Hormonal therapy defined

There are no well-defined clinical characteristics or established tests to identify patients likely to benefit from chemotherapy. Factors associated with an increased probability of response that have been identified include a good performance status, a limited number (one to two) of disease sites, and patients who respond to chemotherapy or hormonal therapy with a long disease-free interval. Patients who have progressive disease during chemotherapy have a lower probability of response to a different type of chemotherapy. However, this is not necessarily true for patients who are given chemotherapy after some interval during which they have received no chemotherapy. Patients who do not respond to endocrine therapy are as likely to respond to chemotherapy as patients who are treated with chemotherapy as their initial treatment modality. Age, menopausal status, and receptor status have not been associated with favorable or unfavorable response to chemotherapy. 

Subclinical hypothyroidism, defined as an elevated TSH level and normal thyroid hormone levels, is found in 4-10% of the general population but increases to 20% in women older than age 50. The consensus of expert thyroid organizations concluded that thyroid hormone therapy should be considered for patients with TSH levels greater than 10 mlU/L while close TSH monitoring is appropriate for those with lower TSH elevations. 

Fournier A, Fabre A, Mesrine S, Boutron-Ruault M-C, Berrino F, Clavel-Chapelon F. Use of different postmenopausal hormone therapies and risk of histology- and hormone receptor-defined invasive breast cancer. J Clin Oncol 2008 26 1260-8. 

Optimal management of the postmenopausal patient requires careful assessment of her symptoms as well as consideration of her age and the presence of (or risks for) cardiovascular disease, osteoporosis, breast cancer, and endometrial cancer. Bearing in mind the effects of the gonadal hormones on each of these disorders, the goals of therapy can then be defined and the risks of therapy assessed and discussed with the patient. 

Studies and reviews sponsored by the manufacturer of tibolone have over many decades argued that, as one reviewer puts it, tibolone may provide a safer alternative to traditional hormone replacement therapy , but even this review adds that the impact of tibolone on the risk of breast cancer or cardiovascular and thromboembolic events is not well defined (2). Bearing in mind that these are precisely the questions that have cast a shadow over other forms of hormone replacement therapy, this is a serious defect in the evidence about the drug s safety it is possible that the extent of use of tibolone has been insufficient to provide well-documented answers. 

Walsh (2003) defined biopharmaceuticals as therapeutic protein or nucleic acid preparations made by techniques involving recombinant deoxyribonucleic acid (DNA) technology. Therapeutic proteins include blood clotting factors and plasminogen activators, hemopoietic factors, hormones, interferons and interleukins, and monoclonal antibodies (LeVine, 2006). Over time, the term biopharmaceutical has broadened, and, in addition to proteins and nucleic acids, now includes bacteriophages, viral and bacterial vaccines, vectors for gene therapy, and cells for cell therapy (Primrose and Twyman, 2004). Attention here focuses on proteins, since the majority of approved biopharmaceuticals are proteins. 

The clinical uses of progestational agents are ill-defined, apart from contraception, the menopause and postmenopausal hormone replacement therapy (see above). 

From the studies described in this section, it is apparent that in selected clinical conditions associated with either primary or secondary immunodeficiency, various thymic preparations are capable of restoring T cell numbers and function. However, clinical trials with thymic hormones are in their infancy and a number of questions still must be resolved before thymic factor therapy can become an accepted form of treatment. Most of the reported studies to date, particularly in primary immunodeficiency disorders, were nonrandomized and involved small patient numbers, and so they need confirmation in large-scale, randomized trials. Both the dosage and schedule dependency of each of the thymic factors have been empirically established, and further emphasis is needed in defining the optimal dosage and frequency of administration. Nevertheless, because they are nontoxic preparations, the thymic factors hold promise as important new drugs for treating a wide variety of disorders associated with abnormalities of thymic-dependent immunity. 

Clarification of the controversial literature could be achieved by new prospective randomised control trials (RCT) with clearly defined sensitive and objective outcomes, larger sample size, longer duration of therapy, homogeneity in thyroid disease xmder treatment and consistency in the levothyroxine/T3 ratio, all factors lacking in earlier trials. Combination therapy requires creative insights into new formulations that will mimic physiology thyroid hormone levels. 

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