Adjuvant Effect of Molecular Iodine in Conventional Chemotherapy for Breast Cancer. Randomized Pilot Study

• DOI: 10.20944/preprints201907.0152.v1
• Publication Date: 2019-07-11T02:51:26Z
• Authors: Aura Moreno-Vega; Laura Vega-Riveroll; Tonatiuh Ayala; Guillermo Peralta; Jose Miguel Torre...; Joel Rojas; Perla Mondragon; Adriana Dominguez; Rodrigo De Obaldia; Carlos Avecilla-G...; Brenda Anguiano; Evangelina Delgad...; Xochitl Zambrano-...; Olga Cuenca-Mico; Olivia De La Puente; Alfredo Varela-Ec...; Carmen Aceves
• Keywords: Adult; Aged, 80 and over; 0303 health sciences; molecular iodine; chemoresistance; Antineoplastic Agents; Breast Neoplasms; Pilot Projects; Middle Aged; immune response; Article; Disease-Free Survival; Neoadjuvant Therapy; Trace Elements; 3. Good health; 03 medical and health sciences; breast cancer; Humans; Female; transcriptomic analysis; oncology_oncogenics; Aged; Iodine

This study analyzes 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 absence of tumor chemoresistance. Control, I2, FEC/TE, and FEC/TE+I2 groups exhibit response rate 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 with I2 supplement before and after surgery compared to those receiving the supplement only after surgery (82% vs. 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 analyzing chemotherapy + I2 treatment for advanced breast cancer.