title: Multimodality approach in extra cervical locally advanced cervical cancer: chemoradiation, surgery and intra-operative radiation therapy. A phase II trial.
abstract: BACKGROUND
  The goal of this study was to determine the rational of radical surgery with intra-operative high-dose radiotherapy after chemoradiation (RT-CT) in extra cervical locally advanced cervical cancer (LACC) patients.
  
  
  METHODS
  Between 2000 and 2007, 42 LACC (stage IIA bulky-IVA) patients were treated at the Gynecologic Oncology Unit of the C.R.O. of Aviano in a Phase II Clinical Trial. Radiotherapy was administered to the whole pelvic region (50.4 Gy in 28 fractions) in combination with cisplatin (60 mg/mq) plus 5FU (750 mg/mq for 4 days) on first and fifth week of RT. Radical surgery with Intra-Operative Radiation Therapy (IORT) was performed 6-8 weeks after the end of RT-CT treatment.
  
  
  RESULTS
  After RT-CT, 35/42 patients (83%) underwent radical surgery and IORT treatment. At pathologic examination 8/35 (23%) patients showed complete response, while the rest (27/35) had residual disease either microscopic (17/27) or gross (10/27). The 5-year disease free survival (DFS) and the 5-year overall survival (OS) were 46% and 49% respectively. There were significant better DFS and OS when residual tumor was absent or limited to the cervix, respectively 78% versus 16% and 81% versus 20% (p < 0.001). All recurrences occurred within 24 months from treatment.
  
  
  CONCLUSIONS
  RT-CT followed by surgery and IORT in LACC patients seems to be active in a subgroup of patients with pathological complete response to treatment or partial response with residual tumor limited to the cervix.
authors.affiliation: National Cancer Institute, Centro di Riferimento Oncologico, Gynecologic Oncology Unit, Via Franco Gallini 2, 33081 Aviano (PN), Italy. ggiorda@cro.it
authors.forename: G
authors.initials: G
authors.lastname: Giorda
authors.forename: G
authors.initials: G
authors.lastname: Boz
authors.forename: A
authors.initials: A
authors.lastname: Gadducci
authors.forename: E
authors.initials: E
authors.lastname: Lucia
authors.forename: G
authors.initials: G
authors.lastname: De Piero
authors.forename: A
authors.initials: A
authors.lastname: De Paoli
authors.forename: R
authors.initials: R
authors.lastname: Innocente
authors.forename: M
authors.initials: M
authors.lastname: Trovò
authors.forename: R
authors.initials: R
authors.lastname: Sorio
authors.forename: E
authors.initials: E
authors.lastname: Campagnutta
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D016009:Chi-Square Distribution; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007432:Intraoperative Period; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009364:Neoplasm Recurrence, Local / Q000628:therapy; D009367:Neoplasm Staging; D018365:Neoplasm, Residual / Q000473:pathology* / Q000628:therapy*; D011379:Prognosis; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology* / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*
chemical_list: D002945:Cisplatin; D005472:Fluorouracil