title: Adjuvant chemotherapy in stage I-II uterine leiomyosarcoma: a multicentric retrospective study of 140 patients.
abstract: OBJECTIVE
  About 50-60% of patients with stage I-II uterine leiomyosarcoma (ULMS), primarily treated with surgery, relapse and die from progressive disease. In this retrospective study we describe the impact of adjuvant chemotherapy in this subset of patients.
  
  
  METHODS
  140 women treated from 1976 to 2011 were included in the study. Univariate and multivariate analysis were used to test the association of clinical features and adjuvant treatments with overall survival (OS) and disease-free survival (DFS).
  
  
  RESULTS
  62 women did not receive any further treatment after hysterectomy, 14 had radiotherapy (RT), 52 chemotherapy and 12 chemo-radiotherapy. Chemotherapy based on doxorubicin and ifosfamide combination was used in 54 cases. After a median follow-up of 63months, 87 women (62%) have relapsed, and 62 (44%) have died. The vast majority of patients who relapsed had distant recurrences (72%). The 5year median DFS and OS were 43% and 64% respectively. After 5years of follow up 68.7% of women treated with chemotherapy (±RT) vs 65.6% of patients only observed were alive (p=0.521). In the univariate analysis no factors had a statistical impact on DFS, while number of mitosis (>20×10HPF), age (>60years) and adjuvant radiotherapy were found as negative prognostic factors for OS. In the multivariate analysis only mitosis and age remained significant for OS.
  
  
  CONCLUSIONS
  Adjuvant chemotherapy was not associated with a significant survival benefit and should not be considered as standard of care for patients with stage I-II ULMS until randomized clinical studies will give further information.
authors.affiliation: Division of Gynecologic Oncology, European Institute of Oncology, Viale Ripamonti 435, 20085 Milan, Italy. Electronic address: rosanna.mancari@ieo.it.
authors.forename: Rosanna
authors.initials: R
authors.lastname: Mancari
authors.affiliation: Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy; University of Milan-Bicocca, Milan, Italy. Electronic address: maurosignorelli78@gmail.com.
authors.forename: Mauro
authors.initials: M
authors.lastname: Signorelli
authors.affiliation: Department of Procreative Medicine, Division of Gynecology and Obstetrics, University of Pisa, Italy. Electronic address: a.gadducci@obgyn.med.unipi.it.
authors.forename: Angiolo
authors.initials: A
authors.lastname: Gadducci
authors.affiliation: Division of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy. Electronic address: silvestro.carinelli@ieo.it.
authors.forename: Silvestro
authors.initials: S
authors.lastname: Carinelli
authors.affiliation: Medical Physics Department, San Gerardo Hospital, Monza, Italy. Electronic address: e.deponti@hsgerardo.org.
authors.forename: Elena
authors.initials: E
authors.lastname: De Ponti
authors.affiliation: Clinical Data Managing, European Institute of Oncology, Milan, Italy. Electronic address: silviasesana16@tiscali.it.
authors.forename: Silvia
authors.initials: S
authors.lastname: Sesana
authors.affiliation: Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy; University of Milan-Bicocca, Milan, Italy. Electronic address: silviacorso80@gmail.com.
authors.forename: Silvia
authors.initials: S
authors.lastname: Corso
authors.affiliation: Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy; University of Milan-Bicocca, Milan, Italy. Electronic address: valentina.chiappa@gmail.com.
authors.forename: Valentina
authors.initials: V
authors.lastname: Chiappa
authors.affiliation: Division of Gynecologic Oncology, European Institute of Oncology, Viale Ripamonti 435, 20085 Milan, Italy. Electronic address: nicoletta.colombo@ieo.it.
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Colombo
authors.affiliation: Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy; University of Milan-Bicocca, Milan, Italy. Electronic address: andreaalberto.lissoni@unimib.it.
authors.forename: Andrea Alberto
authors.initials: AA
authors.lastname: Lissoni
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D059186:Chemoradiotherapy, Adjuvant / Q000379:methods; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007044:Hysterectomy; D007069:Ifosfamide / Q000008:administration & dosage; D007890:Leiomyosarcoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D015999:Multivariate Analysis; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011379:Prognosis; D018714:Radiotherapy, Adjuvant / Q000379:methods; D012189:Retrospective Studies; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D055815:Young Adult
chemical_list: D004317:Doxorubicin; D007069:Ifosfamide
keywords: Adjuvant therapy; Chemotherapy; Prognostic factors; Uterine leiomyosarcoma