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Clinical Trial 2001; 22(1): 45-47 PubMed PMID: 11335879 Citation  Keywords:  Adult, Aged, Bone Neoplasms:secondary, Carcinoma:blood, Carcinoma, Hepatocellular:blood, Carcinoma, Non-Small-Cell Lung:blood, Carcinoma, Renal Cell:blood, Colorectal Neoplasms:blood, Disease Progression, Endothelial Growth Factors:blood, Female, Humans, .   

OBJECTIVES: The anticancer activity of the indole melatonin has been explained to be due to its immunomodulatory, anti-prolferative and anti-oxidant effects, whereas at present no data are available about its possible influence on the angiogenesis, which has been shown to be one of the main biological mechanisms responsible for tumor dissemination. Vascular endothelial growth factor (VEGF) is the most active angiogenic factor, and the evidence of abnormally high blood levels or VEGF has been proven to be associated with poor prognosis in cancer patients. To investigate the influence of melatonin on angiogenesis, in this preliminary study we have evaluated the effects of melatonin therapy on VEGF blood levels in advanced cancer patients.

MATERIAL & METHODS: The study included 20 metastatic patients, who progressed on previous conventional antitumor therapies and for whom no other effective treatment was available. Melatonin was given orally at 20 mg/day in the evening for at least 2 months. Serum levels of VEGF were measured by an enzyme immunoassay on venous blood samples collected at 15-day intervals.

RESULTS: The clinical response consisted of minor response (MR) in 2, stable disease (SD) in 6 and progressive disease (PD) in the remaining 12 patients. VEGF mean levels decreased on therapy, without, however, statistical differences with respect to the pre-treatment values. In contrast, by evaluating changes in VEGF levels in relation to the clinical response, non-progressing patients (MR + SD) showed a significant decline in VEGF mean concentrations, whereas no effect was achieved in progressing patients.

CONCLUSIONS: This study, by showing that melatonin-induced control or the neoplastic growth is associated with a decline in VEGF secretion, would suggest that the pineal hormone may control tumor growth at least in part by acting as a natural anti-angiogenic molecule, with a following opposition or angiogenesis-dependent cancer proliferation....

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Clinical Trial 2001; 22(1): 27-29 PubMed PMID: 11335876 Citation  Keywords:  Adult, Aged, Antineoplastic Agents, Phytogenic:administration & dosage, Antineoplastic Combined Chemotherapy Protocols:administration & dosage, Biomarkers, Tumor:blood, Bone Neoplasms:secondary, Breast Neoplasms:blood, Disease Progression, Female, Humans,.   

OBJECTIVES: Recent data have suggested that the efficacy of cancer chemotherapy does not depend only on tumor-related characteristics, but also on patient biological status, namely immune and endocrine functions. In particular, it has been shown that prolactin (PRL) is a growth factor for breast cancer, and abnormally high blood levels of PRL have been described in metastatic breast cancer patients. The present study was performed to evaluate the efficacy of chemotherapy with taxanes in relation to PRL blood levels in metastatic breast cancer.

MATERIAL & METHODS: The study included 20 metastatic breast cancer patients, who were treated with taxotere (100 mg/mq I.V. every 21 days) for at least 3 consecutive cycles. Serum levels of PRL were measured by RIA before the onset of treatment and at 21-days intervals.

RESULTS: The clinical response consisted of partial response (PR) in 6, stable disease (SD) in 7 and progressive disease (PD) in the remaining 7 patients. Abnormally high pre-treatment levels of PRL were seen in 7/20 patients. The percent of patients who had PD in response to chemotherapy was significantly high in patients with pre-treatment hyperprolactinemia than in those with normal blood levels of PRL before therapy.

CONCLUSIONS: This study shows that the evidence of abnormally high serum levels of PRL correlates with resistance to chemotherapy with taxanes in metastatic breast cancer. Therefore, a concomitant administration of anti-prolactinemic agents, such as bromocriptine, could enhance the efficacy of chemotherapy itself....

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