title: Patient-reported outcomes in relapsed ovarian cancer: results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone.
abstract: OBJECTIVE
  Trabectedin in combination with PLD improves progression-free survival (PFS) and overall response rate (ORR) in comparison to PLD alone in patients with relapsed ovarian cancer (J Clin Oncol; 2010 28:3107-14). Here we report the impact of the treatment combination on patient-reported functional status and symptoms.
  
  
  METHODS
  Patient-reported outcome (PRO) questionnaires, EORTC-QLQ C30, OV28, and EQ-5D were completed by patients at screening and on Day 1 of every other treatment cycle starting with Cycle 1, and at the end-of-treatment visit.
  
  
  RESULTS
  Of the 672 patients randomized in this study, 663 treated patients completed at least one of the baseline questionnaires. Median cycles of treatment was 6 (131 days) for the combination arm and 5 (143 days) for the monotherapy arm. Longitudinal data analyses showed no significant differences between the treatment arms for any of the pre-specified scales. Similar analyses of other scales, including Health Index scores and Health State on the Visual Analog Scale, support these findings. Start of subsequent therapy was significantly delayed in the combination arm compared with the monotherapy arm (p=0.0032).
  
  
  CONCLUSIONS
  The addition of trabectedin to PLD led to little or no decrement in patient-reported functional status and symptoms in patients with relapsed ovarian cancer, as compared to treatment with PLD alone. The combination led to manageable and non-cumulative overall toxicity with a fewer PLD-associated adverse events, and a significant improvement in PFS and ORR compared to single agent.
authors: Massachusetts General Hospital, Boston, MA 02114, USA. cnkrasner@partners.org
authors: Carolyn N
authors: CN
authors: Krasner
authors: Andres
authors: A
authors: Poveda
authors: Thomas J
authors: TJ
authors: Herzog
authors: Jan B
authors: JB
authors: Vermorken
authors: Stanley B
authors: SB
authors: Kaye
authors: Antonio
authors: A
authors: Nieto
authors: Pilar Lardelli
authors: PL
authors: Claret
authors: Youn Choi
authors: YC
authors: Park
authors: Trilok
authors: T
authors: Parekh
authors: Bradley J
authors: BJ
authors: Monk
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004149:Dioxoles / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D010051:Ovarian Neoplasms / Q000188:drug therapy; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage / Q000009:adverse effects; D000077606:Trabectedin; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000077606:Trabectedin