MARS 2
Research type
Research Study
Full title
A study to determine if it is feasible to recruit into a randomised trial comparing (extended) pleurectomy decortication versus no pleurectomy decortication in the multimodality management of patients with malignant pleural mesothelioma
IRAS ID
132746
Contact name
Eric Lim
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Research summary
Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2300 people in the UK are diagnosed with mesothelioma each year and the average survival is approximately 17 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 30-40 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) surgery is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to determine if it is feasible to enrol patients with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and lung-sparing surgery. Patients will be followed up regularly at their usual clinic visits for to 5 years. Patients will be asked to complete a Quality of Life Questionnaire at these visits. Tissue samples will be taken at the time of diagnosis and at surgery (if they are randomised to surgery) for mesothelioma research central storage and blood samples will be taken at the clinic visits up to 12 months for mesothelioma research central storage. If we can show the feasibility of recruitment we will apply to continue the study to include more patients in order to determine if lung-sparing surgery improves survival and quality of life for mesothelioma patients.
Lay summary of study results: The MARS 2 trial showed that chemotherapy and surgery did not help people live longer than chemotherapy alone. Generally, those having both chemotherapy and surgery had more serious side effects of treatment. It cost the NHS more for people to have both surgery and chemotherapy than chemotherapy alone.
392 people joined the trial and had 2 cycles of chemotherapy followed by a CT scan. The CT scan was used to look at how big the cancer was and whether it had spread.
335 people were then able to be put into 1 of 2 treatment groups. This was based on the CT scan results and how the people taking part were feeling. This part of the trial was randomised. There were:
166 people in the chemotherapy group
169 people in the surgery and chemotherapy groupEveryone had up to 2 to 4 more cycles of standard chemotherapy. And people had the type of surgery that their treatment team thought would be most beneficial.
Not everyone completed treatment on the trial. 81 out of the 335 people stopped chemotherapy after the second cycle. This was for a number of reasons including:
their mesothelioma had got worse, or they became less well in themselves they chose not to take part any longer their doctor thought it was not beneficial for them to continue to take part
12 people had died by this stage of the trial.93 out of 166 people (56%) in the chemotherapy alone group completed 6 cycles of chemotherapy in total.
157 out of 169 people (93%) in the surgery and chemotherapy group had surgery as part of the trial. Most people having surgery had an extended pleurectomy decortication.
66 out of 169 people (39%) in the surgery and chemotherapy group completed 6 cycles of chemotherapy in total.
The trial team followed up to people taking part for 22.4 months on average.
They looked at how long people lived from when they joined a treatment group. They found this was on average:
24.8 months for people in the chemotherapy group
19.3 months for people in the chemotherapy and surgery group They also looked at how many people were alive from each group after 5 years. They found it was similar in both groups. It was:6 people (4%) in the chemotherapy group
7 people (4%) in the surgery and chemotherapy groupThe researchers looked at the quality of life of people taking part. They found that this was worse for people in the surgery group.
The trial team calculated the costs to the NHS of both treatment groups. Chemotherapy and surgery together were more expensive than just chemotherapy.
Side effects
Most people had at least one side effect that was likely to be from treatment.
There were severe side effects in both groups.
80 out of 166 people (48%) had a severe side effect in the chemotherapy group. The most common severe side effects included:
infection
a breathing or chest disorder
digestive system problems
heart problems Open a glossary item
107 out of 169 people (63%) had a severe side effect in the chemotherapy and surgery group. The most common severe side effects included:infection
a breathing or chest disorder
heart problems
digestive system problems
needing a second operationConclusion
This trial shows that extended pleurectomy decortication with chemotherapy is not useful for this type and stage of mesothelioma. But this trial has still added to our knowledge and understanding of mesothelioma and how to treat it.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
13/LO/1481
Date of REC Opinion
7 Nov 2013
REC opinion
Further Information Favourable Opinion