RESUMEN
BACKGROUND: The approval of epoetin biosimilars in the European Union requires extensive scientific evaluation and stringent regulatory procedures, including post-marketing studies. The ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an observational, longitudinal, multicentre study performed in France to evaluate the efficacy and safety of biosimilar epoetins for the treatment of chemotherapy-induced anaemia (CIA) in the clinical setting. METHODS: Patients >18 years with CIA (haemoglobin [Hb] <11 g/dL) in association with solid tumours, lymphoma or myeloma and eligible for treatment with an epoetin biosimilar were included in this study. Patient characteristics were recorded at baseline along with anaemia-related information, such as observed and target Hb (as chosen by the treating clinician), brand and dose of epoetin biosimilar prescribed, and details of any other treatments. Patients were then followed-up at 3 and 6 months. The primary endpoint was Hb response (defined as Hb reaching ≥10 g/dL, an increase of Hb ≥1 g/dL since inclusion visit or reaching physician-defined target Hb, with no blood transfusions in the 3 weeks prior to measurement). Other endpoints included adverse events, achievement of target Hb and associated treatments. RESULTS: Overall, 2333 patients >18 years (mean age 66.5 years) with CIA (haemoglobin [Hb] <11 g/dL) in association with solid tumours, lymphoma or myeloma and eligible for biosimilar epoetin treatment were included. 99.9% of patients received epoetin zeta (median dose 30,000 IU/week). Mean baseline Hb was 9.61 g/dL, with 35.6% of patients having moderate anaemia (Hb 8-9.5 g/dL). Hb response was achieved in 81.6% and 86.5% of patients at 3 and 6 months, respectively. Overall mean change in Hb level was 1.52 ± 1.61 and 1.72 ± 1.61 g/dL at 3 and 6 months, respectively. Transfusion and thromboembolic event rates were 9.4% and 2.4% at 3 months, and 5.8% and 1.5% at 6 months, respectively. CONCLUSIONS: Epoetin zeta was effective and well tolerated in the management of CIA in patients with solid tumours, lymphoma and myeloma. TRIAL REGISTRATION NUMBER: NCT02140736 (date of registration: 14 May 2014).
Asunto(s)
Anemia/tratamiento farmacológico , Biosimilares Farmacéuticos/administración & dosificación , Eritropoyetina/administración & dosificación , Neoplasias Hematológicas/tratamiento farmacológico , Adulto , Anciano , Anemia/inducido químicamente , Biosimilares Farmacéuticos/efectos adversos , Eritropoyetina/efectos adversos , Femenino , Francia , Neoplasias Hematológicas/complicaciones , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversosRESUMEN
OBJECTIVES: To determine short- and long-term outcomes of major hepatectomy in patients with downstaged colorectal liver metastases considered initially unresectable (IU). BACKGROUND: Improvements in both surgical technique and efficacy of chemotherapy have increased the rate of resection for IU colorectal liver metastases. The outcome of these patients needs to be reassessed. PATIENTS AND METHODS: From 2000 to 2011, 257 patients underwent major hepatectomy for colorectal liver metastases. Of these, 87 (34%) IU patients required portal vein occlusion after chemotherapy downstaging. Patients requiring less than 12 cycles and 12 or more cycles of chemotherapy before resection were defined as fast responders and slow responders, respectively. RESULTS: Compared with fast responders, slow responders had increased mortality (0% vs 19%, P = 0.003) and major morbidity rates (20% vs 55%, P < 0.001) despite almost identical tumor characteristics and similar procedures. In multivariate analysis, the only factor associated with increased major morbidity was the existence of a number of chemotherapy cycles of 12 or more (hazard ratio [HR]: 5.32, confidence interval [CI]: 1.69-16.7, P = 0.004). One-, 3-, and 5-year disease-free survival rates for the entire population were 48%, 17.5%, and 13%, respectively. Multivariate analysis found that slow responders (HR: 2.89, CI: 1.67-5.04, P < 0.001) and patients without adjuvant chemotherapy (HR: 2.38, CI: 1.33-4.35, P = 0.004) had a significantly decreased disease-free survival. All slow responders postoperatively recurred within 3 years. CONCLUSIONS: Liver resection in slow responders, that is, IU patients requiring 12 or more chemotherapy cycles and portal vein occlusion to achieve resectability, is associated with poor short- and long-term outcomes. These patients would probably benefit from more conservative strategies.
Asunto(s)
Neoplasias Colorrectales/patología , Hepatectomía , Neoplasias Hepáticas/secundario , Neoplasias Hepáticas/cirugía , Anciano , Quimioterapia Adyuvante , Neoplasias Colorrectales/mortalidad , Terapia Combinada , Femenino , Humanos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/mortalidad , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Estadificación de Neoplasias , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Medición de Riesgo , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
PURPOSE: The aim of this pharmaco-epidemiological study was to evaluate the prevalence of oropharyngeal candidiasis (OPC) in cancer patients treated with chemotherapy and/or radiotherapy. METHODS AND MATERIALS: Signs and symptoms of OPC were noted for all patients. Antifungal therapeutic management was recorded in OPC patients. Patients receiving local antifungal treatments were monitored until the end of treatment. RESULTS: Enrolled in the study were 2,042 patients with solid tumor and/or lymphoma treated with chemotherapy and/or another systemic cancer treatment and/or radiotherapy. The overall prevalence of OPC was 9.6% (95% confidence interval, 8.4%-11.0%] in this population. It was most frequent in patients treated with combined chemoradiotherapy (22.0%) or with more than two cytotoxic agents (16.9%). Local antifungal treatments were prescribed in 75.0% of OPC patients as recommended by guidelines. The compliance to treatment was higher in patients receiving once-daily miconazole mucoadhesive buccal tablet (MBT; 88.2%) than in those treated with several daily mouthwashes of amphotericin B (40%) or nystatin (18.8%). CONCLUSION: OPC prevalence in treated cancer patients was high. Local treatments were usually prescribed as per guidelines. Compliance to local treatments was better with once-daily drugs.