ESTENSIONE DELLE INDICAZIONI SULLA BASE DELLA DELIBERA AIFA (corsivo) E DI NUOVE EVIDENZE SCIENTIFICHE (grassetto)

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1 Allegato A NOME COMPOSTO ANASTROZOLO -Carcinoma della mammella in donne in post-menopausa ARSENICO TRIOSSIDO -Trattamento adiuvante negli stadi precoci, estrogeno-positivi -Leucemia promielocitica acuta -Trattamento del tumore della mammella maschile -Trattamento neoadiuvante delle forme localmente avanzate del carcinoma della mammella -Mieloma multiplo refrattario o recidivante -Sindromi mielodisplastiche -Leucemia/Linfomi a cellule T Trattamento neoadiuvante nelle forme localmente avanzate del carcinoma della mammella Viola G et al. Neoadjuvant endocrine therapy for locally advanced breast cancer. Clin Ter 2007;158: Freedman OC et al. Using aromatase inhibitors in the neoadjuvant setting: evolution or revolution? Cancer Treat Rev 2005;31:1-17 Dixon JM et al. Neoadjuvant endocrine therapy of breast cancer: a surgical perspective. Eur J Cancer 2002;38: Mieloma multiplo refrattario o recidivante Berenson JR et al. Efficacy and safety of melphalan, arsenic trioxide and ascorbic acid combination therapy in patients with relapsed or refractory multiple myeloma: a prospective, multicentre, phase II, single-arm study. Br J Haematol 2006;135: Berenson JR et al. A phase I/II study of arsenic trioxide/bortezomib/ascorbic acid combination therapy for the treatment of relapsed or refractory multiple myeloma. Clin Cancer Res 2007;13: Wu KL et al. Phase II multicenter study of arsenic trioxide, ascorbic acid and dexamethasone in patients with relapsed or refractory multiple myeloma. Haematologica 2006;91: Sindromi mielodisplastiche Schiller GJ et al. Phase II multicenter study of arsenic trioxide in patients with myelodysplastic syndromes. J Clin Oncol 2006;24: Vey N et al. Arsenic trioxide in patients with myelodysplastic syndromes: a phase II multicenter study. J Clin Oncol 2006;24: Leucemia/Linfomi a cellule T Ishitsuka K et al. Therapeutic potential of arsenic trioxide with or without interferon-alpha for relapsed/refractory adult T-cell leukemia/lymphoma. Haematologica 2007;92: Hermine O et al. Phase II trial of arsenic trioxide and alpha interferon in patients with relapsed/refractory adult T-cell 1

2 BLEOMICINA Attività metaplastiche di alcuni tessuti (epiteli malpighiani ad alta cheratinizzazione) -In regimi di associazione nel linfoma di Hodgkin -Da solo o in associazione, nei tumori solidi -Cicli di combinazione per linfomi non Hodgkin -Tumore dell ovaio a cellule germinali -Carcinoma squamoso della cervice uterina -Neoplasie non melanomatose della cute BORTEZOMIB -Mieloma multiplo -Linfoma non-hodgkin indolente -Linfoma non-hodgkin mantellare -Sindromi mielodisplastiche leukemia/lymphoma. Hematol J 2004;5: Cicli di combinazione per linfomi non-hodgkin Gobbi PG et al. The role of dose size in a chemotherapy regimen (ProMECE-CytaBOM) for the first-line treatment of large B-cell lymphomas: a randomized trial by the Gruppo Italiano Studio Linfomi (GISL). Ann Oncol 2006;17: Tumore dell ovaio a cellule germinali Pectasides D et al. Granulosa cell tumor of the ovary. Cancer Treat Rev 2007 [Epub ahead of print] Lu KH et al. Update on the management of ovarian germ cell tumors. J Reprod Med 2005;50: Carcinoma squamoso della cervice uterina Vermorken JB et al. Randomized phase III trial of bleomycin, vindesine, mitomycin-c, and cisplatin (BEMP) versus cisplatin (P) in disseminated squamous-cell carcinoma of the uterine cervix: an EORTC Gynecological Cancer Cooperative Group study. Ann Oncol 2001;12: Smith HO et al. Treatment of advanced or recurrent squamous cell carcinoma of the uterine cervix with mitomycin-c, bleomycin, and cisplatin chemotherapy. Gynecol Oncol 1993;48:11-15 Neoplasie della cute non melanomatose Mishima Y et al. Effect of bleomycin on benign and malignant cutaneous tumours. Acta Derm Venereol 1972;52: Linfoma non-hodgkin indolente e mantellare O'Connor OA et al. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non- Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol 2005;23: Fisher RI et al. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol 2006;24: Kane RC et al. Bortezomib for the treatment of mantle cell lymphoma. Clin Cancer Res 2007;13:

3 Chen CI et al. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007;25: Treon SP et al. Multicenter clinical trial of bortezomib in relapsed/refractory Waldenstrom's macroglobulinemia: results of WMCTG Trial Clin Cancer Res 2007;13: Goy A et al. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-hodgkin's lymphoma. J Clin Oncol 2005;23: Sindromi mielodisplastiche Terpos E et al. Bortezomib is an effective agent for MDS/MPD syndrome with 5q- anomaly and thrombocytosis. Leuk Res 2007;31: CAPECITABINA -Carcinoma del colon e del retto: adiuvante nello stadio III o in monoterapia nelle forme metastatiche -Tumore della mammella localmente avanzato o metastatico -Tumore dello stomaco avanzato -Carcinomi del colon-retto in fase avanzata o metastatica da sola o in associazione ad altri farmaci antitumorali registrati per questa patologia -Alternativa al fluorouracile dove non si ritenga opportuno o indicato un trattamento infusionale -Carcinoma della mammella localmente avanzato o metastatico in associazione ad altri farmaci antineoplastici registrati in tale patologia Carcinoma del pancreas localmente avanzato o metastatico Boeck S et al. Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mgemox): final results of a multicenter randomized phase II trial in advanced pancreatic cancer. Ann Oncol 2007 [Epub ahead of print] Park BB et al. A phase II trial of gemcitabine plus capecitabine for patients with advanced pancreatic adenocarcinoma. Cancer Chemother Pharmacol 2007;60: Herrmann R et al. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol 2007;25: Carcinoma del pancreas localmente avanzato o metastatico -Carcinoma a cellule renali metastatico in monoterapia Carcinoma a cellule renali metastatico in monoterapia Oevermann K et al. Capecitabine in the treatment of metastatic renal cell carcinoma. Br J Cancer 2000;83: Pagliaro LC et al. Phase II study of capecitabine single-agent therapy in patients with metastatic renal cell carcinoma. Urol Oncol 2006;24: Carcinoma dello stomaco Carcinoma dello stomaco

4 CARBOPLATINO -Carcinoma epiteliale avanzato dell ovaio -Carcinoma epidermoide del distretto cervico-facciale -Carcinoma del polmone a piccole cellule -Teratoma -Carcinoma del colon e del retto (Dukes B/stadio II) per i quali non si ritenga opportuno un trattamento infusionale con fluorouracile o fluorouracile in bolo in associazione con leucovorin -Colangiocarcinoma -Alternativa al cisplatino quando questo è controindicato oppure quando, a parità di efficacia, carboplatino risulti essere meno tossico -Tumori ovarici e polmonari (associato a tassani) -Seminoma -Mesotelioma pleurico -Carcinoma della mammella (da solo o in associazione) -Ad alte dosi nei regimi di condizionamento nel trapianto di cellule staminali emopoietiche -In sostituzione al cisplatino ed in associazione nel salvataggio di linfomi Ajani J. Review of capecitabine as oral treatment of gastric, gastroesophageal, and esophageal cancers. Cancer 2006;107: Carcinoma del colon e del retto (Dukes B/stadio II) Figueredo A et al. Adjuvant therapy for stage II colon cancer after complete resection. Provincial Gastrointestinal Disease Site Group. Cancer Prev Control 1997;1: Feliu J et al. XELOX (capecitabine plus oxaliplatin) as first-line treatment for elderly patients over 70 years of age with advanced colorectal cancer. Br J Cancer 2006;94: Colangiocarcinoma Iyer RV et al. A phase II study of gemcitabine and capecitabine in advanced cholangiocarcinoma and carcinoma of the gallbladder: a single-institution prospective study. Ann Surg Oncol 2007;14: Carcinoma della cervice uterina Tangjitgamol S et al. Paclitaxel and carboplatin for large cell neuroendocrine carcinoma of the uterine cervix. J Obstet Gynaecol Res 2007;33: Lee MY et al. Concurrent radiotherapy with paclitaxel/carboplatin chemotherapy as a definitive treatment for squamous cell carcinoma of the uterine cervix. Gynecol Oncol 2007;104:95-99 Kim K et al. Efficacy of paclitaxel and carboplatin as a regimen for postoperative concurrent chemoradiotherapy of high risk uterine cervix cancer. Gynecol Oncol 2006;101: Glioblastoma multiforme Aoki T et al. Phase II study of nimustine, carboplatin, vincristine, and interferon-beta with radiotherapy for glioblastoma multiforme: experience of the Kyoto Neuro- Oncology Group. J Neurosurg 2006;105: Nakagawa T et al. The combined effects of multiple chemotherapeutic agents for malignant glioma cells. J Neurooncol 2007;84:

5 Hodgkin e non-hodgkin Kim JW et al. Current management strategies for intraocular retino-blastoma. Drugs 2007;67: Rabdomiosarcoma -Carcinoma della cervice uterina -Glioblastoma multiforme Chisholm JC et al. Children's Cancer and Leukaemia Group (CCLG; formerly United Kingdom Children's Cancer Study Group). Efficacy of carboplatin given in a phase II window study to children and adolescents with newly diagnosed metastatic soft tissue sarcoma. Eur J Cancer 2007;43: Rabdomiosarcoma -Neoplasie a sede primitiva ignota Van Winkle P et al. Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience. Pediatr Blood Cancer 2005;44: Neoplasie a sede primitiva ignota Schneider BJ et al. Phase II trial of carboplatin, gemcitabine, and capecitabine in patients with carcinoma of unknown primary site. Cancer 2007;110: Pittman KB et al. Gemcitabine and carboplatin in carcinoma of unknown primary site: a phase 2 Adelaide Cancer Trials and Education Collaborative study. Br J Cancer 2006;95: CARMUSTINA -Mieloma multiplo -Condizionamento pre-trapianto Condizionamento pre-trapianto -Linfomi non Hodgkin -Tumori cerebrali -Glioma maligno di grado elevato Buser AS et al. High-dose chemotherapy using BEAM without autologous rescue followed by reduced-intensity conditioning allogeneic stem-cell transplantation for refractory or relapsing lymphomas: a comparison of delayed versus immediate transplantation. Bone Marrow Transplant 2007;39: Josting A et al. Dexamethasone, carmustine, etoposide, cytarabine, and melphalan (dexa-beam) followed by high-dose chemotherapy and stem cell rescue-a highly effective regimen for patients with refractory or relapsed indolent lymphoma. Leuk Lymphoma 2000;37: Faulkner RD et al. BEAM-alemtuzumab reduced-intensity allogeneic stem cell transplantation for lymphoproliferative diseases: GVHD, toxicity, and survival in 65 patients. Blood 2004;103: CISPLATINO -Tumore del testicolo -Carcinoma della mammella Carcinoma squamoso dell ano Hung A et al. Cisplatin-based combined modality therapy for

6 CITARABINA -Carcinoma dell ovaio -Carcinoma del distretto cervicofacciale -Carcinoma della vescica -Carcinoma della prostata -Tumore dell endometrio -Linfomi -Alcune neoplasie dell'infanzia -Sarcomi -Linfomi -Tumore del polmone -Tumore dell esofago -Tumore della tiroide -Neuroblastoma -Melanoma maligno -Leucemia acuta mieloide dell adulto e del bambino -Altre forme proliferative della serie bianca -Mesotelioma pleurico -Carcinoma dello stomaco -Carcinoma spinocellulare della cute -Carcinoma del pancreas -Neoplasie cerebrali -Carcinoma della cervice uterina -Neoplasie a sede primitiva ignota -Colangiocarcinoma e carcinomi delle vie biliari -Regimi di associazione nel trattamento di salvataggio dei linfomi Hodgkin e non- Hodgkin -Carcinoma squamoso dell ano -Regimi terapeutici per mobilizzazione di cellule staminali periferiche -Mieloma multiplo -Ad alte dosi nelle leucemie acute, nei linfomi non-hodgkin, e in regime di condizionamento nel trapianto di cellule staminali emopoietiche -Linfoma di Hodgkin anal carcinoma: a wider therapeutic index. Cancer 2003;97: Regimi terapeutici per mobilizzazione di cellule staminali periferiche Watts MJ et al. ESHAP and G-CSF is a superior blood stem cell mobilizing regimen compared to cyclophosphamide 1.5 g m(-2) and G-CSF for pre-treated lymphoma patients: a matched pairs analysis of 78 patients. Br J Cancer 2000;82: Lee JL et al. ESHAP plus G-CSF as an effective peripheral blood progenitor cell mobilization regimen in pretreated non- Hodgkin's lymphoma: comparison with high-dose cyclophosphamide plus G-CSF. Bone Marrow Transplant 2005;35: De Latour RP et al. Mobilization of peripheral blood progenitor cells after DHAP regimen with or without rituximab: a large multicenter comparative study in patients with malignant lymphoma. Leuk Lymphoma 2007;48: Mieloma multiplo Corso A et al. The VAD-DCEP sequence is an effective pretransplant therapy in untreated multiple myeloma. Haematologica 2004;89: D'Sa S et al. Etoposide, methylprednisolone, cytarabine and cisplatin successfully cytoreduces resistant myeloma patients and mobilizes them for transplant without adverse effects. Br J Haematol 2004;125: Linfoma di Hodgkin Schütt P et al. Ifosfamide, etoposide, cytarabine, and dexamethasone as salvage treatment followed by high-dose cyclophosphamide, melphalan, and etoposide with autologous peripheral blood stem cell transplantation for relapsed or refractory lymphomas. Eur J Haematol 2007;78: Olivieri A et al. Salvage therapy with an outpatient DHAP schedule followed by PBSC transplantation in 79 lymphoma patients: an intention to mobilize and transplant analysis. Eur J Haematol 2004;72:10-17 CLADRIBINA -Leucemia a cellule capellute -Linfoma non-hodgkin indolente Linfoma non-hodgkin indolente 6

7 -Leucemia linfatica cronica B resistente a terapia alchilante -Macroglobulinemia di Waldenström Blum KA et al. Prolonged follow-up after initial therapy with 2- chlorodeoxyadenosine in patients with indolent non-hodgkin lymphoma: results of Cancer and Leukemia Group B Study Cancer 2006;107: Robak T et al. Rituximab combined with cladribine or with cladribine and cyclophosphamide in heavily pretreated patients with indolent lymphoproliferative disorders and mantle cell lymphoma. Cancer 2006;107: Robak T et al. Cladribine combined with cyclophosphamide and mitoxantrone is an active salvage therapy in advanced non- Hodgkin's lymphoma. Leuk Lymphoma 2007;48: Macroglobulinemia di Waldenström Weber DM et al. 2-Chlorodeoxyadenosine alone and in combination for previously untreated Waldenstrom's macroglobulinemia. Semin Oncol 2003;30: Gertz MA et al. Treatment recommendations in Waldenstrom's macroglobulinemia: consensus panel recommendations from the Second International Workshop on Waldenstrom's Macroglobulinemia. Semin Oncol 2003;30: Treon SP et al. Update on treatment recommendations from the Third International Workshop on Waldenstrom's macroglobulinemia. Blood 2006;107: DACARBAZINA -Melanoma metastatico -Sarcomi dei tessuti molli -Linfoma di Hodgkin -Carcinomi neuroendocrini -Tumori desmoidi Carcinomi neuroendocrini Bajetta E et al. 5-Fluorouracil, dacarbazine, and epirubicin in the treatment of patients with neuroendocrine tumors. Cancer 1998;83: Nocera M et al. Treatment of advanced medullary thyroid cancer with an alternating combination of doxorubicin-streptozocin and 5 FU-dacarbazine. Groupe d'etude des Tumeurs à Calcitonine (GETC). Br J Cancer 2000;83: Orlandi F et al. Chemotherapy with dacarbazine and 5- fluorouracil in advanced medullary thyroid cancer. Ann Oncol 1994;5: Tumori desmoidi Gega M et al. Successful chemotherapeutic modality of doxorubicin plus dacarbazine for the treatment of desmoid tumors in association with familial adenomatous polyposis. J

8 Clin Oncol 2006;24: DOCETAXEL -Tumore della mammella -Tumore del polmone non a piccole cellule -Carcinoma della prostata -Adenocarcinoma dello stomaco -Tumori del distretto cervicofacciale -Carcinoma della mammella, in trattamento neoadiuvante -Carcinoma avanzato dell ovaio precedentemente trattato -Carcinoma del pancreas -Carcinoma del polmone a piccole cellule -Sarcomi -Carcinoma della vescica -Carcinoma dell esofago Trattamento neoadiuvante del carcinoma della mammella Estévez LG et al. Evidence-based use of neoadjuvant taxane in operable and inoperable breast cancer. Clin Cancer Res 2004;10: Jørgensen J et al. Primary inoperable breast cancer. Ugeskr Laeger 2007;169: Carcinoma avanzato dell ovaio Ferrandina G et al. Docetaxel and oxaliplatin in the second-line treatment of platinum-sensitive recurrent ovarian cancer: a phase II study. Ann Oncol 2007;18: Strauss HG et al. Phase II trial of docetaxel and carboplatin in recurrent platinum-sensitive ovarian, peritoneal and tubal cancer. Gynecol Oncol 2007;104: Vasey PA et al. Phase III randomized trial of docetaxelcarboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst 2004;96: Carcinoma del pancreas Burtness B et al. Phase II trial of weekly docetaxel/irinotecan combination in advanced pancreatic cancer. Cancer J 2007;13: Fine RL et al. The gemcitabine, docetaxel and capecitabine (GTX) regimen for metastatic pancreatic cancer: a retrospective analysis. Cancer Chemother Pharmacol 2008;61: Carcinoma del polmone a piccole cellule Pallis AG et al. A multicenter phase II study of the combination of gemcitabine and docetaxel in previously treated patients with small cell lung cancer. Lung Cancer 2004;43: Skarlos DV et al. Docetaxel and gemcitabine combination, as first-line treatment, in patients with extensive disease small-cell lung cancer. A phase II study of the Hellenic Cooperative Oncology Group. Lung Cancer 2003;41:

9 Sarcomi Bay JO et al. Docetaxel and gemcitabine combination in softtissue sarcomas treatment. Bull Cancer 2007;94:S122-S126 Maki RG. Gemcitabine and docetaxel in metastatic sarcoma: past, present and future. Oncologist 2007;12: Carcinoma della vescica Galsky MD. The role of taxanes in the management of bladder cancer. Oncologist 2005;10: Carcinoma dell esofago Tanaka T et al. Second-line combination chemotherapy with docetaxel for cisplatin-pretreated refractory metastatic esophageal cancer: a preliminary report of initial experience. Chemotherapy 2007;53: Albertsson M et al. Phase II studies on docetaxel alone every third week, or weekly in combination with gemcitabine in patients with primary locally advanced, metastatic, or recurrent esophageal cancer. Med Oncol 2007;24: Ajani JA. Chemotherapy for advanced gastric or gastroesophageal cancer: defining the contributions of docetaxel. Expert Opin Pharmacother 2006;7: DOXORUBICINA -Sarcoma dei tessuti molli e osteosarcoma -Linfoma di Hodgkin e non Hodgkin -Lucemia linfoblastica acuta -Leucemia mieloblastica acuta -Carcinoma della tiroide -Carcinoma della mammella -Carcinoma dell'ovaio -Mieloma multiplo, in regimi di associazione - Sarcomi (tutti gli istotipi) -Carcinoma dell endometrio -Carcinoma della cervice uterina -Tumori maligni del timo Carcinoma dell endometrio Kodama J et al. Chemotherapy for high-risk early-stage endometrial cancer. Curr Opin Obstet Gynecol 2007;19:42-47 Carcinoma della cervice uterina Papadimitriou CA et al. A phase II trial of methotrexate, vinblastine, doxorubicin, and cisplatin in the treatment of metastatic carcinoma of the uterine cervix. Cancer 1997;79: Tumori maligni del timo Yokoi K et al. Multidisciplinary treatment for advanced invasive thymoma with cisplatin, doxorubicin, and methylprednisolone. J Thorac Oncol 2007;2:

10 -Carcinoma della vescica -Carcinoma polmonare -Neuroblastoma -Tumore di Wilms -Tumori superficiali della vescica -Carcinoma dello stomaco -Carcinoma del fegato -Carcinoma del pancreas -Carcinoma del sigma retto -Carcinoma del distretto cervicofacciale -Carcinoma della prostata ormonorefrattario DOXORUBICINA LIPOSOMIALE -Tumore della mammella metastatico -Tumore dell ovaio -Sarcoma di Kaposi AIDS- correlato -Carcinoma della mammella localmente avanzato -Rabdomiosarcoma -Sarcoma di Ewing -Mieloma multiplo -Linfomi Hodgkin e non-hodgkin -Tumori maligni della tiroide Carcinoma della mammella localmente avanzato Ulrich-Pur H et al. Phase II trial of pegylated liposomal doxorubicin (Caelyx) plus gemcitabine in chemotherapeutically pretreated patients with advanced breast cancer. Acta Oncol 2007;46: Ardavanis A et al. Pegylated liposomal doxorubicin in combination with vinorelbine as salvage treatment in pretreated patients with advanced breast cancer: a multicentre phase II study. Cancer Chemother Pharmacol 2006;58: Alexopoulos A et al. Phase II study of pegylated liposomal doxorubicin (Caelyx) and docetaxel as first-line treatment in metastatic breast cancer. Ann Oncol 2004;15: Rabdomiosarcoma e Sarcoma di Ewing Nielsen OS et al. Phase 1 European Organisation for Research and Treatment of Cancer study determining safety of pegylated liposomal doxorubicin (Caelyx) in combination with ifosfamide

11 in previously untreated adult patients with advanced or metastatic soft tissue sarcomas. Eur J Cancer 2006;42: Skubitz KM. Phase II trial of pegylated-liposomal doxorubicin (Doxil) in sarcoma. Cancer Invest 2003;21: Mieloma multiplo Rifkin RM et al. Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple myeloma: a Phase III multicenter randomized trial. Cancer 2006;106: Orlowski RZ et al. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol 2007;25: Zervas K et al. Greek Myeloma Study Group. Primary treatment of multiple myeloma with thalidomide, vincristine, liposomal doxorubicin and dexamethasone (T-VAD doxil): a phase II multicenter study. Ann Oncol 2004;15: Linfomi Hodgkin e non-hodgkin Macpherson N et al. Liposomal encapsulated doxorubicin (Caelyx) in the treatment of relapsed aggressive non-hodgkin's lymphoma: a phase II study. Leuk Lymphoma 2006;47: Di Bella NJ et al. Pegylated liposomal doxorubicin as singleagent treatment of low-grade non-hodgkin's lymphoma: a phase II multicenter study. Clin Lymphoma 2003;3: Orlowski RZ et al. Phase 1 trial of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies. Blood 2005;105: Tumori maligni della tiroide Moscetti L et al. A partial response in anaplastic carcinoma of the thyroid with liposomal doxorubicin. J Exp Clin Cancer Res 2005;24: Tennvall J et al. Anaplastic thyroid carcinoma: three protocols

12 combining doxorubicin, hyperfractionated radiotherapy and surgery. Br J Cancer 2002;86: EPIRUBICINA ETOPOSIDE -Carcinoma della mammella -Sarcomi delle parti molli -Carcinoma dello stomaco -Carcinoma del fegato -Carcinoma del pancreas -Carcinoma del sigma-retto -Carcinoma del distretto cervicofacciale -Carcinoma del polmone -Carcinoma dell ovaio -Leucemie -Linfomi -Carcinoma della vescica superficiale -Profilassi delle recidive dopo intervento di resezione transuretrale -Tumori del polmone a piccole cellule -Carcinoma del testicolo non seminomatoso resistente -Linfoma di Hodgkin -Linfomi non Hodgkin Può essere utilizzata al posto della doxorubicina da sola od in associazione nel trattamento dei tumori solidi, sia in fase precoce che avanzata -Tumori neuroendocrini -Carcinoma dell esofago -Carcinoma della prostata -Carcinoma della cervice uterina -Terapie ad alte dosi sequenziali nel condizionamento pre-trapianto -In associazione nella leucemia linfatica acuta e nel mieloma multiplo -Sarcomi -Tumori a cellule germinali Tumori neuroendocrini Bajetta E et al. 5-Fluorouracil, dacarbazine, and epirubicin in the treatment of patients with neuroendocrine tumors. Cancer 1998;83: Bajetta E et al. Efficacy of a chemotherapy combination for the treatment of metastatic neuroendocrine tumours. Ann Oncol 2002;13: Carcinoma dell esofago Choi IK et al. Epirubicin, cisplatin, oral UFT, and leucovorin combination chemotherapy in advanced and metastatic esophageal cancer. Med Oncol 2007;24:33-37 Ross P et al. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J Clin Oncol 2002;20: Carcinoma della prostata Petrioli R et al. Weekly docetaxel and epirubicin in treatment of advanced hormone-refractory prostate cancer. Urology 2007;69: Carcinoma della cervice uterina D'Agostino G et al. Neoadjuvant treatment of locally advanced carcinoma of the uterine cervix with epirubicin, paclitaxel and cisplatin. Cancer Chemother Pharmacol 2002;49: Tumori a cellule germinali Marwaha S et al. The importance of the dose of etoposide in the initial treatment of metastatic germ cell tumors and advances in management of patients that relapse. Can J Urol 2007;14: Kondagunta V et al. Germ-cell tumors. N Engl J Med 2007;357:1773 Carcinoma dello stomaco e dell esofago 12 Lokich JJ et al. Combined paclitaxel, cisplatin, and etoposide for

13 -Leucemie acute -Coriocarcinoma gestazionale -Carcinoma dello stomaco e dell esofago -Carcinoma del testicolo -Tumori maligni intracranici -Tumori del distretto cervicale patients with previously untreated esophageal and gastroesophageal carcinomas. Cancer 1999;85: Chiou TJ et al. Treatment of advanced gastric cancer with a modified regimen of etoposide/leucovorin/5-fluorouracil. Cancer Invest 1996;14: Carcinoma del testicolo -Tumori neuroendocrini Bamias A et al. Two cycles of etoposide/cisplatin cured all patients with stage I testicular seminoma: risk-adapted protocol of the Hellenic Cooperative Oncology Group. Urology 2007;70: Tumori maligni intracranici López-Aguilar E et al. Preirradiation ifosfamide, carboplatin, and etoposide for the treatment of anaplastic astrocytomas and glioblastoma multiforme: a phase II study. Arch Med Res 2000;31: Tumori del distretto cervicale Tanaka T et al. Optimal combination chemotherapy and chemoradiotherapy with etoposide for advanced cervical squamous cancer cells in vitro. Oncol Rep 2006;15: Tumori neuroendocrini Hainsworth JD et al. Phase II trial of paclitaxel, carboplatin, and etoposide in advanced poorly differentiated neuroendocrine carcinoma: a Minnie Pearl Cancer Research Network Study. J Clin Oncol 2006;24: FLUOROURACILE -Trattamento palliativo delpuò essere utilizzato, da solo o in associazione, carcinoma della mammella, delnei tumori solidi (*) colon, del retto, dello stomaco e del pancreas -Carcinoma del colon (adiuvante) -Tumori del fegato -Tumori dell utero -Carcinoma dell esofago -Carcinoma del pancreas (adiuvante) Carcinoma del colon (adiuvante) Chung KY and Saltz LB. Adjuvant therapy of colon cancer: current status and future directions. Cancer J 2007;13: Kuebler JP et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol 2007;25: De Gramont A et al. Targeted agents for adjuvant therapy of 13

14 -Tumori dell ovaio -Tumori della vescica -Tumori maligni a cellule di Langerhans -Carcinoma del pene -Trattamento profilattico delle -Carcinoma della prostata recidive di tumore del colon-retto dopo chirurgia -Carcinoma gastrico (adiuvante e neoadiuvante) -Tumori del distretto cervico-facciale -Tumori maligni nasofaringei -Tumore dell ano (*) La Commissione Terapeutica ha ritenuto opportuno documentare meglio alcune indicazioni già presenti nella lista AIFA colon cancer. Semin Oncol 2006; 33:42-45 Carcinoma dell esofago Lin CC et al. Multifractionated paclitaxel and cisplatin combined with 5-fluorouracil and leucovorin in patients with metastatic or recurrent esophageal squamous cell carcinoma. Anticancer Drugs 2007,18: O'Connor BM et al. Concurrent oxaliplatin, 5-fluorouracil, and radiotherapy in the treatment of locally advanced esophageal carcinoma. Cancer J 2007;13: Sasamoto R et al. Long-term results of chemoradiotherapy for locally advanced esophageal cancer, using daily low-dose 5- fluorouracil and cis-diammine-dichloro-platinum (CDDP). Int J Clin Oncol 2007;12:25-30 Carcinoma del pancreas (adiuvante) Ghaneh P et al. Neoadjuvant and adjuvant strategies for pancreatic cancer. Eur J Surg Oncol 2007 [Epub ahead of print] Aung KL et al. Adjuvant therapy for pancreatic cancer. Expert Opin Pharmacother 2007;8: Cantore M et al. Adjuvant intra-arterial 5-fluoruracil, leucovorin, epirubicin and carboplatin with or without systemic gemcitabine after curative resection for pancreatic adenocarcinoma. Cancer Chemother Pharmacol 2006;58: Tumori maligni a cellule di Langerhans Strosberg J et al. Effective treatment of locally advanced endocrine tumors of the pancreas with chemoradiotherapy. Neuroendocrinology 2007;85: Carcinoma del pene Culkin DJ and Beer TM. Advanced penile carcinoma. J Urol 2003;170: Roth AD et al. Intra-arterial chemotherapy in locally advanced or recurrent carcinomas of the penis and anal canal: an active treatment modality with curative potential. Br J Cancer 2000;83: Eisenberger MA, Chemotherapy for carcinomas of the penis and urethra. Urol Clin North Am 1992;19:

15 Carcinoma della prostata Lin CC et al. Weekly paclitaxel and high-dose 5-fluorouracil plus leucovorin in hormone-refractory prostate cancer: in vitro combined effects and a phase II trial. Urol Oncol 2007;25: Swanson GP et al. Locally advanced prostate cancer treated with concomitant radiation and 5-fluorouracil: Southwest Oncology Group Study J Urol 2006;176: Birtle AJ et al. Epirubicin carboplatin and 5-fluorouracil (ECarboF) chemotherapy in metastatic hormone refractory prostate cancer. Br J Cancer 2004;91: Carcinoma gastrico (adiuvante e neo-adiuvante) Ng K et al. Adjuvant and neoadjuvant approaches in gastric cancer. Cancer J 2007;13: Saletti P et al. Adjuvant chemotherapy (ECF regimen) for patients with gastric adenocarcinoma. Hepatogastroenterology 2007;54: Koo DH et al. Adjuvant chemotherapy with 5-fluorouracil, doxorubicin and mitomycin-c (FAM) for 6 months after curative resection of gastric carcinoma. Eur J Surg Oncol 2007;33: Tumori del distretto cervico-facciale Tulunay OE et al. Pilot study of intraoperative chemotherapy with cisplatin and 5-fluorouracil in patients with advanced squamous cell carcinoma of the head and neck. Head Neck 2007;29: Baghi M et al. Adjuvant docetaxel, cisplatin and 5-fluorouracil (TPF) in locally advanced squamous cell carcinoma of the head and neck. Anticancer Res 2006;26: Faivre S et al. Preoperative sequential chemotherapy in locally advanced squamous cell carcinoma of the head and neck. Head Neck 2005;27: Tumori maligni nasofaringei Fuwa N et al. Treatment results of alternating chemoradiotherapy for nasopharyngeal cancer using cisplatin and 5-fluorouracil--a 15

16 GEMCITABINA -Carcinoma polmonare non a-terapia di salvataggio della neoplasia piccole cellule localmente avanzatogerminale del testicolo o metastatico -Sarcomi dei tessuti molli -Adenocarcinoma del pancreas -Colangiocarcinoma e carcinomi delle vie biliari localmente avanzato o metastatico -Neoplasie del distretto cervico-facciale -Carcinoma della vescica -Linfomi di Hodgkin e non Hodgkin -Carcinoma della mammella non resecabile localmente ricorrente o metastatico -Carcinoma del colon e del retto -Carcinoma ricorrente dell'epitelio -Mesotelioma maligno dell'ovaio -Carcinoma del polmone a piccole cellule -Sarcoma (tutti gli istotipi) -Tumori a cellule germinali phase II study. Oral Oncol 2007;43: Yau TK et al. Treatment of Stage IV(A-B) nasopharyngeal carcinoma by induction-concurrent chemoradiotherapy and accelerated fractionation: impact of chemotherapy schemes. Int J Radiat Oncol Biol Phys 2006;66: Wong AS et al. Paclitaxel, 5-fluorouracil and hydroxyurea concurrent with radiation in locally advanced nasopharyngeal carcinoma. Ann Oncol 2006;17: Tumore dell ano Das P et al. Current treatment for localized anal carcinoma. Curr Opin Oncol 2007;19: Hatfield P et al. Involved-field, low-dose chemoradiotherapy for early-stage anal carcinoma. Int J Radiat Oncol Biol Phys 2008;70: Charnley N et al. Effective treatment of anal cancer in the elderly with low-dose chemoradiotherapy. Br J Cancer 2005;92: Carcinoma del colon e del retto Ziras N et al. Multicenter phase II study of gemcitabine and oxaliplatin (GEMOX) as second-line chemotherapy in colorectal cancer patients pretreated with 5-fluorouracil plus irinotecan. Oncology 2006;70: Correale P et al. Chemo-immunotherapy of metastatic colorectal carcinoma with gemcitabine plus FOLFOX 4 followed by subcutaneous granulocyte macrophage colony-stimulating factor and interleukin-2 induces strong immunologic and antitumor activity in metastatic colon cancer patients. J Clin Oncol 2005;23: Correale P et al. A novel biweekly multidrug regimen of gemcitabine, oxaliplatin, 5-fluorouracil (5-FU), and folinic acid (FA) in pretreated patients with advanced colorectal carcinoma. Br J Cancer 2004;90: Mesotelioma maligno Kalmadi SR et al. Gemcitabine and cisplatin in unresectable malignant mesothelioma of the pleura: A phase II study of the Southwest Oncology Group (SWOG 9810). Lung Cancer 2007, 16

17 [Epub ahead of print] Lucchi M et al. Four-modality therapy in malignant pleural mesothelioma: a phase II study. J Thorac Oncol 2007;2: Utkan G et al. Divided dose of cisplatin combined with gemcitabine in malignant mesothelioma. Lung Cancer 2006;53: Carcinoma del polmone a piccole cellule Ohyanagi F et al. Phase II trial of gemcitabine and irinotecan in previously treated patients with small-cell lung cancer. Cancer Chemother Pharmacol 2007 [Epub ahead of print] Hesketh PJ et al. Phase II study of gemcitabine and cisplatin in patients with previously untreated extensive stage small cell lung cancer: Southwest Oncology Group Study J Thorac Oncol 2007;2: Schuette W et al. Phase II trial of gemcitabine/irinotecan in refractory or relapsed small-cell lung cancer. Clin Lung Cancer 2005;7: Sarcoma Maki RG. Gemcitabine and docetaxel in metastatic sarcoma: past, present, and future. Oncologist 2007;12: Maki RG et al. Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002. J Clin Oncol 2007;25: Dileo P et al. Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas: results of a phase II trial. Cancer 2007;109: Tumori a cellule germinali Einhorn LH et al. Phase II study of paclitaxel plus gemcitabine salvage chemotherapy for germ cell tumors after progression following high-dose chemotherapy with tandem transplant. J Clin Oncol 2007;25: De Giorgi U et al. Phase II study of oxaliplatin and gemcitabine salvage chemotherapy in patients with cisplatin-refractory 17

18 IDARUBICINA -Leucemia acuta non linfoblastica -Cancro della mammella in stadio avanzato -Leucemia acuta linfocitica nell'adulto e nel bambino -Linfomi non-hodgkin in prima linea o pretrattati, in combinazione con altri chemioterapici nonseminomatous germ cell tumor. Eur Urol 2006;50: Pectasides D et al. Gemcitabine and oxaliplatin (GEMOX) in patients with cisplatin-refractory germ cell tumors: a phase II study. Ann Oncol 2004;15: Linfomi non-hodgkin in prima linea o pretrattati, in combinazione con altri chemioterapici Zinzani PL et al. Effectiveness of fludarabine, idarubicin and cyclophosphamide (FLUIC) combination regimen for young patients with untreated non-follicular low-grade non-hodgkin's lymphoma. Leuk Lymphoma 2004;45: Morra E et al. Treatment of patients with high-grade non- Hodgkin's lymphoma aged over 70 years with an all-oral regimen combining idarubicin, etoposide and alkylators. Crit Rev Oncol Hematol 2000;35: Oyan B et al. Ifosfamide, idarubicin, and etoposide in relapsed/refractory Hodgkin disease or non-hodgkin lymphoma: a salvage regimen with high response rates before autologous stem cell transplantation. Biol Blood Marrow Transplant 2005;11: IDROSSIUREA Leucemia mieloide cronica -Mielofibrosi -Trombocitemia essenziale -Policitemia vera Mielofibrosi, trombocitemia essenziale, policitemia vera Cervantes F et al. New and old treatment modalities in primary myelofibrosis. Cancer J 2007;13: Finazzi G et al. Expertise-based management in essential thrombocythemia and polycythemia vera. Cancer J 2007;13: Barbui T et al. Therapy for polycythemia vera and essential thrombocythemia is driven by the cardiovascular risk. Semin Thromb Hemost 2007;33:

19 IFOSFAMIDE -Carcinoma bronchiale -Carcinoma dell ovaio -Tumori del testicolo -Sarcomi delle parti molli -Carcinoma della mammella -Carcinoma del pancreas -Ipernefroma -Carcinoma dell endometrio -Linfomi maligni -Può essere utilizzato, da solo o in associazione, nei tumori solidi sulla base delle evidenze scientifiche presenti in letteratura ed in particolare: -Sarcomi (tutti gli istotipi) -Regime di condizionamento pretrapianto di cellule staminali emopoietiche -Tumore a cellule germinali dell ovaio -Carcinoma del polmone a piccole cellule -Tumori del distretto cervico-facciale -Carcinoma nasofaringeo -Tumori maligni del timo -Tumore a cellule germinali -Carcinoma della cervice uterina Tumore a cellule germinali dell ovaio Popadiuk S et al. Ovarian malignant tumours. Efficacy of germ cell and sex cord tumour treatment protocol in Poland. Med Wieku Rozwoj 2006;10: Balat O et al. Remission of recurrent mixed germ cell tumor of the ovary after treatment with vincristine, carboplatin, fluorouracil, and ifosfamide: a case report and review of the literature. Eur J Gynaecol Oncol 1996;17: Gershenson DM. Update on malignant ovarian germ cell tumors. Cancer 1993;71: Carcinoma del polmone a piccole cellule Thatcher N et al. Ifosfamide, carboplatin, and etoposide with midcycle vincristine versus standard chemotherapy in patients with small-cell lung cancer and good performance status: clinical and quality-of-life results of the British Medical Research Council multicenter randomized LU21 trial. J Clin Oncol 2005;23: Iwasaki Y et al. Double-cycle, high-dose ifosfamide, carboplatin, and etoposide followed by peripheral blood stem-cell transplantation for small cell lung cancer. Chest 2005;128: Marangolo M and Giovanis P. Ifosfamide in small cell lung cancer. Oncology 2003;65:46-49 Tumori del distretto cervico-facciale Pai VR et al. Two- vs three-drug combination chemotherapy in advanced or recurrent head and neck cancer: a single institution experience of 361 patients. Med Oncol 2004;21: Airoldi M et al., Ifosfamide in the treatment of head and neck cancer. Oncology 2003;65:37-43 Shin DM et al. Phase II study of induction chemotherapy with paclitaxel, ifosfamide, and carboplatin (TIC) for patients with locally advanced squamous cell carcinoma of the head and neck. Cancer 2002;95: Carcinoma nasofaringeo 19

20 Chua DT et al. A phase II study of ifosfamide, 5-fluorouracil and leucovorin in patients with recurrent nasopharyngeal carcinoma previously treated with platinum chemotherapy. Eur J Cancer 2000;36: Tumori maligni del timo Iwasaki Y et al. Multidisciplinary therapy including high-dose chemotherapy followed by peripheral blood stem cell transplantation for invasive thymoma. Chest 2002;122: Geffen DB et al. Multimodal treatment of metastatic thymic carcinoma including high-dose chemotherapy with autologous stem cell transplantation: report of a case with more than 4-year disease-free survival. Am J Clin Oncol 2001;24: Highley MS et al. Treatment of invasive thymoma with singleagent ifosfamide. J Clin Oncol 1999;17: Tumore a cellule germinali Einhorn LH et al. High-dose chemotherapy and stem-cell rescue for metastatic germ-cell tumors. N Engl J Med 2007;357: Lorch A et al. Single versus sequential high-dose chemotherapy in patients with relapsed or refractory germ cell tumors: a prospective randomized multicenter trial of the German Testicular Cancer Study Group. J Clin Oncol 2007;25: Kondagunta GV et al. Paclitaxel plus ifosfamide followed by high-dose carboplatin plus etoposide in previously treated germ cell tumors. J Clin Oncol 2007;25:85-90 Carcinoma della cervice uterina Serkies K et al. Chemotherapy with mitomycin C, ifosfamide and cisplatin for recurrent or persistent cervical cancer. Int J Gynecol Cancer 2006;16: Buda A et al. Randomized trial of neoadjuvant chemotherapy comparing paclitaxel, ifosfamide and cisplatin with ifosfamide and cisplatin followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the SNAP01 (Studio Neo-Adjuvante Portio) Italian Collaborative Study. J Clin Oncol 2005;23: Buda A et al. Role of ifosfamide in cervical cancer: an overview. Oncology 2003;65: