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Stereotactic body radiotherapy for non-spine bone metastases: A meta-analysis and international stereotactic radiosurgery society (ISRS) clinical practice guidelines
ChemoID-guided therapy improves objective response rate in recurrent platinum-resistant ovarian cancer randomized clinical trial
Patients with recurrent platinum-resistant ovarian cancer (PROC) have poor clinical outcomes, owing mainly to the presence of therapy-resistant cancer stem cells (CSCs). The NCT03949283 randomized clinical trial enrolled patients with recurrent PROC to receive ChemoID-guided chemotherapy or the best physician-choice regimen selected from the same list of thirteen mono or combination chemotherapies. The primary outcome was objective response rate (ORR) assessed on CT scans using the RECIST 1.1 criteria at 6 months follow-up. Subjects treated with the ChemoID assay had an ORR of 55% (CI95 39% - 73%), compared to 5% (CI95 0% - 11%) for those treated with physician\u27s choice chemotherapy (p \u3c 0.0001). Secondary endpoints of duration of response (DOR) and progression-free survival (PFS) of subjects treated with chemotherapies guided by the ChemoID assay versus physician\u27s choice chemotherapy were a median of 8 months vs. 5.5 months (p \u3c 0.0001), and 11.0 months (CI95 8.0- NA) vs 3.0 months (CI95 2.0- 3.5) with 27% of hazard ratio (CI95, 0.15-0.49; p \u3c 0.001), respectively
Phase I Clinical Trial of High Doses of Seleno-L-methionine in Combination with Axitinib in Patients with Previously Treated Metastatic Clear-cell Renal Cell Carcinoma
Purpose: Data on clear-cell renal cell carcinoma (ccRCC) xenografts defined the seleno-L-methionine (SLM) dose and the plasma selenium concentrations associated with the enhancement of hypoxia-inducible factor-1α/2α degradation, stabilization of tumor vasculature, enhanced drug delivery, and efficacy of axitinib. The data provided the rationale for the development of this phase I clinical trial of SLM and axitinib in advanced or metastatic relapsed ccRCC.
Patients and methods: Patients were ≥18 years with histologically and radiologically confirmed advanced or metastatic ccRCC who had received at least one prior systemic therapy, which could include axitinib (last dose ≥6 months prior to enrollment). Escalating dose levels of SLM (2,500, 3,000, and 4,000 μg) were administered orally twice daily for 14 days and then once daily concurrently with axitinib 5 mg twice daily using a 3 + 3 design in phase I. Patients were treated at the 4,000 μg dose level in the expansion cohort to obtain preliminary estimates of efficacy.
Results: No dose-limiting toxicities occurred at the 4,000 μg SLM dose level. Among the 27 patients treated with 4,000 μg of SLM, the overall response rate was 55.6%, median duration of response was 18.4 months, median progression-free survival was 14.8 months, and median overall survival was 19.6 months. Preliminary results have shown that plasma selenium concentrations, inhibition of TGF-β1, and stabilization of tumor vasculature by SLM are time dependent