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AUSL 4 Prato

Oncologia Medica Prato

Ospedale "Misericordia e Dolce" c/o U.O. Oncologia Medica
Piazza dell'Ospedale 2 - 59100 Prato
Segretaria Scientifica
Tel: + 39 0574 434766
Fax: 0574 29798
CORD
Tel: + 39 0574 434246
Fax: 0574 435040
Responsabile: Angelo Di Leo

Progetti Specifici

  • Carcinoma mammario
    • Glaxo: "Studio di fase III, randomizzato, multicentrico, in doppio cieco, controllato con placebo, a 2 bracci con GW572016 orale in combinazione con Paclitaxel in soggetti non trattati in precedenza per carcinoma mammario localmente avanzato o metastatico." (fino maggio 2005)
    • International Breast Cancer Study Group (IBCSG) Studi randomizzati di fase III nel trattamento precauzionale (adiuvante) di donne in premenopausa con carcinoma mammario potenzialmente endocrinoresponsivo. SOFT: Ruolo della soppressione della funzione ovarica e dell'exemestane TEXT: Ruolo dell'exemestane associato all'analogo dell'LHRH PERCHE: Ruolo della chemioterapia nella terapia adiuvante di donne in premenopausa con carcinoma mammario potenzialmente endocrinoresponsivo. (fino 2008) CASA: Studio sulla chemioterapia adiuvante per donne in età avanzata Studio di fase III per la valutazione del ruolo di una chemioterapia adiuvante con doxorubicina liposomiale pegilata (PLD, Caelyx®, Doxil®) per donne (a partire dai 66 anni d'età) con carcinoma mammario non endocrino-responsivo che NON sono idonee a ricevere un "regime di chemioterapia standard".
    • Sperimentazione spontanea (CTC): Identificazione di cellule tumorali circolanti nel sangue periferico di pazienti affette da carcinoma della mammella metastatico con tumore primitivo HER2 negativo; (2005-2006).
    • Sperimentazione spontanea: Studio pilota al fine di testare l'utilizzo di regime adiuvante con capecitabina e variando la densità di dose del docetaxel in pazienti con carcinoma mammario endocrino resistente. (2006-2007)
    • CONFIRM: Studio di fase III, randomizzato, multicentrico, in doppio cieco, per comparare l'efficacia e la tollerabilità del Fulvestrant (FASLODEX™) 500 mg con Fulvestrant (FASLODEX™) 250 mg in donne in post-menopausa con recettori estrogeno positivi con carcinoma mammario avanzato in progressione o dopo ricaduta da terapia endocrina. (2005-2008)
    • IJB: Capecitabina adiuvante in pazienti anziane con carcinoma della mammella in stadio precoc e: studio di fase II.". (2005-2006)
    • Sperimentazione spontanea: Profilo metabolico urinario e cambiamenti nei livelli sierici di BNP come marcatori di tossicità cardiaca precoce in pazienti con carcinoma mammario in fase precoce che ricevono terapia adiuvante a base d'antracicline. (2005-2008)
    • Sperimentazione spontanea: Analisi spettroscopica basata sulla risonanza magnetica nucleare (NMR): Valutazione dei profili metabolici delle urine come indicatori della risposta alla terapia in pazienti affette da carcinoma mammario avanzato(2005-2008)
    • Pfizer: Studio randomizzato di fase 2 del farmaco SU011248 Verso terapia standard in pazienti con carcinoma mammario con recettori ER, PR, e Her2 negativi, in stadio recidivato, precedentemente trattato. (2005...)
  • Carcinoma polmone
    • Istituto Nazionale Tumori di Napoli: Studio randomizzato di fase II di cetuximab in combinazione con gemcitabina o gemcitabina seguita da cetuximab in pazienti con carcinoma polmonare non a piccole cellule avanzato, non candidati a terapia contenente un derivato del platino (2005-2006)
    • Pfizer: International, Randomized, open-label, phase 3 trial of Paclitaxel/Carboplatin plus PF3512676 versus Paclitaxel/Carboplatin alone as first-line treatment of patients with advanced Non-Small Cell Lung Cancer-
  • Carcinoma colorettale metastatico
    • Roche:"Studio multicentrico, randomizzato di fase II, di valutazione dell'efficacia di tre regimi chemioterapici in combinazione con Bevacizumab per il trattamento in prima linea del carcinoma colorettale metastatico". (2005-2007)
    • Studio xeloxiri – asl605liom02 Studio pilota multicentrico di chemioterapia con capecitabina + oxaliplatino (lohp) + irinotecano (cpt-11) in pazienti con carcinoma colo-rettale metastatico
  • Carcinoma dello stomaco
    • Istituto di ricerche Mario Negri :Studio randomizzato, in aperto, di fase III, multicentrico, di chemioterapia adiuvante per l'adenocarcinoma dello stomaco o della giunzione gastroesofagea operato radicalmente: confronto di un trattamento sequenziale (CPT-11+5-FU/LV TXT+CDDP) versus un regime 5-FU/LV (2005-2008)
  • Mielodisplasie
    • Schering–Plough Research Institute: "Studio pilota randomizzato di Lonafarnib (SCH 66336) verso placebo nel trattamento di pazienti con sindrome mielodisplasica (MDS) o leucemia cronica mielomonocitica (CMML) che siano dipendenti da trasfusioni piastriniche con o senza anemia"

Grants

  • AIRC (Associazione Italiana Ricerca Cancro), Associazione Sandro Pitigliani

Collaborazioni

  • altre Unità I.T.T.
  • Jules Bordet Institute International Breast Cancer Study Group

Pubblicazioni (dal 2001)

  1. Cardoso F, Ferreira Filho AF, Crown J, Dolci S, Paesmans M, Riva A, Di Leo A et al: Doxorubicin followed by docetaxel versus docetaxel followed by doxorubicin in the adjuvant treatment of node positive breast cancer : results of a feasibility study. Anticancer Res 21: 789-95, 2001.
  2. Lohrisch C, Di Leo A et al : Optimal adjuvant cytotoxic therapy for breast cancer. In : American Society of Clinical Oncology educational booklet pp 61-70 2001.
  3. Cardoso F, Di Leo A et al : Evaluation of HER2,p53,bcl 2,topoisomerase II-alpha,heat shock proteins 27 and 70 in primary breast cancer and metastatic ipsilateral axillary lymph nodes. Ann Oncol 12: 615-20, 2001.
  4. Piccart MJ, Di Leo A et al : Four-year results of a multicenter phase III trial comparing a full dose epirubicin-cyclophosphamide regimen with classical CMF and with a low dose epirubicin-cyclophosphamide regimen in the adjuvant therapy of node-positive pre- and postmenopausal breast cancer patients. J Clin Oncol 19: 3103-10, 2001.
  5. Di Leo A et al : HER-2 and topoisomerase II alpha as predictive markers in a population of node-positive breast cancer patients randomly treated with adjuvant CMF or epirubicin plus cyclophosphamide. Ann Oncol 12: 1081-89,2001.
  6. Di Leo A : Adjuvant therapy of breast cancer : state of the art in the year 2001. Folia Oncologica , May 2001.
  7. Di Leo A et al : Current status of docetaxel in adjuvant and neo-adjuvant trials for breast cancer. Advances in breast cancer 3: 6-8, 2001.
  8. Lohrisch C, Di Leo A, et al : Optimal adjuvant cytotoxic therapy for breast cancer . The Breast 10 (supp 3), 2001.
  9. Di Leo et al: Carcinoma della mammella. In " Terapia medica oncologica" by Santoro A (ed.), EdiSes Napoli, Italy, pp 519-44, 2001.
  10. Ferreira Filho AF, Cardoso F, Di Leo A et al : Clinical case : carcinomatous meningitis as a clinical manifestation of pancreatic carcinoma. Ann Oncol 12: 1757-59, 2001.
  11. Piccart MJ, Lohrisch C, Di Leo A et al : The predictive value of HER-2 in breast cancer.Oncology 61: 73-82, 2001.
  12. Bleiberg H, Di Leo A : Mortality associated with irinotecan plus bolus fluorouracil/leucovorin. J Clin Oncol 20: 1145, 2002.
  13. Piccart MJ, Cardoso F, Di Leo A, et al : Areas of controversy in the adjuvant systemic therapy of endocrine-nonresponsive breast cancer. Am Soc Clin Oncol Educational Book, pages 144-55, 2002.
  14. Piccart MJ, Mano M, Lohrisch C, and Di Leo A : Herceptin for the treatment of breast cancer: what we have yet to learn. Cancer Futures 1: 73-79, 2002.
  15. Di Leo A et al : Equivalence between ovarian suppression and chemotherapy in the adjuvant treatment of endocrine-responsive breast cancer. J Clin Oncol 20:1954-55, 2002.
  16. Gancberg D, Di Leo A et al : Reliability of the tissue microarray-based FISH for evaluation of the HER-2 oncogene in breast carcinoma. J Clin Pathol 55: 0-2, 2002.
  17. Cardoso F, Di Leo A et al : Second and subsequent lines of chemotherapy for metastatic breast cancer : what did we learn in the last two decades ? Ann Oncol, 13:197-207, 2002.
  18. Ferreira Filho AF, Di Leo A et al : The feasibility of classical cyclophosphamide, methotrexate ,5-fluorouracil (CMF) for pre- and post-menopausal node-positive breast cancer patients in a Belgian multicentric trial :a study of consistency in relative dose intensity (RDI)and cumulative doses across institutions. Ann Oncol, 13: 416-21, 2002.
  19. Di Leo A et al : HER-2 amplification and topoisomerase II alpha gene aberrations as predictive markers in node-positive breast cancer patients randomly treated either with an anthracycline-based therapy or with CMF. Clin Cancer Res 8: 1107-16, 2002.
  20. Gancberg D, Di Leo A et al : Comparison of HER-2 status between primary breast cancer and corresponding distant metastatic sites. Ann Oncol 13: 1036-43, 2002.
  21. Gancberg D, Jarvinen T, Di Leo A et al : Evaluation of HER-2/Neu protein expression in breast cancer by immunohistochemistry: an interlaboratory study assessing the reproducibility of HER-2/Neu testing. In press, Breast Cancer Res Treat 74: 113-20, 2002.
  22. Larsimont D, Di Leo A et al : Evaluation of HER-2/Neu by different immunohistochemistry methods and fluorescence in-situ hybridization in more than three hundreds archival primary breast cancer samples: implications for daily laboratory practice. In press, Anticancer Res 22: 2485-90, 2002.
  23. Ferreira Filho AF, and Di Leo A : Three-year results of docetaxel-based sequential and combination regimens in the adjuvant therapy of node-positive breast cancer. Results of a pilot study. In press, Anticancer Res 22: 2471-76, 2002.
  24. Piccart MJ, Cardoso F, Awada A, Di Leo A et al :Kontroversen in der adjuvanten systemischen therapie des rezeptornegativen mammakarzinoms.In "Diagnostik und therapie des mammakarzinoms-State of the Art", by Untch M, Sittek H,Bauerfeind I,Konecny G, Reiser M, Hepp H (eds).W Zuckschwerdt Verlag, Munchen, pages 372-388, 2002.
  25. Di Leo A et al : Predictive molecular markers in the adjuvant therapy of breast cancer :state of the art in the year 2002. Int J Clin Oncol 7: 245-53, 2002.
  26. Di Leo A et al : Current status of HER2 testing. Oncology 63 Supp 1, 25-32, 2002.
  27. Cardoso F, Piccart MJ, Durbecq V, and Di Leo A : Resistance to transtuzumab : a necessary evil or a temporary challenge ? Clin Breast Cancer 3: 247-57, 2002.
  28. Di Leo A : The European experience with docetaxel in the treatment of early-stage breast cancer. Clin Breast Cancer 3: Supp 2, S59-S62, 2002.
  29. Cardoso F, Di Leo A, et al : Controversies in the adjuvant systemic therapy of endocrine-non-responsive breast cancer. Cancer Treat Rev 28:275-290, 2002.
  30. Bernard-Marty C, Treilleux I, and Di Leo A : Microtubule-associated parameters as predictive markers of docetaxel activity in advanced breast cancer patients. Results of a pilot study. Clin Breast Cancer 3: 341-45, 2002.
  31. Di Leo A : Treatment of advanced breast cancer: Highlights from the third European Breast Cancer Conference. Cancer Abstracts and Summaries 3: 3-4,2002.
  32. Di Leo A et al : Predictive molecular markers : a new window of opportunity in the adjuvant therapy of breast cancer. In "Breast cancer management: Application of clinical and translational evidence to patient care" (2nd edition), by Nabholtz JM, Tonkin K, Reese DM, Aapro MS, Buzdar AU (eds). Lippincott Williams and Williams Philadelphia PA, USA, pp: 367-80, 2003.
  33. Durbecq V, Di Leo A et al : Comparison of topoisomerase II alpha gene status between primary breast cancer and corresponding distant metastatic sites. Breast Cancer Res Treat 77: 199-204, 2003.
  34. Bernard-Marty C, Mano M, and Di Leo A : Second malignancies following adjuvant chemotherapy: 6-year results from a Belgian randomized study comparing cyclophosphamide, methotrexate and 5-fluorouracil (CMF) with an anthracycline-based regimen in adjuvant treatment of node-positive breast cancer patients. Ann Oncol 14: 693-698, 2003.
  35. Di Leo A et al : Overall survival is not a realistic end point for clinical trials of new drugs in advanced solid tumors: a critical assessment based on recently reported phase III trials in colorectal and breast cancer. J Clin Oncol 21: 2045-47, 2003.
  36. Di Leo A et al : Topoisomerase II alpha as a marker predicting the efficacy of anthracyclines in breast cancer patients: Are we at the end of the beginning ? Clin Breast Cancer vol 4, 2003.
  37. Mano MS, Awada A, Di Leo A et al : Rates of topoisomerase II-alpha and HER-2 gene amplification and expression in epithelial ovarian carcinoma. Gynecologic Oncology 92: 887-95, 2004.
  38. Di Leo A et al : Use of chemotherapy in patients with node-negative breast cancer. Amer Soc of Clin Onc educational book p. 36-43 2004.
  39. Di Leo A et al : Is overall survival a realistic primary end point in advanced colorectal cancer studies? A critical assessment based on four clinical trials comparing fluoracil plus leucovorin with the same treatment combined either with oxaliplatin or with CPT-11. Ann Oncol 15: 545-49, 2004.
  40. Biganzoli L, Minisini A, Aapro M, Di Leo A : Chemotherapy for metastatic breast cancer. Curr Opin Obstet Gynecol 16: 37-41, 2004.
  41. Cardosa F, Durbecq V, Larismont D, Paesmans M, Leroy JY, Rouas G, Sotiriou C, Renard N, Richard V, Piccart MJ, Di Leo A : Correlation between complete response to anthracycline-based chemotherapy and topoisomerase II-a gene amplification and protein overexpression in locally advanced/metastatic breast cancer. Int'l. J Onc. 24: 201-09, 2004.
  42. Durbecq V, Paesmans M, Cardoso F, Desmedt C, Di Leo A, et al : Topoisomerase-II alpha expression as a predictive marker in a population of advanced breast cancer patients randomly treated either with single-agent doxorubicin or single-agent docetaxel. Mol. Cancer Ther. 3(10) : 1207-14, Oct. 2004.
  43. Di Leo A, et al : HER-2/neu as a predictive marker in a population of advanced breast cancer patients randomly treated either with single-agent doxorubicin or single-agent docetaxel. Breast Cancer Res Treat 86: 197-206, 2004.
  44. Cardoso F, Paesmans M, Larsimont D, Durbecq V, Bernard-Marty, C, Rouas G, Dolci S, Sotiriou C, Piccart M, Di Leo A. Potential predicitive value of Bcl-2 for response to tamoxifen in the adjuvant setting of node-positive breast cancer. Clin. Breast Cancer 5 (5): 364-369, Dec. 2004.
  45. Di Leo A, et al : Controversies in the adjuvant treatment of breast cancer : the role of taxanes. Ann. Oncol. 15 (suppl.) 4: iv 17-21 review, 2004.
  46. Vinci EM, Biganzoli L, Ciarlo A, Panella M, Pozzessere D, Santini S, Di Leo A : Ruolo di HER2 come fattore prognostico e predittivo nel tumore della mammella in face precoce. Rivista di Oncologia Pratica e Sperimentale Anno III – no. 6 dicembre 2004.
  47. Mano MS, Awada A, Minisini A, Durbecq V, Di Leo A, et al : Activation of the tumor suppressor PTEN a san alternative explanation for trastuzumab's mechanism of action. Breast 14(2) : 176 2005.
  48. Ma Y, Lespagnard L, Durbecq V, Paesmans M, Desmedt C, Gomez-Galdon M, Veys I, Cardoso F, Sotiriou C, Di Leo A, et al. HER-2/neu status elaboration in breast cancer: effect on daily practice. Clin Cancer Res. 15;11(12):4393-9, 2005