RESUMO
The purpose of this phase II trial was to investigate the efficacy and safety of a combination chemotherapy with gemcitabine, vinorelbine and cisplatin in the first-line treatment of advanced non-small cell lung cancer (NSCLC). Patients with NSCLC stage IIIB or IV disease received 1000 mg/m(2) gemcitabine and 25 mg/m(2) vinorelbine on days 1 and 8 and 75 mg/m(2) cisplatin on day 2, every 3 weeks. From December 1998 to May 1999, 31 patients (21 stage IV and 10 stage IIIB disease), with a median age of 59 years (range 40-72 years) were enrolled. The overall intent-to-treat response rate was 45% (95% confidence interval (CI): 27-64%) with 2 complete responders (CR) and 12 partial responders (PR), 7 patients had stable disease and 10 progressed. Median survival was 12.8 months (95% CI: 6.5-12.8+ months), median time to progression was 5.1 months (95% CI: 3.5-7.7 months), and the 1-year survival rate was 52.9% (95% CI: 36.7-76.2%). Patients with stage IIIB disease had a significantly longer overall survival than patients with stage IV disease (P=0.05). Transient World Health Organization (WHO) grade IV leucopenia, anaemia and thrombocytopenia occurred in 3 (10%), 2 (6%) and 3 (10%) patients, respectively. The predominant non-haematological toxicities were alopecia and nausea/vomiting. 15 patients (48%) had WHO grade II and III alopecia and 14 patients (45%) nausea/vomiting. The combination of gemcitabine, vinorelbine and cisplatin has demonstrated major antitumour efficacy in advanced NSCLC with a manageable toxicity profile.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Desoxicitidina/análogos & derivados , Neoplasias Pulmonares/tratamento farmacológico , Vimblastina/análogos & derivados , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma Pulmonar de Células não Pequenas/patologia , Cisplatino/administração & dosagem , Cisplatino/efeitos adversos , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Intervalo Livre de Doença , Esquema de Medicação , Feminino , Doenças Hematológicas/induzido quimicamente , Humanos , Avaliação de Estado de Karnofsky , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Taxa de Sobrevida , Resultado do Tratamento , Vimblastina/administração & dosagem , Vimblastina/efeitos adversos , Vinorelbina , GencitabinaRESUMO
Seroepidemiological studies have shown previously that cancer patients are less likely to have antibodies against the tumour suppressive adeno-associated virus (AAV) than control groups. To examine the influence of AAV infection on the development of adult T-cell leukaemia lymphoma (ATLL), an endemic disease in Southern Japan that is caused by infection with the human T-cell leukaemia virus type 1 (HTLV-I), the prevalence of serum antibodies to AAV type 2 (AAV-2) was tested in healthy HTLV-I carriers (n = 39) and patients with ATLL (n = 31). The results showed a significant difference in AAV-2 seropositivity between the two groups: Only 29% of the ATLL patients had IgG antibodies against AAV-2, whereas 84.6% of the healthy HTLV-I carriers were seropositive. Analysis of total serum IgG and antibodies against the Epstein-Barr virus (EBV) EBNA1 antigen showed that the lack of AAV antibodies in patients was not due to an ATLL-associated immune deficiency. The lower level of AAV-2 seropositivity in ATLL-patients may indicate that AAV-2 antibody-positive HTLV-I carriers might be less likely to develop ATLL or that loss of AAV-2 antibodies may parallel the development of disease.