Effectiveness of epoetin beta 30,000 UI once weekly (QW) for treatment of anemia in solid tumor patients under chemotherapy

19588 Background: Anemia is the most frequent hematological complication of cancer. Epoetin beta (E), an effective treatment of anemia in patients with solid tumors (ST) was administered three-times weekly. However, the QW regimen used in patients with hematological malignancies would be more convenient and may improve patient compliance. The aim of our study was to evaluate efficacy and safety of E 30 000 IU QW in patients with ST. Methods: This study was an open-label, single-arm, multicenter trial carried out in 87 French centers between December 2003 and August 2005. Eligibility criteria were: informed consent, age =18 yrs, WHO performance status 0–2, malignant ST or non-myeloid hematological malignancy, on-going chemotherapy and anemia: hemoglobin (Hb) &lt;12 g/dl. E 30 000 IU QW was administered SC for up to 16 weeks. Follow-up visits were scheduled after each chemotherapy cycle. Primary endpoint was Hb response defined as an Hb increase of =2 g/dl (whatever the baseline Hb level) and/or an achievement of Hb level of =12 g/dl or 13 g/dl (patients with Hb levels &lt;11 g/dl or &gt;11 g/dl at baseline respectively). Delay of Hb response, transfusion requirement, mood and cognitive functions were also assessed. Here we focus specifically on the subgroup of patients with ST. Results: In total, 365 patients with ST were included. The most frequent cancer sites were: lung (102 pts) and breast (86 pts). Median Hb level at baseline was 10.4 g/dl [7.9–12.3]. At endpoint, median Hb level increased to 12.5 g/dl [8.4–15.0]. Hb response rate (RR) was: 61% (IC95: 55–66%), 50% (IC95: 38–55%) in patients treated with platinum based regimen and 72% (IC95 : 62–76%) in patients treated without platinum. RR was 54% in lung (IC95: 44–64%), 76% in breast (IC95: 67- 85%). E treatment was well tolerated. Thromboembolic events occurred in 7% of patients, a rate consistent with information provided in the current label for E. Conclusion: Epoetin beta 30 000 IU once weekly is effective and well tolerated in anemic patients with solid tumor treated with chemotherapy. Once weekly treatment offers a convenient therapy which will improve patient compliance. [Table: see text] </jats:p

Intensive chemotherapy as salvage treatment for solid tumors: focus on germ cell cancer

International audienceGerm cell tumors present contrasting biological and molecular features compared to many solid tumors, which may partially explain their unusual sensitivity to chemotherapy. Reduced DNA repair capacity and enhanced induction of apoptosis appear to be key factors in the sensitivity of germ cell tumors to cisplatin. Despite substantial cure rates, some patients relapse and subsequently die of their disease. Intensive doses of chemotherapy are used to counter mechanisms of drug resistance. So far, high-dose chemotherapy with hematopoietic stem cell support for solid tumors is used only in the setting of testicular germ cell tumors. In that indication, high-dose chemotherapy is given as the first or late salvage treatment for patients with either relapsed or progressive tumors after initial conventional salvage chemotherapy. High-dose chemotherapy is usually given as two or three sequential cycles using carboplatin and etoposide with or without ifosfamide. The administration of intensive therapy carries significant side effects and can only be efficiently and safely conducted in specialized referral centers to assure optimum patient care outcomes. In breast and ovarian cancer, most studies have demonstrated improvement in progression-free survival (PFS), but overall survival remained unchanged. Therefore, most of these approaches have been dropped. In germ cell tumors, clinical trials are currently investigating novel therapeutic combinations and active treatments. In particular, the integration of targeted therapies constitutes an important area of research for patients with a poor prognosis