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All-trans Retinoic Acid and Anthracycline Monochemotherapy for the Treatment of Elderly Patients with Acute Promyelocyti

All-trans Retinoic Acid and Anthracycline Monochemotherapy for the Treatment of Elderly Patients with Acute Promyelocytic Leukaemia.

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All-trans Retinoic Acid and Anthracycline Monochemotherapy for the Treatment of Elderly Patients with Acute Promyelocyti

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  1. All-trans Retinoic Acid and Anthracycline Monochemotherapy for the Treatment of Elderly Patients with Acute Promyelocytic Leukaemia P. Montesinos, E. Vellenga, C. Rayón, V. Rubio, S. Brunet, J. Díaz-Mediavilla, C. Rivas, J. Bueno, J. de la Serna, E. Amutio, S. Negri, G. Milone, A. Holowiecka, J. Bergua, A. Novo, E. de Lisa, J. Mayer, B. Lowenberg, and M.A. Sanz on behalf of the PETHEMA Group APL meeting 2009, Rome, Italy. Sept. 25 2009

  2. Background Therapeutic results in elderly patients with acute promyelocytic leukemia (APL) have been generally reported as less effective than for younger patients.

  3. Results of the GIMEMA, European APL Group, and PETHEMA studies 1- Leukemia 2003; 2- Leukemia 2005; 3- Blood 2004

  4. More low-risk among elderly Sanz et al., Blood 2004

  5. Study Aims Update the analysis of the LPA96 and LPA99 trials including a significantly higher number of elderly patients and longer follow-up.

  6. PETHEMA LPA96 TrialAll patients All patients #1 IDA 5 mg/m²/d × 4 MTZ 10 mg/m²/d× 5 #2 #3 IDA 12 mg/m²/d× 1 INDUCTION AIDA ATRA 45 mg/m²/d until CR IDA 12 mg/m² d2, 4, 6, 8 CONSOLIDATION MAINTENANCE 2 year ATRA + MP + MTX

  7. intermediate and high risk low risk #1 IDA 7 mg/m²/d × 4 + ATRA× 15 d #1 IDA 5 mg/m²/d × 4 MTZ 10 mg/m²/d× 5 + ATRA × 15 d #2 MTZ 10 mg/m²/d× 5 #2 #3 IDA 12 mg/m²/d× 2 + ATRA × 15 d #3 IDA 12 mg/m²/d× 1 PETHEMA LPA99 TrialPatients >60 years (Risk-adapted) INDUCTION AIDA ATRA 45 mg/m²/d until CR IDA 12 mg/m² d2, 4, 6, 8 CONSOLIDATION MAINTENANCE 2 year ATRA + MP + MTX

  8. PETHEMA LPA 2005 TrialPatients >60 years low risk #1 IDA 5 mg/m²/d × 4 + ATRA x15d MTZ 10 mg/m²/d× 3 + ATRA x15d #2 #3 IDA 12 mg/m²/d× 1 + ATRA x15d (Dose reduction) INDUCTION AIDA ATRA 45 mg/m²/d until CR IDA 12 mg/m² d2, 4, 6, 8 CONSOLIDATION Intermediate and high risk #1 IDA 7 mg/m²/d × 4 + ATRA x15d MTZ 10 mg/m²/d× 3 + ATRA x15d #2 #3 IDA 12 mg/m²/d×2 + ATRA x15d MAINTENANCE 2 year ATRA + MP + MTX

  9. PETHEMA LPA96, 99 & 2005 TrialsAccrual • Study period: November 1996 – July 2009 • Accrual 270 • Ineligible 69 (25.5%) • Eligible 201 • Non evaluable 6 (2.9%) • Evaluable 195 • 195 elderly (17.3%) of 1130 patients included

  10. PETHEMA LPA96, 99 & 2005 TrialsDemographic and baseline characteristics

  11. PETHEMA LPA96, 99 & 2005 TrialsDemographic and baseline characteristics

  12. Induction Outcome with AIDA Regimen

  13. PETHEMA LPA96, 99 & 2005 TrialsPost-remission events (154 of 159 completed the consolidation therapy)

  14. PETHEMA LPA96, 99 & 2005 TrialsOverall survival OS 63% OS by LPA trial P = 0.13 OS by Relapse Risk 73% 63% 75% 67% 51% 72% P = 0.003 Low Intermediate LPA 2005 LPA 99 LPA96 High

  15. OS by Age 69% 49% Age >70 P = 0.06 Age <70

  16. PETHEMA LPA96, 99 & 2005 Trials Relapse-free survival Overall RFS 89% RFS by LPA trial RFS by Relapse Risk P = 0.90 95% 87% 82% 87% 89% 91% P = 0.21 Low LPA 2005 Intermediate LPA 99 High LPA96

  17. PETHEMA Trials in Elderly PatientsConcluding remarks • This study confirms the high antileukemic efficacy and high degree of compliance of protocols using ATRA and anthracycline monochemotherapy for induction and consolidation therapy in elderly patients. • Induction death remains the most challenging cause of therapeutic failure, especially in patients with WBC >10.000xµL.

  18. PETHEMA Trials in Elderly PatientsConcluding remarks • Consolidation and maintenance chemotherapy was relatively well tolerated in low-risk patients and in younger than 70 years. • “Age-adapted” strategies focusing on decreasing the intensity of chemotherapy, while maintaining the antileukemic efficacy, should be a major objective in future studies.

  19. Participating Institutions H.U. La Fe, Valencia H. Carlos Haya, Málaga H. Dr. Negrin, Las Palmas H. Central, Asturias H.C.U. Santiago H. M-Infantil, Las Palmas H.J. Canalejo, Coruña H. Reina Sofia, Córdoba H. Basurto, Bilbao H. General, Jerez H. Dr. Peset, Valencia H. R. Hortega, Valladolid H. Clinic, Barcelona H. San Pau, Barcelona H.C.U. Zaragoza H.G.E. Ciudad de Jaén H. Joan XXIII, Tarragona H.C. S. Carlos, Madrid H.U. V. Victoria, Málaga H. Clínico, Valencia H.U. V. D'Hebron, Barcelona H.General, Castellón H. Cruces, Baracaldo C.H. León H.U. V. Arrixaca, Murcia H. 12 Octubre, Madrid H. Navarra, Pamplona H. Montecelo, Pontevedra H.C.U. Salamanca H.C. Valladolid F. Jiménez Díaz, Madrid H. Son Dureta, Mallorca H. G. Albacete C.H. de Segovia H.U. P. del Mar, Cádiz H. M. Valdecilla, Santander H. Meixoeiro, Vigo H. Insular, Las Palmas H.U. V. D'Hebron (Inf), Barna H. Severo Ochoa, Leganés C.H. Xeral-Calde, Lugo H. La Princesa, Madrid H.G. Murcia H. General, Alicante H. Ramón y Cajal, Madrid H.S.P.Alcántara, Cáceres H.U. G. Trias i Pujol, Barna H. San Jorge, Huesca

  20. GATLA (Argentina) Fundaleu, Buenos Aires H. Clemente Álvarez, Rosario H. General San Martín, La Plata H. Rossi, La Plata H. General San Martín, Paraná I. Trasplante de Médula Ósea, La Plata I. P. de Hematología, Paraná H. de Clínicas, Buenos Aires Participating Institutions H.U. del Aire, Madrid H. Sta María Rosell, Cartagena H. del Mar, Barcelona H. San Rafael, Madrid H. Dr. Trueta, Gerona H. Virgen de la Cinta, Tortosa H. Niño Jesús, Madrid H. C. Haya (Inf), Málaga H. Virgen del Rocío, Sevilla H.C. San Carlos (Inf), Madrid H.G. Valencia I.C.O., Hospitalet de Llobregat H. Xeral-Cies, Vigo H. N.S. Sonsoles, Ávila SHOP (Spain) H. Txagorritxu, Vitoria H.U. La Fe (Inf), Valencia H. General (Inf), Alicante H. La Paz (Inf), Madrid H. Río Carrión, Palencia H. Maciel, Montevideo (Uruguay) H.U. Arrixaca (Inf), Murcia H. C. Haya (Inf), Málaga H. P. Asturias, A. Henares H. Mutua, Terrasa HOVON (The Netherlands) F. Hospital, Brno (Czec Rep.)

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