Martin R. Stockler1, Felix Hilpert1, Michael Friedlander1, Madeleine King1, Lari Wenzel1, Chee Khoon Lee1, Florence Joly2,1, N de Gregorio1, José Ángel Arranz1, Mansoor Raza Mirza3,1, Roberto Sorio4,1, Ulrich Freudensprung5,1, Vesna Šneller5,1, Gill Hales5,1, Éric Pujade-Lauraine6,1
1Martin R. Stockler, Madeleine T. King, Chee Khoon Lee, The University of Sydney; Michael Friedlander, Prince of Wales Clinical School, University of New South Wales, Sydney, Australia; Felix Hilpert, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Klinik für Gynäkologie und Geburtshilfe, Kiel; Nikolaus de Gregorio, AGO and University of Ulm Medical Center, Ulm, Germany; Lari Wenzel, University of California Irvine, Irvine, CA; Florence Joly, Group d'Investigateurs Nationaux pour l'Etude des...
2 Eric Pujade-Lauraine, GINECO and Centre Hospitalier Universitaire Hotel Dieu, Paris, France
3 Roberto Sorio, Multicenter Italian Trials in Ovarian Cancer and Centro di Riferimento Oncologico-Istituto di Ricovero e Cura a Carattere Scientifico, Aviano, Italy
4 and Ulrich Freudensprung, Vesna Sneller, Gill Hales, F. Hoffmann-La Roche, Basel, Switzerland.
5F.Hoffmann-La Roche AG
6CHU, Paris
Tóm tắt
Purpose To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial. Patients and Methods Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy–Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data. Results Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/GI symptoms at week 8/9 (primary PRO end point, 21.9% v 9.3%; difference, 12.7%; 95% CI, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% CI, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1%; difference, 9.0%; 95% CI, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions. Conclusion Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer.
