Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(16)(p13q22) or t(16;16)(p13;q22): Results from CALGB 8461

John C. Byrd, Amy S. Ruppert, Krzysztof Mrózek, Andrew J. Carroll, Colin G. Edwards, Diane C. Arthur, Mark J. Pettenati, Judith Stamberg, Prasad R K Koduru, Joseph O. Moore, Robert J. Mayer, Frederick R. Davey, Richard A. Larson, Clara D. Bloomfield

Research output: Contribution to journalArticle

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Abstract

Purpose: To study the impact of repetitive (three to four courses) versus a single course of high-dose cytarabine (HDAC) consolidation therapy on outcome of patients with acute myeloid leukemia (AML) and inv(16)(p13q22) or t(16;16)(p13;q22). Patients and Methods: We examined the cumulative incidence of relapse (CIR). relapse-free survival (RFS), and overall survival (OS) for 48 adults younger than 60 years with inv(16)/t(16;16) who had attained a complete remission on one of four consecutive clinical trials and were assigned to receive HDAC consolidation therapy. Twenty-eight patients were assigned to either three or four courses of HDAC, and 20 patients were assigned to one course of HDAC followed by alternative intensive consolidation therapy. Results: Pretreatment features were similar for the two groups. The CIR was significantly decreased in patients assigned to receive three to four cycles of HDAC compared with patients assigned to one course (P = .03; 5-year CIR, 43% v 70%, respectively). The difference in RFS also approached statistical significance (P = .06). In a multivariable analysis that adjusted for potential confounding covariates, only treatment assignment (three to four cycles of HDAC) predicted for superior RFS (P = .02). The OS of both groups was similar (P = .93; 5-year OS, 75% for the three to four cycles of HDAC group v 70% for the one cycle of HDAC group), reflecting a high success rate with stem-cell transplantation salvage treatment administered among patients in both treatment groups. Conclusion: We conclude that, in AML patients with inv(16)/t(16;16), repetitive HDAC therapy decreases the likelihood of relapse compared with consolidation regimens including less HDAC.

Original languageEnglish (US)
Pages (from-to)1087-1094
Number of pages8
JournalJournal of Clinical Oncology
Volume22
Issue number6
DOIs
StatePublished - 2004

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Cytarabine
Acute Myeloid Leukemia
Recurrence
Survival
Incidence
Therapeutics
Salvage Therapy
Stem Cell Transplantation
Young Adult
Clinical Trials

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(16)(p13q22) or t(16;16)(p13;q22) : Results from CALGB 8461. / Byrd, John C.; Ruppert, Amy S.; Mrózek, Krzysztof; Carroll, Andrew J.; Edwards, Colin G.; Arthur, Diane C.; Pettenati, Mark J.; Stamberg, Judith; Koduru, Prasad R K; Moore, Joseph O.; Mayer, Robert J.; Davey, Frederick R.; Larson, Richard A.; Bloomfield, Clara D.

In: Journal of Clinical Oncology, Vol. 22, No. 6, 2004, p. 1087-1094.

Research output: Contribution to journalArticle

Byrd, JC, Ruppert, AS, Mrózek, K, Carroll, AJ, Edwards, CG, Arthur, DC, Pettenati, MJ, Stamberg, J, Koduru, PRK, Moore, JO, Mayer, RJ, Davey, FR, Larson, RA & Bloomfield, CD 2004, 'Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(16)(p13q22) or t(16;16)(p13;q22): Results from CALGB 8461', Journal of Clinical Oncology, vol. 22, no. 6, pp. 1087-1094. https://doi.org/10.1200/JCO.2004.07.012
Byrd, John C. ; Ruppert, Amy S. ; Mrózek, Krzysztof ; Carroll, Andrew J. ; Edwards, Colin G. ; Arthur, Diane C. ; Pettenati, Mark J. ; Stamberg, Judith ; Koduru, Prasad R K ; Moore, Joseph O. ; Mayer, Robert J. ; Davey, Frederick R. ; Larson, Richard A. ; Bloomfield, Clara D. / Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(16)(p13q22) or t(16;16)(p13;q22) : Results from CALGB 8461. In: Journal of Clinical Oncology. 2004 ; Vol. 22, No. 6. pp. 1087-1094.
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abstract = "Purpose: To study the impact of repetitive (three to four courses) versus a single course of high-dose cytarabine (HDAC) consolidation therapy on outcome of patients with acute myeloid leukemia (AML) and inv(16)(p13q22) or t(16;16)(p13;q22). Patients and Methods: We examined the cumulative incidence of relapse (CIR). relapse-free survival (RFS), and overall survival (OS) for 48 adults younger than 60 years with inv(16)/t(16;16) who had attained a complete remission on one of four consecutive clinical trials and were assigned to receive HDAC consolidation therapy. Twenty-eight patients were assigned to either three or four courses of HDAC, and 20 patients were assigned to one course of HDAC followed by alternative intensive consolidation therapy. Results: Pretreatment features were similar for the two groups. The CIR was significantly decreased in patients assigned to receive three to four cycles of HDAC compared with patients assigned to one course (P = .03; 5-year CIR, 43{\%} v 70{\%}, respectively). The difference in RFS also approached statistical significance (P = .06). In a multivariable analysis that adjusted for potential confounding covariates, only treatment assignment (three to four cycles of HDAC) predicted for superior RFS (P = .02). The OS of both groups was similar (P = .93; 5-year OS, 75{\%} for the three to four cycles of HDAC group v 70{\%} for the one cycle of HDAC group), reflecting a high success rate with stem-cell transplantation salvage treatment administered among patients in both treatment groups. Conclusion: We conclude that, in AML patients with inv(16)/t(16;16), repetitive HDAC therapy decreases the likelihood of relapse compared with consolidation regimens including less HDAC.",
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T1 - Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(16)(p13q22) or t(16;16)(p13;q22)

T2 - Results from CALGB 8461

AU - Byrd, John C.

AU - Ruppert, Amy S.

AU - Mrózek, Krzysztof

AU - Carroll, Andrew J.

AU - Edwards, Colin G.

AU - Arthur, Diane C.

AU - Pettenati, Mark J.

AU - Stamberg, Judith

AU - Koduru, Prasad R K

AU - Moore, Joseph O.

AU - Mayer, Robert J.

AU - Davey, Frederick R.

AU - Larson, Richard A.

AU - Bloomfield, Clara D.

PY - 2004

Y1 - 2004

N2 - Purpose: To study the impact of repetitive (three to four courses) versus a single course of high-dose cytarabine (HDAC) consolidation therapy on outcome of patients with acute myeloid leukemia (AML) and inv(16)(p13q22) or t(16;16)(p13;q22). Patients and Methods: We examined the cumulative incidence of relapse (CIR). relapse-free survival (RFS), and overall survival (OS) for 48 adults younger than 60 years with inv(16)/t(16;16) who had attained a complete remission on one of four consecutive clinical trials and were assigned to receive HDAC consolidation therapy. Twenty-eight patients were assigned to either three or four courses of HDAC, and 20 patients were assigned to one course of HDAC followed by alternative intensive consolidation therapy. Results: Pretreatment features were similar for the two groups. The CIR was significantly decreased in patients assigned to receive three to four cycles of HDAC compared with patients assigned to one course (P = .03; 5-year CIR, 43% v 70%, respectively). The difference in RFS also approached statistical significance (P = .06). In a multivariable analysis that adjusted for potential confounding covariates, only treatment assignment (three to four cycles of HDAC) predicted for superior RFS (P = .02). The OS of both groups was similar (P = .93; 5-year OS, 75% for the three to four cycles of HDAC group v 70% for the one cycle of HDAC group), reflecting a high success rate with stem-cell transplantation salvage treatment administered among patients in both treatment groups. Conclusion: We conclude that, in AML patients with inv(16)/t(16;16), repetitive HDAC therapy decreases the likelihood of relapse compared with consolidation regimens including less HDAC.

AB - Purpose: To study the impact of repetitive (three to four courses) versus a single course of high-dose cytarabine (HDAC) consolidation therapy on outcome of patients with acute myeloid leukemia (AML) and inv(16)(p13q22) or t(16;16)(p13;q22). Patients and Methods: We examined the cumulative incidence of relapse (CIR). relapse-free survival (RFS), and overall survival (OS) for 48 adults younger than 60 years with inv(16)/t(16;16) who had attained a complete remission on one of four consecutive clinical trials and were assigned to receive HDAC consolidation therapy. Twenty-eight patients were assigned to either three or four courses of HDAC, and 20 patients were assigned to one course of HDAC followed by alternative intensive consolidation therapy. Results: Pretreatment features were similar for the two groups. The CIR was significantly decreased in patients assigned to receive three to four cycles of HDAC compared with patients assigned to one course (P = .03; 5-year CIR, 43% v 70%, respectively). The difference in RFS also approached statistical significance (P = .06). In a multivariable analysis that adjusted for potential confounding covariates, only treatment assignment (three to four cycles of HDAC) predicted for superior RFS (P = .02). The OS of both groups was similar (P = .93; 5-year OS, 75% for the three to four cycles of HDAC group v 70% for the one cycle of HDAC group), reflecting a high success rate with stem-cell transplantation salvage treatment administered among patients in both treatment groups. Conclusion: We conclude that, in AML patients with inv(16)/t(16;16), repetitive HDAC therapy decreases the likelihood of relapse compared with consolidation regimens including less HDAC.

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