Abstract
This study analyzes an oral supplement of molecular iodine (I2), alone and in combination with the neoadjuvant therapy 5-fluorouracil/epirubicin/cyclophosphamide or taxotere/epirubicin (FEC/TE) in women with Early (stage II) and Advanced (stage III) breast cancer. In the Early group, 30 women were treated with I2 (5 mg/day) or placebo (colored water) for 7–35 days before surgery. For the Advanced group, 30 patients received I2 or placebo, along with FEC/TE treatment. After surgery, all patients received FEC/TE + I2 for 170 days. I2 supplementation showed a significant attenuation of the side effects and an absence of tumor chemoresistance. The control, I2, FEC/TE, and FEC/TE + I2 groups exhibited response rates of 0, 33%, 73%, and 100%, respectively, and a pathologic complete response of 18%, and 36% in the last two groups. Five-year disease-free survival rate was significantly higher in patients treated with the I2 supplement before and after surgery compared to those receiving the supplement only after surgery (82% versus 46%). I2-treated tumors exhibit less invasive potential, and significant increases in apoptosis, estrogen receptor expression, and immune cell infiltration. Transcriptomic analysis indicated activation of the antitumoral immune response. The results led us to register a phase III clinical trial to analyze chemotherapy + I2 treatment for advanced breast cancer.
Highlights
The main causes of the failure of breast cancer treatments are the rapid development of metastases and tumor resistance to antineoplastic drugs [1,2]
We observed that after I2 treatment, the number of CD8+ T cells, dendritic cells, cytotoxic lymphocytes, and B-lineage cells appears to be enriched when compared with the control group. These results suggested that I2 supplementation increases tumor immune infiltration and that the presence of fluorouracil/epirubicin/cyclophosphamide or taxotere/epirubicin (FEC/TE) may synergize such an immune response
The consistent attenuation of side effects and the antineoplastic response associated with the presence of this halogen, highlight the relevance of a phase III study to analyze the supplement of I2 in conventional treatments against advanced breast cancer. This is a pilot study that analyzed the adjuvant effect of molecular iodine together with the most widely used chemotherapeutic treatment in Mexico against breast cancer
Summary
The main causes of the failure of breast cancer treatments are the rapid development of metastases and tumor resistance to antineoplastic drugs [1,2]. 5-fluorouracil/epirubicin/cyclophosphamide or taxotere/epirubicin (FEC/TE) combination therapy for advanced breast cancer. Continued research is necessary to develop novel breast cancer drugs that prevent these detrimental side effects. Several groups, including ours, have shown that these anti-proliferative and anti-inflammatory actions can be observed in preclinical and clinical models of benign prostatic hyperplasia and cancer of various organs that uptake iodine [7,8,9]. We reported that I2 exerts synergistic effects when used in combination with DOX antineoplastic treatments in both rodent [10]
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