title: Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Paediatric Oncology.
abstract: The aim of this phase II study was to determine the efficacy of high-dose ifosfamide with moderate dose etoposide in childhood osteosarcoma. From January 1992 to January 1995, 27 children (15 male, 12 female) with relapsed or refractory evaluable osteosarcoma were included in a phase II study of two courses of ifosfamide 3g/m2/day and etoposide 75 mg/m2/day for 4 days. Median age was 14 years (7-19 years). All but one had received high-dose methotrexate and doxorubicin as first-line treatment. 22 patients had previously received ifosfamide. This regimen was given as first-line in 1 patient, second-line in 23 and third-line in 3. Evaluable disease was lung metastases in 21 patients, local relapse in 5 and adenopathy in 1. There were six complete responses, seven partial responses, three minor responses, six stable disease and five progressive disease (including one mixed response). Response rate was 48% (95% confidence interval, 29-67%). Duration of response was not available (10 responding patients had other treatments). Response rate was equivalent in the subgroup of 22 patients who had previously received ifosfamide (4 CR, 6 PR). Among 3 patients who received the phase II regimen as third-line chemotherapy, there was 1 PR. All but 4 patients had a well tolerated grade 4 neutropenia. Transient mild confusion or seizures were each observed once. 5 patients are alive 15-31 months after the beginning of chemotherapy. This combination of drugs at this dosage has tolerable toxicity, is efficient and deserves evaluation in phase III studies.
authors.affiliation: Fédération d'Oncologie Pédiatrique, Children's Hospital, Marseille, France.
authors.forename: J C
authors.initials: JC
authors.lastname: Gentet
authors.forename: M
authors.initials: M
authors.lastname: Brunat-Mentigny
authors.forename: M C
authors.initials: MC
authors.lastname: Demaille
authors.forename: F
authors.initials: F
authors.lastname: Pein
authors.forename: H
authors.initials: H
authors.lastname: Avet-Loiseau
authors.forename: C
authors.initials: C
authors.lastname: Berger
authors.forename: L
authors.initials: L
authors.lastname: De Lumley
authors.forename: H
authors.initials: H
authors.lastname: Pacquement
authors.forename: C
authors.initials: C
authors.lastname: Schmitt
authors.forename: E
authors.initials: E
authors.lastname: Sariban
authors.forename: P
authors.initials: P
authors.lastname: Pillon
authors.forename: J L
authors.initials: JL
authors.lastname: Bernard
authors.forename: C
authors.initials: C
authors.lastname: Kalifa
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy*; D002648:Child; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D012516:Osteosarcoma / Q000188:drug therapy*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D005047:Etoposide; D007069:Ifosfamide