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Disclosures for Palumbo Antonio, MD

Disclosures for Palumbo Antonio, MD. Honoraria to disclose Celgene Janssen-Cilag. A Phase III Study of VMPT versus VMP in newly diagnosed elderly myeloma patients. GIMEMA: Italian Myeloma Network.

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Disclosures for Palumbo Antonio, MD

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  1. Disclosures for Palumbo Antonio, MD Honoraria to disclose Celgene Janssen-Cilag

  2. A Phase III Study of VMPT versus VMP in newly diagnosed elderly myeloma patients GIMEMA: Italian Myeloma Network Antonio Palumbo1, Sara Bringhen1, Davide Rossi2, Salvatore Berretta3, Vittorio Montefusco4, Jacopo Peccatori5, Monica Galli6, Angelo Carella7, Paola Omedè1, Mario Boccadoro1 1Divisione di Ematologia dell’Università di Torino, A.O.U. San Giovanni Battista, Torino, Italy; 2Università del Piemonte Orientale Amedeo Avogadro, Novara, Italy; 3Ospedale Ferrarotto, Università di Catania, Catania, Italy; 4Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy; 5Istituto Scientifico San Raffaele, Milano, Italy; 6Ospedali Riuniti, Bergamo, Italy; 7A.O.U. San Martino, Genova, Italy.

  3. Rationale: 3 drug combinations V = Bortezomib; M= Melphalan; P = Prednisone; T= Thalidomide 1 San Miguel JF et al. New Eng J Med 2008; 359: 906-17 2 Palumbo et al. Blood 2008;112: 3107-3114

  4. Rationale: 4 drug combinations V=Bortezomib; M=Melphalan; P=Prednisone; T=Thalidomide; R=Lenalidomide; C=Cyclophosphamide; D=Dexametasone 3 Palumbo et al. Blood 2007;109: 2767-2772 4 Palumbo ASH 2008; 112: 868 5 Kumar ASH 2008; 112: 93

  5. Aims • VMPT: superior to VMP? • Weekly infusion of bortezomib: safety improvement?

  6. VMP Cycles 1-9 Bortezomib 1.3 mg/m2 IV: days 1,8,15,22* Melphalan 9 mg/m2 and prednisone 60 mg/m2 days 1-4 NO MAINTENANCE R A N D O M I Z E 9 x 5-week cycles in both arms Until relapse MAINTENANCE Bortezomib 1.3 mg/m2 IV: days 1,15 Thalidomide 50 mg/day continuously VMPT Cycles 1-9 Bortezomib 1.3 mg/m2 IV: days 1,8,15,22* Melphalan 9 mg/m2 and prednisone 60 mg/m2 days 1-4 Thalidomide 50 mg/day continuously Treatment schedule • 511 patients (older than 65 years) randomized from 58 Italian centers • Patients: Symptomatic disease, organ damage, measurable disease • ≥65 yrs or <65 yrs and not transplant-eligible; creatinine ≤ 2.5 mg/dL * 64 VMP patients and 71 VMPT patients were treated with twice-weekly infusions of Bortezomib

  7. Patient Characteristics

  8. VMPT N=221 Median No. of cycles 5 VMP N=229 Median No. of cycles 5 51%* § P < 0.0001 * P = 0.06 42%* % of patients % of patients 35 § 21 § SD PD CR VGPR PR SD PD CR VGPR PR BestResponse

  9. 100 90 80 70 60 50 40 30 20 10 0 PR CR % of patients Treatment cycle Time to response

  10. VMPT VMP VMPT: PFS @ 36 months = 71% VMP: PFS @ 36 months = 56% Time to next therapy Progression free survival Median follow-up 16.1 months Time to next therapy Progression free survival VMPT VMP % of patients VMPT: TTNT @ 36 months = 80% VMP: TTNT @ 36 months = 78% P = 0.30 P = 0.13 Months Months

  11. VMP All patients Age ≤75 years Age ≤75 years Age >75 years Age >75 years % of patients % of patients P=0.47 P=0.02 months months VMPT Age ≤75 years Age >75 years % of patients P=0.006 months Progression free survival Age: ≤ 75 years vs > 75 years

  12. ≥VGPR ≥PR % of patients % of patients CR P=0.0003 months months VGPR All patients PR CR % of patients ≥PR P=0.005 months Progression free survival Response rate: CR vs VGPR vs PR All patients All patients

  13. All patients VMP % of patients % of patients P=0.39 P=0.81 months months VMPT % of patients P=0.25 months Progression free survival FISH analisis: t(4;14) or t(14;16) or del17 Standard Risk Standard Risk High Risk High Risk Standard Risk High Risk

  14. All patients VMP ISS 1 ISS 1 ISS 2-3 ISS 2-3 % of patients % of patients P=0.30 P=0.04 months months VMPT ISS 2-3 ISS 1 % of patients P=0.45 months Progression free survival International Staging System: ISS 1 vs ISS 2-3

  15. All patients Standard Risk VMPT High Risk Standard Risk % of patients High Risk P=0.02 % of patients months P=0.06 months Progression free survival FISH analisis t(4;14) or t(14;16) or del17 and ISS 2-3 VMP Standard Risk High Risk % of patients P=0.08 months

  16. VMPT VMP % of patients Grade 3-4 Hematologic Adverse EventsVMP vs VMPT

  17. VMPT VMP % of patients Grade 3-4 Non-hematologic Adverse Events VMP vs VMPT

  18. Efficacy and Toxicity bortezomib infusion schedule 25 VMPT and 19 VMP patients received both twice- and once-weekly *Due to peripheral neuropathy

  19. Conclusion *For patients (VMPT 150; VMP 165)who received weekly infusion of bortezomib,) §Due to peripheral neuropathy

  20. We Are Grateful to All Patients, Nurses and Physicians of the Participating Centers 1. ALESSANDRIA Levis, Baraldi 2. ANCONA Leoni, Offidani 3. AOSTA Di Vito 4. ASCOLI PICENO Galieni, Bigazzi 5. ASTI Scassa, Campa 6. AVELLINO Cantore, Volpe 7. AVIANO Tirelli, Rupolo 8. BARI Dammacco, Lauta 9. BARI Liso 10. BERGAMO Barbui, Galli 11. BIELLA Tonso 12. BOLOGNA Cavo, Tosi 13. BOLZANO Pescosta 14. BRA Vanni, Stefani 15. BRESCIA Rossi, Crippa 16. CAGLIARI Angelucci, Carubelli 17. CAGLIARI Mantovani 18. CAMPOBASSO Storti 19. CANDIOLO Aglietta, Capaldi 20. CATANIA Giustolisi, Di Raimondo 21. CATANZARO Piro 22. CATTOLICA Pasquini 23. CESENA Guardigni 24. CHIOGGIA Battista 25. CIRIE' Freilone, Beggiato 26. COSENZA Morabito 27. CREMONA Passalacqua, Morandi 28. CREMONA Morandi 29. CUNEO Gallamini, Grasso 30. FIRENZE Bosi, Nozzoli 31. FOGGIA Monaco, Ferrandina 32. FOGGIA Monaco 33. FORLI’ Amadori, Gentilini 34. GALLARATE Ciambelli 35. GENOVA Gobbi, Canepa 36. GENOVA Carella 37. LATINA Zapone 38. LECCE Pavone 39. MATERA Ciancio 40. MESSINA Brugiatelli, Mamone 41. MESSINA Musolino 42. MILANO Corradini, Montefusco 43. MILANO Morra 44. MILANO Bregni 45. MODENA Narni 46. MONTEFIASC. Montanaro, Niscola 49. MONZA Pogliani, Rossini 50. NAPOLI Rotoli,Catalano 51. NAPOLI Ferrara 52. NOCERA INF. D’Arco, Califano 53. NOVARA Gaidano, Rossi 54. NUORO Latte, Palmas 55. ORBASSANO Saglio, Guglielmelli 56. PADOVA Semenzato, Zambello 57. PALERMO Mirto, Cangialosi 58. PARMA Rizzoli, Giuliani 59. PAVIA Lazzarino, Corso 60. PERUGIA Liberati, Nunzi 61. PESARO Visani, Leopardi 62. PESCARA Fioritoni, Spadano 63. PIACENZA Cavanna, Lazzaro 64. PINEROLO Griso 65. PISA Petrini/Benedetti 66. POTENZA Ricciuti, Vertone 67. RAVENNA Zaccaria, Molinari 68. REGGIO CAL. Nobile, Callea 69. REGGIO EMILIA Gugliotta,Masini 70. RIMINI Pasquini, Fattori 71. ROMA Annino, Bongarzoni 72. ROMA Andriani 73. ROMA 1 Foà, Petrucci 74. ROMA Cattolica Leone, De Stefano 75. ROMA R.Elena Petti, Pisani 76. ROMA S. Camillo Majolino, De Rosa 77. ROMA T. Vergata Amadori, Caravita 78. ROZZANO Santoro, Nozza 79. S. G. ROTONDO Musto, Merla 80. SASSARI Longinotti, Dore 81. SIENA Lauria, Gozzetti 82. TARANTO Mazza, Casulli 83. TORINO 1 Boccadoro 84. TORINO 2 Gallo, Pregno 85. TORINO MAURIZ. Poccardi, Gottardi 86. TORINO S. VITO Marinone, Ficara 87. TORINO VALD.SE Bazzan, Rus 88. TREVISO Foscolo, Gherlinzoni 89. TRIESTE De Sabbata 90. UDINE Fanin, Patriarca 91. VARESE Pinotti 92. VENEZIA Chisesi 93. VERBANIA Montanara, Luraschi 94. VERONA Pizzolo, Meneghini 95. VICENZA Rodeghiero, Elice

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