title: Trabectedin is a feasible treatment for soft tissue sarcoma patients regardless of patient age: a retrospective pooled analysis of five phase II trials.
abstract: BACKGROUND
  This retrospective pooled analysis assessed the effect of age on the efficacy and safety of trabectedin in young and elderly patients with recurrent advanced soft tissue sarcoma (STS).
  
  
  METHODS
  Data from 350 adults with STS treated in five phase II trials with trabectedin were divided in the younger (<60 years; n=267) and the older cohort (≥60 years; n=83).
  
  
  RESULTS
  The response rate did not differ with age (younger: 10.1% vs elderly 9.6%). No significant differences were found in median progression-free survival (PFS) in younger (2.5 months) and older (3.7 months) cohort with a comparable PFS rates at 3 (45.1% vs 55.1%) and 6 months (29.5% vs 36.4%). Similar median overall survival was observed in both cohorts (13.0 vs 14.0 months). Reversible neutropenia and aspartate aminotransferase/alanine aminotransferase elevation were the most common abnormalities. A higher incidence of grade 3/4 neutropenia (43.6% vs 60.2%) and fatigue (6.3% vs 14.4%) was observed in older patients. In 24 patients aged ≥70 years, no significant differences in efficacy or safety outcomes were found.
  
  
  CONCLUSIONS
  This analysis demonstrated that trabectedin is a feasible treatment in young and elderly patients with STS, with meaningful clinical benefits and an acceptable safety profile, essential in palliative treatment of elderly patients.
authors.affiliation: Department of Medicine, Institut Gustave Roussy, 39/53 rue Camille Desmoulins, FR-94805 Villejuif Cedex, France.
authors.forename: A L
authors.initials: AL
authors.lastname: Cesne
authors.forename: I
authors.initials: I
authors.lastname: Judson
authors.forename: R
authors.initials: R
authors.lastname: Maki
authors.forename: F
authors.initials: F
authors.lastname: Grosso
authors.forename: S
authors.initials: S
authors.lastname: Schuetze
authors.forename: M V
authors.initials: MV
authors.lastname: Mehren
authors.forename: S P
authors.initials: SP
authors.lastname: Chawla
authors.forename: G D
authors.initials: GD
authors.lastname: Demetri
authors.forename: A
authors.initials: A
authors.lastname: Nieto
authors.forename: A
authors.initials: A
authors.lastname: Tanovic
authors.forename: J-Y
authors.initials: JY
authors.lastname: Blay
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D004149:Dioxoles / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality*; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D000077606:Trabectedin; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin
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