title: Ovarian cancer in elderly patients: carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in late relapse: a Gynecologic Cancer Intergroup (GCIG) CALYPSO sub-study.
abstract: BACKGROUND
  CALYPSO (CAeLYx in Platinum Sensitive Ovarian) patients compared carboplatin-pegylated liposomal doxorubicin (C-PLD) with carboplatin-paclitaxel (C-P) in patients with late-relapsing recurrent ovarian cancer (ROC). We analyzed outcomes in patients ≥70 years.
  
  
  METHODS
  Nine hundred and seventy-six patients with taxane-pretreated ROC relapsing >6 months after first- or second-line platinum-based therapy were randomly assigned to 4-weekly C area under the curve (AUC) 5 plus PLD 30 mg/m(2) or 3-weekly C AUC 5 plus P 175 mg/m(2) for six or more cycles.
  
  
  RESULTS
  One hundred and fifty-seven (16%) patients ≥70 years (median: 74 years, C-PLD; 73 years, C-P; range 70-82 years) were included (n = 71, C-PLD; n = 86, C-P). In comparing elderly and younger, elderly patients experienced fewer grade ≥2 allergic reactions (P = 0.005) but more grade ≥2 sensory neuropathy (P = 0.007). Myelosuppression did not differ with age. Elderly patients completed planned treatment as frequently as younger (79%, C-PLD; 82%, C-P). In comparing arms within elderly patients, C-P was associated with more grade ≥2 alopecia, sensory neuropathy, arthralgia/myalgia (P < 0.001 for all), severe leukopenia plus febrile neutropenia; C-PLD was associated with more grade ≥2 hand-foot syndrome (P = 0.005). Median progression-free survival was 11.6 months (C-PLD) and 10.3 months (C-P; P = 0.44).
  
  
  CONCLUSIONS
  Patients ≥70 years experienced more neuropathy, with a higher incidence in the C-P arm. Similar to all study patients, C-PLD provided a better therapeutic index with less toxicity than C-P in elderly women with platinum-sensitive ROC.
authors.affiliation: Department of Hematology and Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg. Electronic address: j-emmanuel.kurtz@chru-strasbourg.fr.
authors.forename: J E
authors.initials: JE
authors.lastname: Kurtz
authors.affiliation: Department of Medical Oncology, Centre Alexis Vautrin, Vandoeuvre les Nancy.
authors.forename: M C
authors.initials: MC
authors.lastname: Kaminsky
authors.affiliation: Department of Medical Oncology, Institut Bergonié, Bordeaux, France.
authors.forename: A
authors.initials: A
authors.lastname: Floquet
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, Sydney, Australia.
authors.forename: A S
authors.initials: AS
authors.lastname: Veillard
authors.affiliation: Department of Gynecology and Obstetrics, University of Duisburg-Essen, Essen, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Kimmig
authors.affiliation: Department of Gynecologic Oncology, The Norwegian Radium Hospital, Oslo, Norway.
authors.forename: A
authors.initials: A
authors.lastname: Dorum
authors.affiliation: Department of Gynecologic Oncology, Juravinski Cancer Centre, Hamilton, Canada.
authors.forename: L
authors.initials: L
authors.lastname: Elit
authors.affiliation: Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Buck
authors.affiliation: Department of Gynecology and Obstetrics, Medical University of Graz, Graz, Austria.
authors.forename: E
authors.initials: E
authors.lastname: Petru
authors.affiliation: Beatson Oncology Centre, Gartnavel General Hospital, Glasgow, UK.
authors.forename: N
authors.initials: N
authors.lastname: Reed
authors.affiliation: Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome.
authors.forename: G
authors.initials: G
authors.lastname: Scambia
authors.affiliation: Department of Gynecology and Obstetrics, AOR Villa Sofia-Cervello, Palermo, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Varsellona
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, Sydney, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Brown
authors.affiliation: University Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre site Hôtel-Dieu, France.
authors.forename: E
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000367:Age Factors; 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; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin; D017239:Paclitaxel