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Progestagens and Corticosteroids in the Management of Cancer Cachexia

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Progestagens and Corticosteroids in the Management of Cancer Cachexia Chapter 10.11 Progestagens and Corticosteroids in the Management of Cancer Cachexia Davide Tassinari, Marco Maltoni Introduction rect clinical research can be hard in palliative care, because of the peculiar characteristics of patients Over the past few years, many authors have with advanced or terminal disease. The treatment approached the problem of the treatment of can- of cancer cachexia with corticosteroids or prog- cer cachexia focusing on either the knowledge of estagens is based on a quite solid evidence of the main pathogenetic events, or the outcomes of activity. However, despite the large number of tri- the treatment in terms of symptoms or improve- als supporting their use in clinical practice, some ment in quality of life [1–8]. The relevance of clini- aspects still remain undefined and deserve to be cal investigations of cancer anorexia-cachexia has looked at in more depth. epidemiological and clinical roots, considering that it is very frequent in advanced and terminal disease (up to 40% of patients with advanced dis- Biological Rationale of Medical Treatment of ease, and more than 80% of terminal patients), and Cancer Cachexia that its clinical manifestations often represent a source of great concern for both patients and rela- Recently, many authors have investigated the dif- tives [1–5]. The clinical approach to cancer ferent pathogenetic events responsible for the clin- anorexia-cachexia has been directed towards dif- ical behaviour of cancer cachexia, and suggested a ferent targets, and it can be aetiological, patho- role for both tumour cells and immuno-mediated genetic or symptomatic according to the attention responses to tumour growth, as important events paid to tumour growth, the main pathogenetic in the pathogenesis of the syndrome [1, 7, 9–41]. events, or the clinical behaviour of the syndrome. Although the main pathogenetic events are not However, it is mandatory to define both the biolog- fully understood and the relationship between ical and clinical rationale of the different thera- tumour factors and host inflammatory cytokines peutic options, and the outcomes of every thera- still remains undefined, a role of different tumour peutic approach, using an evidence-based model. products and an immuno-mediated action of the There are two main questions concerning clinical monocyte-macrophage system seem to be involved research in cancer anorexia-cachexia: in the pathogenesis of cancer cachexia (Fig. 1). – Does a treatment exist that could act against Besides the speculative value of the biological the main pathogenetic events and influence the knowledge about the role of host and tumour clinical outcome behaviour of cancer cachexia? cytokines, the efforts of clinical researchers have – What are the main outcomes of a treatment been addressing the possibility of down-regulating against cancer cachexia, and are these out- the pro-cachectic action of cytokines, favouring a comes actually based on evidence-based tools? control of the clinical manifestations of the syn- The need for an evidence-based palliative med- drome. To this end, progestagens and corticos- icine represents one of the main topics of palliative teroids (and also non-steroidal anti-inflammatory care, as it would be incorrect to avoid an evidence- drugs, eicosapentaenoic acid, melatonin and based model when making decisions in clinical thalidomide) have been evaluated and proposed as practice. On the other hand, methodologically cor- active options in the treatment of cachexia-related 654 Davide Tassinari, Marco Maltoni TUMOUR Aetiological approach HOST CACHECTIC CYTOKINES UNKNOWN FACTORS MECHANISMS ACUTE PHASE PROTEIN INCREASE HYPERMETABOLISM NEUROHORMONAL ALTERATION IN AND MUSCLE CONTROL OF FOOD ANABOLIC PROTEOLYSIS INTAKE HORMONES ANOREXIA Pathogenetic approach LOSS OF MUSCLE MASS AND FUNCTION LOSS OF FAT Symptomatic Fig. 1. Main pathogenetic approach events and sites of action of therapeutic options symptoms [24–26, 42–57]. Two considerations can ease represents one of the main topics of modern be made, coupling the biological dimension and oncology, and some different models of clinical the clinical approach: research and clinical practice support the activity – Besides representing a pathogenetic treatment, and effectiveness of such an approach in the treat- a treatment addressed towards one or more ment of solid and haematological cancers [58–66]. steps in the pathogenesis of the clinical syn- There are two fields that might represent an inter- drome might also be considered a kind of ‘tar- esting dimension in the pathogenetic approach to get treatment’ in palliative care [42–44, 46, 47] the palliative treatment of cancer cachexia: – The different sites of action of the different – The use of biological markers to select the molecules might represent the starting point patients with the highest probability of for a poly-pharmacotherapy against different response to the treatment (predictive value of steps in the same cascade [55–57]. the marker) The concept of a treatment designed on the – The use of biological markers as surrogate end- basis of the biological characterisation of the dis- points of response. 10.11 Progestagens and Corticosteroids in the Management of Cancer Cachexia 655 This kind of approach has recently been evalu- sent the primary end-point of a trial in palliative ated in clinical research, and some preliminary care. However, although quality of life can surely results seem promising, but it would be hasty to represent the main end-point whenever an state that the treatment of cancer cachexia as a improvement in survival is not reasonably expect- ‘target approach’ is possible [57, 67]. Indeed, the ed, the way by which quality of life should be reasons limiting a ‘target approach’ are various, assessed in clinical research and in daily clinical and not well known. Besides the role of cytokines practice is not yet well defined [70, 71]. Some pre- (interleukin 1, interleukin 6, interferon gamma liminary differences are worthy of being defined: and tumour necrosis factor alpha) in the patho- – The activity of a treatment defines if the treat- genesis of cachexia, some other mechanisms might ment could act play a pathogenetic role together with or instead of – The efficacy of a treatment defines how much a the cytokine cascade, favouring a low activity of an treatment should act ‘anti-cytokines’ approach, or a mechanism of – The effectiveness of a treatment defines if the ‘escape’ in some patients [1, 68]. However, the pos- treatment actually acts in clinical practice [72,73]. sible variables occurring in the ‘cytokine-mediat- On the one hand, activity, efficacy and effec- ed’ anorexia-cachexia syndrome probably repre- tiveness are strictly related to each other; on the sent one of the main reasons supporting a target other hand, they are very different from a method- approach. An improvement in clinical results ological point of view: might be achievable by selecting patients using – The activity of a treatment is defined by phase biological predictive factors of response, when we II trials are able to detect biological markers in daily clini- – The efficacy of a treatment is defined by phase cal practice [31–39, 42–44]. III trials – The effectiveness of a treatment is defined by phase IV trials. Outcomes of a Palliative Treatment of Cancer Moreover, the main outcomes and the surrogate Cachexia outcomes of a medical approach should be defined in clinical research, and the relationship between Although a ‘target approach’ to cancer cachexia is main and surrogate outcomes represents an open still too far off to be validated definitively, the question not yet fully answered [74–79]. Indeed, assessment of the outcome of a treatment repre- there are no definitive data distinguishing main and sents an interesting field of investigation in clini- surrogate end-points in quality-of-life assessment, cal practice. The definition of an outcome in pal- and the relationship between symptom control and liative medicine may be considered a general prob- quality of life in an outcome analysis is still unclear. lem, but cancer cachexia represents one of the Symptom assessment surely represents the core of most paradigmatic examples in this field of clini- the validated instruments for quality-of-life assess- cal research. Some years ago, the consensus data of ment, but it cannot represent by itself a validated the Outcomes Working Group of the American instrument for quality-of-life assessment. It follows Society of Clinical Oncology (ASCO) distinguished that symptom assessment can be an index of activi- the outcomes of a treatment into patient outcomes ty of a treatment, or a surrogate end-point of quali- (survival and quality of life) and cancer outcomes ty of life, but quality of life must be considered (response rate), and gave higher priority to patient either the main outcome of a treatment in palliative outcomes [69]. Although the guidelines of the care, or the main index of efficacy of the treatment working group did not strictly concern palliative [74]. If we assume that symptom assessment repre- care, they can be translated into the palliative care sents an index of activity, and quality of life an dimension, as similar documents have never been index of efficacy of a treatment, we can re-analyse produced for palliative care. It follows that quality the clinical trials investigating corticosteroids or of life should be identified as the main patient out- progestagens in cancer anorexia-cachexia, revisiting come,
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