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- W2025879427 abstract "Purpose To determine whether maintaining HGB levels ≥12.0 g/dL with recombinant human erythropoietin (R-HUEPO) compared to “standard” treatment (transfusion for HGB ≤10.0 g/dL) improves progression-free survival (PFS), overall survival (OS) and local control (LC) in women receiving concurrent weekly cisplatin and radiation (CT/RT) for carcinoma of the cervix. In addition, to determine whether platinum–DNA adducts were associated with clinical characteristics or outcome. Methods Patients with stage IIB–IVA cervical cancer and HGB <14.0 g/dL were randomly assigned to CT/RT±R-HUEPO (40,000 units s.c. weekly). R-HUEPO was stopped if HGB >14.0 g/dL. Endpoints were PFS, OS and LC. Platinum–DNA adducts were quantified using immunocytochemistry assay in buccal cells. Results Between 08/01 and 09/03, 109 of 114 patients accrued were eligible. Fifty-two received CT/RT and 57 CT/RT+R-HUEPO. The study closed prematurely, with less than 25% of the planned accrual, due to potential concerns for thromboembolic event (TE) with R-HUEPO. Median follow-up was 37 months (range 9.8–50.4 months). PFS and OS at 3 years should be 65% and 75% for CT/RT and 58% and 61% for CT/RT+R-HUEPO, respectively. TE occurred in 4/52 receiving CT/RT and 11/57 with CT/RT+R-HUEPO, not all considered treatment related. No deaths occurred from TE. High-platinum adducts were associated with inferior PFS and LC. Conclusion TE is common in cervical cancer patients receiving CT/RT. Difference in TE rate between the two treatments was not statistically significant. The impact of maintaining HGB level >12.0 g/dL on PFS, OS and LC remains undetermined." @default.
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- W2025879427 date "2008-02-01" @default.
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- W2025879427 title "Phase III trial to evaluate the efficacy of maintaining hemoglobin levels above 12.0 g/dL with erythropoietin vs above 10.0 g/dL without erythropoietin in anemic patients receiving concurrent radiation and cisplatin for cervical cancer" @default.
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- W2025879427 doi "https://doi.org/10.1016/j.ygyno.2007.10.011" @default.
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