RESUMO
OBJECTIVES: The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and patient characteristics. METHODS: This two-stage, multicenter, single arm, phase II trial enrolled eligible patients to receive hu3S193 weekly at a dose of 20mg/m(2) intravenously for 8 weeks (1 cycle) to a maximum of 3 cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24 weeks). RESULTS: 26 of 31 patients were eligible for efficacy analysis. No complete/partial responses were observed. Six patients had stable disease for 24+weeks [clinical benefit rate 23% (95% CI=9.77%-46.71%)]. Median PFS was 8.4 weeks (95% CI=6.0 to 16.1). Median PFS differed between patients with no ascites and no visceral disease and patients with ascites and/or visceral disease [16.1 vs. 8.1 weeks (p=0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 patients (5 with Grade 1/2; 1 with Grade 3). CONCLUSIONS: Hu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in patients with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested.
Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Neoplasias das Tubas Uterinas/terapia , Neoplasias Epiteliais e Glandulares/terapia , Neoplasias Ovarianas/terapia , Neoplasias Peritoneais/terapia , Adulto , Idoso , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/imunologia , Anticorpos Monoclonais Humanizados/farmacocinética , Carcinoma Epitelial do Ovário , Intervalo Livre de Doença , Resistencia a Medicamentos Antineoplásicos , Neoplasias das Tubas Uterinas/imunologia , Neoplasias das Tubas Uterinas/metabolismo , Feminino , Humanos , Antígenos do Grupo Sanguíneo de Lewis/imunologia , Pessoa de Meia-Idade , Neoplasias Epiteliais e Glandulares/imunologia , Neoplasias Epiteliais e Glandulares/metabolismo , Compostos Organoplatínicos/farmacologia , Neoplasias Ovarianas/imunologia , Neoplasias Ovarianas/metabolismo , Neoplasias Peritoneais/imunologia , Neoplasias Peritoneais/metabolismo , Adulto JovemRESUMO
AIM: Managed Flow C20 (MFC20) is an integrated care pathway (ICP) for rectal cancer implemented at a public teaching hospital. This study aims to quantify resource utilization and estimate direct costs and outcomes associated with the use of this ICP. METHODS: We evaluated consecutive rectal cancer patients treated with neoadjuvant chemoradiotherapy (nCRT) followed by surgery, comparing the period before the ICP implementation (Pre-MFC20 group) and after (MFC20 group). We assessed times between treatment steps and quantified the resources utilized, as well as their costs. RESULTS: There were 112 patients in the Pre-MFC20 group and 218 in the MFC20 group. The mean treatment intervals were significantly shorter in the MFC20 group - from the first medical consultation to nCRT (48.3 vs. 87.5 days; Pâ<â0.001); and from nCRT to surgery (14.8 vs. 23.0 weeks; Pâ<â0.001) - as was the mean total treatment time (192.0 vs. 290.2 days; Pâ<â0.001). Oncology consultations, computed tomography, MRI, and radiotherapy sessions were utilized more frequently in the Pre-MFC20 group (Pâ<â0.001). The median per-patient cost was US$11â180.92 in the Pre-MFC20 group, compared with US$10â412.88 in the MFC20 group (Pâ=â0.125). Daily hospital charges and consultations were the major determinants of the total cost of the treatment. There was no statistical difference in overall survival in the time periods examined. CONCLUSION:: Implementation of a rectal cancer ICP reduced all treatment intervals and promoted rational utilization of oncology consultations and imaging, without increment in per-patient costs or detrimental effects in overall survival.