RESUMO
Patients with cervical cancer frequently suffer from anemia. This two-stage, adaptive-design study investigated the effect of anemia correction with epoetin beta on treatment outcomes. Patients with stage IIB-IVA cervical cancer received radiochemotherapy (RCT) and were randomized to epoetin 150 IU/kg three times weekly (n = 34) or standard care (control; n = 40) for up to 12 weeks. Primary end point for stage 1 aimed to establish a correlation between anemia correction and treatment failure (no complete response or relapsing within 6 months after RCT initiation) as a proof of concept before moving into stage 2. Secondary end points included progression/relapse-free survival, overall survival, response to RCT, hemoglobin (Hb) response, and safety. Median baseline Hb was 11.4 and 11.6 g/dL in epoetin and control groups, respectively. At treatment end point, median Hb increased by 1.3 g/dL with epoetin, but decreased by 0.7 g/dL in the control group (P < 0.0001). No significant correlation between Hb increase and treatment failure was demonstrated. There were no significant differences between epoetin and control groups in progression/relapse-free survival (29.4% vs 32.5% patients with events; P = 0.96), overall survival (23.5% vs 12.5% patients with events; P = 0.22) or overall complete response (53% vs 58%; P = 0.86). Adverse events were well matched between groups. This study shows that epoetin beta rapidly, effectively, and safely increases Hb levels in patients with cervical cancer receiving RCT. No positive correlation of Hb increase and improvement in clinical outcomes could be demonstrated.
Assuntos
Anemia/tratamento farmacológico , Eritropoetina/administração & dosagem , Neoplasias do Colo do Útero/tratamento farmacológico , Neoplasias do Colo do Útero/radioterapia , Adulto , Anemia/etiologia , Quimioterapia Adjuvante/efeitos adversos , Terapia Combinada , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Seguimentos , Humanos , Imuno-Histoquímica , Injeções Subcutâneas , Modelos Logísticos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Probabilidade , Radioterapia Adjuvante/efeitos adversos , Proteínas Recombinantes , Valores de Referência , Medição de Risco , Análise de Sobrevida , Resultado do Tratamento , Neoplasias do Colo do Útero/mortalidade , Neoplasias do Colo do Útero/patologiaRESUMO
BACKGROUND: Anaemia is a common complication of chemotherapy (CT), including both non-platinum (Pt)-based as well as Pt-based CT. PATIENTS AND METHODS: Patients from three controlled trials with solid tumours receiving either Pt- or non-Pt-based CT, who had been randomised to epoetin beta treatment or standard care, were included in this meta-analysis (n=255, n=199, respectively), to see if epoetin beta was equally effective in both CT types. The primary endpoint was haemoglobin (Hb) change. Secondary end-points included transfusion requirement, adverse events (AEs), survival, time to tumour progression and thromboembolic events (TEEs). RESULTS: All patients responded rapidly to epoetin beta treatment, showing a median Hb increase of > or = 1 g/dl from baseline at week 4. A median Hb of 12.2, 12.5 and 11.8 g/dl was achieved in all patients, those receiving Pt-based CT and those receiving non-Pt-based CT, respectively, after 16 weeks of treatment. Transfusion risk reductions associated with epoetin beta treatment of 53% (p<0.0001), 61% (p<0.0001) and 26% (non significant) were observed for all patients, Pt- and non-Pt-based CT patients, respectively. Overall, for all three populations, there were no risks identified for tumour progression or overall survival. There was a statistically non-significant incidence of TEEs (5.9% versus 4.5%) and no marked differences were observed between groups for frequency or type of AEs reported. CONCLUSION: The type of CT has no impact on the ability of epoetin beta to rapidly increase Hb in patients with solid tumours and CT-induced anaemia.