planned systemic treatment, to see if this practice reduces the occurrence of chest wall nodules post instrumentation. To show a reduction in occurrence of nodules from 20% to 5% with a power of 80%, we would need 81 patients in each arm. We plan to stratify for chemotherapy, type of intervention and centres. An outline proposal has been submitted to the NCRI Lung Clinical Studies Group. If the PIT trial is supported we are planning to submit it to CTAAC in the autumn for funding. Email: Corinne.Finn@christie.nhs.uk

Dr Corinne Faivre-Finn

MD, PhD, FRCR

Department of Clinical Oncology, ChristieHospital NHS Trust, Wilmslow Road, Manchester, M20 4BX. UK.