2017 ASCO Annual Meeting!
Session: Gynecologic Cancer
Type: Oral Abstract Session
Time: Friday June 2, 3:00 PM to 6:00 PM
Health-related quality of life (HRQOL) and patient-centered outcomes with maintenance olaparib compared with placebo following chemotherapy in patients with germline (g) BRCA-mutated (m) platinum-sensitive relapsed serous ovarian cancer (PSR SOC): SOLO2 phase III trial.
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr 5507)
Author(s): Michael Friedlander, Val Gebski, Emma Gibbs, Ralph Bloomfield, Felix Hilpert, Lari B. Wenzel, Florence Joly, Daniel Eek, Manuel Rodrigues, Andrew R. Clamp, Richard T. Penson, Diane M. Provencher, Jacob Korach, Tomasz Huzarski, Laura Vidal, Vanda Salutari, Clare L. Scott, Maria Ornella Nicoletto, Kenji Tamura, Eric Pujade-Lauraine; UNSW Clinical School, Prince of Wales Hospital, Randwick, Australia; NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia; AstraZeneca, Cambridge, United Kingdom; Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Krankenhaus Jerusalem Hamburg, Hamburg, Germany; University of California, Irvine, Irvine, CA; GINECO and Regional Centre Control Against Cancer Francois Baclesse, Caen, France; AstraZeneca, Gothenburg, Sweden; Institut Curie, Paris, France; The Christie NHS Foundation Trust and The University of Manchester, Manchester, United Kingdom; Harvard Medical School, Boston, MA; University of Montreal, Montreal, QC, Canada; Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel; Pomeranian Medical University, Szczecin, Poland; Hospital Clínic de Barcelona, Barcelona, Spain; Policlinico Universitario A. Gemelli, Rome, Italy; Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia; Instituto Oncologico Veneto, Padua, Italy; Department of Breast and Medical Oncology, National Cancer Center Hospital East, Tokyo, Japan; Université Paris Descartes, AP-HP, Paris, France
Background: The median PFS after chemotherapy in PSR SOC is less than 6 months in many patients. In SOLO2 (ENGOT Ov-21; NCT01874353), maintenance olaparib (O) given after response to chemotherapy resulted in a significant improvement in PFS vs placebo (P) in patients with gBRCAm PSR SOC (hazard ratio [HR] 0.30, 95% CI 0.22, 0.41; P<0.0001; median 19.1 vs 5.5 months; 63% data maturity; Pujade-Lauraine et al. SGO 2017). Our a priori hypothesis was that maintenance therapy with O would not negatively impact HRQOL compared with P and would be associated with additional patient-centered benefits to support the prolongation of PFS, the primary endpoint of SOLO2. Methods: HRQOL was evaluated by the Functional Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O TOI) in all 295 patients. This measures functional and physical well-being and symptoms, including adverse events. Change from baseline in FACT-O TOI score during the first 12 months was the primary HRQOL analysis (mixed model repeated measures). Secondary planned analyses included duration of ‘good quality of life’ by time without symptoms of disease or toxicity (TWiST) and quality-adjusted PFS (QAPFS; a single measure of PFS and HRQOL outcomes). Results: There was no significant detrimental effect of O vs P on HRQOL analyzed by change from baseline in TOI score (–3.1 vs –2.9, respectively, difference (O minus P) –0.2; 95% CI –2.4, 2.1; P=0.88). There was a significant improvement for patients on maintenance O in TWiST (13.5 vs 7.2 months, difference 6.3; 95% CI 2.9, 8.6; P<0.001) and QAPFS (mean 14.0 vs 7.3 months for O and P, respectively, difference 6.7; 95% CI 5.0, 8.5; P<0.0001). Conclusions: Maintenance O did not detrimentally impact HRQOL relative to P. The significant improvement in PFS with O was associated with additional patient-centered benefits, including a longer duration without symptoms of disease or treatment toxicity and longer QAPFS. Clinical trial information: NCT01874353