Health-related quality of life in women with recurrentovarian cancer receiving paclitaxel plus trebananib orplacebo (TRINOVA-1)

K. Fujiwara, B. J. Monk, C. Lhommé, R. L. Coleman, A. Brize, A. Oaknin, I. Ray-Coquard, M. Fabbro, D. Provencher, A. Bamias, I. Vergote, A. DeCensi, K. Zhang, F. D. Vogl, B. A. Bach, F. Raspagliesi

Research output: Contribution to journalArticle

Abstract

Background: To evaluate the influence of treatment on health-related quality of life (HRQoL) in 919 women withrecurrent ovarian cancer enrolled in the TRINOVA-1 study, a randomized, placebo-controlled phase III study that demonstratedthat trebananib 15 mg/kg QW plus weekly paclitaxel significantly improved progression-free survival (PFS) comparedwith 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 treatmenton day 1 of weeks 1, 5, 9, 13, 17, and every 8 weeks thereafter and at the safety follow-up visit. A pattern-mixture modelwas 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

Original languageEnglish
Article numbermdw147
Pages (from-to)1006-1013
Number of pages8
JournalAnnals of Oncology
Volume27
Issue number6
DOIs
Publication statusPublished - Jun 18 2016

Keywords

  • Edema
  • Health-related quality of life
  • Recurrent ovarian cancer
  • Trebananib

ASJC Scopus subject areas

  • Oncology
  • Hematology

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    Fujiwara, K., Monk, B. J., Lhommé, C., Coleman, R. L., Brize, A., Oaknin, A., Ray-Coquard, I., Fabbro, M., Provencher, D., Bamias, A., Vergote, I., DeCensi, A., Zhang, K., Vogl, F. D., Bach, B. A., & Raspagliesi, F. (2016). Health-related quality of life in women with recurrentovarian cancer receiving paclitaxel plus trebananib orplacebo (TRINOVA-1). Annals of Oncology, 27(6), 1006-1013. [mdw147]. https://doi.org/10.1093/annonc/mdw147