title: Quality of surgery and neoadjuvant combined therapy in the ISG-GEIS trial on soft tissue sarcomas of limbs and trunk wall.
abstract: BACKGROUND
  To explore correlation between the quality of surgery and outcome in high-risk soft tissue sarcoma (STS) patients treated within a phase III randomized trial.
  
  
  METHODS
  In the trial, all patients received three cycles of preoperative chemotherapy (CT) with epirubicin 120 mg/m(2) and ifosfamide 9 g/m(2) and were randomly assigned to receive two further postoperative cycles. Radiotherapy (RT) could be delivered in the preoperative or postoperative setting. The association between surgical margins and overall survival (OS) was studied in a univariate and multivariate fashion.
  
  
  RESULTS
  Two hundred and fifty-two patients completed the whole treatment and were operated conservatively. At a median follow-up of 60 months (IQR, 45-74 months), the 5-year OS was 0.73, even in patients with positive and negative margins. The 5-year cumulative incidence (CI) of local recurrence (LR) in patients with positive and negative microscopic margins was 0.17 (standard error, SE, 0.08) and 0.03 (SE, 0.01), respectively. In the subgroup of patients receiving combined preoperative CT-RT and with positive surgical margins, the CI of LR was 0.
  
  
  CONCLUSIONS
  In this setting of high-risk STS treated by preoperative CT or CT-RT, the negative impact of positive margins on the outcome was limited. When close margins can be anticipated preoperative CT-RT may be a reasonable option to maximize the chance of cure.
authors.affiliation: Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan 20133, Italy. alessandro.gronchi@istitutotumori.mi.it
authors.forename: A
authors.initials: A
authors.lastname: Gronchi
authors.forename: P
authors.initials: P
authors.lastname: Verderio
authors.forename: A
authors.initials: A
authors.lastname: De Paoli
authors.forename: A
authors.initials: A
authors.lastname: Ferraro
authors.forename: O
authors.initials: O
authors.lastname: Tendero
authors.forename: J
authors.initials: J
authors.lastname: Majò
authors.forename: J
authors.initials: J
authors.lastname: Martin
authors.forename: A
authors.initials: A
authors.lastname: Comandone
authors.forename: G
authors.initials: G
authors.lastname: Grignani
authors.forename: S
authors.initials: S
authors.lastname: Pizzamiglio
authors.forename: V
authors.initials: V
authors.lastname: Quagliuolo
authors.forename: P
authors.initials: P
authors.lastname: Picci
authors.forename: S
authors.initials: S
authors.lastname: Frustaci
authors.forename: A P
authors.initials: AP
authors.lastname: Dei Tos
authors.forename: E
authors.initials: E
authors.lastname: Palassini
authors.forename: S
authors.initials: S
authors.lastname: Stacchiotti
authors.forename: S
authors.initials: S
authors.lastname: Ferrari
authors.forename: M
authors.initials: M
authors.lastname: Fiore
authors.forename: P G
authors.initials: PG
authors.lastname: Casali
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015251:Epirubicin / Q000008:administration & dosage; D005121:Extremities / Q000473:pathology / Q000601:surgery; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012509:Sarcoma / Q000401:mortality / Q000628:therapy*; D012983:Soft Tissue Neoplasms / Q000401:mortality / Q000628:therapy*; D013514:Surgical Procedures, Operative / Q000592:standards*; D013899:Thoracic Neoplasms; D060726:Torso / Q000473:pathology / Q000601:surgery; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015251:Epirubicin; D007069:Ifosfamide