Watch and wait Monitoring while treatment is not necessary

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1 Watch and wait Monitoring while treatment is not necessary Revised December 2011

2 The diagnosis of a blood cancer can be a devastating event for patients, families and friends. It is therefore vital for everyone to have access to reputable and understandable information to help cope with the illness. Whenever possible our booklets are written in line with national guidelines for the treatment of patients with a blood cancer. The information in our booklets is more detailed than in many others but is written in a clear style with all scientific terms explained for the general reader. We recognise that the amount and level of information needed is a personal decision and can change over time. Particularly at the time of diagnosis, patients may prefer less detailed information. A number of alternative sources of information are available which complement our publications. The booklets in this series are intended to provide general information about the topics they describe. In many cases the treatment of individual patients will differ from that described in the booklets. At all times patients should rely on the advice of their specialist who is the only person with full information about their diagnosis and medical history. For further information please contact the patient information team on Leukaemia & Lymphoma Research, Eagle Street, London WC1R 4TH T: E: W: beatingbloodcancers.org.uk Series compiled by Ken Campbell MSc, revised December The design of this booklet has been produced with kind assistance from Euro RSCG Life. All rights reserved. No part of this publication may be reproduced or transmitted without permission in writing from Leukaemia & Lymphoma Research.

3 Contents 2. Watch and wait 4. Indications for watch and wait 5. Specific conditions 10. Summary 11. Questions 12. Notes 1

4 Watch and wait Some forms of leukaemia and related diseases progress very slowly, often over many years. People affected by these diseases frequently have no symptoms for very long periods of time, and the presence of the leukaemia or other disease does not affect their general feeling of wellbeing. For this reason, it has been common practice for many years to limit treatment of such conditions to those patients who have symptoms, or whose health is threatened for other reasons by the disease. Many studies over the last 30 to 40 years have confirmed that this watch and wait approach is safe and does not reduce the chances of survival for patients with these diseases. This is more likely to be the case when a disease has been diagnosed by chance; for example when a blood test performed during a routine check-up or for an unrelated condition reveals an unexpected diagnosis. If the tests show signs of early disease, specialists may recommend a 'watch and wait' policy. This may also be known as 'active monitoring' or 'watchful waiting', which emphasises that doctors are not passively waiting for the disease to progress; the patient s condition will be constantly monitored to ensure intervention at the earliest appropriate time. Decisions on management will be influenced by the age and overall fitness of the patient. For example, a younger patient may be a candidate for a stem cell transplant, which may be curative. 2

5 In this setting doctors may recommend intervening at an early stage rather than delaying treatment until the disease progresses. There is no standard approach to this and the specialist and patient will decide together, after discussion of the advantages and risks of early treatment. Patients sometimes describe the policy as 'watch and worry', because this can understandably be a very stressful time. No drugs or other treatments are recommended at this stage but they will see their specialist and have blood tests or other investigations at regular intervals. The timing of visits and tests will depend on the initial diagnosis and how likely the condition is to progress to a stage where treatment is necessary. Some patients on a watch and wait programme will never progress whereas others may need treatment soon after diagnosis. Watch and wait should not be confused with palliative or symptomatic therapy. Palliative treatment differs from watch and wait in that there is active treatment rather than simply monitoring of progress. The conditions most commonly managed with watch and wait are chronic lymphocytic leukaemia, indolent non-hodgkin lymphoma (follicular and marginal zone), MGUS/smouldering myeloma and related conditions, early myelodysplastic syndromes and early myeloproliferative neoplasms. Watch and wait is not used for chronic myeloid leukaemia (CML) because untreated CML will transform into a more aggressive condition. 3

6 Indications for watch and wait There are many different types of leukaemia, lymphoma and related blood or bone marrow diseases. Aggressive forms of these diseases show rapid onset and progression unless effectively treated; these will always require active treatment from the time of diagnosis. The less aggressive (indolent) forms show gradual onset and either stable disease or slow progression even without treatment; these may be candidates for a watch and wait approach if there are no troublesome symptoms from the disease. The main advantage of watch and wait is that it ensures that patients are not exposed to potentially toxic treatments before this is clearly necessary. This also reduces the risk of resistance to chemotherapy, which is more likely to happen if drugs are used before they are needed. When resistance does arise there may be problems with drug treatment at a later time. 4 The main disadvantage of watch and wait is that patients may experience anxiety. Obviously patients will react to watch and wait in very different ways. Some patients will cope perfectly well with the situation, while other patients will be more anxious. When a patient is told they have a a blood cancer but no treatment is to be given they, and their family or friends, may wrongly assume that this means that their condition is untreatable. In reality, most patients managed on watch and wait enjoy a long period of good quality of life before treatment begins and respond well to treatment when this becomes necessary. Treatment following watch and wait will, in many cases, prolong survival and will always be planned to improve quality of life.

7 Specific conditions Each of the conditions for which watch and wait may be recommended is described briefly below; Leukaemia & Lymphoma Research provides separate booklets on each of these conditions. In some conditions sophisticated tests can predict whether patients presenting with early disease are at a high or low risk of disease progression. The policy of watch and wait in different diseases is under continuous review; clinical studies are done to test the potential benefits of early treatment. The investigations required for patients on active monitoring and the frequency of these tests will vary from centre to centre. Typical schedules for monitoring are given below but patients should not be concerned if the practice at their specialist clinic differs from these. Chronic lymphocytic leukaemia Chronic lymphocytic leukaemia (CLL) is one of the commonest indications for watch and wait management. The condition is commonly diagnosed in older patients and is increasingly found by chance following routine blood tests. It is current standard practice to watch and wait in patients with early stage disease and no troublesome symptoms. Patients with early stage CLL are usually seen in the clinic every three or four months. At each visit, the patient will be asked if they have any 5

8 typical symptoms such as fevers or sweats. A physical examination will be performed looking for evidence of enlarged lymph nodes or a large liver or spleen; patients will also require a blood count and tests of kidney and liver function. It is not routine to perform scans in patients with CLL, since the blood count usually provides adequate information on the status of the disease. Indolent non-hodgkin lymphoma Indolent (or low-grade) non-hodgkin lymphoma (NHL) is the commonest form of lymphoma; there are several different sub-types of the disease and management varies between them. These conditions are slow growing and, even though they are often widespread at the time of diagnosis, many patients have few or no symptoms. In Western populations, about 80% of indolent NHL is of a type known as follicular lymphoma. There are often few or no symptoms in the early stages of indolent NHL because the nodes enlarge slowly. Patients with indolent NHL are likely to have lymphoma in more than one site and it may be present in the bone marrow but this does not, in itself, mean that patients necessarily need active treatment as soon as they are diagnosed. Follicular lymphoma (the commonest of the indolent NHLs) is often managed by active monitoring because studies have found no advantage for patients who receive early treatment. A more recent study has indicated that active monitoring may be best for patients with indolent NHL who have no symptoms; this is most clearly the case in patients over 70 years of age. Further studies might be needed to establish whether earlier active treatment may benefit a sub-group of younger, fitter patients. Rapid developments are taking place in the treatment of NHL and the introduction of new drugs may influence future policies on watch and wait. Patients may well be asked to consider taking part in studies to determine whether early use of these drugs is preferable to watch and wait. 6

9 Sometimes indolent NHL will transform to a more aggressive lymphoma; studies are being carried out to find whether early treatment reduces this risk. At present, there is no clear evidence on this question and it does not influence the choice of management. Patients with indolent NHL are typically seen in the clinic every three or four months. At each visit, the patient will be asked about typical symptoms such as fevers or sweats. A physical examination will be performed looking for evidence of enlarged lymph nodes or a large liver or spleen. Routine blood tests will also be performed. Typically, this will include a blood count and tests of kidney and liver function. The LDH (lactate dehydrogenase) level is measured because it may be elevated in patients with active lymphoma. It is typical to perform routine CT scans of the chest, abdomen and pelvis every six months or so, at least for the first two to three years of follow up. After that the frequency of routine CT scans may be reduced. The value of newer tests such as PET scans is not yet clear, and they are not used routinely. Other forms of indolent lymphoma behave differently and the use of watch and wait in these patients is less well studied. Patients with these forms of lymphoma will be given an opportunity to discuss treatment options with their specialist(s). MGUS/smouldering myeloma Multiple myeloma is a malignancy affecting immune system cells called plasma cells, which normally produce special proteins - antibodies - which recognise foreign proteins. One of the hallmarks of myeloma is the presence in the blood or urine of abnormal antibody-like proteins called paraproteins this is called a monoclonal gammopathy. Sometimes, particularly in the elderly, monoclonal gammopathy is present without any of the other diagnostic criteria for myeloma and this is known as Monoclonal Gammopathy of Undetermined Significance (MGUS). In other cases, gammopathy is present along with some of the other signs 7

10 or symptoms of myeloma, but there is no evidence of damage to organs such as the kidney due to the disease, and this is called smouldering (or indolent) multiple myeloma (SMM). Neither MGUS nor SMM are considered a reason to begin treatment but patients with either of these conditions will be carefully monitored. SMM is more likely than MGUS to progress to symptomatic disease whereas many patients with MGUS never develop signs or symptoms and never require any form of treatment. Currently there are no indications for treating this condition. Follow up, however, is essential. Over a 10-year period approximately 10% of patients will develop multiple myeloma and it is for this reason that long-term follow up is important. If the paraprotein level is low and stable, then follow up is typically at six-month to one-year intervals. For cases with higher levels of paraprotein, monitoring is more frequent. It is routine at follow-up visits to measure full blood count, kidney function and calcium level; serum paraprotein, Bence Jones protein in the urine, and the serum free light chain where this test is available are also measured. Smouldering myeloma has similar features to multiple myeloma, but these are not associated with significant organ damage. Examples of such damage would include anaemia, a low white cell count, kidney disease, high calcium or damage to bone. These signs, however, can develop over time. The rate of transformation of smouldering/asymptomatic disease to myeloma is very much higher than for MGUS and so the interval between follow ups needs to be much closer. Myelodysplastic syndromes The myelodysplastic syndromes (MDS) are a group of conditions that share certain common features, such as anaemia. There is a very wide variation in the severity of the conditions and in the likelihood of progression of the disease. Active monitoring is the normal management of low risk 8

11 MDS, where a patient has no specific symptoms and is not in need of transfusions for anaemia. Patients who have low blood counts but minimal or no symptoms, including no infections or bleeding, may be safely followed with watch and wait. The interval between clinic visits will depend on how low the blood counts are and how stable the disease is. Myeloproliferative neoplasms The myeloproliferative neoplasms (MPN) are a group of conditions in which there is over-production of one or more cell types by the bone marrow. An overproduction of red blood cells is called polycythaemia vera (PV); over-production of platelets is called primary (or essential) thrombocythaemia (ET); myelofibrosis (MF) is a condition in which the marrow contains too much fibrous (supporting) tissue this is associated with an increase in spleen size. Whether a patient requires treatment will depend to a large extent on age and whether there are signs or symptoms attributable to the condition. For example, an older patient may live for the same length of time without treatment as they would with treatment; this is less likely for a much younger patient. Patients whose disease is stable, and who are not receiving treatment to lower their blood counts, may be managed on a watch and wait basis. Such patients will often be given low dose aspirin (especially if their platelet count is raised) and seen in clinic every three to six months. A physical examination will usually be performed to check whether the spleen is enlarged. Routine blood tests include a full blood count, but in some cases other investigations will be required. 9

12 Summary Watch and wait policies are continually reviewed as new diagnostic techniques allow doctors to more confidently predict which patients are most likely to have progression of their disease or benefit from earlier treatment. Newer, more specific, treatments may alter the balance in favour of earlier treatment. For many patients with indolent disease, a period of active monitoring or watch and wait will be recommended following diagnosis. Treatment will be commenced either when a patient starts to experience significant symptoms or when the results of investigations indicate that the condition either is progressing or is likely to do so in the near future. The major disadvantage of a watch and wait strategy is the stress this may cause for patients and others. This is offset by the benefits of avoiding possible side effects from chemotherapy until treatment is clearly necessary and by minimising the risk of patients developing drug-resistant disease through unnecessary exposure to chemotherapy drugs. 10

13 Questions When watch and wait is recommended rather than active treatment, patients may have a number of concerns. Below are some questions that patients may wish to ask of their doctor. It is important to stress that doctors can only give a generalised answer. It is rarely, if ever, possible to predict exactly how an individual patient s condition will progress. How long is watch and wait likely to last before treatment is required? If and when treatment becomes necessary, what will this consist of? Are there any specific precautions which should be taken whilst on watch and wait? (e.g. flu vaccinations, precautions against infection) Are there any specific signs or symptoms which need to be promptly reported to the specialist? How often will follow up appointments be necessary and what investigations will be needed? 11

14 12 Notes

15

16 The following patient information booklets are available free of charge from Leukaemia & Lymphoma Research. You can download them from our website or request copies by phone. Acute Promyelocytic Leukaemia (APL) Adult Acute Lymphoblastic Leukaemia (ALL) Adult Acute Myeloid Leukaemia (AML) Childhood Acute Lymphoblastic Leukaemia (ALL) Childhood Acute Myeloid Leukaemia (AML) Chronic Lymphocytic Leukaemia (CLL) Chronic Myeloid Leukaemia (CML) Aplastic Anaemia (AA) The Myelodysplastic Syndromes (MDS) The Myeloproliferative Neoplasms (MPN) Multiple Myeloma (MM) Hodgkin Lymphoma (HL) Non-Hodgkin Lymphoma (NHL) Leaflets on a range of associated blood disorders are also available from Leukaemia & Lymphoma Research Bone Marrow and Stem Cell Transplantation (BMT) for children and adults Donating stem cells what's involved? Donor Lymphocyte Infusion (DLI) what s involved? The Seven Steps Blood & bone marrow transplantation Undergoing high dose therapy and autologous stem cell transplant Chemotherapy what do I need to know? Clinical Trials Complementary and Alternative Medicine (CAM) Dietary advice for patients with neutropenia Supportive care Treatment decisions Watch and wait Young adults with a blood cancer what do I need to know? Jack's Diary: an illustrated children's book to help young patients understand and deal with blood cancers, treatment and life changes Wiggly's World: a colourful A-Z illustrated booklet, designed to take the anxiety out of treatment for children and their parents Leukaemia & Lymphoma Research, Eagle Street, London WC1R 4TH T: E: W: beatingbloodcancers.org.uk Registered charity (England & Wales) SC (Scotland) W&W 12/11

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