Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group

Josep Maria Ribera; Olga García; Albert Oriol; Cristina Gil; Pau Montesinos; Teresa Bernal; José González-Campos; Esperanza Lavilla; Jordi Ribera; Salut Brunet; María Pilar Martínez; Mar Tormo; Eulàlia Genescà; Pere Barba; Josep Sarrà; María Carmen Monteserín; Beatriz Soria; Mercedes Colorado; Antònia Cladera; Antoni García-Guiñón; María Calbacho; Alfons Serrano; Xavier Ortín; María Pedreño; Maria Luz Amigo; Lourdes Escoda; Evarist Feliu

doi:10.1016/j.leukres.2015.11.012

Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group

Josep Maria Ribera, Olga García, Albert Oriol, Cristina Gil, Pau Montesinos, Teresa Bernal, José González-Campos, Esperanza Lavilla, Jordi Ribera, Salut Brunet, María Pilar Martínez, Mar Tormo, Eulàlia Genescà, Pere Barba, Josep Sarrà, María Carmen Monteserín, Beatriz Soria, Mercedes Colorado, Antònia Cladera, Antoni García-GuiñónMaría Calbacho, Alfons Serrano, Xavier Ortín, María Pedreño, Maria Luz Amigo, Lourdes Escoda, Evarist Feliu

Department of Medicine

Research output: Contribution to journal › Article › Research › peer-review

28 Citations (Scopus)

Abstract

Copyright © 2015 Elsevier Ltd. All rights reserved. BACKGROUND AND OBJECTIVE: The prognosis of acute lymphoblastic leukemia (ALL) is poor in older adults and elderly patients, and subtype-oriented prospective trials are scarce in these patients. We present the results of three prospective parallel subtype-oriented protocols in fit patients older than 55 years.PATIENTS AND METHODS: In 2008, three prospective phase II trials in patients older than 55 years were activated: ALLOLD07 for Philadephia (Ph) chromosome-negative ALL, ALLOPH07 for Ph-positive ALL, and BURKIMAB08 for mature B-ALL. Early death (ED), complete remission (CR), disease-free survival (DFS), overall survival (OS) and toxicity were analyzed.RESULTS: 56, 53 and 21 patients from the ALLOLD07, ALLOPH07 and BURKIMAB08 trials, respectively, were evaluable. CR was 74%, 87% and 70%, with an ED rate of 13%, 11% and 15%, respectively. The medians of DFS were 8 and 38 months for ALLOLD07 and ALLOPH07 protocols, not being achieved in the BURKIMAB08 trial (p=0.001), and the median OS was 12, 37 and 25 months, respectively (p=0.030). Neutropenia, thrombocytopenia and infections were less frequent in the ALLOPH07 trial vs. ALLOLD07 and BURKIMAB trials, and renal toxicity and mucositis were more frequent in the BURKIMAB08 trial vs. the ALLOLD07 and ALLOPH07 trials. ECOG score and WBC count had prognostic significance for OS in ALLOPH07 and BURKIMAB08 trials, whereas no prognostic factors were identified in ALLOLD07 protocol.CONCLUSION: Subtype-oriented treatment had an impact in the outcome of older adults with ALL. The poorest outcome was observed in Ph-negative non-Mature B-cell ALL patients, for whom improvements in therapy are clearly needed.

Original language	English
Pages (from-to)	12-20
Journal	Leukemia Research
Volume	41
DOIs	https://doi.org/10.1016/j.leukres.2015.11.012
Publication status	Published - 1 Feb 2016

Keywords

Acute lymphoblastic leukemia
Elderly
Risk-adapted therapy

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Ribera, J. M., García, O., Oriol, A., Gil, C., Montesinos, P., Bernal, T., González-Campos, J., Lavilla, E., Ribera, J., Brunet, S., Martínez, M. P., Tormo, M., Genescà, E., Barba, P., Sarrà, J., Monteserín, M. C., Soria, B., Colorado, M., Cladera, A., ... Feliu, E. (2016). Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group. Leukemia Research, 41, 12-20. https://doi.org/10.1016/j.leukres.2015.11.012

Ribera, Josep Maria ; García, Olga ; Oriol, Albert ; Gil, Cristina ; Montesinos, Pau ; Bernal, Teresa ; González-Campos, José ; Lavilla, Esperanza ; Ribera, Jordi ; Brunet, Salut ; Martínez, María Pilar ; Tormo, Mar ; Genescà, Eulàlia ; Barba, Pere ; Sarrà, Josep ; Monteserín, María Carmen ; Soria, Beatriz ; Colorado, Mercedes ; Cladera, Antònia ; García-Guiñón, Antoni ; Calbacho, María ; Serrano, Alfons ; Ortín, Xavier ; Pedreño, María ; Amigo, Maria Luz ; Escoda, Lourdes ; Feliu, Evarist. / Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group. In: Leukemia Research. 2016 ; Vol. 41. pp. 12-20.

@article{bb4ab069952640f4bb208adc43105c31,

title = "Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group",

abstract = "Copyright {\textcopyright} 2015 Elsevier Ltd. All rights reserved. BACKGROUND AND OBJECTIVE: The prognosis of acute lymphoblastic leukemia (ALL) is poor in older adults and elderly patients, and subtype-oriented prospective trials are scarce in these patients. We present the results of three prospective parallel subtype-oriented protocols in fit patients older than 55 years.PATIENTS AND METHODS: In 2008, three prospective phase II trials in patients older than 55 years were activated: ALLOLD07 for Philadephia (Ph) chromosome-negative ALL, ALLOPH07 for Ph-positive ALL, and BURKIMAB08 for mature B-ALL. Early death (ED), complete remission (CR), disease-free survival (DFS), overall survival (OS) and toxicity were analyzed.RESULTS: 56, 53 and 21 patients from the ALLOLD07, ALLOPH07 and BURKIMAB08 trials, respectively, were evaluable. CR was 74%, 87% and 70%, with an ED rate of 13%, 11% and 15%, respectively. The medians of DFS were 8 and 38 months for ALLOLD07 and ALLOPH07 protocols, not being achieved in the BURKIMAB08 trial (p=0.001), and the median OS was 12, 37 and 25 months, respectively (p=0.030). Neutropenia, thrombocytopenia and infections were less frequent in the ALLOPH07 trial vs. ALLOLD07 and BURKIMAB trials, and renal toxicity and mucositis were more frequent in the BURKIMAB08 trial vs. the ALLOLD07 and ALLOPH07 trials. ECOG score and WBC count had prognostic significance for OS in ALLOPH07 and BURKIMAB08 trials, whereas no prognostic factors were identified in ALLOLD07 protocol.CONCLUSION: Subtype-oriented treatment had an impact in the outcome of older adults with ALL. The poorest outcome was observed in Ph-negative non-Mature B-cell ALL patients, for whom improvements in therapy are clearly needed.",

keywords = "Acute lymphoblastic leukemia, Elderly, Risk-adapted therapy",

author = "Ribera, {Josep Maria} and Olga Garc{\'i}a and Albert Oriol and Cristina Gil and Pau Montesinos and Teresa Bernal and Jos{\'e} Gonz{\'a}lez-Campos and Esperanza Lavilla and Jordi Ribera and Salut Brunet and Mart{\'i}nez, {Mar{\'i}a Pilar} and Mar Tormo and Eul{\`a}lia Genesc{\`a} and Pere Barba and Josep Sarr{\`a} and Monteser{\'i}n, {Mar{\'i}a Carmen} and Beatriz Soria and Mercedes Colorado and Ant{\`o}nia Cladera and Antoni Garc{\'i}a-Gui{\~n}{\'o}n and Mar{\'i}a Calbacho and Alfons Serrano and Xavier Ort{\'i}n and Mar{\'i}a Pedre{\~n}o and Amigo, {Maria Luz} and Lourdes Escoda and Evarist Feliu",

year = "2016",

month = feb,

day = "1",

doi = "10.1016/j.leukres.2015.11.012",

language = "English",

volume = "41",

pages = "12--20",

journal = "Leukemia Research",

issn = "0145-2126",

publisher = "Elsevier Limited",

}

Ribera, JM, García, O, Oriol, A, Gil, C, Montesinos, P, Bernal, T, González-Campos, J, Lavilla, E, Ribera, J, Brunet, S, Martínez, MP, Tormo, M, Genescà, E, Barba, P, Sarrà, J, Monteserín, MC, Soria, B, Colorado, M, Cladera, A, García-Guiñón, A, Calbacho, M, Serrano, A, Ortín, X, Pedreño, M, Amigo, ML, Escoda, L & Feliu, E 2016, 'Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group', Leukemia Research, vol. 41, pp. 12-20. https://doi.org/10.1016/j.leukres.2015.11.012

Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group. / Ribera, Josep Maria; García, Olga; Oriol, Albert; Gil, Cristina; Montesinos, Pau; Bernal, Teresa; González-Campos, José; Lavilla, Esperanza; Ribera, Jordi; Brunet, Salut; Martínez, María Pilar; Tormo, Mar; Genescà, Eulàlia; Barba, Pere; Sarrà, Josep; Monteserín, María Carmen; Soria, Beatriz; Colorado, Mercedes; Cladera, Antònia; García-Guiñón, Antoni; Calbacho, María; Serrano, Alfons; Ortín, Xavier; Pedreño, María; Amigo, Maria Luz; Escoda, Lourdes; Feliu, Evarist.

In: Leukemia Research, Vol. 41, 01.02.2016, p. 12-20.

Research output: Contribution to journal › Article › Research › peer-review

TY - JOUR

T1 - Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group

AU - Ribera, Josep Maria

AU - García, Olga

AU - Oriol, Albert

AU - Gil, Cristina

AU - Montesinos, Pau

AU - Bernal, Teresa

AU - González-Campos, José

AU - Lavilla, Esperanza

AU - Ribera, Jordi

AU - Brunet, Salut

AU - Martínez, María Pilar

AU - Tormo, Mar

AU - Genescà, Eulàlia

AU - Barba, Pere

AU - Sarrà, Josep

AU - Monteserín, María Carmen

AU - Soria, Beatriz

AU - Colorado, Mercedes

AU - Cladera, Antònia

AU - García-Guiñón, Antoni

AU - Calbacho, María

AU - Serrano, Alfons

AU - Ortín, Xavier

AU - Pedreño, María

AU - Amigo, Maria Luz

AU - Escoda, Lourdes

AU - Feliu, Evarist

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Copyright © 2015 Elsevier Ltd. All rights reserved. BACKGROUND AND OBJECTIVE: The prognosis of acute lymphoblastic leukemia (ALL) is poor in older adults and elderly patients, and subtype-oriented prospective trials are scarce in these patients. We present the results of three prospective parallel subtype-oriented protocols in fit patients older than 55 years.PATIENTS AND METHODS: In 2008, three prospective phase II trials in patients older than 55 years were activated: ALLOLD07 for Philadephia (Ph) chromosome-negative ALL, ALLOPH07 for Ph-positive ALL, and BURKIMAB08 for mature B-ALL. Early death (ED), complete remission (CR), disease-free survival (DFS), overall survival (OS) and toxicity were analyzed.RESULTS: 56, 53 and 21 patients from the ALLOLD07, ALLOPH07 and BURKIMAB08 trials, respectively, were evaluable. CR was 74%, 87% and 70%, with an ED rate of 13%, 11% and 15%, respectively. The medians of DFS were 8 and 38 months for ALLOLD07 and ALLOPH07 protocols, not being achieved in the BURKIMAB08 trial (p=0.001), and the median OS was 12, 37 and 25 months, respectively (p=0.030). Neutropenia, thrombocytopenia and infections were less frequent in the ALLOPH07 trial vs. ALLOLD07 and BURKIMAB trials, and renal toxicity and mucositis were more frequent in the BURKIMAB08 trial vs. the ALLOLD07 and ALLOPH07 trials. ECOG score and WBC count had prognostic significance for OS in ALLOPH07 and BURKIMAB08 trials, whereas no prognostic factors were identified in ALLOLD07 protocol.CONCLUSION: Subtype-oriented treatment had an impact in the outcome of older adults with ALL. The poorest outcome was observed in Ph-negative non-Mature B-cell ALL patients, for whom improvements in therapy are clearly needed.

AB - Copyright © 2015 Elsevier Ltd. All rights reserved. BACKGROUND AND OBJECTIVE: The prognosis of acute lymphoblastic leukemia (ALL) is poor in older adults and elderly patients, and subtype-oriented prospective trials are scarce in these patients. We present the results of three prospective parallel subtype-oriented protocols in fit patients older than 55 years.PATIENTS AND METHODS: In 2008, three prospective phase II trials in patients older than 55 years were activated: ALLOLD07 for Philadephia (Ph) chromosome-negative ALL, ALLOPH07 for Ph-positive ALL, and BURKIMAB08 for mature B-ALL. Early death (ED), complete remission (CR), disease-free survival (DFS), overall survival (OS) and toxicity were analyzed.RESULTS: 56, 53 and 21 patients from the ALLOLD07, ALLOPH07 and BURKIMAB08 trials, respectively, were evaluable. CR was 74%, 87% and 70%, with an ED rate of 13%, 11% and 15%, respectively. The medians of DFS were 8 and 38 months for ALLOLD07 and ALLOPH07 protocols, not being achieved in the BURKIMAB08 trial (p=0.001), and the median OS was 12, 37 and 25 months, respectively (p=0.030). Neutropenia, thrombocytopenia and infections were less frequent in the ALLOPH07 trial vs. ALLOLD07 and BURKIMAB trials, and renal toxicity and mucositis were more frequent in the BURKIMAB08 trial vs. the ALLOLD07 and ALLOPH07 trials. ECOG score and WBC count had prognostic significance for OS in ALLOPH07 and BURKIMAB08 trials, whereas no prognostic factors were identified in ALLOLD07 protocol.CONCLUSION: Subtype-oriented treatment had an impact in the outcome of older adults with ALL. The poorest outcome was observed in Ph-negative non-Mature B-cell ALL patients, for whom improvements in therapy are clearly needed.

KW - Acute lymphoblastic leukemia

KW - Elderly

KW - Risk-adapted therapy

U2 - 10.1016/j.leukres.2015.11.012

DO - 10.1016/j.leukres.2015.11.012

M3 - Article

VL - 41

SP - 12

EP - 20

JO - Leukemia Research

JF - Leukemia Research

SN - 0145-2126

ER -