Abstract
Purpose. Cisplatin-based combination chemotherapy is considered standard treatment for advanced/recurrent cervical carcinoma; however, the majority of patients do not respond. This study was undertaken to identify the prognostic factors and develop a model predictive of (non-) response to chemotherapy.
Methods. Four-hundred twenty-eight patients with advanced cervical cancer who received a cisplatin-containing combination in three Gynecologic Oncology Group (GOG) protocols (110, 169 and 179) were evaluated for baseline clinical characteristics and mUltivariate analysis was conducted to identify factors independently prognostic predictive of response using a Logistic regression model. A predictive model was developed and externally validated using an independent GOG protocol (149) data.
Results. Multivariate analysis identified five factors (African-American, performance status [PS] >0, pelvic disease, prior radiosensitizer and time interval from diagnosis to first recurrence <1 year) independently prognostic of poor response. A simple prognostic index was derived based on the total number of risk factors. When patients were classified into three risk groups (low risk: 0-1 factor: mid risk: 2-3 factors; high risk: 45 factors), patients with 4-5 risk factors were estimated to have a response rate of only 13%, and median progression-free and overall Survival of 2.8 months and 5.5 months, respectively. The accuracy of the index was supported by both internal and external datasets.
Conclusions. A simple index based on five prognostic factors may have utility in clinical practice to identify the women who are not likely to respond to the cisplatin-containing regimens. This subgroup of patients should be considered for non-cisplatin chemotherapy or investigational trials. (C) 2009 Elsevier Inc. All rights reserved.