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- W4242304439 abstract "1561 Background: 538 patients with brain metastases from selected solid tumors were randomized in a study of standard WBRT (30 Gy in 10 fractions) and supplemental oxygen with or without the radiation sensitizer RSR13 (efaproxiral) (Control n=267, RSR13 n=271). A non-significant improvement in MST was seen in favor of the RSR13 arm when results were analyzed by undajusted log-rank. The study showed a survival advantage for RSR13-treated patients versus controls after adjusting for imbalances in prognostic factors (Cox multiple regression) with the patients with breast cancer deriving the largest benefit from RSR13. Since a clear PK/Pharmacodynamic (PK = RSR13 concentration in RBCs and Pharmacodynamic = p50 shift) correlation had been established for RSR13 in previous studies, PK analyses were incorporated in the design of the present study. Methods: Blood samples were drawn for RSR13 PK analyses on Day 1 of RSR13 and at least once during the second week of RSR13 therapy. 188 patients had at least 2 PK determinations, 64 had 1 PK determination and 19 had no PK evaluation. Results: Higher PK were observed in patients with higher body weight and in women. Patients were assigned to 1 of 5 groups based on the number of WBRT fractions and the number of RSR13 doses received, as shown in the table below. Conclusions: These analyses reveal that patients with RSR13 concentrations in RBCs that reached optimal levels had a better outcome than those patients who did not. A clear correlation between PK, number of RSR13 doses, and MST was established. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Allos Therapeutics, Inc. Allos Therapeutics, Inc. Allos Therapeutics, Inc." @default.
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- W4242304439 date "2004-07-15" @default.
- W4242304439 modified "2023-09-27" @default.
- W4242304439 title "Pharmacokinetics (PK) of RSR13 (efaproxiral) predict survival in patients with brain metastases randomized to receive whole brain radiation therapy (WBRT) with or without RSR13 (REACH RT-009)" @default.
- W4242304439 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.1561" @default.
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