ABSTRACT
Background: To investigate whether ivermectin inhibits SARS-CoV-2 proliferation in patients with mild-to-moderate COVID-19 using time to a negative COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) test. Methods: CORVETTE-01 was a double-blind, randomized, placebo-controlled study (August 2020-October 2021) conducted in Japan. Overall, 248 patients diagnosed with COVID-19 using RT-PCR were assessed for eligibility. A single oral dose of ivermectin (200 µg/kg) or placebo was administered under fasting. The primary outcome was time to a negative COVID-19 RT-PCR test result for SARS-CoV-2 nucleic acid, assessed using stratified log-rank test and Cox regression models. Results: Overall, 112 and 109 patients were randomized to ivermectin and placebo, respectively; 106 patients from each group were included in the full analysis set (male [%], mean age: 68.9%, 47.9 years [ivermectin]; 62.3%, 47.5 years [placebo]). No significant difference was observed in the occurrence of negative RT-PCR tests between the groups (hazard ratio, 0.96; 95% confidence interval [CI] 0.70-1.32; p = 0.785). Median (95% CI) time to a negative RT-PCR test was 14.0 (13.0-16.0) and 14.0 (12.0-16.0) days for ivermectin and placebo, respectively; 82.1% and 84% of patients achieved negative RT-PCR tests, respectively. Conclusion: In patients with COVID-19, single-dose ivermectin was ineffective in decreasing the time to a negative RT-PCR test. Clinical Trial Registration: ClinicalTrials.gov, NCT04703205.
Subject(s)
Docosahexaenoic Acids/blood , Longevity , Aged , Humans , Nursing Homes , Predictive Value of TestsABSTRACT
A 32-year-old woman was seen in our hospital for complaints of bulge and pain in the sternum, and upon examination showed a lump in the left breast and enlarged left axillary lymph nodes. The patient was diagnosed with invasive ductal carcinoma with metastasis to the sternum that was T2N1M1(OSS), Stage IV, hormone-receptor-positive, and HER2-negative. Four courses each of EC and taxane therapy were performed as primary systemic chemotherapy in combination with zoledronic acid, which resulted in calcification of the osteolytic lesion in the sternum and reduced tumor mass in the breast. The patient was judged to have a partial response(PR)to the treatment. Eight months later, breast-conserving surgery and axillary lymph node dissection were performed, followed by radiation therapy to the left breast and sternum. Treatment with zoledronicac id is ongoing and postoperative hormonal therapy has been started. Four years and 4 months after the initial diagnosis, the lesion in the sternum has calcified and hardened and the patient has not had a recurrence in the same breast or elsewhere in the body.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bone Neoplasms/drug therapy , Breast Neoplasms/therapy , Carcinoma, Ductal, Breast/therapy , Sternum/pathology , Adult , Bone Neoplasms/secondary , Breast Neoplasms/pathology , Bridged-Ring Compounds/administration & dosage , Carcinoma, Ductal, Breast/pathology , Chemoradiotherapy , Cyclophosphamide/administration & dosage , Epirubicin/administration & dosage , Female , Humans , Mastectomy, Segmental , Neoplasm Staging , Taxoids/administration & dosageABSTRACT
Lobular carcinoma of the breast is known to metastasize to unusual sites such as the gastrointestinal tract, peritoneum, and gynecologic organs. We report a patient with intraperitoneal metastases from lobular carcinoma who was originally treated for an unknown primary cancer. Ten years later, a tumor was found in her left breast and the diagnosis was changed to peritoneal metastases from invasive lobular carcinoma. Immunohistochemistry revealed that the metastases were high molecular weight cytokeratin (CK34betaE12) and estrogen receptor-positive, but were E-cadherin-negative. These results assisted in diagnosis. Surgeons should be aware of the characteristics of metastasis lobular carcinoma.
Subject(s)
Breast Neoplasms/diagnosis , Carcinoma, Ductal, Breast/diagnosis , Carcinoma, Lobular/diagnosis , Duodenal Neoplasms/diagnosis , Neoplasms, Multiple Primary/diagnosis , Neoplasms, Unknown Primary/diagnosis , Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/secondary , Carcinoma, Lobular/secondary , Diagnosis, Differential , Duodenal Neoplasms/secondary , Female , Humans , Middle Aged , Neoplasm Metastasis , Neoplasms, Multiple Primary/secondary , Neoplasms, Unknown Primary/pathologyABSTRACT
Lobular carcinoma of the breast presents with various clinical manifestations. Lobular carcinoma comprises about one fifth of cases of ductal carcinoma. Intestinal metastasis is dominant in cases of lobular carcinoma. Without a prior diagnosis of lobular carcinoma of the breast, the diagnosis of intestinal metastasis from breast cancer is difficult. A 52-year-old women underwent duodenogastrectomy for duodenal cancer. About 18 months later, she underwent mastectomy for lobular carcinoma of the breast. The duodenal cancer consisted mainly of malignant cells invading the submucosa that were identical to those in the breast. Immunohistochemical assays for estrogen receptor also confirmed breast cancer metastasis. Duodenal obstruction was the first sign of isolated metastatic lobular carcinoma of the breast in this case. The characteristic metastatic pattern of lobular carcinoma, which differs from that of ductal carcinoma, should be kept in mind to ensue proper diagnosis. Preceding breast surgery for lobular carcinoma should prompt investigation based on the typical metastatic pattern.