Recruitment is at an all time high – over 8% in RCTs and over 18% in all trials.Studies include the use of novel viruses to boost the immune system, DNA studies looking at the concordance of EGFR mutations in mutated tumour tissue and circulating blood in lung cancer patients (this will enable appropriate targeted therapies to be prescribed), and survivorship studies (To explore unmet needs within the local late effects community),Our hospital treats Gestational Trophoblastic Neoplasm, which is a very rare cancer.
The paperwork required for trials has increased to the extent that a new administrative position is being considered. Much of the requirement is from industry, who are progress chasing trials.
The patient satisfaction survey asked whether patients attending clinic saw any evidence of research activities. Sadly, for us, the answer was no. This will probably be rectified in 2013 with notice boards and posters ‘advertising’ that we do research.
Sadly, the move to thank participants in clinical trials has been sidelined until later in the year.
At the September meeting, it was agreed that the principle of thanking participants in clinical trials should be adopted, and made standard operating procedure. A colleague has informed us that CRUK now request this, and also that patients be told where to find a lay summary of trial results if they wish to read them. It is quite possible that our centre is the first to achieve this. (As my colleague says, we are probably pushing at an open door but don’t realise it.)
The May and July meetings were attended. (June not possible owing to a clash with NRES meeting.)For patients involved in trials, there is a move towards informing GPs of drugs taken as part of the trial, and for them to contact the research nurse before prescribing other drugs to patient. Work is being done on Standard Operating Procedures (SOPs) to put this into effect – this should improve patient safety.Following on from the adoption of Head and Neck 5000, three more trials were adopted in July. These are concerned with quality of life, and include:
1 and 2 An assessment of the effect of radiotherapy dose or chemo-RT on taste function in patients with oral cavity and oropharyngeal cancers. Loss of taste function severely affects quality of life, and it is hoped that therapy which is more tightly targeted (IMRT) will mean that not only are later effects of RT reduced, but that the sense of taste returns. The four major components of taste will be tested, as well as Umami, or savouriness. (There is a cross-sectional study, and a longitudinal study).
2 Olfactory rehabilitation in total laryngectomy patients using Nasal Airflow Inducing Manoeuvre, or NAIM. Patients in this group do not have a pathway from nose to lungs, so scents do not pass over the olfactory organs. However, using the NAIM technique, air can be directed through the nasal passages by keeping the lips closed, the soft palate relaxed, and simultaneously lowering the base of the tongue and the floor of the mouth. (Known as the polite yawn.) In a pilot study, 72% of patients gained improvement, and NAIM can be taught to patients who are many years past their surgery.
Other trials include PIT, prophylactic irradiation of tracts resulting from invasive chest wall interventions in patients with malignant pleural mesothelioma. These procedures eg biopsies, thorascopy, thoracotomy etc often result in tumour seeding at the site of the intervention. In some hospitals this RT is routine, and in others not. It is not known for certain whether the use of RT in this way is beneficial. These metastases tend not to respond very well to subsequent RT so the question is an important one.
Our member attended the meetings in December, January and February. It had been requested of CTE that they look at the Head and Neck 5000 study, and after a member of the Panel spoke on the topic at H&N SSG the study went to CTE on 13 March.More novel agents are coming through, and more trials aimed at using compounds in ways which have the same curative/amelioration properties, but not so difficult for the patient to tolerate.CTE have designed a leaflet explaining about use of tissue, intended for any patient.
The Chair and the Admin met with the consultant pathologist to progress the visit to the histopathology labs. We were given an overview of the future plans for the service which include total renovation of the facilities, and a tour of the labs.
7.1% of patients are randomised into NTCN trials, 20.3% into NCRN studies, and 23.5% into all trials.
Work continues on the release of biopsy tissue to enable patients with a poor prognosis to enter clinical trials, even if their stored tissue is at risk of becoming exhausted. The two patient groups were thanked for their input. Talks have taken place between the Histopathology Department and clinicians, and a leaflet explaining the topic is being designed. (Members of our local PPI group have contributed to this.) The outcome of this work is likely to be an improved IT service for tissue samples (the work is currently carried out using a paper-based system), improvements to Standard Operating Procedures, and a new local policy for tissue release. This will be incorporated in the new leaflet, which patients will be given before consenting to clinical trials.Talks and workshops attended at the NCRI conference begin to make more sense, as new drugs targeting genetic markers come on stream for trials. The new therapies are tolerable, and are reported as having few side effects. I’m sure patients will be grateful.CTE was given information about the Head and Neck 5000 trial.
Recruitment to trials was 6.8% to RCTs, 20.3% to NCRN trials, and 23.6% to all studies. Progress is being made on all fronts, and a local linked unit recruited 2 patients to the Persephone study.
The last meeting attended was on 12th September. One developing trend is trials involving a reduction in the amount of radiotherapy given, or drugs, or no treatment at all if the prognosis for the form of disease being treated is good. One such example is the FAST_FORWARD trial, where a control group of women given 3 weeks radiotherapy of 40 Gray over 3 weeks (2.67 Gray per sitting) is being compared in two arms. The first will be given 27 Gray (5.4 Gy per sitting) over 1 week, and the second will be given 26 Gray (5.2 Gy per sitting) over 1 week. Quality of life will be measured at 3, 6 and 12 months, then 2, 5, and 10 years. Women will be expected to have annual mammograms, but women who prefer sonograms and physical examination rather than incur the extra radiation risk posed by these, will not be excluded from the trial. The women are being monitored over 10 years, because there are concerns that there may be very late effects.
When I was diagnosed 8 years ago, I was recommended 7 weeks radiotherapy. This has come down to 5 weeks, then three. It seems that things are moving on fast. Think of the time saving for patients, not to mention the cost to the NHS. This is the sort of trial which I strongly support, and make my feelings clear at the meetings.
Another such trial is ION, where patients with thyroid cancer which is differentiated and has an excellent prognosis, may benefit from not having treatment with radioactive iodine, which has significant side effects, Outcomes for patients having surgery and treatment with iodine (which dispenses 1.1 GigaBequerels of radiation – a dose that in itself has been reduced to a third of the previous standard), will be compared with patients having surgery only. This trial also received my full support. I do hope we have more of these.
It was reported that the number of patients in clinical trials is 6.4% to RCTs, NCRN 17.1%, and 21.1% for all trials.
As there is closer involvement with industry, requests for invasive procedures such as biopsies increase in number, as do requests for imaging and blood tests.
A trial of particular interest has been GALA5, an evaluation of the tolerability and feasibility of combining 5AminoLevulinic Acid (5ALA) with carmustine wafers (Gliadel) in the surgical management of primary glioblastoma Gliadel. 5ALA is a dye absorbed by the tumour, which fluoresces under UV light, and enables the surgeon to dissect out the tumourous tissue with greater accuracy. Gliedel is a wafer holding carmustine, the chemotherapy drug, which is implanted in the brain.
Recruitment levels for all trials were reported as high in December, standing at 25.7%.
Our STOMP trial came through for approval in January and is expected to open in February. (STOMP uses Olaparib against placebo to assess survival of NSCLC patients.)
In general, trials seem to be becoming more sophisticated, using IMRT and complex combinations of old and new drugs. There is also much more involvement from industry as new ideas and drugs are channelled via ECMC.
New trials approved include adding a tumour-bed radiation boost to improve outcomes for women who had had breast-conserving surgery. It is anticipated that this will reduce the risk of relapse at 8 years from the current rate of 15/20%. A trial of chemo-embolisation (where the drug is infused into the nearest artery) is being undertaken to improve survival for liver cancer patients who are usually sent to Leeds for this procedure. Vascular radiologists will be trained, and in due course, this will be a new service provided by the unit. There have also been studies approved of novel agents for leukaemia. This is in addition to trials of standard agents in new combinations. New studies are starting to come through from ECMC and NTCRN-AstraZeneca collaboration, including A double blind randomised phase 2 trial of docetaxel with or without AZD6244 in wt BRAF advanced melanoma (DOC-MEK). AZD6244 is a MEK inhibitor and may stop the growth of tumour cells by blocking some of the enzymes needed for cell growth.
CTE intend to be more pro-active highlighting when money is being saved by participating in a trial; for example some trials can be a big saving for Pharmacy.
It is beginning to be more accepted that extra travel for patients in trials will be funded for them, and that when patients do well on a novel drug, that patients may continue on the drug after the trial has ended. However, I continue to push the matter.
In general, it is encouraging to see that some novel drugs recently approved by NICE are now accepted as standard therapy, but quality of life during survival needs to be emphasised more often.
Anti-cancer agents with more specific activity are being researched in greater numbers, and reductions in radiotherapy dosages are being explored. There has been some debate about a trial involving chemo-embolisation, a technique which is not currently offered in this city. (Patients need to travel to Leeds to be treated.) New staff have been employed who have done this in previous employment and who are keen to set up a service here.
I continue to request travel expenses be paid routinely where patients need to make extra visits to clinic as part of a trial, and that patients doing well on novel drugs should continue to receive them as long as they are benefiting. Several trials have incorporated these requests successfully.
Trials continue to be put forward, few of them being contentious and many involving new (for which read ‘expensive’) drugs. I continue to put forward the patient view, emphasising the importance of quality of life as well as quantity.
The closer involvement with industry is becoming more apparent, and an area of concern is the hold that the funding parties ie industry, may have over the data, which may affect the quality of the trial reports and papers.