title: Long-term results of the Spanish Protocol SO-95 for the treatment of non-metastatic high-grade osteosarcoma of the extremities in children.
abstract: BACKGROUND
  The long-term results of the Spanish Study Protocol SEOP-SO-95 for treatment of localised osteosarcoma of the extremities in children were evaluated.
  
  
  METHODS
  One hundred consecutive patients under 18 years of age from 22 institutions were enrolled from January 1995 to December 2000. Immunohistochemical expression of p53, HER/erbB-2 and P-glycoprotein were retrospectively studied in 27 patients. Treatment consisted of: preoperative chemotherapy with doxorubicin, cisplatin, high-dose methotrexate with leucovorin rescue and ifosfamide for 14 weeks; surgery of primary tumour in week 16; postoperative chemotherapy with the above-mentioned drugs for 25 weeks.
  
  
  RESULTS
  With a median follow-up of 124 months (range 84-158 months), 69 patients (69%) were continuously event-free survivors; the 10-year probability of event-free survival (EFS) was 62%. Conservative surgery was performed in 85% of patients. Twenty-six patients had local recurrence or distant relapse. The median time to recurrence/ relapse was 27 months (range 17-93 months). The local recurrence rate was 7% (7 of the 100 patients); 4 had wide surgical margins, 2 marginal and 1 intralesional. Four patients died as a result of chemotherapy-related toxicity and 1 developed a second neoplasia (acute myeloid leukaemia). p53 expression and HER2/erbB-2 expression showed no effect on survival or EFS.
  
  
  CONCLUSIONS
  This therapeutic protocol achieved good oncologic and orthopaedic results. We observed a significant treatment-related toxicity.
authors.affiliation: Servicio de Pediatría, Hospital Ramón y Cajal-Universidad de Alcalá, ES-28034 Madrid, Spain. amvillatv@yahoo.es
authors.forename: Arturo
authors.initials: A
authors.lastname: Muñoz
authors.forename: José
authors.initials: J
authors.lastname: Alfaro
authors.forename: Nuria
authors.initials: N
authors.lastname: Pardo
authors.forename: Purificación
authors.initials: P
authors.lastname: García-Miguel
authors.forename: Víctor
authors.initials: V
authors.lastname: Quintero
authors.forename: Luis
authors.initials: L
authors.lastname: Gros
authors.forename: Carmen
authors.initials: C
authors.lastname: Melero
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Antuña
authors.forename: Guillermo
authors.initials: G
authors.lastname: Ocete
authors.forename: Jorge
authors.initials: J
authors.lastname: de Las Heras
authors.forename: Manuel
authors.initials: M
authors.lastname: Ruiz del Portal
authors.forename: Ramón
authors.initials: R
authors.lastname: Huguet
authors.forename: María Soledad
authors.initials: MS
authors.lastname: Maldonado
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005121:Extremities; D005260:Female; D005500:Follow-Up Studies; D019450:Genes, MDR; D018734:Genes, erbB-2; D016158:Genes, p53; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D012516:Osteosarcoma / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000601:surgery; D011183:Postoperative Complications / Q000139:chemically induced / Q000401:mortality; D013030:Spain / Q000453:epidemiology