title: Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial.
abstract: BACKGROUND
  To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial.
  
  
  METHODS
  CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤ 12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety.
  
  
  RESULTS
  A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm).
  
  
  CONCLUSIONS
  Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.
authors: Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France. Electronic address: gladieff.laurence@claudiusregaud.fr.
authors: L
authors: L
authors: Gladieff
authors: Academic Division of Gynecologic Oncology, Mauriziano Hospital, Torino, Italy.
authors: A
authors: A
authors: Ferrero
authors: Department of clinical Oncology, Institut Sainte-Catherine, Avignon, France.
authors: G
authors: G
authors: De Rauglaudre
authors: NHMRC Clinical Trials Centre, Sydney, Australia.
authors: C
authors: C
authors: Brown
authors: University of Queensland, Brisbane, Australia.
authors: P
authors: P
authors: Vasey
authors: Department of Gynecology and Gynecologic Oncology, Medical University of Vienna - General Hospital of Vienna, Vienna, Austria.
authors: A
authors: A
authors: Reinthaller
authors: Department of Medical Oncology, Medicale Hopital Hotel-Dieu and Universite Paris Descartes, Paris, France.
authors: E
authors: E
authors: Pujade-Lauraine
authors: Gartnavel General Hospital, Beatson Oncology Centre, Glasgow, UK.
authors: N
authors: N
authors: Reed
authors: Department of Obstetrics and Gynecology, University of Sacred Heart, Roma, Italy.
authors: D
authors: D
authors: Lorusso
authors: Department of Oncology, Ospedale Niguarda Ca' Granda, Milano, Italy.
authors: S
authors: S
authors: Siena
authors: Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway.
authors: H
authors: H
authors: Helland
authors: Department of Gynecologic Oncology, Juravinski Cancer Centre, Hamilton, Canada.
authors: L
authors: L
authors: Elit
authors: Department of Gynecology and Gynecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors: S
authors: S
authors: Mahner
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D017671:Platinum Compounds / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D017671:Platinum Compounds; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin; D017239:Paclitaxel