K Fujiwara1, B J Monk2, C Lhommé3, R L Coleman4, A Brize5, A Oaknin6, I Ray-Coquard7, M Fabbro8, D Provencher9, A Bamias10, I Vergote11, A DeCensi12, K Zhang13, F D Vogl13, B A Bach13, F Raspagliesi14. 1. Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi, Japan fujiwara@saitama-med.ac.jp. 2. University of Arizona Cancer Center at Saint Joseph's Hospital and Medical Center, Phoenix, USA. 3. Gustave Roussy, Villejuif, France. 4. Department of Gynecologic Oncology, University of Texas MD Anderson Cancer Center, Houston, USA. 5. Hematology & Chemotherapy, Riga East Clinical University Hospital, Riga, Latvia. 6. Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. 7. Department of Medicine, Centre Léon Bérard and University Claude Bernard, Lyon. 8. Medical Oncology, Institut Régional du Cancer Montpellier, Montpellier, France. 9. Department of Obstetrics and Gynecology, Centre Hospitalier de L'Université de Montreal Notre-Dame, Montreal, Canada. 10. Department of Clinical Therapeutics, Alexandra Hospital, Athens, Greece. 11. University Hospitals-KU Leuven, Leuven Cancer Institute, Leuven, Belgium. 12. Medical Oncology, Ente Ospedaliero Ospedali Galliera, Genova, Italy. 13. Amgen Inc., Thousand Oaks, USA. 14. Surgery, Fondazione IRCCS Istituto Nazionale per la Cura e lo Studio dei Tumori, Milan, Italy.
Abstract
BACKGROUND: To evaluate the influence of treatment on health-related quality of life (HRQoL) in 919 women with recurrent ovarian cancer enrolled in the TRINOVA-1 study, a randomized, placebo-controlled phase III study that demonstrated that trebananib 15 mg/kg QW plus weekly paclitaxel significantly improved progression-free survival (PFS) compared with placebo plus weekly paclitaxel (7.2 versus 5.4 months; hazard ratio, 0.66; 95% confidence interval 0.57-0.77; P < 0.001). PATIENTS AND METHODS: HRQoL was assessed with the Functional Assessment of Cancer Therapy-Ovary [FACT-O; comprising FACT-G and the ovarian cancer-specific subscale (OCS)] and EuroQOL EQ-5D instruments before treatment on day 1 of weeks 1, 5, 9, 13, 17, and every 8 weeks thereafter and at the safety follow-up visit. A pattern-mixture model was used to evaluate the influence of patient dropout on FACT-O and OCS scores over time. RESULTS:Of 919 randomized patients, 834 (91%) had a baseline and ≥1 post-baseline HRQoL assessment. At baseline, scores for all instruments were similar for both arms. At 25 weeks, mean ± SD changes from baseline were negligible, with mean ± SD changes typically <1 unit from baseline: -2.4 ± 16.6 in the trebananib arm and -1.6 ± 15.2 in the placebo arm for FACT-O, -0.71 ± 5.5 in the trebananib arm and -0.86 ± 4.9 in the placebo arm for OCS, and -0.02 ± 0.22 in the trebananib arm and 0.02 ± 0.19 in the placebo arm for EQ-5D. Distribution of scores was similar between treatment arms at baseline and over the course of the study. In pattern-mixture models, there was no evidence that patient dropout affected differences in mean FACT-O or OCS scores. Edema had limited effect on either FACT-O or OCS scores in patients with grade ≥2 edema or those with grade 1 or no edema. CONCLUSIONS: Our results demonstrate that the improvement in PFS among patients in the trebananib arm in the TRINOVA-1 study was achieved without compromising HRQoL. CLINICALTRIALSGOV IDENTIFIER: NCT01204749.
RCT Entities:
BACKGROUND: To evaluate the influence of treatment on health-related quality of life (HRQoL) in 919 women with recurrent ovarian cancer enrolled in the TRINOVA-1 study, a randomized, placebo-controlled phase III study that demonstrated that trebananib 15 mg/kg QW plus weekly paclitaxel significantly improved progression-free survival (PFS) compared with placebo plus weekly paclitaxel (7.2 versus 5.4 months; hazard ratio, 0.66; 95% confidence interval 0.57-0.77; P < 0.001). PATIENTS AND METHODS: HRQoL was assessed with the Functional Assessment of Cancer Therapy-Ovary [FACT-O; comprising FACT-G and the ovarian cancer-specific subscale (OCS)] and EuroQOL EQ-5D instruments before treatment on day 1 of weeks 1, 5, 9, 13, 17, and every 8 weeks thereafter and at the safety follow-up visit. A pattern-mixture model was used to evaluate the influence of patient dropout on FACT-O and OCS scores over time. RESULTS: Of 919 randomized patients, 834 (91%) had a baseline and ≥1 post-baseline HRQoL assessment. At baseline, scores for all instruments were similar for both arms. At 25 weeks, mean ± SD changes from baseline were negligible, with mean ± SD changes typically <1 unit from baseline: -2.4 ± 16.6 in the trebananib arm and -1.6 ± 15.2 in the placebo arm for FACT-O, -0.71 ± 5.5 in the trebananib arm and -0.86 ± 4.9 in the placebo arm for OCS, and -0.02 ± 0.22 in the trebananib arm and 0.02 ± 0.19 in the placebo arm for EQ-5D. Distribution of scores was similar between treatment arms at baseline and over the course of the study. In pattern-mixture models, there was no evidence that patient dropout affected differences in mean FACT-O or OCS scores. Edema had limited effect on either FACT-O or OCS scores in patients with grade ≥2 edema or those with grade 1 or no edema. CONCLUSIONS: Our results demonstrate that the improvement in PFS among patients in the trebananib arm in the TRINOVA-1 study was achieved without compromising HRQoL. CLINICALTRIALSGOV IDENTIFIER: NCT01204749.
Authors: May Elbanna; Ashley R Orillion; Nur P Damayanti; Remi Adelaiye-Ogala; Li Shen; Kiersten Marie Miles; Sreenivasulu Chintala; Eric Ciamporcero; Swathi Ramakrishnan; Sheng-Yu Ku; Karen Rex; Sean Caenepeel; Angela Coxon; Roberto Pili Journal: Mol Cancer Ther Date: 2019-10-03 Impact factor: 6.261