title: Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients.
abstract: BACKGROUND
  The CALYPSO phase III trial compared CD (carboplatin-pegylated liposomal doxorubicin (PLD)) with CP (carboplatin-paclitaxel) in patients with platinum-sensitive recurrent ovarian cancer (ROC). Overall survival (OS) data are now mature.
  
  
  METHODS
  Women with ROC relapsing > 6 months after first- or second-line therapy were randomised to CD or CP for six cycles in this international, open-label, non-inferiority trial. The primary endpoint was progression-free survival. The OS analysis is presented here.
  
  
  RESULTS
  A total of 976 patients were randomised (467 to CD and 509 to CP). With a median follow-up of 49 months, no statistically significant difference was observed between arms in OS (hazard ratio = 0.99 (95% confidence interval 0.85, 1.16); log-rank P = 0.94). Median survival times were 30.7 months (CD) and 33.0 months (CP). No statistically significant difference in OS was observed between arms in predetermined subgroups according to age, body mass index, treatment-free interval, measurable disease, number of lines of prior chemotherapy, or performance status. Post-study cross-over was imbalanced between arms, with a greater proportion of patients randomised to CP receiving post-study PLD (68%) than patients randomised to CD receiving post-study paclitaxel (43%; P < 0.001).
  
  
  CONCLUSIONS
  Carboplatin-PLD led to delayed progression and similar OS compared with carboplatin-paclitaxel in platinum-sensitive ROC.
authors: Department of Gynecology, Gynecologic Endocrinology and Oncology, University Hospital of Gießen and Marburg, Baldingerstrasse, 35043 Marburg, Germany. uwe.wagner@med.uni-marburg.de
authors: U
authors: U
authors: Wagner
authors: C
authors: C
authors: Marth
authors: R
authors: R
authors: Largillier
authors: J
authors: J
authors: Kaern
authors: C
authors: C
authors: Brown
authors: M
authors: M
authors: Heywood
authors: T
authors: T
authors: Bonaventura
authors: I
authors: I
authors: Vergote
authors: M C
authors: MC
authors: Piccirillo
authors: R
authors: R
authors: Fossati
authors: V
authors: V
authors: Gebski
authors: E P
authors: EP
authors: Lauraine
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D010984:Platinum / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D010984:Platinum; D004317:Doxorubicin; D016190:Carboplatin; D017239:Paclitaxel