title: Palonosetron plus single-dose dexamethasone for the prevention of nausea and vomiting in women receiving anthracycline/cyclophosphamide-containing chemotherapy: meta-analysis of individual patient data examining the effect of age on outcome in two phase III trials.
abstract: OBJECTIVE
  Data from two randomized trials, evaluating a single-day regimen of palonosetron plus dexamethasone against emesis due to moderately emetogenic chemotherapy, were assessed for the impact of age on outcome in a pooled sample of women receiving anthracycline and/or cyclophosphamide (AC)-containing chemotherapy.
  
  
  METHODS
  Chemo-naïve breast cancer patients randomized to receive palonosetron (0.25 mg) plus dexamethasone (8 mg IV) on day 1 of chemotherapy (n = 200), or the same regimen followed by oral dexamethasone (8 mg) on days 2 and 3 (n = 205), were included in the analysis. The primary endpoint was complete response (CR: no vomiting and no rescue anti-emetics) in the 5-day study period. The effect of the 1-day regimen and age (<50 and ≥ 50 years) was investigated by a meta-analysis of individual patient data.
  
  
  RESULTS
  Younger patients comprised 43 % and 49 % of the 1-day and 3-day regimen groups, respectively; 94 % of the pooled sample received the AC combination. There were no between-treatment differences in CR rate according to age during all observation periods. In the 1-day regimen group, 55.2 % of younger patients achieved overall CR compared with 54 % of older patients. In the 3-day regimen group, 51.5 % of younger patients achieved overall CR compared with 58.7 % of older patients. In the adjusted analysis, younger age was not associated with overall CR to treatment (risk difference, -3.1 %; 95 % CI, -13.0 to 6.7 %; P = 0.533).
  
  
  CONCLUSIONS
  These results provide evidence that, irrespective of age, the dexamethasone-sparing regimen is not associated with a significant loss in overall anti-emetic protection in women undergoing AC-containing chemotherapy.
authors.affiliation: Medical Oncology Unit 1, Fondazione IRCCS Istituto Nazionale Tumori, Via Venezian 1, 20133, Milan, Italy. luigi.celio@istitutotumori.mi.it
authors.forename: Luigi
authors.initials: L
authors.lastname: Celio
authors.forename: Erminio
authors.initials: E
authors.lastname: Bonizzoni
authors.forename: Emilio
authors.initials: E
authors.lastname: Bajetta
authors.forename: Silvia
authors.initials: S
authors.lastname: Sebastiani
authors.forename: Tania
authors.initials: T
authors.lastname: Perrone
authors.forename: Matti S
authors.initials: MS
authors.lastname: Aapro
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D000077924:Palonosetron; D011812:Quinuclidines / Q000008:administration & dosage / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*
chemical_list: D018943:Anthracyclines; D000932:Antiemetics; D018906:Antineoplastic Agents, Alkylating; D007546:Isoquinolines; D011812:Quinuclidines; D012702:Serotonin Antagonists; D000077924:Palonosetron; D003907:Dexamethasone; D003520:Cyclophosphamide