Better Cancer Care, An Action Plan

SECTION SIX: TREATMENT

There are many different types of cancer, each with its own particular behaviour. Cancer treatment can involve surgery, radiotherapy, chemotherapy (includes drug therapy, hormone therapy and other agents) or often all three, with the choice of therapy depending on the location and natural history of the particular tumour type. Treatment can be curative for many patients, whilst in others, it may offer a partial cure or palliation of symptoms.

Figure 12: Different types of treatment for patients with cancer in Scotland in 2001 and 2005

Figure 12 refers only to patients receiving treatment within six months of diagnosis, and primary (first time) cases only. This does not reflect the ultimate utilisation of any particular treatment in the course of an illness.

Data Source: ISD

Decisions about the appropriate treatment for each patient are made following a multi-disciplinary team ( MDT) meeting and in discussion with patients and carers. It is important that primary care teams are aware of these discussions and conclusions as soon as practical to enable them to answer questions that patients may have and help to ensure a seamless service for patients.

Surgery

Surgery remains one of the most important treatments for cancer, for example, in the period of 2001-2005 (Table 5) nearly 80% of patients diagnosed with breast cancer underwent surgery in the first six months after diagnosis.

Table 5: Surgery rates ^a for patients diagnosed with cancer ^b in the period 2001-2005, Scotland

Cancer type	Number of cancer registrations	Number undergoing surgery	% of tumour type undergoing surgery
Head and Neck	5,090	2,695	52.9
Oesophagus	4,115	944	22.9
Stomach	4,281	1,368	32.0
Colorectal	17,341	13,027	75.1
Trachea, bronchus and lung	22,979	2,454	10.7
Breast	19,241	15,341	79.7
Ovary	3,106	1,967	63.3
Prostate	12,266	2,766	22.6
Other malignant neoplasms	45,272	17,813	39.9
All malignant neoplasms	133,691	58,375	43.7

a Analysis restricted to treatment in the period covering the first six months after diagnosis

b All malignant neoplasms excluding non-melanoma skin cancer

Data Source: ISD

Many patients are admitted to hospitals as emergencies and are then diagnosed with cancer during the course of their admission. It is therefore important that surgical services are available locally wherever possible and that patient outcomes are comparable across Scotland.

Surgical Audit

Many tumour-specific clinical networks have progressed local, regional and national audits that highlight areas of relative strengths and weaknesses. Such approaches enable services to take action to improve performance and should be encouraged across all tumour-specific networks. National indicators of quality and national audit data will be collected as part of a work programme to improve the quality of cancer services. This will enable services to be benchmarked at regional level and allow NHS Boards to examine their local data to ensure that the treatment provided is of the highest standard. This includes not only the surgery itself, but both pre-operative and post-operative care, infection control and paying close attention to patient safety issues. Therefore, it is important that processes as well as the outcomes are scrutinised. There will be further discussion relating to quality and the need for audit in other treatments in the Improving Quality for Cancer Care for Patients section.

Capacity and Demand Planning

As surgery is such an important treatment for cancer, NHS Boards need to work in collaboration with the three regional cancer networks to ensure that there are the right facilities, in the right places to meet the demand for surgical care. Cancer Scenarios examines the projected growth in each tumour type and it may aid planners in understanding how the demand will change in the coming years. This will allow the capacity to be put in place to cope with future demand.

Laparoscopic Colorectal Surgery

The National Institute for Health and Clinical Excellence ( NICE) issued guidance in 2006 which recommended laparoscopic surgery as an alternative to open colorectal surgery, as there is evidence that clinical outcomes improve as a result. Key to the safe performance of the technique is optimal training and the Scottish Association of Medical Directors is carrying out a local needs assessment that can then inform decisions about how best to deliver and ensure consistent training throughout Scotland and assess the outcomes achieved from this technique.

Sentinel Node Biopsy in Breast Cancer

Sentinel Node Biopsy is a surgical technique used to identify the axillary node most likely to contain a tumour, so that only nodes with possible tumour involvement need to be removed at the time of staging surgery. Sentinel Node Biopsy replaces axillary lymph node clearance, or sampling, avoids the significant morbidity, reduces operative and theatre time, and also decreases hospital stay; indeed, some women now undergo surgery as a day case. Considerable progress has been made in introducing this technique across NHSScotland and many patients have already benefited from its use. Further development and training is required to complete implementation in all Scottish breast units surgically managing breast cancer. The Regional Cancer Advisory Groups ( RCAGs), together with NHS Boards, will explore the feasibility of Sentinel Node Biopsy being made available across Scotland.

Chemotherapy and Drug Treatments

Chemotherapy is the use of medicines to destroy cells, including cancer cells. It includes cytotoxic ('cell-killing') drugs as well as hormonal and other biological medicines. The role of chemotherapy has expanded greatly since it was first used in the 1960s. Chemotherapy might now be used as the sole treatment, as initial treatment prior to surgery or radiotherapy ('neo-adjuvant' treatment), following these treatments ('adjuvant' treatment) or be reserved until recurrence or spread of the cancer beyond the scope of further local treatment.

Treatment with chemotherapy carries the risk of short-term and long-term side-effects. Complex treatment requires highly-skilled staff to deliver doses of medication (often in combination) usually tailored specifically for each patient. Every effort is made through careful planning of treatment arrangements to minimise unpleasant side-effects. Side-effects from chemotherapy need to be balanced against the benefits that the treatment aims to achieve.

The most important opportunity to make a major impact on the behaviour of a newly diagnosed cancer lies with the first treatments offered. Regional and national tumour-specific Managed Clinical Networks ( MCNs) have developed clinical management guidelines and protocols, including the most effective use of any Scottish Medicines Consortium-approved medicines, for each cancer type. Prospective evaluation of the use of second-line and subsequent chemotherapy should be coordinated. The development of controlled trials to assess the anti-tumour effectiveness, impact on quality of life and costs (personal and financial) of these treatments is to be encouraged, as the benefits of subsequent treatments are sometimes much less clear and need to be carefully audited.

Cytotoxic medicines also pose a risk to the staff who handle them, and measures are in place to minimise exposure. All chemotherapy services in Scotland must meet the stringent safety and quality standards set out in HDL (2005) 29 Guidance for the Safe Use of Cytotoxic Chemotherapy. All RCAGs and NHS Boards have either recently or are currently reviewing their chemotherapy services against the criteria in the HDL as well as the locations where chemotherapy can be safely delivered. In the light of concerns in England about the safe use of oral chemotherapy, quality standards in Scotland were reviewed in June 2008. This demonstrated that the issues raised are fully covered by the existing standards and will next be reviewed in 2011.

Example of Good Practice in Scotland

Over the last three years, clinical staff in NHS Orkney and the Aberdeen Cancer Centre collaborated to deliver more services and treatments in local communities. The outcome of this service development has been that NHS Orkney moved from administering very little chemotherapy prior to 2003, to over 140 treatments per annum in 2004, to 240 treatments in 2006.

Whilst it is recognised that not all chemotherapy can be given outside of cancer centres, it is possible to provide safe services closer to the patient's home for many chemotherapy regimens, where this is delivered within a shared care framework.

The experience in NHS Orkney is that success is dependent on the following:

• Developing relationships and collaborative working
• Defining responsibilities through shared care agreements
• Implementing local and regional protocols
• Supporting the services with telemedicine and other eHealth tools.

The benefits for patients receiving some of their chemotherapy in Orkney are:

• It greatly reduces the travel burden and time away from home for patients
• Patients are more satisfied
• It is safer (when given in a structured system) as local staff are more aware of potential problems and have the appropriate training to respond as necessary
• It reduces travel costs and inpatient admissions, helping to address capacity issues in the cancer centre.

"During the course of the patient journey, often there is no contact out of hours with the GP and a lack of liaison between branches. The hospital may not always be aware or the drug/treatment that the patient is on. Communication between primary and secondary care has to be improved." Better Cancer Care WoSCAN Roadshow Participant

Work is continuing to determine the best ways to ensure that all involved (patients, carers, primary care services and out-of-hours ( OOH) services) are fully and rapidly aware of the nature of the chemotherapy that a patient has received, potential side-effects and their appropriate management at any time of day or night. Some cancer centres already use a form of patient-held record for this purpose which might be utilised nationally. Other possibilities to be explored include electronic communication between chemotherapy services, GP practices, OOH services and NHS 24. This work will be taken forward by the Scottish Chemotherapy Advisory Group.

As more treatments have become available, the amount of chemotherapy delivered to patients in Scotland has increased dramatically over recent years (Figures 13 and 14).

Figure 13: Increase in chemotherapy activity for the Beatson West of Scotland Cancer Centre 1999-2007

Figure 14: Financial increase in spend on cancer chemotherapy and biological therapies for the West of Scotland Cancer Network

Good information is important in the planning and provision of NHS services, facilitating the modernisation of pharmaceutical and clinical care and maximising access to chemotherapy. Safe delivery of chemotherapy needs to be supported by information technology ( IT) systems, which will include an appropriately specified electronic prescribing and administration system (known as CEPAS). A preferred supplier of such a system for NHSScotland has been identified and contract negotiations are underway (at time of publication).

With an increasing number of patients receiving chemotherapy, capacity planning has also become a priority for chemotherapy services, and modelling tools, such as C-Port, have been developed to support this. The Scottish Government is supporting a one-year evaluation of C-Port both for improving current services and planning for the incorporation of new treatments and regimens in the future.

New Cancer Medicines

The Scottish Government is committed to ensuring the speedy implementation of effective new medicines and treatments in Scotland, and that implementation is achieved on an equitable basis. New treatments are often heralded as a 'cure', which can raise the expectations of patients and their families before evidence of the real benefits are available. Early research findings take several years to evaluate and may fail to translate into actual and effective treatment at an affordable cost. In Scotland, clinical and cost effectiveness of new drugs is assessed by the Scottish Medicines Consortium. A distinctive feature of the Scottish process is that the NHS has information on the clinical and cost effectiveness of a product at an early stage after the drug receives a marketing authorisation. This minimises the uncertainty on the part of NHSScotland and patients as to whether a medicine is approved for use or not.

NICE undertakes appraisals of groups of medicines (termed Multiple Technology Appraisals) on behalf of the Department of Health and the Welsh Assembly. If endorsed by NHSQIS, NHSScotland will adopt these recommendations as these appraisals consider a range of treatments (including drugs) against a more comprehensive evidence base (such as clinical trials) than is possible at the time of licensing. The remit and status of the output of the Scottish Medicines Consortium and its working relationship with NHSQIS is available on the following website:

www.nhshealthquality.org/nhsqis/files/22512NHSQISNICEAdvice.pdf

The Scottish Medicines Consortium horizon scanning initiative aims to prepare NHSScotland for the availability of new medicines. This supports NHS Boards with their financial planning and facilitates early patient access to those new medicines that Scottish Medicines Consortium later advises to be clinically and cost effective. As treatments become available for cancers with previously limited treatment options, the need for advance warning becomes increasingly important. The application of models, such as C-Port will assist in evaluating the service impact of new treatments.

The future challenge is to achieve transparency in these processes to allow a better understanding of these systems. This includes the work of the exceptional panels that consider appeals against decisions by NHS Boards, and reassure patients and their families that those with cancer are receiving the most appropriate treatment for their specific circumstances. In 2008, the Scottish Parliament Petitions Committee conducted an inquiry into the availability of cancer drugs in Scotland. The Scottish Government's response to the Committee's recommendations is available from:

www.scottish.parliament.uk/s3/committees/petitions/inquiries/cancerDrugs/ScottishGovernmentResponse.pdf

Sustained national and international research efforts over many years have meant that the number of new medicines and classes of medicines coming forward for marketing authorisation is now greater than ever. The European Medicines Agency Annual Report for 2007 highlights cancer treatments as the most represented therapeutic area for marketing authorisation application for new medicines; 16 of the 56 applications were for cancer medicines.

Radiotherapy

The report, Radiotherapy Activity Planning 2011-2015 reaffirmed that radiotherapy is a key component of modern cancer treatment and will remain so for the foreseeable future. It may be given as the sole curative treatment (for example, cancer of the larynx) or as part of a treatment plan also incorporating surgery and chemotherapy. It also has an important role in the palliation of many symptoms. Approximately half of all cancer patients will require radiotherapy at some point in their treatment.

Radiotherapy is a technically demanding treatment requiring the combined efforts of skilled physics, radiography, nursing and medical staff. Quality in radiotherapy departments is subject to International Organisation for Standardisation ( ISO)/The British Standards Institution ( BSI) accreditation, and safety of staff, patients and the environment is subject to legislation which is regulated by the Health and Safety Executive, the Scottish Ministers and the Scottish Environment Protection Agency.

Inspections of all Scottish radiotherapy facilities have been undertaken, on behalf of the Scottish Ministers, to assess levels of compliance with the Ionising Radiation(Medical Exposures) Regulations IR(ME)R and associated guidance on good practice. As a result of these inspections, coordinated efforts are being made by all centres to achieve full regulatory compliance, with clear identification of the related roles and responsibilities.

All Scottish radiotherapy departments have modern equipment capable of delivering technically complex treatment. There is a long-term planned programme of replacement to ensure continuing efficiency. Scotland has one linear accelerator (the machines that delivery radiotherapy) per 204,000 of its population, with 25 in total:

Table 6: Number of linear accelerators per cancer centre catchment area

In addition to the predicted substantial rise in demand for radiotherapy, the complexity of planning and treatment is also likely to rise as the role of newer techniques such as Intensity Modulated Radiotherapy ( IMRT) and Image Guided Radiotherapy ( IGRT) becomes more clearly defined and incorporated into standard practice. Other techniques, such as stereotactic intracranial radiotherapy will also increase in use.

These developments will have significant implications for workforce planning and development. There are currently significant shortages in radiotherapy physics staff, and further actions beyond the increase in training posts already in place following the recommendations of the Radiotherapy Activity Planning for Scotland 2011-2015 report are required. The expansion of IMRT and IGRT, in particular, is dependent on sufficient physics expertise. There is a need, therefore, to explore further cooperation and collaboration at a national level between the five radiotherapy physics departments, particularly for complex radiotherapy treatment planning.

The Scottish Radiotherapy Advisory Group ( SRAG) is reviewing the Radiotherapy Activity Planning for Scotland 2011-2015 report to determine the continuing accuracy of the assumptions that underpinned it and to update the capacity estimates required for the future. It is likely this work will be repeated every three to four years and will form a major part of the work plan for the SRAG. The current update is expected in early 2009.

The Radiotherapy Activity Planning for Scotland 2011-2015 report considered the extension of the working day as a way of providing some of the increased capacity that may be needed, however, a combination of issues (such as staff shortages) has made this difficult to implement in all areas. Any additional capacity indentified by the review of the report is likely to require additional machines and workforce. The possibility of one or more small 'satellite' centre(s) (a centre on the site of a District General Hospital) should be explored as they might allow some treatment to be delivered closer to patients' homes.

The Technical Specification and Evaluation subgroup of the SRAG has proven an extremely effective forum for ensuring the timely replacement and efficient procurement of the stock of treatment machines across the cancer centres and ensuring that all have the equipment to deliver modern radiotherapy safely and the Group should continue with this role.

The complex nature of radiotherapy means that the five cancer centres providing treatment cooperate in the provision of some treatments that may only be required infrequently. Not all centres can or should provide all treatments, and provision of highly-specific treatments needed by a small number of patients should be considered by the SRAG, with a view to ensuring the most appropriate provision and referral pathways for patients wherever they live. Similarly, robust arrangements need to be in place for contingency planning to ensure continuity of treatment in the event of protracted machine failure or staff sickness. Contingency agreements were reached by all centres, brokered by the SRAG, to provide mutual support for all radiotherapy centres.

Research continues to be an important role for many clinicians and centres. Participation in radiotherapy trials with national research groups, such as the National Cancer Research Network ( NCRN) and Academic Clincial Oncology and Radiobiology Research Network ( ACORRN), and with international groups, such as the European Organisation for the Research and Treatment of Cancer ( EORTC), will continue to be encouraged. It is recognised however, that due to increased quality assurance implications, participation is demanding of all staff groups. The Chief Scientist Office will therefore fund additional quality assurance support where this is an issue for participation in National Cancer Research Network trials.

New Techniques

There are few clear mechanisms for horizon scanning new techniques and technologies which may be used for either diagnosis or treatment. Some of these are in early stages of development, whilst others are already set to move into mainstream practice. This means that their introduction can be irregular with no coherent assessment of effectiveness once they have been adopted. There are essentially five steps in the life of a technology:

1. Innovation and Research and Development - require horizon scanning

2. Adoption pre-requisite - Health Technology Assessment ( HTA), as a necessary first step

3. Ongoing assessment - proper audit and evaluation

4. Optimal utilisation - outcomes

5. Obsolescence - managing out of mainstream.

NICE reviews and issues Interventional Procedures Programme guidance (which is applicable in Scotland) on whether a technique is safe and efficacious. These recommendations vary depending on the quality of the evidence available and a health technology assessment is still required to consider the cost and effectiveness of each procedure. A national approach will ensure that such guidance is implemented and monitored in a coordinated and safe way. This will be supported by the Scottish Health Technologies Group, NHS Boards, NHSQIS and the RCAGs.

Expenditure on Cancer Research

Each year the Scottish Government, through the Chief Scientist Office spends about £2.9 million on directly-funded research projects and initiatives as well as £10 million to support cancer research within NHSScotland. When cancer research financially supported by all funders is considered, Scottish researchers are highly successful and are granted 13.5% of UK expenditure - £392.7 million in 2006. Patient benefit is at the heart of this investment in cancer research, particularly through large intervention trials. These trials are not restricted to new drugs but include screening, diagnostics, therapies, surgery and newer treatment options. The aim is to integrate research into routine care and improve patient care by speeding up access to the best care and treatments across the country.

Example of Best Practice in Scotland

Cancer research has led the way in the UK Clinical Research Collaborative, with the creation of a Scottish Cancer Research Network in 2002. One of the network's initial targets was to double trial recruitment over a three-year period from a baseline of 3.7% of cancer patients. Recruitment rates have risen each year and reached 13.9% in 2005/06. A further aim of Scottish Cancer Research Network was to facilitate patients outwith the main cancer centres to participate in clinical trials and in 2005/06 this target was exceeded with 28% of these patients being recruited to trials. Indeed, this was a specific goal of the West of Scotland Cancer Research Network which recruited over 50% of its patients from outwith the main West of Scotland Oncology Centre.

Recruitment into trials fell quite significantly in 2006/07. There are a number of different factors that may have contributed to this, including increased European regulations, since similar falls were observed across the whole of the UK National Cancer Research Network (Figure 15).

Figure 15: Annual accrual to National Cancer Research Network Studies ( UK)

Data Source: NCRN

The Scottish Cancer Research Network is bidding for extra funding (at time of publication) from the Chief Scientist Office for 2009-2012, at which time specific new targets for increased recruitment of patients to trials will be agreed to ensure recruitment exceeds the level of 13.9% achieved in 2005/06. These are likely to include:

• A greater focus on key, UK flagship trials, carried out across Scotland in the common tumour types; for example, breast, colorectal and lung
• A specific focus to increase recruitment in under-recruited groups, for example, lung, prostate, head and neck
• Conducting work to test whether electronic datasets available through ISD can be used to reliably capture long-term follow-up data.

Experimental Cancer Medicine

The Scottish Government has invested in translational cancer research. This is an exciting initiative, aimed at bringing together laboratory and clinical patient-based research to speed up the development of new treatments through Experimental Cancer Medicine Centres. Both Edinburgh and Glasgow Cancer Centres have been awarded Experimental Cancer Medicine Centre status. The total funding to each centre has increased with government funding matched by Cancer Research UK (total investment of £3.5 million over five years).

Translational research is now an integral part of early clinical trials in order to optimise the therapy being developed. This research is also essential in late clinical trials in order to define different patient populations that may benefit to differing degrees from new treatments. Support of translational research is therefore essential for clinical practice to move towards more personalised medicine.

Early achievements from the centres include the collection in Glasgow of samples of tumour and blood to form a repository of over 1,000 cases. These are being used in studies of drug resistance, in the development of novel biomarkers and should add to the efforts of other centres to develop individualised therapies. Edinburgh has developed an annotated tumour collection of patients treated with platinum drugs (500 patients) and the technology to use ribonucleic acid ( RNA) from this archival material to conduct biomarker studies. There is also considerable scope for molecular imaging to facilitate such translational cancer research and this can be exploited through investment in PET/ CT scanners for service provision.

We will:

• Support the continued development of regional and national audits to drive performance improvements
• Set out the best available information on future capacity and demand plans for surgery to support NHS Boards in service, financial and workforce planning
• Ensure NHS Boards undertake a needs assessment for laparoscopic colorectal surgery and support the development of a Scottish surgical network around this procedure
• Together with the RCAGs and NHS Boards, we will explore the feasibility of Sentinel Node Biopsy being made available across NHSScotland
• Work with patients, carers and other stakeholders to improve the transparency and accessibility to patients of the arrangements for introducing new drugs into the NHS in Scotland
• Support regional and national tumour-specific MCNs with the ongoing development of clinical management guidelines and protocols, including the most effective use of any Scottish Medicines Consortium-approved medicines
• Coordinate detailed prospective evaluation of the use of second-line and subsequent chemotherapy, and encourage the development of controlled trials to assess the effectiveness, impact on quality of life and costs (personal and financial) of these treatments.

We will:

• Evaluate and, if appropriate, support the widespread adoption of C-Port and CEPAS as a modelling tool for future service delivery
• Review chemotherapy safety and quality standards in 2011 and keep a watching brief on any new issues that may arise before then
• Encourage engagement and involvement in experimental cancer medicine to facilitate the evaluation and introduction of new cancer medicines for patients
• Support Scotland's five radiotherapy centres to enable a coordinated approach to contingency planning, workforce planning and horizon scanning
• Consider opportunities to meet the future demands identified from the review of The Radiotherapy Activity Planning 2011-2015, including the possibility of satellite centre(s)
• Explore further the potential of the five radiotherapy physics departments working in coordinated and collaborative ways, particularly for complex radiotherapy treatment planning
• Work with NHS Boards and other stakeholders to further develop improved mechanisms for the assessment and introduction of new techniques and technologies
• Set new targets to support increased recruitment of patients to trials, to ensure recruitment continues to exceed 13.9%.