SINTESI DELLE ESTENSIONE DELLE Protocolli...

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SINTESI DELLEINDICAZIONI GIÀ

AUTORIZZATE PERL’IMPIEGO IN

PEDIATRIA

ESTENSIONE DELLEINDICAZIONI SULLA BASE

DELLA DELIBERA AIFA (corsivo) EDI NUOVE EVIDENZE

SCIENTIFICHE (grassetto)

BIBLIOGRAFIA

a sostegno dell’estensione dell’indicazione

Protocollinazionali e

internazionali inuso

1

ACIDOTRANSRETINOICO

ACIDO 13-CIS-RETINOICO

Nessuna

Nessuna

-Neuroblastoma

-Nefroblastoma

-Leucemia promielocitica acuta

-Neuroblastoma

Neuroblastoma e Nefroblastoma

Adamson PC et al. A phase 2 trial of all-trans-retinoic acidin combination with interferon-alpha2a in children withrecurrent neuroblastoma or Wilms tumor: a PediatricOncology Branch, NCI and Children's Oncology GroupStudy. Pediatr Blood Cancer 2007;49:661-665

Leucemia promielocitica acuta

Dvorak CC et al. Reinduction of relapsed acutepromyelocytic leukemia with ATRA and low doseantimetabolite-based chemotherapy. Pediatr Blood Cancer2007;48:582-585

Ortega JJ et al. Treatment with all-trans retinoic acid andanthracycline monochemotherapy for children with acutepromyelocytic leukemia: a multicenter study by thePETHEMA Group. J Clin Oncol 2005;23:7632-7640

Neuroblastoma

Veal G et al. Pharmacokinetics and pharmacogenetics of13-cis-retinoic acid in children with high riskneuroblastoma. A study of the UK Children’s CancerStudy Group. Br J Cancer 2007;96:424-431

Reynolds CP et al. Retinoid therapy of high-riskneuroblastoma.Cancer Lett 2003;197:185-192

- AIDA-Prot.(lap0493)GIMEMA AIEOP

- NB-AR-01

Allegato A – Farmaci oncologici off-label per uso pediatrico

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2

ACTINOMICINA-D -Nefroblastoma

-Neuroblastoma

- Tumori solidi(nel primo anno di vita)

- Rabdomiosarcoma

- Tumori della famiglia del sarcoma diEwing

- Emangiopericitoma

- Carcinoma del rene a cellule chiare

- Carcinoma nasofaringeo

- Tumori a cellule germinali

Tumori solidi (nel primo anno di vita)

Orbach D et al. Soft tissue sarcoma or malignantmesenchymal tumors in the first year of life: experience ofthe International Society of Pediatric Oncology (SIOP)Malignant Mesenchymal Tumor Committee. J Clin Oncol2005;23:4363-4371

Rabdomiosarcoma

Waiterhouse I and Watson A. Optimal managementstrategies for rhabdomyosarcoma in children. PaediatrDrugs 2007;9:391-400

Tumori della famiglia del sarcoma di Ewing

Bernstein M et al. Ewing’s sarcoma family of tumors:current management. Oncologist 2006;11:503-519

Emangiopericitoma

Gowans LK et al. Successful treatment of an infant withconstitutional chromosomal abnormality andhemangiopericytoma with chemotherapy alone. J PediatrHematol Oncol 2007;29:409-411

Carcinoma del rene a cellule chiare

Varan A et al. Renal cell carcinoma in children:experience of a single center. Nephron Clin Pract2007;105:58-61

Carcinoma nasofaringeo

Küpeli S et al. Treatment results of 84 patients withnasopharyngeal carcinoma in childhood. Pediatr BloodCancer 2006;46:454-458

Tumori a cellule germinali

Lo Curto M et al. Mature and immature teratomas: results ofthe first paediatric Italian study. Pediatr Surg Int2007;23:315-322

- AIEOP T.Wilms,2003

- EpSSG-RMS &NRSTS, 2005

- ISG/SSG III

- ISG/SSG IV

- AIEOP/ ISG 02(EW- REC)

- AIEOP/SICPTREP, 2005

ALEMTUZUMAB Nessuna -Anemia aplastica grave Anemia aplastica grave e Sindromi mielodisplastiche

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3

-Sindromi mielodisplastiche

-Trapianto di midollo osseo

Rzepecki P et al. Alemtuzumab, fludarabine andmelphalan as a conditioning therapy in severe aplasticanemia and hypoplastic myelodysplastic syndrome –singlecenter experience–. Jpn J Clin Oncol 2006;36:46-49

Trapianto di midollo osseo

Benesch M et al. Five-month marrow aplasia in a childwith refractory acute myeloid leukaemia: successfulmanagement with continuous granulocyte support andreduced intensity conditioning followed by matchedunrelated bone marrow transplantation. J Pediatr HematolOncol 2005;27:236-238

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4

ARSENICO TRIOSSIDO Nessuna -Leucemia acuta promielocitica Leucemia acuta promielociticaMantadakis E et al. A comprehensive review of acutepromyelocytic leukemia in children. Acta Haematol2008;119:73-82

Fox E et al. Phase 1 trial and pharmacokinetic study ofarsenic trioxide in children and adolescents with refractoryor relapsed acute leukemia, including acute promyelocyticleukemia or lymphoma. Blood 2008;111:566-573

Clark JJ et al. Update in childhood acute myeloidleukemia: recent developments in the molecular basis ofdisease and novel therapies. Curr Opin Hematol2003;10:31-39

- ICC APL 01

BEVACIZUMAB Nessuna -Tumori solidi refrattari

-Carcinoma del rene a cellule chiare

-Carcinoma del colon-retto

Tumori solidi refrattari

Bender JL et al. Phase I trial and pharmacokinetic study ofbevacizumab in pediatric patients with refractory solidtumors: a Children's Oncology Group Study. J Clin Oncol2008;26:399-405

Benesch M et al. Compassionate use of bevacizumab(Avastin) in children and young adults with refractory orrecurrent solid tumors. Ann Oncol 2008;19:807-813


Joshi DD and Banerjee T. Vascular endothelial growthfactor (VEGF) receptor antibody bevacizumab (avastin)induces regression of renal cell carcinoma in an adolescentresulting in residual tumorectomy. Pediatr Blood Cancer2008;50:903-904

Benesch M et al. Compassionate use of bevacizumab

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5

(Avastin) in children and young adults with refractory orrecurrent solid tumors. Ann Oncol 2008;19:807-813

Carcinoma del colon-retto

Saab R and Furman WL. Epidemiology and managementoptions for colorectal cancer in children. Paediatr Drugs2008;10:177-192

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6

BLEOMICINA Nessuna -In associazione negli schemi PEB per itumori germinali e ABVD nel linfoma diHodgkin

-Tumori del SNC

Tumori del SNC

Hukin J et al. Intracystic bleomycin therapy forcraniopharyngioma in children: the Canadian experience.Cancer 2007;109:2124-2131

- AIEOP LH 2004

- AIEOP TCG 2004

- AIEOP/SICPTREP 2005

BUSULFANO -Policitemia vera

-Trombocitopeniaessenziale

-Condizionamento pre-trapianto

-Neuroblastoma in stadio 4, inassociazione a melphalan nei regimimieloablativi

-Sarcomi della famiglia Ewing a cattivaprognosi in associazione a melphalannei regimi mieloablativi

- Leucemia mielomonocitica giovanile

- Sindrome di Shwachman-Diamond

- Medulloblastoma

Leucemia mielomonocitica giovanile

Locatelli F et al. Hematopoietic stem cell transplantation(HSCT) in children with juvenile myelomonocyticleukemia (JMML): results of the EWOG-MDS/EBMTtrial. Blood 2005;105:410-419

Sindrome di Shwachman-Diamond

Sauer M et al. Substitution of cyclophosphamide andbusulfan by fludarabine, treosulfan and melphalan in apreparative regimen for children and adolescents withShwachman-Diamond syndrome. Bone MarrowTransplant 2007;9:143-147

Medulloblastoma

Ridola V et al. High-dose chemotherapy with autologousstem cell rescue followed by posterior fossa irradiation forlocal medulloblastoma recurrence or progression afterconventional chemotherapy. Cancer 2007;110:156-163

- AIEOP LAM2002/01-02

- NB-AR-01

- SIOP-AIEOP NBInfant

- AIEOP LAMREC/01

- AIEOP LLA REC2003

- AIEOP ALCL 99

- HLH 2004

- INTERINFAN 06

- ISG/SSG IIIISG/SSG IV

- AIEOP/ISG 02(EW-REC)

CARBOPLATINO -Carcinoma dell’ovaiodell’adolescente/giovaneadulta

-Neuroblastoma (stadio 3 e 4) incombinazione con altri citotossici

-Tumore di Wilms ad istologiasfavorevole o metastatico incombinazione con altri farmaci

Sarcomi dei tessuti molli

Bernbeck B et al. Serial intense chemotherapy combiningtopotecan, etoposide, carboplatin and cyclophosphamide(TECC) followed by autologous hematopoietic stem cellsupport in patients with high risk soft tissue sarcoma(STS). Klin Pediatr 2007;219:318-322

- EICNHL ( ALCLrelapse )

- SIOPEL 3

- SIOPEL 4

- AIEOP T.Wilms

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7

-Rabdomiosarcoma localizzato eavanzato

-Gliomi a basso ed alto grado

-Retinoblastoma localmente avanzato emetastatico

-Epatoblastoma a prognosi sfavorevole

-Medulloblastoma localizzato inalternativa a cisplatino

-Sarcomi dei tessuti molli

-Osteosarcoma

-Tumori a cellule germinali

-Sarcoma di Ewing ad alto rischio

Osteosarcoma

del Prever AB et al. Long-term survival in high-gradeaxial osteosarcoma with bone and lung metastases treatedwith chemotherapy only. J Pediatr Hematol Oncol2005;27:42-45

Daw NC et al. Metastatic osteosarcoma. Cancer2006;106:403-412


Lo Curto M et al. Malignant germ cell tumors inchildhood: results of the first Italian cooperative study"TCG 91". Med Pediatr Oncol 2003;41:417-425

Sarcoma di Ewing ad alto rischio

Burdach S et al. Allogeneic and autologous stem-celltransplantation in advanced Ewing tumors. An updateafter long-term follow-up from two centers of theEuropean Intergroup study EICESS. Stem-Cell TransplantPrograms at Düsseldorf University Medical Center,Germany and St. Anna Kinderspital, Vienna, Austria. AnnOncol 2000;11:1451-1462

Van Winkle P et al. Ifosfamide, carboplatin and etoposide(ICE) reinduction chemotherapy in a large cohort ofchildren and adolescents with recurrent/refractorysarcoma: the Children's Cancer Group (CCG) experience.Pediatr Blood Cancer 2005;44:338-347

Milano GM et al. High histologic and overall response todose intensification of ifosfamide, carboplatin andetoposide with cyclophosphamide, doxorubicin andvincristine in patients with high-risk Ewing sarcomafamily tumors: the Bambino Gesù Children's Hospitalexperience. Cancer 2006;106:1838-1845

2003

- NB- AR-01


- SIOP EUROPEUnresectNB 00

- AIEOP/ISGOSTEO REC VHR

- AIEOP/ISG 02(EW -REC)

- AIEOP RB 05

- AIEOP SNC95-01

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8

Chastagner P et al. Outcome of children treated withpreradiation chemotherapy for a high-grade glioma:results of a French Society of Pediatric Oncology (SFOP)Pilot Study. Pediatr Blood Cancer 2007;49:803-807

- HIT – SIOPPNET 4

CICLOFOSFAMIDE Nessuna -Neuroblastoma

-Tumori della famiglia del sarcoma diEwing

-Gliomi a basso grado di malignità

-Leucemia linfoblastica acuta

-Linfoma di Hodgkin

-Linfoma non-Hodgkin

-Medulloblastoma

-Osteosarcoma

-Epatoblastoma


-Rabdomiosarcoma

Neuroblastoma

Donfrancesco A et al. Prolonged response to oral gefitinib,cyclophosphamide and topotecan in heavily pretreatedrelapsed stage 4 neuroblastoma: a case report. J PediatrHematol Oncol 2007;29:799-803

Simon T et al. Topotecan, cyclophosphamide andetoposide (TCE) in the treatment of high-riskneuroblastoma. Results of a phase-II trial. J Cancer ResClin Oncol 2007;133:653-661


Miser JS et al. Treatment of metastatic Ewing sarcoma/primitive neuroectodermal tumor of bone: evaluation ofincreasing the dose intensity of chemotherapy-a reportfrom the Children's Oncology Group. Pediatric BloodCancer 2007;49:894-900

Bernstein ML et al. Intensive therapy with growth factorsupport for patients with Ewing tumor metastatic atdiagnosis: Pediatric Oncology Group/Children's CancerGroup Phase II Study 9457--a report from the Children'sOncology Group. J Clin Oncol 2006;24:152-159

Gliomi a basso grado di malignità

Lee MJ et al. Effectiveness of novel combinationchemotherapy, consisting of 5-fluorouracil, vincristine,cyclophosphamide and etoposide, in the treatment of low-grade gliomas in children. J Neurooncol 2006;80:277-284

Leucemia linfoblastica acuta

Shah AJ et al. Busulfan and cyclophosphamide as a

- AIEOP LAM2002/01-02


- AIEOP EsPhALL

- AIEOP LH 2004

- EURO LB-02

- AIEOP ALCL 99



- AIEOP/ISG 02(EW -REC)

- ISG-AIEOP/ VHR-EW-2

- EpSSG RMS &NRSTS 2005

- SIOPEL 3

- AIEOP2° Ependi 03

- SIOP LGG 2004

- NB-AR-01

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9

conditioning regimen for pediatric acute lymphoblasticleukemia patients undergoing bone marrowtransplantation. J Pediatr Hematol Oncol 2004;26:91-97

Aricò M et al. Long-term results of the AIEOP-ALL-95Trial for Childhood Acute Lymphoblastic Leukemia:insight on the prognostic value of DNA index in theframework of Berlin-Frankfurt-Muenster basedchemotherapy. J Clin Oncol 2008;26:283-289

Linfoma di Hodgkin

Krasin MJ et al. Patterns of treatment failure in pediatricand young adult patients with Hodgkin's disease: localdisease control with combined-modality therapy. J ClinOncol 2005;23:8406-8413

Linfoma non-Hodgkin

Patte C et al. Results of the randomized internationalFAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it ispossible to reduce treatment for the early respondingpatients. Blood 2007;109:2773-2780

Medulloblastoma

Dhall G et al. Outcome of children less than three yearsold at diagnosis with non-metastatic medulloblastomatreated with chemotherapy on the "Head Start" I and IIprotocols. Pediatr Blood Cancer 2008;50:1169-1175

Osteosarcoma

Tunn PU and Reichardt P. Chemotherapy forosteosarcoma without high-dose methotrexate: a 12-yearfollow-up on 53 patients. Onkologie 2007;30:228-232

Epatoblastoma

Cacciavillano WD et al. Phase II study of high-dosecyclophosphamide in relapsing and/or resistant

- SIOP-AIEOP NBinfant

-AIEOPInterinfant 99

- INTERINFAN 06

- HLH 2004

- AIEOP LLAREC 2003

- AIEOP LAMREC/01

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10

hepatoblastoma in children: a study from the SIOPELgroup. Eur J Cancer 2004;40:2274-2279

Condizionamento pre-trapianto

Shah AJ et al. Busulfan and cyclophosphamide as aconditioning regimen for pediatric acute lymphoblasticleukemia patients undergoing bone marrowtransplantation. J Pediatr Hematol Oncol 2004;26:91-97

Rabdomiosarcoma

Meza JL et al. Analysis of prognostic factors in patientswith nonmetastatic rhabdomyosarcoma treated onintergroup rhabdomyosarcoma studies III and IV: theChildren's Oncology Group. J Clin Oncol 2006;20:3844-3851

CISPLATINO Nessuna -Neuroblastoma

-Epatoblastoma

-Medulloblastoma


-Osteosarcoma

-Tumori germinali

-Linfomi Hodgkin e non-Hodgkinrecidivanti

- Tumori desmoplastici a piccolecellule rotonde


Tumori desmoplastici a piccole cellule rotonde

Hayes-Jordan A et al. Continuous hyperthermic peritonealperfusion for desmoplastic small round cell tumor. JPediatr Surg 2007;42:29-32



Carcinoma corticosurrenalico

Zancanella P et al. Mitotane associated with cisplatin,etoposide and doxorubicin in advanced childhoodadrenocortical carcinoma: mitotane monitoring and tumorregression. J Pediatr Hematol Oncol 2006;28:513-524

Retinoblastoma

de Aguirre Neto JC et al. Retinoblastoma in children olderthan 5 years of age. Pediatr Blood Cancer 2007;48:292-295

- ISG/OSI

- AIEOP/ISG/SSG02 (EW REC)

- ISG -AIEOP/VHR-EW-2


- SIOPEL 3

- SIOPEL 4

- AIEOP TCG 2004

- SIOP LGG 2004

- HIT-SIOP PNET 4

- AIEOPSNC 95-01

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11

-Carcinoma corticosurrenalico

-Retinoblastoma

-Tumore del seno endodermico dellavagina

-Carcinoma nasofaringeo

-Tumori ovarici dello stromagonadico (sex cord-stromal)

Tumore del seno endodermico della vagina

Terenziani M et al. Endodermal sinus tumor of the vagina.Pediatr Blood Cancer 2007;48:577-578



Tumori ovarici dello stroma gonadico (sex cord-stromal)

Schneider DT et al. Ovarian sex cord-stromal tumors inchildren and adolescents. J Reprod Med 2005;50:439-446


CITARABINA -Leucemia mieloide acutae cronica




Silverman LB. Acute lymphoblastic leukemia in infancy.Pediatr Blood Cancer 2007;49:1070-1073

Linfoma non-Hodgkin

Patte C et al. The Société Française d'OncologiePédiatrique LMB89 protocol: highly effective multiagentchemotherapy tailored to the tumor burden and initialresponse in 561 unselected children with B-celllymphomas and L3 leukemia. Blood 2001;97:3370-3379

- AIEOP LAM2002/01-02


- AIEOP LLA RECPh+ 2002

- AIEOP LLA R-2006

- AIEOP LAM REC/01

- AIEOP LNH 97- ICC APL 01- AIEOP ALCL 99- EURO LB-02- LCH-S-2005- AIEOPInterinfant 99

- INTERFAN T06

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12

CITARABINALIPOSOMIALE

Nessuna -Tumori del SNC

-Leucemia mieloide acuta


Tumori del SNC

Lassaletta A et al. Successful treatment of intracranialependymoma with leptomeningeal spread with systemicchemotherapy and intrathecal liposomal cytarabine in atwo-year-old child. J Neurooncol 2007;83:303-306

Leucemia mieloide acuta e Leucemia linfoblasticaacuta

Benesch M and Urban C. Liposomal cytarabine forleukemic and lymphomatous meningitis: recentdevelopments. Expert Opin Pharmacother 2008;9:301-309

Benesch M et al. Feasibility and toxicity of intrathecalliposomal cytarabine in 5 children and young adults withrefractory neoplastic meningitis. J Pediatr Hematol Oncol2007;29:222-226

- AIEOP EsPhALL

CLADRIBINA Nessuna -Istiocitosi a cellule di Langerhans Istiocitosi a cellule di LangerhansMottl H et al. Treatment of recurrent Langerhans cellhistiocytosis in children with 2-chlorodeoxyadenosine.Leuk Lymphoma 2006;47:1881-1884

- LCH -S-2005

CLORAMBUCILE Nessuna -Linfoma di Hodgkin Linfoma di HodgkinHall GW et al. Outcome of children with nodularlymphocyte predominant Hodgkin lymphoma - aChildren's Cancer and Leukaemia Group report-. Br JHaematol 2007;138:761-768

Capra M et al. Long-term outcome in children withHodgkin's lymphoma: the United Kingdom Children'sCancer Study Group HD82 trial. Eur J Cancer2007;43:1171-1179

DACARBAZINA Nessuna -Linfoma di Hodgkin Linfoma di HodgkinEngert A et al. Two cycles of doxorubicin, bleomycin,

- AIEOP LH 2004

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13

-Sarcomi dei tessuti molli vinblastine and dacarbazine plus extended-fieldradiotherapy is superior to radiotherapy alone in earlyfavorable Hodgkin's lymphoma: final results of the GHSGHD7 trial. J Clin Oncol 2007;25:3495-3502

Hsu SC et al. Comparison of treatment outcomes ofchildhood Hodgkin lymphoma in two US centers and acenter in Recife, Brazil. Pediatr Blood Cancer2007;49:139-144

Kung FH et al. POG 8625: a randomized trial comparingchemotherapy with chemoradiotherapy for children andadolescents with stages I, IIA, IIIA1 Hodgkin disease: areport from the Children's Oncology Group. J PediatrHematol Oncol 2006;28:362-368


Pratt CB et al. Treatment of unresectable or metastaticpediatric soft tissue sarcomas with surgery, irradiation andchemotherapy: a Pediatric Oncology Group Study. MedPediatr Oncol 1998;30:201-209

DAUNORUBICINA Nessuna -Leucemie e linfomi del bambinorecidivanti




Linfoma non-Hodgkin

Crosswell HE et al. Successful treatment with modifiedCHOP-rituximab in pediatric AIDS-related advancedstage Burkitt lymphoma. Pediatr Blood Cancer2008;50:883-885


Escherich G et al. Daunomicin–induced cell kill with 1-hour versus 24–hours infusion: a randomized comparisonin children with newly diagnosed acute lymphoblasticleukaemia. Klin Padiatr 2007;219:134-138

Leucemia mieloide acuta

Creutzig U et al. Significance of age in acute myeloidleukemia patients younger than 30 years: a common

- AIEOP EsPhALL

- AIEOPInterinfant 99

- INTERINFAN 06

- EURO LB-02

- AIEOP LNH 97

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14

analysis of the pediatric trials AML-BFM 93/98 and theadult trials AMLCG 92/99 and AMLSG HD93/98A.Cancer 2008;112:562-571

Lange BJ et al. Outcomes in CCG-2961, a children'soncology group phase 3 trial for untreated pediatric acutemyeloid leukemia: a report from the Children's OncologyGroup. Blood 2008;111:1044-1053

DOXORUBICINA -Osteosarcoma



-Neuroblastoma

-Nefroblastoma

-Leucemia linfoblasticaacuta


-Sarcoma di Ewing in prima linea orecidivante

-Rabdomiosarcoma in prima linea orecidivante

-Epatoblastoma in prima linea orecidivante


- Tumori del SNC

- Emangiopericitoma

- Carcinoma surrenalico

- Tumori rabdoidi

- Retinoblastoma

- Istiocitosi a cellule di Langerhans


Castex MP et al. Extraosseous localized Ewing tumors:improved outcome with anthracyclines-the French societyof pediatric oncology and international society of pediatriconcology. J Clin Oncol 2007;25:1176-1182

Tumori del SNC

Fiorillo A et al. Shunt-related abdominal metastases in aninfant with medulloblastoma: long-term remission bysystemic chemotherapy and surgery. J Neurooncol2001;52:273-276

Emangiopericitoma


Carcinoma surrenalico

Zancanella P et al. Mitotane associated with cisplatin,etoposide and doxorubicin in advanced childhoodadrenocortical carcinoma: mitotane monitoring and tumorregression. J Pediatr Hematol Oncol 2006;28:513-524

Tumori rabdoidi

Hosoi H et al. Continuous remission in an infant withchest wall malignant rhabdoid tumor after relapse. J

- AIEOP Es Ph ALL

- AIEOP ALCL 99

- EURO LB-02

- AIEOP LNH 97

- AIEOP LH 2004

- ISG/OSI

- ISG/SSG III

- ISG/SSG IV

- AIEOPT.Wilms 2003

- SIOPEL 3

- SIOPEL 4


- ISG-AIEOP/VHREW2

- AIEOP RB 05


- EpSSG RMS &NRSTS 2005

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15

Pediatr Surg 2007;42:9-12

Retinoblastoma

Mustafa MM et al. Adjuvant chemotherapy withvincristine, doxorubicin and cyclophosphamide in thetreatment of postenucleation high risk retinoblastoma. JPediatr Hematol Oncol 1999;21:364-369

Istiocitosi a cellule di Langerhans

Morimoto A et al. Improved outcome in the treatment ofpediatric multifocal Langerhans cell histiocytosis: Resultsfrom the Japan Langerhans Cell Histiocytosis StudyGroup-96 protocol study. Cancer 2006;107:613-619


- AIEOP/ISG 02(EW- REC)

- AIEOP NBrec/ res 00

- SIOP/EUROPEUnresectNB 00

DOXORUBICINALIPOSOMIALE

Nessuna -Tumori del SNC ad alto grado dimalignità

-Leucemia linfatica acuta in recidiva

-Tumori solidi refrattari

Tumori del SNC ad alto grado di malignità

Wagner S et al. Pegylate liposomial doxorubicin and oraltopotecan in eight children with relapsed high-grademalignant brain tumors. J Neurooncol 2008;86:175-181

Leucemia linfatica acuta in recidiva

Hempel et al. Population pharmacokinetics of liposomaldaunorubicin in children. Br J Clin Pharmacol2003;56:370-377

Tumori solidi refrattari

Lowe E et al. Phase I trial and pharmacokinetic study ofliposomal doxorubicin in children with refractory solidtumors. Proc Ann Meet ASCO 2002;21:1099

AIEOP LLA Rec2003

EPIRUBICINA Nessuna -Sarcomi dei tessuti molli



-Epatoblastoma ed epatocarcinoma

-Tumori mesenchimali (nel primoanno di vita)


Stohr W et al. Comparison of epirubicin and doxorubicincardiotoxicity in children and adolescents treated withinthe German Cooperative Soft Tissue Sarcoma Study. JCancer Res Clin Oncol 2006;132:35-40

Linfoma non-Hodgkin

Pocali B et al. Ifosfamide, epirubicin and etoposide (IEV)regimen as salvage and mobilization therapy for refractoryor early relapsing patients with aggressive non-Hodgkin's

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16

lymphoma. Leuk Lymphoma 2004;45:1605-1609


Bhutani M et al. Randomized study comparing 4'-epi-doxorubicin (epirubicin) versus doxorubicin as a part ofinduction treatment in adult acute lymphoblastic leukemia.Am J Hematol 2002;71:241-247

Eksborg S et al. A comparative pharmacokinetic study ofdoxorubicin and 4'-epi-doxorubicin in children with acutelymphocytic leukemia using a limited sampling procedure.Anticancer Drugs 2000;11:129-136

Epatoblastoma ed epatocarcinoma

Casanova M et al. Etoposide, cisplatin, epirubicinchemotherapy in the treatment of pediatric liver tumors.Pediatr Hematol Oncol 2005;22:189-198

Tumori mesenchimali (nel primo anno di vita)


ETOPOSIDE Nessuna -Tumore di Wilms a prognosisfavorevole e metastatico

-Neuroblastoma di grado 3 e 4

-Sarcomi dei tessuti molli alla ricaduta

-Famiglia dei sarcomi di Ewing

-Rabdomiosarcoma recidivante

-Osteosarcoma


Gassas A et al. Comparative outcome of hematopoieticstem cell transplant for pediatric acute lymphoblasticleukaemia following cyclophosphamide and total bodyirradiation or VP16 and total body irradiation conditioningregimens. Bone Marrow Transplant 2006;38:739-743


Styczynski J et al. Fludarabine, treosulfan and etoposidesensitivity and the outcome of hematopoietic stem celltransplantation in childhood acute myeloid leukemia.

- AIEOP LLA RECPh+ 2002

- HLH 2004


- INTERINFAN 06

- AIEOP ALCL 99

- AIEOP LNH 97

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17


-Ependimomi

-Tumori neuroectodermici primitivicerebrali

-Retinoblastoma localmente avanzato ometastatico

-Istiocitosi a cellule di Langerhans



-Epatoblastoma

-Tumori a cellule germinali

-Carcinoma surrenalico

-Linfoma di Hodgkin


Anticancer Res 2007;27:1547-1551

Ayas M et al. The outcome of children with acute myeloidleukemia (AML) post-allogeneic stem cell transplantation(SCT) is not improved by the addition of etoposide to theconditioning regimen. Pediatr Blood Cancer 2006;47:926-930

Epatoblastoma

Casanova M et al. Etoposide, cisplatin, epirubicinchemotherapy in the treatment of pediatric liver tumors.Pediatr Hematol Oncol 2005;22:189-198

Häberle B et al. Differentiated treatment protocols forhigh- and standard-risk hepatoblastoma- an interim reportof the German Liver Tumor Study HB99-. Klin Padiatr2003;215:159-165


Shinkoda Y et al. Successful treatment of an endodermalsinus tumor of the vagina by chemotherapy alone: a rarecase of an infant diagnosed by pathological examinationof discharged tumor fragment. Pediatr Hematol Oncol2006;23:563-569

Cushing B et al. Randomized comparison of combinationchemotherapy with etoposide, bleomycin and either high-dose or standard-dose cisplatin in children and adolescentswith high-risk malignant germ cell tumors: a pediatricintergroup study -Pediatric Oncology Group 9049 andChildren's Cancer Group 8882-. J Clin Oncol2004;22:2691-2700


Zancanella P et al. Mitotane associated with cisplatin,etoposide and doxorubicin in advanced childhoodadrenocortical carcinoma: mitotane monitoring and tumor

- AIEOP LH 2004

- AIEOP LAM2002/01-02

- ISG/SSG III

- ISG/SSG IV

- AIEOPT Wilms 2003

- AIEOP SNC 99

- AIEOP RB 05

- AIDA –Prot.(lap0493GIMEMA AIEOP)

- SIOP LGG 2004



- AIEOP SNC95-01

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regression. J Pediatr Hematol Oncol 2006;28:513-524

Linfoma di Hodgkin

Landman-Parker J et al. Localized childhood Hodgkin'sdisease: response-adapted chemotherapy with etoposide,bleomycin, vinblastine and prednisone before low-doseradiation therapy-results of the French Society of PediatricOncology Study MDH90. J Clin Oncol 2000;18:1500-1507

Linfoma non-Hodgkin

Patte C et al. The Société Française d'OncologiePédiatrique LMB89 protocol: highly effective multiagentchemotherapy tailored to the tumor burden and initialresponse in 561 unselected children with B-celllymphomas and L3 leukemia. Blood 2001;97:3370-3379

FLUDARABINA Nessuna -Leucemia mieloide acuta in recidivapre-trapianto

-Leucemia linfoblastica acuta inrecidiva

-Anemia di Fanconi


Leucemia mieloide acuta in recidiva pre-trapianto

Styczynski J et al. Fludarabine, treosulfan and etoposidesensitivity and the outcome of hematopoietic stem celltransplantation in childhood acute myeloid leukemia.Anticancer Res 2007;27:1547-1551

Leucemia linfoblastica acuta in recidiva

Gutierrez-Aguirre CH et al. Non-myeloablative stem celltransplantation in patients with relapsed acutelymphoblastic leukemia: results of a multicenter study.Bone Marrow Transplant 2007;40:535-539

Anemia di Fanconi

Wagner JE et al. Unrelated donor bone marrowtransplantation for the treatment of Fanconi anemia. Blood2007;109:2256-2262



- ISG/OSI


- ISG-AIEOP/VHR-EW-2

- NB-AR-01

- AIEOP LAMREC/01

- EICNHL(ALCL-relapse)

- SIOP EUROPEUnresect NB 00

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19

Kornguth DG et al. Fludarabine allows dose reduction fortotal body irradiation in pediatric hematopoietic stem celltransplantation. Int J Radiat Oncol Biol Phys2007;68:1140-1144

Sauer M et al. Substitution of cyclophosfamide andbusulfan by fludarabine, treosulfan and melphalan in apreparation regimen for children and adolescents withShwachman-Diamond syndrome. Bone MarrowTransplant 2007;39:143-147

Sauer M et al. Complete substitution of cyclophosphamideby fludarabine and ATG in a busulfan based preparativeregimen for children and adolescents with beta-Thalassemia. Bone Marrow Transplant 2005;36:383-387

- AIEOP LLA Rec2003

FLUOROURACILE Nessuna -Carcinoma nasofaringeo

-Tumori maligni del fegato



Haimi M et al. Nasopharyngeal carcinoma in the pediatricage group: the northern Israel (Rambam) medical centerexperience, 1989-2004. J Pediatr Hematol Oncol2005;27:510-516

Rodriguez-Galindo C et al. Preradiation chemotherapywith methotrexate, cisplatin, 5-fluorouracil and leucovorinfor pediatric nasopharingeal carcinoma. Cancer2005;103:850-857

Tumori maligni del fegato

Malogolowkin MH et al. Intensified platinum therapy isan ineffective strategy for improving outcome in pediatricpatients with advanced hepatoblastoma. J Clin Oncol2006;24:2879-2884

Katzenstein HM et al. Fibrolamellar hepatocellularcarcinoma in children and adolescents. Cancer2003;97:2006-2012


Varan A et al. Renal cell carcinoma in children:experience of a single center. Nephron Clin Pract


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2007;105:58-61

GEMCITABINA Nessuna -Tumori pediatrici refrattari

-Linfoma di Hodgkin

-Carcinoma midollare del rene

Tumori pediatrici refrattari

Fulfaro F et al. Antiblastic drug combinations withifosfamide: an update. Oncology 2003;65:21-30

Linfoma di Hodgkin

Ozkaynak MF and Jayabose S. Gemcitabine andvinorelbine as a salvage regimen for relapse in Hodgkinlymphoma after autologous hematopoietic stem celltransplantation. Pediatr Hematol Oncol 2004;21:107-113

Carcinoma midollare del rene

Strouse JJ et al. Significant responses to platinum-basedchemotherapy in renal medullary carcinoma. PediatrBlood Cancer 2005;44:407-411

Bell MD. Response to paclitaxel, gemcitabine andcisplatin in renal medullary carcinoma. Pediatr BloodCancer 2006;47:228

- Ep SSG RMS &NRSTS 2005

GEMTUZUMAB Nessuna -Leucemia acuta promielociticarefrattaria o recidivante

Leucemia acuta promielocitica refrattaria orecidivante

Aplenc R et al. Safety and efficacy of gemtuzumabozogamicin in combination with chemotherapy forpediatric acute myeloid leukemia: a report from theChildren's Oncology Group. J Clin Oncol 2008;26:2390-3295

Aribi A et al. Combination therapy with arsenic trioxide,all-trans retinoic acid and gemtuzumab ozogamicin inrecurrent acute promyelocytic leukemia. Cancer2007;109:1355-1359

Corey SI. New agents in the treatment of childhoodleukemias and myelodysplastic syndromes. Curr Oncol

- ICC APL 01

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Rep 2005;7:399-405

IDARUBICINA -Leucemia linfociticaacuta (II linea)

-Leucemia promielocitica acuta


-Tumori del SNC

Leucemia promielocitica acuta

Testi AM et al. GIMEMA-AIEOPAIDA protocol for thetreatment of newly diagnosed acute promyelociticleukaemia (APL) in children. Blood 2005;106:447-453


Liang DCI et al. Improved treatment results for childhoodacute myeloid leukemia in Taiwan. Leukemia2006;20:136-141

Lange BJ et al. Outcomes in CCG-2961, a children'soncology group phase 3 trial for untreated pediatric acutemyeloid leukemia: a report from the children's oncologygroup. Blood 2008;111:1044-1053

Tumori SNC

Dreyer ZE et al. Phase 2 study of idarubicin in pediatricbrain tumors: Pediatric Oncology Group study POG 9237.Neuro Oncol 2003;5:261-267

- AIEOPLAM2002/01-02


- ICC APL 01

- AIEOP ALCL 99

-AIEOP LLA Rec2003

IDROSSIUREA -Leucemia mieloidecronica

-Drepanocitosi

-Talassemia intermedia

Drepanocitosi

Zimmerman SA et al. Hydroxyurea therapy lowerstranscranial Doppler flow velocities in children with sicklecell anemia. Blood 2007;110:1043-1047

De Baun MR et al. Hydroxyurea as secondary prevention forstroke in children with sickle cell anemia. J Pediatr2005;147:560-561

Ware RE et al. Prevention of secondary stroke and resolutionof transfusional iron overload in children with sickle cellanemia using hydroxyurea and phlebotomy. J Pediatr2004;145:346-352

Talassemia intermedia

Dixit A et al. Hydroxyurea in thalassemia intermedia – Apromising therapy. Ann Hematol 2005;84:441-446

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Koren A et al. Response to hydroxyurea therapy in beta-thalassemia. Am J Hematol 2008;83:366-370

IFOSFAMIDE Nessuna -Tumore di Wilms a prognosisfavorevole o metastatico

-Epatoblastoma a prognosi sfavorevoleo metastatico

-Sarcoma di Ewing

-Osteosarcoma

-Rabdomiosarcoma

-Neuroblastoma


-Tumori del SNC

-Linfoma di Hodgkin


-Retinoblastoma

-Carcinoma surrenalico

-Blastoma pleuropolmonare


Ferrari A et al. Adult-type soft tissue sarcomas in pediatricage patients: experience at the Istituto Nazionale Tumoriin Milan. J Clin Oncol 2005;23:4021-4030

Tumori del SNC

Burzynski SR. Treatments for astrocytic tumors inchildren: current and emerging strategies. Paediatr Drugs2006;8:167-168

Tekautz TM et al. Atypical teratoid/rhabdoid tumors(ATRT): improved survival in children 3 years age andolder with radiation therapy and high-dose alchilatorbased chemotherapy J Clin Oncol 2005;23:1491-1499

Linfoma di Hodgkin

Schellong G et al. Salvage therapy of progressive andrecurrent Hodgkin's disease: results from a multicenter studyof the pediatric DAL/GPOH-HD study group. J Clin Oncol2005;23:6181-6189

Linfoma non-Hodgkin

Spreafico F et al. Intensive, very short-term chemotherapy foradvanced Burkitt's lymphoma in children. J Clin Oncol2002;20:2783-2788

Voûte PA et al. Ifosfamide in the treatment of pediatricmalignancies. Semin Oncol 1996;23:8-11

Seidemann K et al. Short-pulse B-non-Hodgkin lymphoma-type chemotherapy is efficacious treatment for pediatricanaplastic large cell lymphoma: a report of the Berlin-Frankfurt-Münster Group Trial NHL-BFM 90. Blood2001;97:3699-3706

Retinoblastoma

- AIEOP EsPhALL

- AIEOP ALCL 99

- AIEOP LNH 97

- AIEOP LH 2004

- ISG/OSI

- ISG/SSG III

- ISG/SSG IV

- AIEOPT. Wilms 2003

- AIEOP RB 05


- ISG AIEOP/VHR-EW-2


- AIEOP TCG 2004

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De Aguirre Neto JC et al. Retinoblastoma in children olderthan 5 years of age. Pediatr Blood Cancer 2007;48:292-295


Imataki O et al. Intensive multimodality therapy includingpaclitaxel and reduced-intensity allogeneic hematopoieticstem cell transplantation in the treatment of adrenal cancerwith multiple metastases. Int J Clin Oncol 2006;11:156-158

Blastoma pleuropolmonare

Büyükavci M et al. An aggressive childhood tumormimicking pleural empyema: pleuropulmonary blastoma. JPediatr Hematol Oncol 2006;28:257-259

IMATINIB -Leucemia mieloidecronica Ph+ alla diagnosi oin crisi blastica

-Leucemia linfoblastica acuta Ph+



-Tumori stromali gastrointestinali(GIST)

Leucemia linfoblastica acuta Ph+

Stubbs MC and Armstrong SA. FLT3 as a therapeutictarget in childhood acute leukaemia. Curr Drug Targets2007;8:703-714

Fuster JL et al. Imatinib mesylate in combination withchemotherapy in four children with de novo and advancedstage Philadelphia chromosome-positive acutelymphoblastic leukemia. Haematologica 2007;92:1723-1724


Goemans BF et al. Mutations in KIT and RAS arefrequent events in pediatric core-binding factor acutemyeloid leukemia. Leukemia 2005;19:1536-1542

Corey SI. New agents in the treatment of childhoodleukemias and myelodysplastic syndromes. Curr OncolRep 2005;7:399-405

Skolnik JM. Tyrosine kinase inhibitors in pediatricmalignancies. Cancer Invest 2007;18:1-7

- AIEOP EsPhALL

- AIEOP LLAREC 2003

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Sindromi mielodisplastiche

Bierings IM et al. Stem cell transplantation in pediatricleukemia and mielodisplasia: state of art and currentchalleges. Curr Stem Cell Res Ther 2007;2:53-63

Tumori stromali gastrointestinali (GIST)

Sauseng W et al. Clinical, radiological and pathologicalfindings in four children with gastrointestinal stromaltumors of the stomach. Pediatr Hematol Oncol2007;24:209-219

Skolnik JM and Adamson PC. Tyrosine kinase inhibitorsin pediatric malignancies. Cancer Invest 2007;18:1-7

INTERFERONE ALFA-2B

Nessuna -Carcinoma del rene a cellule chiare

-Anemia diseritropoietica

-Leucemia mieloide cronica

-Neuroblastoma

-Nefroblastoma



Anemia diseritropoietica

Marwaha RK et al. Interferon therapy in congenitaldyserythropoietic anemia type I/II. Pediatr Hematol Oncol2005;22:133-138

Yarali N et al. Successful management of congenitaldyserythropoietic anemia type I with interferon alpha in achild. Pediatr Hematol Oncol 2005;22:265-270

Leucemia mieloide cronica

Millot F et al. Results of a phase II trial testing interferon-alfa 2B and cytarabine in children and adolescents withchronic myelogenous leukaemia. Pediatric Blood Cancer2006;47:555-559

Neuroblastoma e Nefroblastoma

Adamson PC et al. A phase 2 trial of all-trans-retinoic acidin combination with interferon-alpha 2a in children with


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recurrent neuroblastoma or Wilms tumor: a pediatriconcology branch, NCI and children's oncology groupstudy. Pediatr Blood Cancer 2007;49:661-665

INTERLEUCHINA-2 Nessuna -Leucemia mieloide acuta

-Neuroblastoma

-Sarcomi ossei

-Nefroblastoma


-Melanoma


Lange BJ et al. Outcomes in CCG-2961, a Children'sOncology Group Phase 3 Trial for untreated pediatricacute myeloid leukemia: a report from the Children'sOncology Group. Blood 2008;111:1044-1053

Neuroblastoma

Osenga KL et al. A phase I clinical trial of the hu14.18-IL2 (EMD 273063) as a treatment for children withrefractory or recurrent neuroblastoma and melanoma: astudy of the Children's Oncology Group. Clin Cancer Res2006;12:1750-1759

Sarcomi ossei

Luksch R et al. Immunomodulation in a treatmentprogram including pre- and post-operative interleukin-2and chemotherapy for childhood osteosarcoma. Tumori2003;89:263-268

Nefroblastoma

Schwinger W et al. Feasibility of high-dose interleukin-2in heavily pretreated pediatric cancer patients. Ann Oncol2005;16:1199-1206


Selle B et al. Population-based study of renal cellcarcinoma in children in Germany, 1980-2005: morefrequently localized tumors and underlying disorderscompared with adult counterparts. Cancer 2006;107:2906-2914



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Melanoma

Osenga KL et al. A phase I clinical trial of the hu14.18-IL2 (EMD 273063) as a treatment for children withrefractory or recurrent neutroblastoma and melanoma: astudy of the Children’ Oncology Group. Clin Cancer Res2006;12:1750-1759

Schwinger W et al. Feasibility of high-dose interleukin 2in heavily pre-treated pediatric cancer patients. Ann Oncol2005;16:1199-1206

IRINOTECANO Nessuna -Rabdomiosarcoma recidivante

-Sarcomi della famiglia di Ewingrecidivanti


-Tumori del SNC

-Tumori solidi recidivanti o refrattari


Bisogno G et al. Phase II study of a protracted irinotecanschedule in children with refractory or recurrent soft tissuesarcoma. Cancer 2006;106:703-707

Gupta AA and Pappo AS. New drugs for the treatment ofmetastatic or refractory soft tissue sarcomas in children.Future Oncol 2006;2:675-685

Tumori del SNC

Mora J et al. Successful treatment of childhoodintramedullary spinal cord astrocytomas with irinotecanand cisplatin. Neuro Oncol 2007;9:39-46

Tumori solidi recidivanti o refrattari

Vassal G et al. Phase II trial of irinotecan in children withrelapsed or refractory rhabdomyosarcoma: a joint study ofthe French Society of Pediatric Oncology and the UnitedKingdom Children's Cancer Study Group. J Clin Oncol

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2007;25:356-361

Bomgaars L et al. A phase I study of irinotecanadministered on a weekly schedule in pediatric patients.Pediatr Blood Cancer 2006;46:50-55

MELFALAN -Neuroblastoma (stadiavanzati)

-Sarcomi della famiglia di Ewing acattiva prognosi in associazione abusulfano nei regimi mieloablativi

-Tumori del SNC


-Anemia aplastica


-Linfoistiocitosi emofagocitica

-Nefroblastoma

-Sindrome di Shwachman-Diamond

-Retinoblastoma


Tumori del SNC

Pérez-Martínez A et al. High-dose chemotherapy withautologous stem cell rescue as first line of treatment inyoung children with medulloblastoma and supratentorialprimitive neuroectodermal tumors. J Neurooncol2004;67:101-106


Lang P et al. Haploidentical stem cell transplantation inpatients with pediatric solid tumors: preliminary results ofa pilot study and analysis of graft versus tumor effects.Klin Padiatr 2006;218:321-326

Anemia aplastica e Sindromi mielodisplastiche

Stary J et al. Stem cell transplant for aplastic anemia andmyelodysplastic syndrome. Bone Marrow Transplant2005;35:813-816

Linfoistiocitosi emofagocitica

Cesaro S et al. Successful engraftment and stable fulldonor chimerism after myeloablation with thiotepa,fludarabine and melphalan and CD34-selected peripheralallogeneic stem cell transplantation in hemophagocyticlymphohistiocytosis. Am J Hematol 2003;72:143-146

Nefroblastoma

Campbell AD et al. Treatment of relapsed Wilms' tumorwith high-dose therapy and autologous hematopoieticstem-cell rescue: the experience at Children's MemorialHospital. J Clin Oncol 2004;22:2885-2890

Sindrome di Shwachman-Diamond

- AIEOP LAM2002/01-02

- AIEOP LAMREC/01

- AIEOP LLAREC 2003

- INTERINFAN 06

- NB-AR-01

- SIOP- AIEOP NBInfant



- ISG- AIEOP/VHR-EW-2

- AIEOP SNC95-01 < 3 a

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Sauer M et al. Substitution of cyclophosphamide andbusulfan by fludarabine, treosulfan and melphalan in apreparative regimen for children and adolescents withShwachman-Diamond syndrome. Bone MarrowTransplant 2007;39:143-147

Retinoblastoma

Matsubara H et al. A multidisciplinary treatment strategythat includes high-dose chemotherapy for metastaticretinoblastoma without CNS involvement. Bone MarrowTransplant 2005;35:763-766


Izaki S et al. Long-term follow-up of busulfan, etoposideand nimustine hydrochloride (ACNU) or melphalan asconditioning regimens for childhood acute leukemia andlymphoma. Int J Hematol 2007;86:253-260

Puig N et al. Morbidity and transplant-related mortality ofCBV and BEAM preparative regimens for patients withlymphoid malignancies undergoing autologous stem-celltransplantation. Leuk Lymphoma 2006;47:1488-1494

MERCAPTOPURINA Nessuna -Linfoma linfoblastico dell’infanzia




-Leucemia acuta promielocitica

-Malattia di Rosai-Dorfman


Chauvenet AR et al. Antimetabolite therapy for lesser-riskB-lineage acute lymphoblastic leukemia of childhood: areport from Children's Oncology Group Study P9201.Blood 2007;110:1105-1111

Winter SS et al. Antimetabolite-based therapy inchildhood T-cell acute lymphoblastic leukemia: a report ofPOG study 9296. Pediatr Blood Cancer 2006;46:179-186


Perel Y et al. Treatment of childhood acute myeloblasticleukemia: dose intensification improves outcome andmaintenance therapy is of no benefit--multicenter studiesof the French LAME (Leucémie Aiguë MyéloblastiqueEnfant) Cooperative Group. Leukemia 2005;19:2082-2089

- AIEOP EsPhALL

- AIEOP LLA2002

- AIEOP LLAREC 2003


- INTERINFAN 06


- EURO LB-02

- AIEOP LNH 97

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Leucemia acuta promielocitica

Dvorak CC et al. Reinduction of relapsed acutepromyelocytic leukemia with ATRA and low doseantimetabolite-based chemotherapy. Pediatr Blood Cancer2007;48:582-585

Malattia di Rosai-Dorfman

Tasso M et al. Sinus histiocytosis with massivelymphadenopathy (Rosai-Dorfman disease) treated with 2-chlorodeoxyadenosine. Pediatr Blood Cancer2006;47:612-615

- LCH-S-2005

- LCH III 2001

METOTRESSATO -Leucemia linfoblasticaacuta



-Gliomi ad alto grado

-Tumori neuroectodermici primitivicerebrali

-Fibromatosi aggressiva


-Osteosarcoma

-Medulloblastoma


Osteosarcoma

Longhi A et al. Primary bone osteosarcoma in thepediatric age: state of the art. Cancer Treat Rev2006;32:423-436

Medulloblastoma

Yoshimura J et al. Intrathecal chemotherapy for refractorydisseminated medulloblastoma. Childs Nerv Syst2008;24:581-585

Grill J et al. Treatment of medulloblastoma withpostoperative chemotherapy alone: an SFOP prospectivetrial in young children. Lancet Oncol 2005;6:573-580


Rodriguez-Galindo C et al. Preradiation chemotherapywith methotrexate, cisplatin, 5-fluorouracil and leucovorinfor pediatric nasopharyngeal carcinoma. Cancer2005;103:850-857

- AIEOP EsPhALL

- AIEOP LLA 2002

- AIEOP ALCL 99

- AIEOP LLA REC2003

- INTERINFAN 06


- AIEOP LNH 97

- LCH-S-2005

- LCH III 2001


- AIEOP SNC 99

- AIEOP SNC

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30

95-01

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31

Berlin-Frankfurt-Münster 93. J Clin Oncol 2001;19:2705-2713

Dahl GV et al. Mitoxantrone, etoposide and cyclosporinetherapy in pediatric patients with recurrent or refractoryacute myeloid leukemia. J Clin Oncol 2000;18:1867-1875

Leucemia acuta promielocitica

Testi AM et al. GIMEMA-AIEOPAIDA protocol for thetreatment of newly diagnosed acute promyelocyticleukemia (APL) in children. Blood 2005;106:447-453

OXALIPLATINO Nessuna -Tumori solidi refrattari Tumori solidi refrattariSpunt SL et al. Phase I clinical trial of oxaliplatin inchildren and adolescents with refractory solid tumors. JClin Oncol 2007;25:2274-2280

Fouladi M et al. Phase II study of oxaliplatin in childrenwith recurrent or refractory medulloblastoma,supratentorial primitive neuroectodermal tumors andatypical teratoid rhabdoid tumors: a pediatric brain tumorconsortium study. Cancer 2006;107:2291-2297

PACLITAXEL Nessuna -Leucemia refrattaria

-Neuroblastoma disseminato


-Carcinoma midollare del rene

Leucemia refrattaria

Horton TM et al. A Phase 1 and pharmacokinetic clinical trialof paclitaxel for the treatment of refractory leukemia inchildren: a Children's Oncology Group study. Pediatr BloodCancer 2008;50:788-792

Neuroblastoma disseminato

Kretschmar CS et al. Response to paclitaxel, topotecan andtopotecan-cyclophosphamide in children with untreateddisseminated neuroblastoma treated in an upfront phase IIinvestigational window: a pediatric oncology group study. JClin Oncol 2004;22:4119-4126

Surico G et al. New paclitaxel-cisplatin based chemotherapy


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regimen for advanced stage, recurrent or refractoryneuroblastoma-preliminary report. Med Pediatr Oncol2003;40:130-132

Linfoma non-Hodgkin

Berrak SG et al. Partial intestinal obstruction due to childhoodrefractory non-Hodgkin's lymphoma, successfully treatedwith taxol. Eur J Pediatr Surg 2003;13:276-279

Carcinoma midollare del rene

Strouse JJ et al. Significant responses to platinum-basedchemotherapy in renal medullary carcinoma. Pediatr BloodCancer 2005;44:407-411

PROCARBAZINA Nessuna -Linfoma di Hodgkin

-Tumori del SNC

Linfoma di Hodgkin

Fermé C et al. Chemotherapy plus involved-field radiationin early-stage Hodgkin's disease. N Engl J Med2007;357:1916-1927

Eich HT et al. A Contribution to solve the problem of theneed for consolidative radiotherapy after intensivechemotherapy in advanced stages of Hodgkin's lymphoma-analysis of a quality control program initiated by theradiotherapy reference center of the German HodgkinStudy Group (GHSG). Int J Radiat Oncol Biol Phys2007;69:1187-1192

Dann EJ et al. Risk-adapted BEACOPP regimen canreduce the cumulative dose of chemotherapy for standardand high-risk Hodgkin lymphoma with no impairment ofoutcome. Blood 2007;109:905-909

Tumori del SNC

Bruggers CS and Greene D. A phase 2 feasibility study ofsequential, dose intensive chemotherapy to treatprogressive low-grade gliomas in children. J PediatrHematol Oncol 2007;29:602-607

-AIEOP LH 2004

RITUXIMAB Nessuna -Disordini linfoproliferativi CD20+ Disordini linfoproliferativi CD20+

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33

-Porpora trombocitopenica idiopatica(III linea)

-Citopenie autoimmuni

-Neuroblastoma e opsoclono-mioclono

Attias D and Weitzman S. The efficacy of rituximab in high-grade pediatric B-cell lymphoma/leukemia: a review ofavailable evidence. Curr Opin Pediatr 2008;20:17-22

Trappe RU et al. Salvage therapy for relapsed post-transplantlymphoproliferative disorders (PTLD) with a secondprogression of PTLD after upfront chemotherapy: the role ofsingle-agent rituximab. Transplantation 2007;84:1708-1712

Comoli P et al. Preemptive therapy of EBV-relatedlymphoproliferative disease after pediatric haploidenticalstem cell transplantation. Am J Transplant 2007;7:1648-1655

Porpora trombocitopenica idiopatica (III linea)

Arnold DM and Kelton JG. Current options for thetreatment of idiopathic thrombocytopenic purpura. SeminHematol 2007;44:12-23

Rüfer A et al. Rituximab for acute plasma-refractorythrombotic thrombocytopenic purpura. A case report andconcise review of the literature. Swiss Med Wkly2007;137:518-524

Citopenie autoimmuni

Kim JJ et al. Rituximab for the treatment of autoimmunecytopenias in children with immune deficiency. Br JHaematol 2007;138:94-96

Bader-Meunier B et al. Rituximab therapy for childhoodEvans syndrome. Haematologica 2007;92:1691-1694

Zecca M et al. Anti-CD20 monoclonal antibody for thetreatment of severe, immune-mediated, pure red cellaplasia and hemolytic anemia. Blood 2001;97:3995-3997

Neuroblastoma e opsoclono-mioclono

Burke MJ and Cohn SL. Rituximab for treatment ofopsoclonus-myoclonus syndrome in neuroblastoma.Pediatr Blood Cancer 2008;50:679-680

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34

Bell J et al. Response to rituximab in a child withneuroblastoma and opsoclonus-myoclonus. Pediatr BloodCancer 2008;50:370-371

Yao G et al. A systematic review and economic model ofthe clinical and cost-effectiveness of immunosuppressivetherapy for renal transplantation in children. HealthTechnol Assess 2006;10:1-157

SORAFENIB Nessuna -Carcinoma del rene a cellule chiare Carcinoma del rene a cellule chiareGrandinetti CA and Goldspiel BR. Sorafenib andsunitinib: novel targeted therapies for renal cell cancer.Pharmacotherapy 2007;27:1125-1144

SUNITINIB Nessuna -Carcinoma del rene a cellule chiare Carcinoma del rene a cellule chiareGrandinetti CA and Goldspiel BR. Sorafenib and sunitinib:novel targeted therapies for renal cell cancer.Pharmacotherapy 2007;27:1125-1144

TALIDOMIDE Nessuna -Glioblastoma multiforme

-Malattia cronica da reazione deltrapianto contro l’ospite (ChronicGraft versus Host Disease)

-Melanoma oculare

-Tumori refrattari

Glioblastoma multiforme

Turner CD et al. Phase II study of thalidomide andradiation in children with newly diagnosed brain stemgliomas and glioblastoma multiforme. J Neurooncol2007;82:95-101

Malattia cronica da reazione del trapianto control’ospite (Chronic Graft versus Host Disease)

Kulkarni S et al. Thalidomide after allogeneichaematopoietic stem cell transplantation: activity inchronic but not in acute graft-versus-host disease. BoneMarrow Transplant 2003;32:165-170

Cole CH et al. Thalidomide in the management of chronicgraft-versus-host disease in children following bonemarrow transplantation. Bone Marrow Transplant1994;14:937-942

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Melanoma oculare

Soni S et al. Treatment of pediatric ocular melanoma withhigh-dose interleukin-2 and thalidomide. J PediatrHematol Oncol 2002;24:488-491

Tumori refrattari

Kieran MW et al. A feasibility trial of antiangiogenic(metronomic) chemotherapy in pediatric patients withrecurrent or progressive cancer. J Pediatr Hematol Oncol2005;27:573-581

Bessmertny O and Pham T. Thalidomide use in pediatricpatients. Ann Pharmacother 2002;36:521-525

TAMOXIFENE Nessuna -Fibromatosi aggressiva

-Tumori ricorrenti del SNC

-Tumori desmoidi resistenti oinoperabili

Tumori ricorrenti del SNC

Ben Arush MW et al. Clinical and radiographic responsein three children with recurrent malignant cerebral tumorswith high-dose tamoxifen. Pediatr Hematol Oncol1999;16:245-250

Tumori desmoidi resistenti o inoperabili

Lackner H et al. Multimodal treatment of children withunresectable or recurrent desmoid tumors: an 11-yearlongitudinal observational study. J Pediatr Hematol Oncol2004;26:518-522


TEMOZOLOMIDE Nessuna -Tumori del SNC (III linea) Tumori del SNC (III linea)Nicholson HS et al. Phase 2 study of temozolomide inchildren and adolescents with recurrent central nervoussystem tumors: a report from the Children's OncologyGroup. Cancer 2007;110:1542-1550

De Sio L et al. Temozolomide in resistant or relapsedpediatric solid tumors. Pediatr Blood Cancer 2006;47:30-

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36

Korones DN et al. Temozolomide and oral VP-16 forchildren and young adults with recurrent or treatment-induced malignant gliomas. Pediatr Blood Cancer2006;47:37-41

TENIPOSIDE Nessuna -Leucemia linfoblastica acuta



-Retinoblastoma


Winter SS et al. Antimetabolite-based therapy inchildhood T-cell acute lymphoblastic leukemia: a report ofPOG study 9296. Pediatr Blood Cancer 2006;46:179-186

Linfoma non-Hodgkin

Millot F et al. Value of high-dose cytarabine duringinterval therapy of a Berlin-Frankfurt-Munster-basedprotocol in increased-risk children with acutelymphoblastic leukemia and lymphoblastic lymphoma:results of the European Organization for Research andTreatment of Cancer 58881 randomized phase III trial. JClin Oncol 2001;19:1935-1942

Amylon MD et al. Intensive high-dose asparaginaseconsolidation improves survival for pediatric patients withT cell acute lymphoblastic leukemia and advanced stagelymphoblastic lymphoma: a Pediatric Oncology Groupstudy. Leukemia 1999;13:335-342



Retinoblastoma

Antoneli CB et al. The addition of ifosfamide/etoposide tocisplatin/teniposide improves the survival of children with

- AIEOP LLAREC 2003

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retinoblastoma and orbital involvement. J Pediatr HematolOncol 2007;29:700-704

TIOGUANINA -Leucemia linfoblasticaacuta



-Gliomi a basso grado di malignità

Linfoma non-Hodgkin

Chantada GL et al. Results of a BFM-based protocol forthe treatment of childhood B-non-Hodgkin's lymphomaand B-acute lymphoblastic leukemia in Argentina. MedPediatr Oncol 1997;28:333-341

Gliomi a basso grado di malignità

Heath JA et al. Chemotherapy for progressive low-gradegliomas in children older than ten years: the Dana-Farberexperience. Pediatr Hematol Oncol 2003;20:497-504

Lancaster DL et al. Tolerance of nitrosurea-basedmultiagent chemotherapy regime for low-grade pediatricgliomas. J Neurooncol 2003;63:289-294

- AIEOP LLA 2002


- AIEOP LNH 97

- EURO LB-02


- INTERINFAN 06

- AIEOP LAMREC/01

TIOTEPA Nessuna -Regimi mieloablativi dei tumoricerebrali

-Sindrome di Evans

-Tumori della famiglia del sarcoma diEwing

-Neuroblastoma

-Anemia aplastica grave



Sindrome di Evans

Urban C et al. Successful unrelated cord bloodtransplantation in a 7-year-old boy with Evans syndromerefractory to immunosuppression and double autologousstem cell transplantation. Eur J Haematol 2006;76:526-530


Burdach S and Jürgens H. High-dose chemoradiotherapy(HDC) in the Ewing family of tumors (EFT). Crit RevOncol Hematol 2002;41:169-189

Neuroblastoma

Lang P et al. Retransplantation with stem cells frommismatched related donors after graft rejection in pediatric


- ISG-AIEOP/VHR-EW 1e 2

- AIEOP TCG 2004

- AIEOP SNC95-01

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patients. Blood Cells Mol Dis 2008;40:33-39

Kamani N et al. A study of thiotepa, etoposide andfractionated total body irradiation as a preparative regimenprior to bone marrow transplantation for poor prognosispatients with neuroblastoma. Bone Marrow Transplant1996;17:911-916

Anemia aplastica grave

Urban C et al. Non-radiotherapy conditioning with stemcell transplantation from alternative donors in childrenwith refractory severe aplastic anemia. Bone MarrowTransplant 2005;35:591-594

Sindromi mielodisplastiche

Strahm B et al. Reduced intensity conditioning inunrelated donor transplantation for refractory cytopenia inchildhood. Bone Marrow Transplant 2007;40:329-333


Cheuk DK et al. Autologous hematopoietic stem celltransplantation for high-risk brain tumors in children. JNeurooncol 2008;86:337-347

Urban C et al. Non-radiotherapy conditioning with stemcell transplantation from alternative donors in childrenwith refractory severe aplastic anemia. Bone MarrowTransplant 2005;35:591-594

TOPOTECANO Nessuna -Neuroblastoma resistente alla terapiadi prima linea

-Sarcoma di Ewing resistente allaterapia di prima linea


Bernbeck B et al. Serial intense chemotherapy combiningtopotecan, etoposide, carboplatin and cyclophosphamide(TECC) followed by autologous hematopoietic stem cellsupport in patients with high risk soft tissue sarcoma

- NB-AR- 01

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-Rabdomiosarcoma resistente allaterapia di prima linea


-Osteosarcoma

-Tumori della famiglia del sarcoma diEwing (recidivanti o resistenti allaterapia di I linea)

(STS). Klin Padiatr 2007;219:318-322

Osteosarcoma e Tumori della famiglia del sarcoma diEwing (recidivanti o resistenti alla terapia di I linea)

Hawkins DS et al. Topotecan by 21-day continuousinfusion in children with relapsed or refractory solidtumors: a Children's Oncology Group study. Pediatr BloodCancer 2006;47:790-794

VINBLASTINA -Istiocitosi a cellule diLangerhans


-Linfoma di Hodgkin

Fibromatosi aggressiva

Imashuku S et al. Treatment of neurodegenerative CNSdisease in Langerhans cell histiocytosis with acombination of intravenous immunoglobulin andchemotherapy. Pediatr Blood Cancer 2008;50:308-311

Skapek SX et al. Vinblastine and methotrexate fordesmoid fibromatosis in children: results of a PediatricOncology Group Phase II Trial. J Clin Oncol2007;25:501-506

Linfoma di Hodgkin

Fermé C et al. Chemotherapy plus involved-field radiationin early-stage Hodgkin's disease. N Engl J Med2007;357:1916-1927

Chow LM et al. Survival and late effects in children withHodgkin's lymphoma treated with MOPP/ABV and low-dose, extended-field irradiation. J Clin Oncol2006;24:5735-5741

- AIEOP LH 2004

- AIEOP ALCL 99

- LCH III 2001

- LCH-S-05


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VINCRISTINA -Neuroblastoma

-Nefroblastoma

-Rabdomiosarcoma

-Leucemia linfoblasticaacuta

-Tumori del SNC

-Linfoma di Hodgkin enon-Hodgkin

-Sarcoma di Ewing



-Retinoblastoma

-Emangiopericitoma

-Sindrome di Evans


-Blastoma pleuropolmonare


-Sindrome PHACES

-Sindrome di Kasabach-Merritt

-Sarcomi (non rabdomiosarcomi)


Bernstein M et al. Ewing's sarcoma family of tumors:current management. Oncologist 2006;11:503-519

Navid F et al. Concomitant administration of vincristine,doxorubicin, cyclophosphamide, ifosfamide and etoposidefor high-risk sarcomas: the St. Jude Children's ResearchHospital experience. Cancer 2006;106:1846-1856

Miser JS et al. Treatment of metastatic Ewingsarcoma/primitive neuroectodermal tumor of bone:evaluation of increasing the dose intensity ofchemotherapy- a report from the Children's OncologyGroup. Pediatr Blood Cancer 2007;49:894-900

Retinoblastoma

Shields CL et al. Chemoreduction plus focal therapy forretinoblastoma: factors predictive of need for treatmentwith external beam radiotherapy or enucleation. Am JOphthalmol 2002;133:657-664

Antoneli CB et al. Treatment of retinoblastoma patientswith chemoreduction plus local therapy: experience of theAC Camargo Hospital, Brazil. J Pediatr Hematol Oncol2006;28:342-345

Emangiopericitoma


Sindrome di Evans

Urban C et al. Successful unrelated cord bloodtransplantation in a 7-year-old boy with Evans syndromerefractory to immunosuppression and double autologousstem cell transplantation. Eur J Haematol 2006;76:526-

- AIEOP LLA 2002

- AIEOP EsPhALL

- AIEOP LLAREC Ph+ 2002


- INTERINFAN 06

- AIEOP LH 2004

- AIEOP LNH 97

- EURO LB-02

- NB-AR-01


- AIEOP NBrec/res 00




- ISG-AIEOP/VHR-EW 1e 2

- AIEOPT.Wilms 2003

- AIEOP/SICP

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530



Nakamura RA et al. High-dose-rate brachytherapy as partof a multidisciplinary treatment of nasopharyngeallymphoepithelioma in childhood. Cancer 2005;104:525-531

Blastoma pleuropolmonare

Priest JR et al. Type I pleuropulmonary blastoma: a reportfrom the International Pleuropulmonary BlastomaRegistry. J Clin Oncol 2006;24:4492-4498

Fibromatosi aggressiva

Alebouyeh M et al. Aggressive intra-abdominalfibromatosis in children and response to chemotherapy.Pediatr Hematol Oncol 2005;22:447-451

Buitendijk S et al. Pediatric aggressive fibromatosis: aretrospective analysis of 13 patients and review ofliterature. Cancer 2005;104:1090-1099

Sindrome PHACES

Herrero Hernández A et al. Successful treatment withvincristine in PHACES syndrome. Oncol Clin Transl2007;9:262-263

Syndrome di Kasabach-Merritt

Taki M et al. Successful treatment with vincristine of aninfant with intractable Kasabach-Merritt syndrome.Pediatr Int 2006;48:82-84

Hauer J et al. Effective treatment of kaposiformhemangioendotheliomas associated with Kasabach-Merrittphenomenon using four-drug regimen. Pediatr BloodCancer 2007;49:852-854

TREP 2005

- AIEOP SNC 99

- AIEOP SNC95-01 < 3a

- AIEOP2° Ependi 03

- HIT-SIOP PNET 4

- SIOP LGG 2004

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Sarcomi (non rabdomiosarcomi)

Pappo AS et al. Phase II trial of neoadjuvant vincristine,ifosfamide and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents withadvanced-stage nonrhabdomyosarcomatous soft tissuesarcomas: a Pediatric Oncology Group Study. J ClinOncol 2005;23:4031-4038

Nathan PC et al. Adjuvant chemotherapy for the treatmentof advanced pediatric nonrhabdomyosarcoma soft tissuesarcoma: the National Cancer Institute experience. PediatrBlood Cancer 2005;44:449-454

VINDESINA -Leucemia linfoblasticaacuta resistente


-Linfomi

-Osteosarcomi


Reiter A et al. Chemotherapy in 998 unselected childhoodacute lymphoblastic leukemia patients. Results andconclusions of the multicenter trial ALL-BFM 86. Blood1994;84:3122-3133

Linfomi

Fermé C et al. A weekly regimen with dose escalation ofdoxorubicin for patients with advanced Hodgkin'slymphoma: results of a phase II study of the Grouped'Etudes des Lymphomes de l'Adulte (GELA). LeukLymphoma 2007;48:691-698

Ueda T et al. Administration of vindesine sulfate for thetreatment of malignant hematological tumors. Gan ToKagaku Ryoho 1982;9:306-315

Osteosarcoma

Philip T et al. High-dose methotrexate and HELP[Holoxan (ifosfamide), eldesine (vindesine), platinum]-doxorubicin in non-metastatic osteosarcoma of theextremity: a French multicentre pilot study. FédérationNationale des Centres de Lutte contre le Cancer andSociété Française d'Oncologie Pédiatrique. Ann Oncol1999;10:1065-1071

- AIEOP LNH 97

- AIEOP EsPhALL

- AIEOP ALCL 99

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VINORELBINA Nessuna -Fibromatosi aggressiva

-Rabdomiosarcoma

-Tumori del SNC ad alto grado dimalignità

-Linfoma di Hodgkin recidivante

-Tumore desmoplastico a piccolecellule

Tumori del SNC ad alto grado di malignità

Johansen M et al. Phase I evaluation of oral andintravenous vinorelbine in pediatric cancer patients: areport from the Children's Oncology Group. Clin CancerRes 2006;12:516-522

Linfoma di Hodgkin recidivante

Ozkaynak MF and Jayabose S. Gemcitabine andvinorelbine as a salvage regimen for relapse in Hodgkinlymphoma after autologous hematopoietic stem celltransplantation. Pediatr Hematol Oncol 2004;21:107-113

Tumore desmoplastico a piccole cellule

Ferrari A et al. Response to vinorelbine and low-dosecyclophosphamide chemotherapy in two patients withdesmoplastic small round cell tumor. Pediatr BloodCancer 2007;49:864-866

Johansen M et al. Phase I evaluation of oral andintravenous vinorelbine in pediatric cancer patients: areport from the Children's Oncology Group. Clin CancerRes 2006;12:516-522


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