The use of Gemtuzumab-Ozogamicin (GO), an anti-CD33 monoclonal antibody, is associated to a 20–30... more The use of Gemtuzumab-Ozogamicin (GO), an anti-CD33 monoclonal antibody, is associated to a 20–30% response rate in refractory/relapsed AML. We have reviewed the efficacy and the tolerance of a combination of GO plus cytarabine (GOCYT) given to children with refractory/relapsed AML in order to improve the response rate. This retrospective analysis includes 17 children (9M, 8F) who received the same induction schedule on a compassionate-use basis between may 2004 and june 2006: GO 3 mg/m2/d D1, D4, D7 plus cytarabine 100 mg/m2/d CIV for 7 days. In addition, 6 patients received a consolidation course with GO 3 mg/m2 D1 plus cytarabine 100 mg/m2/d D1 to D7 and 1 patient received GO 3 mg/m2 monthly for 4 doses. Median age at diagnosis of AML is 4.5 y (0.4–16.7). The patient distribution is: de novo AML: 13; biclonal (T and myeloid) acute leukemia: 1; erythremia: 1; t-AML: 2. Initial caryotype was unfavourable in 6 cases, intermediate in 9 and favourable in 2. Patient’s status at GOCYT s...
133 Background: T-cell acute lymphoblastic leukemia (ALL) accounts for 15% of ALL cases in childr... more 133 Background: T-cell acute lymphoblastic leukemia (ALL) accounts for 15% of ALL cases in children and has been associated with a higher risk for central nervous system (CNS) relapse and a worse prognosis. In EORTC trials 58831 and 2, standard risk (SR) patients (pts) were not irradiated but received intermediate dose methotrexate (MTX) courses; for medium and high risk pts, high dose (HD) MTX was added to the treatment regimen and the administration of cranial radiotherapy (RT) was randomised. The omission of RT didn't result in an increase of CNS or systemic relapse and consequently, CNS-directed chemotherapy was substituted for RT in all following trials. The long-term outcome of T-ALL pts in the subsequent phase III trials (58881 and 58951) are presented here. Methods: The BFM backbone for ALL treatment was applied to all EORTC-CLG trials since 1983. As CNS treatment in study 58881, SR pts received 4 HD MTX courses (5 g/m2) in interval therapy and 10 IT MTX injections durin...
Publisher Summary This chapter examines the localized gonadal nonseminomatous germ cell tumors. I... more Publisher Summary This chapter examines the localized gonadal nonseminomatous germ cell tumors. In the French Society of Pediatric Oncology Experience protocols for nonseminomatous germ cell tumors, patients with localized gonadal completely removed tumors did not systematically receive chemotherapy after surgery. Markers are closely monitored and CT is begun only if they do not normalize within 3 months or if they rise again. The CT regimens were TGM 85 between January 1985 and December 1989 and TGM 90 after January 1990. In both protocols, courses of vinblastine, bleomycin, platinum compound alternates with course of cyclophosphamide/D-actinomycin. Cis platinum used in TGM 85 protocol has been replaced by carboplatin in TGM 90. Fifty-nine pts with pSI tumors were registered from centers between January 1985 and January 1993:39 TT and 11 OT. Two patients did not have normalization of markers after surgery; both had lumbo-aortic nodes, one of them with pulmonary metastasis. Nine pts had markers which elevated after normalization, eight of them within 3 m after surgery and one at 6 m. Tumor was found only in two, which included lumbo-aortic nodes and subcutaneous metastasis, respectively, 1 pt developed lumbo-aortic metastasis without marker elevation.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2001
The European Organization for Research and Treatment of Cancer 58881 study was designed to test i... more The European Organization for Research and Treatment of Cancer 58881 study was designed to test in a prospective multicentric randomized trial the value of high-dose (HD) intravenous (IV) cytarabine (Ara-C) added to HD IV methotrexate (MTX) to reduce the incidence of CNS and systemic relapses in children with increased-risk acute lymphoblastic leukemia (ALL) or stage III and IV lymphoblastic lymphoma treated with a Berlin-Frankfurt-Munster (BFM)-based regimen. After completion of induction-consolidation phase, children with increased-risk (risk factor > 0.8 or T-lineage) ALL or stage III and IV lymphoblastic lymphoma were randomized to receive four courses of HD MTX (5 g/m(2) over 24 hours every 2 weeks) and four intrathecal administrations of MTX (Arm A) or the same treatment schedule with additional HD IV Ara-C (1 g/m(2) in bolus injection 12 and 24 hours after the start of each MTX infusion) (Arm B). Between January 1990 and January 1996, 653 patients with ALL (593 patients) o...
Two cases of acute megakaryoblastic leukemia in a 4 month-old and a 13 year-old girl are describe... more Two cases of acute megakaryoblastic leukemia in a 4 month-old and a 13 year-old girl are described. In the first case who presented with a large hepatomegaly and portal fibrosis, the diagnosis was made from the surface phenotyping of megakaryoblasts; a trisomy 13, 14 and 19 and an extra chromosome X were present in the bone marrow. An electron microscopy study of megakaryoblasts was necessary to identify the second case. Both children died shortly after treatment (cytosine-arabinoside at low dosage in the first case and polychemotherapy in the second). The 51 other cases reported in the literature are reviewed.
Since January 1988, 91 children with ANLL have been treated with a polychemotherapy regimen conta... more Since January 1988, 91 children with ANLL have been treated with a polychemotherapy regimen containing Mitoxantrone (MTZ), excluding other anthracyclines. Induction consisted of Ara-C, MTZ, and VP 16. Consolidation lasted 6 weeks with Vincristine, MTZ, Ara-C and 6-thioguanine (6TG), and was followed by 2 intensification courses combining High-dose Ara-C with respectively MTZ or VP 16. Maintenance therapy associated 6TG, Ara-C and MTZ up to a cumulative dose of 150 mg/m2. 91 patients are evaluable: 70 (76.9%) achieved complete remission, 59 (64.8%) after induction alone. There were 7 early deaths, 5 deaths in complete remission, and 17 relapses. Major toxic side effects were observed during the consolidation phase, mainly infectious complications, and the median duration of neutropenia was 82 days in this phase, leading to decrease the MTZ dose from 10 to 8 mg/m2. The event-free survival at three years is 38%. Cardiac toxicity is presently absent in children without previous cardiopa...
The use of Gemtuzumab-Ozogamicin (GO), an anti-CD33 monoclonal antibody, is associated to a 20–30... more The use of Gemtuzumab-Ozogamicin (GO), an anti-CD33 monoclonal antibody, is associated to a 20–30% response rate in refractory/relapsed AML. We have reviewed the efficacy and the tolerance of a combination of GO plus cytarabine (GOCYT) given to children with refractory/relapsed AML in order to improve the response rate. This retrospective analysis includes 17 children (9M, 8F) who received the same induction schedule on a compassionate-use basis between may 2004 and june 2006: GO 3 mg/m2/d D1, D4, D7 plus cytarabine 100 mg/m2/d CIV for 7 days. In addition, 6 patients received a consolidation course with GO 3 mg/m2 D1 plus cytarabine 100 mg/m2/d D1 to D7 and 1 patient received GO 3 mg/m2 monthly for 4 doses. Median age at diagnosis of AML is 4.5 y (0.4–16.7). The patient distribution is: de novo AML: 13; biclonal (T and myeloid) acute leukemia: 1; erythremia: 1; t-AML: 2. Initial caryotype was unfavourable in 6 cases, intermediate in 9 and favourable in 2. Patient’s status at GOCYT s...
133 Background: T-cell acute lymphoblastic leukemia (ALL) accounts for 15% of ALL cases in childr... more 133 Background: T-cell acute lymphoblastic leukemia (ALL) accounts for 15% of ALL cases in children and has been associated with a higher risk for central nervous system (CNS) relapse and a worse prognosis. In EORTC trials 58831 and 2, standard risk (SR) patients (pts) were not irradiated but received intermediate dose methotrexate (MTX) courses; for medium and high risk pts, high dose (HD) MTX was added to the treatment regimen and the administration of cranial radiotherapy (RT) was randomised. The omission of RT didn't result in an increase of CNS or systemic relapse and consequently, CNS-directed chemotherapy was substituted for RT in all following trials. The long-term outcome of T-ALL pts in the subsequent phase III trials (58881 and 58951) are presented here. Methods: The BFM backbone for ALL treatment was applied to all EORTC-CLG trials since 1983. As CNS treatment in study 58881, SR pts received 4 HD MTX courses (5 g/m2) in interval therapy and 10 IT MTX injections durin...
Publisher Summary This chapter examines the localized gonadal nonseminomatous germ cell tumors. I... more Publisher Summary This chapter examines the localized gonadal nonseminomatous germ cell tumors. In the French Society of Pediatric Oncology Experience protocols for nonseminomatous germ cell tumors, patients with localized gonadal completely removed tumors did not systematically receive chemotherapy after surgery. Markers are closely monitored and CT is begun only if they do not normalize within 3 months or if they rise again. The CT regimens were TGM 85 between January 1985 and December 1989 and TGM 90 after January 1990. In both protocols, courses of vinblastine, bleomycin, platinum compound alternates with course of cyclophosphamide/D-actinomycin. Cis platinum used in TGM 85 protocol has been replaced by carboplatin in TGM 90. Fifty-nine pts with pSI tumors were registered from centers between January 1985 and January 1993:39 TT and 11 OT. Two patients did not have normalization of markers after surgery; both had lumbo-aortic nodes, one of them with pulmonary metastasis. Nine pts had markers which elevated after normalization, eight of them within 3 m after surgery and one at 6 m. Tumor was found only in two, which included lumbo-aortic nodes and subcutaneous metastasis, respectively, 1 pt developed lumbo-aortic metastasis without marker elevation.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2001
The European Organization for Research and Treatment of Cancer 58881 study was designed to test i... more The European Organization for Research and Treatment of Cancer 58881 study was designed to test in a prospective multicentric randomized trial the value of high-dose (HD) intravenous (IV) cytarabine (Ara-C) added to HD IV methotrexate (MTX) to reduce the incidence of CNS and systemic relapses in children with increased-risk acute lymphoblastic leukemia (ALL) or stage III and IV lymphoblastic lymphoma treated with a Berlin-Frankfurt-Munster (BFM)-based regimen. After completion of induction-consolidation phase, children with increased-risk (risk factor > 0.8 or T-lineage) ALL or stage III and IV lymphoblastic lymphoma were randomized to receive four courses of HD MTX (5 g/m(2) over 24 hours every 2 weeks) and four intrathecal administrations of MTX (Arm A) or the same treatment schedule with additional HD IV Ara-C (1 g/m(2) in bolus injection 12 and 24 hours after the start of each MTX infusion) (Arm B). Between January 1990 and January 1996, 653 patients with ALL (593 patients) o...
Two cases of acute megakaryoblastic leukemia in a 4 month-old and a 13 year-old girl are describe... more Two cases of acute megakaryoblastic leukemia in a 4 month-old and a 13 year-old girl are described. In the first case who presented with a large hepatomegaly and portal fibrosis, the diagnosis was made from the surface phenotyping of megakaryoblasts; a trisomy 13, 14 and 19 and an extra chromosome X were present in the bone marrow. An electron microscopy study of megakaryoblasts was necessary to identify the second case. Both children died shortly after treatment (cytosine-arabinoside at low dosage in the first case and polychemotherapy in the second). The 51 other cases reported in the literature are reviewed.
Since January 1988, 91 children with ANLL have been treated with a polychemotherapy regimen conta... more Since January 1988, 91 children with ANLL have been treated with a polychemotherapy regimen containing Mitoxantrone (MTZ), excluding other anthracyclines. Induction consisted of Ara-C, MTZ, and VP 16. Consolidation lasted 6 weeks with Vincristine, MTZ, Ara-C and 6-thioguanine (6TG), and was followed by 2 intensification courses combining High-dose Ara-C with respectively MTZ or VP 16. Maintenance therapy associated 6TG, Ara-C and MTZ up to a cumulative dose of 150 mg/m2. 91 patients are evaluable: 70 (76.9%) achieved complete remission, 59 (64.8%) after induction alone. There were 7 early deaths, 5 deaths in complete remission, and 17 relapses. Major toxic side effects were observed during the consolidation phase, mainly infectious complications, and the median duration of neutropenia was 82 days in this phase, leading to decrease the MTZ dose from 10 to 8 mg/m2. The event-free survival at three years is 38%. Cardiac toxicity is presently absent in children without previous cardiopa...
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