Author(s)
Bedel J1, Lorusso D2, Aghajanian C3, Oaknin A4, Dean A5, Colombo N6, Weberpals JI7, Clamp AR8, Scambia G2, Leary A9, Holloway RW10, Amenedo Gancedo M11, Fong PC12, O'Malley DM13, Meunier J14, Goble S15, Cameron T15, Mörk AC15, Ledermann JA16, Coleman RL17
1Clovis Oncology, Inc., Zurich, ZH, Switzerland, 2Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Roma, Rome, Italy, 3Memorial Sloan Kettering Cancer Center, New York, NY, USA, 4Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, 5St John of God Subiaco Hospital, Subiaco, Australia, 6European Institute of Oncology and University of Milan-Bicocca, Milan, Italy, 7Ottawa Hospital Research Institute, Ottowa, ON, Canada, 8The Christie NHS Foundation Trust and University of Manchester, Manchester, UK, 9Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Villejuif, France, 10Florida Hospital Cancer Institute, Orlando, FL, USA, 11Oncology Center of Galicia, La Coruña, Spain, 12Auckland City Hospital, Auckland, New Zealand, 13The Ohio State University, James Cancer Center, Columbus, OH, USA, 14Modus Outcomes, Lyon, France, 15Clovis Oncology, Inc., Boulder, CO, USA, 16UCL Cancer Institute and UCL Hospitals, London, UK, 17The University of Texas MD Anderson Cancer Center, Houston, TX, USA
OBJECTIVES : In ARIEL3, rucaparib (600 mg BID) maintenance treatment significantly improved progression-free survival (PFS) vs placebo in all predefined cohorts. This post hoc exploratory analysis investigated quality-adjusted PFS (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST). METHODS : QA-PFS was calculated as PFS function × EQ-5D index score function. Q-TWiST was calculated as (μTOX × TOX) + TWiST. TOX represents the mean duration with grade ≥3 adverse events (AEs) or grade ≥2 AEs of nausea, vomiting, fatigue, and asthenia only. TWiST represents the mean duration without AEs or symptoms of progression. μTOX represents the standardized mean EQ-5D index score. RESULTS : This analysis utilized the primary efficacy data after unblinding (April 15, 2017, visit cutoff). In the intent-to-treat population, for rucaparib (n=375) vs placebo (n=189): mean (95% confidence interval [CI]) QA-PFS was 12.02 (10.96–13.03) months vs 5.74 (4.98–6.42) months (difference, 6.28 [4.85–7.47] months); mean (95% CI) Q-TWiST adjusting for grade ≥3 AEs was 13.32 (12.11–14.46) months vs 6.44 (5.78–7.18) months (difference, 6.88 [5.71–8.23] months); and mean (95% CI) Q-TWiST adjusting for common grade ≥2 AEs was 13.16 (12.01–14.33) months vs 6.40 (5.75–7.15) months (difference, 6.77 [5.64–8.14] months). In patients with a BRCA mutation (germline, somatic, or origin unknown), for rucaparib (n=130) vs placebo (n=66): mean (95% CI) QA-PFS was 15.28 (13.22–17.45) months vs 5.92 (4.71–7.23) months (difference, 9.37 [6.65–11.85] months); mean (95% CI) Q-TWiST adjusting for grade ≥3 AEs was 16.42 (14.29–18.18) months vs 6.70 (5.49–8.02) months (difference, 9.73 [7.10–11.94] months); and mean (95% CI) Q-TWiST adjusting for common grade ≥2 AEs was 16.24 (14.11–17.95) months vs 6.68 (5.45–8.00) months (difference, 9.56 [6.99–11.81] months). CONCLUSIONS : The significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib vs placebo in all predefined cohorts.
Conference/Value in Health Info
2019-05, ISPOR 2019, New Orleans, LA, USA
Value in Health, Volume 22, Issue S1 (2019 May)
Code
PCN295
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Specific Disease