Development and validation of a prognostic nomogram to predict overall survival (OS) in platinum-resistant ovarian cancer (PROC): An AURELIA substudy.

Authors

null

Chee Lee

ANZGOG, NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia

Chee Lee , Emma Gibbs , Felicia T Roncolato , Lucy Claire Davies , Christine Le Maignan , Werner Meier , Maria Angeles Arcusa Lanza , Per Rosenberg , Claudia Marchetti , Ignace Vergote , Petronella Witteveen , Aristotelis Bamias , Sebastian Serra , Jocelyne Provencal , Gaetan De Rauglaudre , Val Gebski , Michael Friedlander , Eric Pujade-Lauraine

Organizations

ANZGOG, NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia, GINECO, Hôpital Saint-Louis, Paris, France, AGO, Frauenklinik, Evangelisches Krankenhaus, Düsseldorf, Germany, GEICO, Hospital de Terrassa, Barcelona, Spain, NSGO, University Hospital Linköping, Linköping, Sweden, MITO, University Sapienza, Roma, Italy, BGOG, University Hospital Leuven, Leuven, Belgium, DGOG, University Medical Center Utrecht, Utrecht, Netherlands, HECOG, University of Athens, Medical School, Athens, Greece, GINECO, Hôpitaux Universitaires de Strasbourg, Strasbourg, France, GINECO, Centre Hospitalier Métropole Savoie, Chambery, France, GINECO, Institut Sainte-Catherine, Avignon, France, ANZGOG, NHMRC Clinical Trials Centre, Sydney, Australia, ANZGOG, Prince of Wales Hospital, Randwick, Australia, GINECO, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu, Paris, France

Research Funding

Other

Background: PROC describes a heterogeneous group of patients (pts) with a variable but generally poor prognosis and low response to chemotherapy. Predicting OS in PROC would help stratify pts in trials and guide treatment decisions. We developed a nomogram to predict OS in PROC. Methods: Data from two randomized phase III trials evaluating chemotherapy for PROC – CARTAXHY [Lortholary Ann Oncol 2012] and AURELIA [Pujade-Lauraine JCO 2014] (chemotherapy-alone arm) – were combined to form the training cohort (N = 331) for nomogram development. Baseline variables significantly associated with OS were identified using Cox regression analysis. Pts were assigned scores based on the weighted sum of the relative importance of each variable in the multivariate model. The nomogram was then validated in the chemotherapy plus bevacizumab arm of the AURELIA trial (N = 166). Nomogram performance was assessed by calculating the c statistic. A classification based on the nomogram’s score was generated to group pts according to prognosis. Results: Poor performance status, CA125 ≥ 100 U/mL, ascites, platinum-free interval < 3 months, primary platinum resistance, and largest tumor > 5cm were associated with shorter OS. The nomogram predicted OS with a c statistic of 0.69 (training) and 0.67 (validation). In the training cohort, the median OS in good (N = 93), intermediate (N = 162), and poor (N = 76) prognostic groups was 25.3, 15.6, and 6.9 months, respectively (P < 0.0001). In the validation cohort, median OS in good (N = 50), intermediate (N = 79), and poor (N = 37) prognostic groups was 26.7, 13.8, and 9.0 months, respectively (P < 0.0001). Conclusions: This nomogram combining six baseline factors accurately predicts OS in PROC pts treated with chemotherapy either alone or in combination with bevacizumab. It could help to select pts for treatment, counsel pts regarding prognosis, and stratify according to risk in trials. Clinical trial information: NCT00976911

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT00976911

Citation

J Clin Oncol 33, 2015 (suppl; abstr 5547)

DOI

10.1200/jco.2015.33.15_suppl.5547

Abstract #

5547

Poster Bd #

105

Abstract Disclosures