Activity Efficacy and Safety of Corticosteroids in Palliative Treatment of Cancer Cachexia

Although many data support the use of corticos-teroids in palliative care, their use is only supported in part by evidence-based rules [84]. The two main reasons for this limit are:

- The use of corticosteroids goes back to a 'pre-evidence-based' era in medicine, and, like some other old approaches, it could be assigned to a kind of'traditional knowledge' in medicine

- The 'experience-based' evidence of their use in clinical practice (methodologically the opposite of the 'evidence-based' approach) is so high that it would be hard for their use not to be considered as the 'standard procedure' in 'evidence-based' confirmatory randomised trials. Many interesting randomised clinical trials support the use of corticosteroids in the treatment of cancer cachexia [85-89]. Although the pivotal

Table 1. Levels of evidence and grading of recommendations

Grading of recommendations Level of evidence Type of evidence

Table 1. Levels of evidence and grading of recommendations

Grading of recommendations Level of evidence Type of evidence

A

I

Evidence is obtained from meta-analysis of multiple, well-designed, controlled studies. Randomised trials with low false-positive and low false-negative errors (high power)

B

II

Evidence is obtained from at least one well-designed experimental study. Randomised trials with high false-positive and/or negative errors (low power)

III

Evidence is obtained from well-designed, quasi experimental studies such as non-randomised, controlled single-group, pre-post, cohort, time or matched case-control series

C

IV

Evidence is from well-designed, non-experimental studies such as comparative and correlational descriptive and case studies

D

V

Evidence is from case reports and clinical examples

trial of Moertel et al. dates back to 1974 [85], and other important trials were published in the 1980s [86-89], some considerations can be made approaching the results from an outcome point of view. All trials showed that corticosteroids (dex-amethasone or prednisolone, or methylpred-nisolone) induce a temporary benefit against different cachexia-related symptoms, improving the appetite, food intake, sensation of well-being, and performance status. Conversely, no trial demonstrated an improvement in body weight. Moreover, the trials of Robustelli della Cuna and Popiela [88, 89] approached the dimension of quality-of-life assessment during the treatment, and tried to go beyond symptom assessment in the outcome assessment in palliative care. Besides these interesting results detailed in Table 2, there is much evidence that corticosteroids can act against some other symptoms, that are related to, but not constitutive of, cancer cachexia, such as asthenia, or nausea and vomiting [90-93]. It follows that corticos-teroids are very useful in some different conditions of clinical practice, when cachexia coexists with other syndromes such as asthenia, nausea and vomiting, or dyspnoea. Such a versatility of corticosteroids is only partially known from a pathophysiological point of view. As concerns cancer cachexia, corticosteroids may be supposed to act by inhibiting the immune response and cytokine cascade, and acting on the central nervous system. However, other characteristics can partially counterbalance the data of activity. The above-mentioned trials and some others reported that the activity against cachexia-related symptoms is limited to a few weeks, and the relevant side-effects (peptic ulcer, cataract, opportunistic infections, glucose intolerance, myopathy) can often make it difficult to use corticosteroids in clinical practice. It follows that corticosteroids can surely be considered an active and probably efficacious approach against cancer cachexia, but shortness of action and side-effects suggest their use is limited to patients with advanced disease and expected short duration of survival [8,94]. Finally, type, dosage and route of administration remain ill defined, and low dosages (less than 1 mg/kg of prednisone equivalent) seem recommendable in daily clinical practice [8].

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