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. |
Publication Type | Journal Article |
Year of Publication | 2008 |
Authors | Thomas G, Ali S, Hoebers FJP, Darcy KM, Rodgers WH, Patel M, Abulafia O, Lucci JA, Begg AC |
Journal | Gynecol Oncol |
Volume | 108 |
Issue | 2 |
Pagination | 317-25 |
Date Published | 2008 Feb |
ISSN | 1095-6859 |
Keywords | Adult, Aged, Anemia, Antineoplastic Agents, Cisplatin, Combined Modality Therapy, DNA Adducts, Erythropoietin, Female, Hemoglobins, Humans, Middle Aged, Neoplasm Staging, Recombinant Proteins, Thromboembolism, Uterine Cervical Neoplasms |
Abstract | PURPOSE: To determine whether maintaining HGB levels > or = 12.0 g/dL with recombinant human erythropoietin (R-HUEPO) compared to "standard" treatment (transfusion for HGB < or = 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. |
DOI | 10.1016/j.ygyno.2007.10.011 |
Alternate Journal | Gynecol Oncol |
PubMed ID | 18037478 |
PubMed Central ID | PMC2350198 |
Grant List | U10 CA027469-24 / CA / NCI NIH HHS / United States U10 CA037517 / CA / NCI NIH HHS / United States CA 37517 / CA / NCI NIH HHS / United States CA 27469 / CA / NCI NIH HHS / United States U10 CA027469 / CA / NCI NIH HHS / United States |
Related Faculty:
William Rodgers, M.D., Ph.D.