RESUMO
INTRODUCTION: A randomised trial implementing Enhanced Recovery After Surgery (ERAS) for high complexity advanced ovarian cancer (AOC) surgery (PROFAST) demonstrated a reduction of median length of stay and hospital readmissions when compared to patients managed conventionally. One secondary objective was to determine if an ERAS pathway in the perioperative management of advanced ovarian cancer patients led to cost savings. MATERIAL AND METHODS: Secondary objective of a prospective randomised trial of patients with suspected or diagnosed advanced ovarian cancer allocated to conventional or ERAS perioperative management, carried out at a referral centre from June 2014 to March 2018. Treatment was determined by a computer-generated random allocation system. METHODS: Gross counting was employed to estimate the cost of hospitalisation in wards, intensive care unit (ICU) and surgical care, while micro-costing was used to obtain image and laboratory test costs. Mean costs between trial arms were considered. Sensitivity analyses were performed. RESULTS: Ninety-nine patients (n = 50 ERAS group, n = 49 Conventional group) were included. Mean costs per patient were 10,719 in the ERAS group and 11,028 in the conventional group, leading to an average saving of 309 per patient. These results were based on 96 patients, excluding 3 extreme outliers mainly related with very high ICU costs. Savings, which were significant for hospital ward costs (-33% total; 759 per patient in first hospitalisation, and 914 per partient/day of readmission) were found as robust in the sensitivity analysis. CONCLUSIONS: Implementation of an ERAS pathway leads to cost savings when compared to conventional management after AOC surgery.
Assuntos
Recuperação Pós-Cirúrgica Melhorada , Neoplasias Ovarianas , Feminino , Humanos , Carcinoma Epitelial do Ovário , Custos Hospitalares , Tempo de Internação , Neoplasias Ovarianas/cirurgia , Complicações Pós-Operatórias , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Our group evaluated the risk of recurrence for optimally treated advanced epithelial ovarian cancer (adEOC) in patients with a low-level rising serum CA-125 concentration within the normal range (0-35 kU/l). In addition, we tested the new proposed early CA-125 signal of progressive disease (EPD) criterion in the same study population. PATIENTS AND METHODS: Patients treated from 1998 to 2006 for adEOC were identified at our institution. Inclusion criteria were as follows: CA-125 at time of diagnosis (>35 kU/l); International Federation of Gynecology and Obstetrics stages III-IV treated with optimal primary treatment; and complete response (CR) to primary treatment with normalization of CA-125. RESULTS: Median progression-free survival and overall survival for the recurrence group (n = 60) were 17.7 and 38.2 months, respectively. The median follow-up time from CR to last contact was 40.2 months for patients in the nonrecurrence group (n = 36). An absolute increase in serum CA-125 levels of >or=5 kU/l compared with baseline CA-125 nadir values was significantly predictive of recurrence (odds ratio for recurrence = 402.98, P < 0.0001). The progression date was predated by the EPD criterion in 77% of patients with known progressive disease (median, 58 days early) with a sensitivity of 90%, a positive predictive value of 96.4%, and a false-positive rate of 5.6%. CONCLUSIONS: Among patients with optimally treated adEOC in complete remission, a low-level increase in serum CA-125 concentration within the normal range is a strong independent predictive factor for disease recurrence. In this patient population, future prospective randomized trials should consider the evaluation of the EPD criterion.
Assuntos
Biomarcadores Tumorais/sangue , Antígeno Ca-125/sangue , Recidiva Local de Neoplasia , Neoplasias Epiteliais e Glandulares/sangue , Neoplasias Epiteliais e Glandulares/patologia , Neoplasias Ovarianas/sangue , Neoplasias Ovarianas/patologia , Adulto , Idoso , Terapia Combinada , Intervalos de Confiança , Progressão da Doença , Intervalo Livre de Doença , Reações Falso-Positivas , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Análise Multivariada , Estadiamento de Neoplasias , Neoplasias Epiteliais e Glandulares/tratamento farmacológico , Neoplasias Epiteliais e Glandulares/cirurgia , Razão de Chances , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/cirurgia , Ovariectomia , Valor Preditivo dos Testes , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Sensibilidade e Especificidade , Análise de Sobrevida , Fatores de Tempo , Adulto JovemRESUMO
BACKGROUND: The amount of residual disease after surgery is considered the most important factor influencing the survival of patients with advanced epithelial ovarian cancer (adEOC). In optimally treated patients with adEOC, there are no well-established prognostic factors [excluding International Federation of Gynecology and Obstetrics (FIGO) stage]. The aim of this retrospective study is to analyze the prognostic value of the CA-125 nadir after the completion of an optimal primary treatment. PATIENTS AND METHODS: Patients treated for adEOC were identified from January 1998 to December 2006. INCLUSION CRITERIA: elevated CA-125 at time of diagnosis (>35 kU/l); FIGO stage III-IV treated with optimal primary treatment (residual tumor <1 cm and carboplatin/taxane-based combination chemotherapy); and complete response to optimal primary treatment with normalization of CA-125. RESULTS: Patients, n = 96: 44 group A (< or =10 kU/l); 52 group B (11-35 kU/l). Median progression-free survival (PFS) was 42 and 20 months for groups A and B, respectively (P = 0.0087). Median overall survival (OS) was 84 and 43 months for groups A and B, respectively (P < 0.0001). The Cox model showed a highly significant impact on PFS and OS in relation to CA-125 nadir levels. CONCLUSIONS: The CA-125 nadir value is a strong independent prognostic factor for optimally treated adEOC after achieving a complete response.
