Salvage therapy for acute myeloid leukemia with fludarabine, cytarabine, and idarubicin with or without gemtuzumab ozogamicin and with concurrent or sequential G-CSF

Mike G. Martin, Kristan M. Augustin, Geoffrey L. Uy, John S. Welch, Lindsay Hladnik, Sagun Goyal, Divya Tiwari, Ryan S. Monahan, Richard M. Reichley, Amanda F. Cashen, Keith Stockerl-Goldstein, Peter Westervelt, Camille N. Abboud, John F. DiPersio, Ravi Vij

Research output: Contribution to journalArticle

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Abstract

The current salvage therapies for relapsed/refractory acute myeloid leukemia (AML) are unsatisfactory. Over the past 7 years, we have used two salvage regimens: fludarabine, cytarabine, and idarubicin with (FLAG-IM) or without gemtuzumab ozogamicin (GO) (9 mg/m2 on Day 8) (FLAG-I) in relapsed/refractory AML. Three-quarters of patients also received concurrent G-CSF. Seventy-one patients were treated, 23 with FLAG-I and 48 with FLAG-IM. The median duration of follow-up was 30.6 months. The treatment groups were well balanced with median ages of 48 years (range 18-70) and 47 years (range 20-68), unfavorable cytogenetics in 57% and 35%, prior allogeneic stem cell transplant in 43% and 42%, and CR1 duration <1 year in 60% and 67%, respectively, for FLAG-I and FLAG-IM. The complete remission (CR) rate in the FLAG-I group was 39% with an additional 13% achieving a CRp [overall response rate (ORR) 52%]; the CR rate in the FLAG-IM group was 29% with an additional 27% achieving a CRp (ORR 56%). The median duration of response (DOR; 16.8 vs. 8.3 months), event-free survival (EFS; 7.4 vs. 4.1 months), and overall survival (OS; 8.8 vs. 5.0 months) trended to favor FLAG-I over FLAG-IM. The patients who received G-CSF concurrent with chemotherapy had superior overall response rate (ORR; 62% vs. 29%, P = 0.026), median EFS (6.2 vs. 3.4 months, P = 0.010), and OS (8.8 vs. 3.9 months, P = 0.004) when compared with those who sequentially received G-CSF and chemotherapy, regardless of chemotherapy regimen. The addition of GO, at this dose and schedule, to FLAG-I failed to improve the outcomes in patients with relapsed/refractory AML. The patients who received G-CSF concurrently with chemotherapy had improved outcomes.

Original languageEnglish (US)
Pages (from-to)733-737
Number of pages5
JournalAmerican Journal of Hematology
Volume84
Issue number11
DOIs
StatePublished - Nov 1 2009

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Idarubicin
Salvage Therapy
Cytarabine
Granulocyte Colony-Stimulating Factor
Acute Myeloid Leukemia
Drug Therapy
Cytogenetics
Disease-Free Survival
Appointments and Schedules
Stem Cells
fludarabine
gemtuzumab
Transplants
Survival

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Salvage therapy for acute myeloid leukemia with fludarabine, cytarabine, and idarubicin with or without gemtuzumab ozogamicin and with concurrent or sequential G-CSF. / Martin, Mike G.; Augustin, Kristan M.; Uy, Geoffrey L.; Welch, John S.; Hladnik, Lindsay; Goyal, Sagun; Tiwari, Divya; Monahan, Ryan S.; Reichley, Richard M.; Cashen, Amanda F.; Stockerl-Goldstein, Keith; Westervelt, Peter; Abboud, Camille N.; DiPersio, John F.; Vij, Ravi.

In: American Journal of Hematology, Vol. 84, No. 11, 01.11.2009, p. 733-737.

Research output: Contribution to journalArticle

Martin, MG, Augustin, KM, Uy, GL, Welch, JS, Hladnik, L, Goyal, S, Tiwari, D, Monahan, RS, Reichley, RM, Cashen, AF, Stockerl-Goldstein, K, Westervelt, P, Abboud, CN, DiPersio, JF & Vij, R 2009, 'Salvage therapy for acute myeloid leukemia with fludarabine, cytarabine, and idarubicin with or without gemtuzumab ozogamicin and with concurrent or sequential G-CSF', American Journal of Hematology, vol. 84, no. 11, pp. 733-737. https://doi.org/10.1002/ajh.21545
Martin, Mike G. ; Augustin, Kristan M. ; Uy, Geoffrey L. ; Welch, John S. ; Hladnik, Lindsay ; Goyal, Sagun ; Tiwari, Divya ; Monahan, Ryan S. ; Reichley, Richard M. ; Cashen, Amanda F. ; Stockerl-Goldstein, Keith ; Westervelt, Peter ; Abboud, Camille N. ; DiPersio, John F. ; Vij, Ravi. / Salvage therapy for acute myeloid leukemia with fludarabine, cytarabine, and idarubicin with or without gemtuzumab ozogamicin and with concurrent or sequential G-CSF. In: American Journal of Hematology. 2009 ; Vol. 84, No. 11. pp. 733-737.
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abstract = "The current salvage therapies for relapsed/refractory acute myeloid leukemia (AML) are unsatisfactory. Over the past 7 years, we have used two salvage regimens: fludarabine, cytarabine, and idarubicin with (FLAG-IM) or without gemtuzumab ozogamicin (GO) (9 mg/m2 on Day 8) (FLAG-I) in relapsed/refractory AML. Three-quarters of patients also received concurrent G-CSF. Seventy-one patients were treated, 23 with FLAG-I and 48 with FLAG-IM. The median duration of follow-up was 30.6 months. The treatment groups were well balanced with median ages of 48 years (range 18-70) and 47 years (range 20-68), unfavorable cytogenetics in 57{\%} and 35{\%}, prior allogeneic stem cell transplant in 43{\%} and 42{\%}, and CR1 duration <1 year in 60{\%} and 67{\%}, respectively, for FLAG-I and FLAG-IM. The complete remission (CR) rate in the FLAG-I group was 39{\%} with an additional 13{\%} achieving a CRp [overall response rate (ORR) 52{\%}]; the CR rate in the FLAG-IM group was 29{\%} with an additional 27{\%} achieving a CRp (ORR 56{\%}). The median duration of response (DOR; 16.8 vs. 8.3 months), event-free survival (EFS; 7.4 vs. 4.1 months), and overall survival (OS; 8.8 vs. 5.0 months) trended to favor FLAG-I over FLAG-IM. The patients who received G-CSF concurrent with chemotherapy had superior overall response rate (ORR; 62{\%} vs. 29{\%}, P = 0.026), median EFS (6.2 vs. 3.4 months, P = 0.010), and OS (8.8 vs. 3.9 months, P = 0.004) when compared with those who sequentially received G-CSF and chemotherapy, regardless of chemotherapy regimen. The addition of GO, at this dose and schedule, to FLAG-I failed to improve the outcomes in patients with relapsed/refractory AML. The patients who received G-CSF concurrently with chemotherapy had improved outcomes.",
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AU - Martin, Mike G.

AU - Augustin, Kristan M.

AU - Uy, Geoffrey L.

AU - Welch, John S.

AU - Hladnik, Lindsay

AU - Goyal, Sagun

AU - Tiwari, Divya

AU - Monahan, Ryan S.

AU - Reichley, Richard M.

AU - Cashen, Amanda F.

AU - Stockerl-Goldstein, Keith

AU - Westervelt, Peter

AU - Abboud, Camille N.

AU - DiPersio, John F.

AU - Vij, Ravi

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N2 - The current salvage therapies for relapsed/refractory acute myeloid leukemia (AML) are unsatisfactory. Over the past 7 years, we have used two salvage regimens: fludarabine, cytarabine, and idarubicin with (FLAG-IM) or without gemtuzumab ozogamicin (GO) (9 mg/m2 on Day 8) (FLAG-I) in relapsed/refractory AML. Three-quarters of patients also received concurrent G-CSF. Seventy-one patients were treated, 23 with FLAG-I and 48 with FLAG-IM. The median duration of follow-up was 30.6 months. The treatment groups were well balanced with median ages of 48 years (range 18-70) and 47 years (range 20-68), unfavorable cytogenetics in 57% and 35%, prior allogeneic stem cell transplant in 43% and 42%, and CR1 duration <1 year in 60% and 67%, respectively, for FLAG-I and FLAG-IM. The complete remission (CR) rate in the FLAG-I group was 39% with an additional 13% achieving a CRp [overall response rate (ORR) 52%]; the CR rate in the FLAG-IM group was 29% with an additional 27% achieving a CRp (ORR 56%). The median duration of response (DOR; 16.8 vs. 8.3 months), event-free survival (EFS; 7.4 vs. 4.1 months), and overall survival (OS; 8.8 vs. 5.0 months) trended to favor FLAG-I over FLAG-IM. The patients who received G-CSF concurrent with chemotherapy had superior overall response rate (ORR; 62% vs. 29%, P = 0.026), median EFS (6.2 vs. 3.4 months, P = 0.010), and OS (8.8 vs. 3.9 months, P = 0.004) when compared with those who sequentially received G-CSF and chemotherapy, regardless of chemotherapy regimen. The addition of GO, at this dose and schedule, to FLAG-I failed to improve the outcomes in patients with relapsed/refractory AML. The patients who received G-CSF concurrently with chemotherapy had improved outcomes.

AB - The current salvage therapies for relapsed/refractory acute myeloid leukemia (AML) are unsatisfactory. Over the past 7 years, we have used two salvage regimens: fludarabine, cytarabine, and idarubicin with (FLAG-IM) or without gemtuzumab ozogamicin (GO) (9 mg/m2 on Day 8) (FLAG-I) in relapsed/refractory AML. Three-quarters of patients also received concurrent G-CSF. Seventy-one patients were treated, 23 with FLAG-I and 48 with FLAG-IM. The median duration of follow-up was 30.6 months. The treatment groups were well balanced with median ages of 48 years (range 18-70) and 47 years (range 20-68), unfavorable cytogenetics in 57% and 35%, prior allogeneic stem cell transplant in 43% and 42%, and CR1 duration <1 year in 60% and 67%, respectively, for FLAG-I and FLAG-IM. The complete remission (CR) rate in the FLAG-I group was 39% with an additional 13% achieving a CRp [overall response rate (ORR) 52%]; the CR rate in the FLAG-IM group was 29% with an additional 27% achieving a CRp (ORR 56%). The median duration of response (DOR; 16.8 vs. 8.3 months), event-free survival (EFS; 7.4 vs. 4.1 months), and overall survival (OS; 8.8 vs. 5.0 months) trended to favor FLAG-I over FLAG-IM. The patients who received G-CSF concurrent with chemotherapy had superior overall response rate (ORR; 62% vs. 29%, P = 0.026), median EFS (6.2 vs. 3.4 months, P = 0.010), and OS (8.8 vs. 3.9 months, P = 0.004) when compared with those who sequentially received G-CSF and chemotherapy, regardless of chemotherapy regimen. The addition of GO, at this dose and schedule, to FLAG-I failed to improve the outcomes in patients with relapsed/refractory AML. The patients who received G-CSF concurrently with chemotherapy had improved outcomes.

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