title: Correlation between overall survival and growth modulation index in pre-treated sarcoma patients: a study from the French Sarcoma Group.
abstract: BACKGROUND
  Growth modulation index (GMI), the ratio of two times to progression measured in patients receiving two successive treatments (GMI = TTP2/TTP1), has been proposed as a criterion of phase II clinical trials. Nevertheless, its use has been limited until now.
  
  
  METHODS
  We carried out a retrospective multicentre study in soft tissue sarcoma patients receiving a second-line treatment after doxorubicin-based regimens to evaluate the link between overall survival and GMI. Second-line treatments were classified as 'active' according to the EORTC-STBSG criteria (3-month progression-free rate >40% or 6-month PFR >14%). Comparisons used chi-squared and log-rank tests.
  
  
  RESULTS
  The population consisted in 106 men and 121 women, 110 patients (48%) received 'active drugs'. Median OS from the second-line start was 317 days. Sixty-nine patients experienced GMI >1.33 (30.4%). Treatments with 'active drug' were not associated with OS improvement: 490 versus 407 days (P = 0.524). Median OS was highly correlated with GMI: 324, 302 and 710 days with GMI <1, GMI = [1.00-1.33], and GMI >1.33, respectively (P < 0.0001). In logistic regression analysis, the sole predictive factor was the number of doxorubicin-based chemotherapy cycles.
  
  
  CONCLUSIONS
  GMI seems to be an interesting end point that provides additional information compared with classical criteria. GMI >1.33 is associated with significant OS improvement.
authors.affiliation: Department of General Oncology, Oscar Lambret Center, Lille.
authors.forename: S
authors.initials: S
authors.lastname: Cousin
authors.affiliation: Department of Medical Oncology, Léon Berard Center, Lyon.
authors.forename: J Y
authors.initials: JY
authors.lastname: Blay
authors.affiliation: Department of Medical Oncology, Paoli-Calmettes Institute, Marseille.
authors.forename: F
authors.initials: F
authors.lastname: Bertucci
authors.affiliation: Department of Medical Oncology, Georges-François Leclerc Center, Dijon.
authors.forename: N
authors.initials: N
authors.lastname: Isambert
authors.affiliation: Department of Medical Oncology, Bergonie Institute, Bordeaux.
authors.forename: A
authors.initials: A
authors.lastname: Italiano
authors.affiliation: Department of Medical Oncology, René Gauducheau Center, St Herblain.
authors.forename: E
authors.initials: E
authors.lastname: Bompas
authors.affiliation: Department of Medical Oncology, Léon Berard Center, Lyon.
authors.forename: I
authors.initials: I
authors.lastname: Ray-Coquard
authors.affiliation: Department of Medical Oncology, Paoli-Calmettes Institute, Marseille.
authors.forename: D
authors.initials: D
authors.lastname: Perrot
authors.affiliation: Department of Medical Oncology, Georges-François Leclerc Center, Dijon.
authors.forename: M
authors.initials: M
authors.lastname: Chaix
authors.affiliation: Department of Medical Oncology, Bergonie Institute, Bordeaux.
authors.forename: B
authors.initials: B
authors.lastname: Bui-Nguyen
authors.affiliation: Department of Medical Oncology, Jean Minjoz University Hospital, Besançon.
authors.forename: L
authors.initials: L
authors.lastname: Chaigneau
authors.affiliation: Department of Paediatrician Oncology, Nantes University Hospital, Nantes.
authors.forename: N
authors.initials: N
authors.lastname: Corradini
authors.affiliation: Department of General Oncology, Oscar Lambret Center, Lille; Research Unit (EA 2694), Medical School University, Lille-Nord-de-France University, France. Electronic address: scientifique@o-lambret.fr.
authors.forename: N
authors.initials: N
authors.lastname: Penel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality; D012983:Soft Tissue Neoplasms / Q000188:drug therapy* / Q000401:mortality; D013534:Survival; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin
keywords: end point; growth modulation index; soft tissue sarcoma; time to progression