RESUMO
In the FUGA-BT trial (JCOG1113), gemcitabine plus S-1 (GS) showed non-inferiority to gemcitabine plus cisplatin (GC) in overall survival (OS) with good tolerance for patients with advanced biliary tract cancer (BTC). We performed a subgroup analysis focused on the elderly cohort of this trial. All 354 enrolled patients in JCOG1113 were classify into two groups; < 75 (non-elderly) and ≥ 75 years (elderly) group. We investigated the influence of age on the safety analysis, including the incidence of chemotherapeutic adverse events and the efficacy analysis, including OS. There were no remarkable differences in OS between the elderly (n = 60) and the non-elderly groups (n = 294). In the elderly group, median OS was 12.7 and 17.7 months for those who received GC (n = 20) and GS (n = 40), respectively. The prevalence of all-grade adverse events was similar between the elderly and the non-elderly groups. However, among the elderly group, Grade ≥ 3 hematological adverse events were more frequently observed in the GC arm than in the GS arm. The clinical outcomes of combination chemotherapy in elderly patients with advanced BTC were comparable to non-elderly patients. GS may be the more favorable treatment for elderly patients with advanced BTC.
Assuntos
Fatores Etários , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias do Sistema Biliar/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias do Sistema Biliar/patologia , Cisplatino/administração & dosagem , Cisplatino/efeitos adversos , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Desoxicitidina/análogos & derivados , Combinação de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ácido Oxônico/administração & dosagem , Ácido Oxônico/efeitos adversos , Tegafur/administração & dosagem , Tegafur/efeitos adversos , Resultado do Tratamento , GencitabinaRESUMO
OBJECTIVE: The efficacy of defibrinogenation therapy for idiopathic sudden sensorineural hearing loss was studied in comparison with high-dose steroid therapy. MATERIAL AND METHODS: Eighty-eight consecutive patients with hearing levels > 40 dB and who had suffered hearing loss for < or = 30 days were enrolled: 40 patients for high-dose steroid therapy (PSL group) and 48 for defibrinogenation therapy (BX group). Hearing recovery was evaluated by grade assessment and by the improvement in hearing compared to the unaffected contralateral ear. RESULTS: The overall hearing outcomes of the two groups were roughly equivalent. However, with regard to patients with initial hearing levels < 80 dB, the hearing improvement rate of the BX group was significantly worse than that of the PSL group (61.2% +/- 7.3% vs 88.7% +/- 8.9%; p < 0.05), whereas in patients with initial hearing levels > or = 80 dB, the hearing outcomes did not differ between the 2 groups. Three patients in the PSL group manifested hyperglycemia while no serious side-effects were observed in the BX group. CONCLUSION: These results indicate that high-dose steroid therapy should be employed in preference to defibrinogenation therapy for patients with moderate hearing loss, whereas defibrinogenation therapy has an advantage for those with severe hearing loss, in view of its lower frequency of side-effects.