title: [Primary chemotherapy with the Rosen T10 protocol before conservative surgery in limb primitive osteosarcomas: results about 56 cases].
abstract: We report the results of a prospective Tunisian study using primary chemotherapy followed by conservative surgery in primitive limb osteosarcoma. From January 1988 to January 1998, 56 patients affected by limb osteosarcoma entered in a prospective study of neoadjuvant chemotherapy with the T10 protocol before surgery with a conservative intent. Initial work-up include: clinical exam with tumor measurements, chest and limb X-rays, limb CT-scan or MRI, chest CT-scan, bone scintigraphy and hematological and renal biological exams. Patients receive pre- and post-operative chemotherapy according to the T10 modified protocol. Fifty-six patients (33 M/23 F) with a mean age of 19 years (8 to 28) are included. Mean clinical and radiological tumor size is around 14 cm. Main histologic type is classic osteosarcoma (50% of cases) and 10 patients (9%) presented with initial metastasis; 42 patients on 56 receive the whole pre-operative protocol. Treatment is well tolerated excluding 18 episodes of mucositis, 29 of leucopenia (< grade 3), 7 of thrombopenia (< grade 3), 4 of cutaneous toxicity, 2 of pulmonary toxicity and 3 of nausea-vomiting. We observe 36% of good histological responders and 64% of bad responders to primary chemotherapy, 27 patients on 49 operated (53%) have a conservative surgery and 18 (47%) a radical surgery. With a median follow-up of 51 months (8 to 128), 29 patients remain alive free of disease (15/17 GR and 14/30 BR), 2 are alive with disease, 2 died by toxicity, 14 died by progressive disease and 9 are lost to follow-up with evolutive disease. Five year disease-free survival is 55% for the 46 non metastatic patients. In univariate analysis, seric alkaline phosphatase level (p = 0.0014) and histological response to chemotherapy (p = 0.0218) are significant factors for prognosis.
authors.affiliation: Institut Salah Azaïz, Tunis, Tunisie. hamouda.boussen@rns.tn
authors.forename: H
authors.initials: H
authors.lastname: Boussen
authors.forename: F
authors.initials: F
authors.lastname: Mezzi
authors.forename: A
authors.initials: A
authors.lastname: Gamoudi
authors.forename: O
authors.initials: O
authors.lastname: Daldoul
authors.forename: H
authors.initials: H
authors.lastname: Ben Hamida
authors.forename: A
authors.initials: A
authors.lastname: Mezlini
authors.forename: S
authors.initials: S
authors.lastname: Khalfallah
authors.forename: S
authors.initials: S
authors.lastname: Karray
authors.forename: K
authors.initials: K
authors.lastname: Ben Romdhane
authors.forename: M
authors.initials: M
authors.lastname: Ben Ghachem
authors.forename: M
authors.initials: M
authors.lastname: Ben Abdallah
authors.forename: M
authors.initials: M
authors.lastname: Douik
authors.forename: A
authors.initials: A
authors.lastname: Saadi
authors.forename: F
authors.initials: F
authors.lastname: Ben Ayed
authors.forename: H
authors.initials: H
authors.lastname: Ben Hassine
mesh_terms: D000293:Adolescent; D000328:Adult; D000469:Alkaline Phosphatase / Q000097:blood; D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D001761:Bleomycin / Q000008:administration & dosage; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002648:Child; D003520:Cyclophosphamide / Q000008:administration & dosage; D003609:Dactinomycin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000097:blood; D002955:Leucovorin / Q000008:administration & dosage; D008279:Magnetic Resonance Imaging; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D012516:Osteosarcoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D011446:Prospective Studies; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014408:Biomarkers, Tumor; D001761:Bleomycin; D003609:Dactinomycin; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D007770:L-Lactate Dehydrogenase; D000469:Alkaline Phosphatase; D002955:Leucovorin; D008727:Methotrexate