Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with refractory leukemia

Francis J. Giles, Guillermo Garcia-Manero, Jorge E. Cortes, Sharyn D. Baker, Carol B. Miller, Susan M. O'Brien, Deborah A. Thomas, Michael Andreeff, Carol Bivins, Jacques Jolivet, Hagop M. Kantarjian

Research output: Contribution to journalArticle

Abstract

Purpose: To investigate the activity of a novel dioxolane L-nucleoside analog, troxacitabine (L-(-)-OddC, BCH-4556), in patients with refractory leukemia. Patients and Methods: Study participants were patients with refractory or relapsed acute myeloid (AML) or lymphocytic (ALL) leukemia, myelodysplastic syndromes (MDS), or chronic myelogenous leukemia in blastic phase (CML-BP). Troxacitabine was provided as an intravenous infusion for more than 30 minutes daily for 5 days at a dose of 8.0 mg/m2/d (40 mg/m2 per course). Courses were given every 3 to 4 weeks according to antileukemic efficacy. Results: Forty-two patients (AML, 18 patients; MDS, one patient; ALL, six patients; CML-BP, 17 patients) were treated. Median age was 51 years (range, 23 to 80 years); 22 patients were male. Stomatitis was the most significant adverse event, with three patients (7%) and two patients (5%), respectively, experiencing grade 3 or 4 toxicity. Ten patients (24%) had grade 3 hand-foot syndrome, and two patients (5%) had grade 3 skin rash. One patient (2%) had grade 3 fatigue and anorexia. Marrow hypoplasia occurred between days 14 and 28 in 12 (75%) of 16 assessable patients with AML. Two complete remissions and one partial remission (18%) were observed in 16 assessable patients with AML. None of six patients with ALL responded. Six (37%) of 16 assessable patients with CML-BP experienced a return to chronic-phase disease. Conclusion: Troxacitabine has significant antileukemic activity in patients with AML and CML-BP.

Original languageEnglish (US)
Pages (from-to)656-664
Number of pages9
JournalJournal of Clinical Oncology
Volume20
Issue number3
DOIs
StatePublished - Feb 1 2002
Externally publishedYes

Fingerprint

Nucleosides
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
formal glycol
troxacitabine
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Hand-Foot Syndrome
Stomatitis
Anorexia
Exanthema
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intravenous Infusions

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Giles, F. J., Garcia-Manero, G., Cortes, J. E., Baker, S. D., Miller, C. B., O'Brien, S. M., ... Kantarjian, H. M. (2002). Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with refractory leukemia. Journal of Clinical Oncology, 20(3), 656-664. https://doi.org/10.1200/JCO.20.3.656

Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with refractory leukemia. / Giles, Francis J.; Garcia-Manero, Guillermo; Cortes, Jorge E.; Baker, Sharyn D.; Miller, Carol B.; O'Brien, Susan M.; Thomas, Deborah A.; Andreeff, Michael; Bivins, Carol; Jolivet, Jacques; Kantarjian, Hagop M.

In: Journal of Clinical Oncology, Vol. 20, No. 3, 01.02.2002, p. 656-664.

Research output: Contribution to journalArticle

Giles, FJ, Garcia-Manero, G, Cortes, JE, Baker, SD, Miller, CB, O'Brien, SM, Thomas, DA, Andreeff, M, Bivins, C, Jolivet, J & Kantarjian, HM 2002, 'Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with refractory leukemia', Journal of Clinical Oncology, vol. 20, no. 3, pp. 656-664. https://doi.org/10.1200/JCO.20.3.656
Giles, Francis J. ; Garcia-Manero, Guillermo ; Cortes, Jorge E. ; Baker, Sharyn D. ; Miller, Carol B. ; O'Brien, Susan M. ; Thomas, Deborah A. ; Andreeff, Michael ; Bivins, Carol ; Jolivet, Jacques ; Kantarjian, Hagop M. / Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with refractory leukemia. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 3. pp. 656-664.
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abstract = "Purpose: To investigate the activity of a novel dioxolane L-nucleoside analog, troxacitabine (L-(-)-OddC, BCH-4556), in patients with refractory leukemia. Patients and Methods: Study participants were patients with refractory or relapsed acute myeloid (AML) or lymphocytic (ALL) leukemia, myelodysplastic syndromes (MDS), or chronic myelogenous leukemia in blastic phase (CML-BP). Troxacitabine was provided as an intravenous infusion for more than 30 minutes daily for 5 days at a dose of 8.0 mg/m2/d (40 mg/m2 per course). Courses were given every 3 to 4 weeks according to antileukemic efficacy. Results: Forty-two patients (AML, 18 patients; MDS, one patient; ALL, six patients; CML-BP, 17 patients) were treated. Median age was 51 years (range, 23 to 80 years); 22 patients were male. Stomatitis was the most significant adverse event, with three patients (7{\%}) and two patients (5{\%}), respectively, experiencing grade 3 or 4 toxicity. Ten patients (24{\%}) had grade 3 hand-foot syndrome, and two patients (5{\%}) had grade 3 skin rash. One patient (2{\%}) had grade 3 fatigue and anorexia. Marrow hypoplasia occurred between days 14 and 28 in 12 (75{\%}) of 16 assessable patients with AML. Two complete remissions and one partial remission (18{\%}) were observed in 16 assessable patients with AML. None of six patients with ALL responded. Six (37{\%}) of 16 assessable patients with CML-BP experienced a return to chronic-phase disease. Conclusion: Troxacitabine has significant antileukemic activity in patients with AML and CML-BP.",
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T1 - Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with refractory leukemia

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AU - Cortes, Jorge E.

AU - Baker, Sharyn D.

AU - Miller, Carol B.

AU - O'Brien, Susan M.

AU - Thomas, Deborah A.

AU - Andreeff, Michael

AU - Bivins, Carol

AU - Jolivet, Jacques

AU - Kantarjian, Hagop M.

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N2 - Purpose: To investigate the activity of a novel dioxolane L-nucleoside analog, troxacitabine (L-(-)-OddC, BCH-4556), in patients with refractory leukemia. Patients and Methods: Study participants were patients with refractory or relapsed acute myeloid (AML) or lymphocytic (ALL) leukemia, myelodysplastic syndromes (MDS), or chronic myelogenous leukemia in blastic phase (CML-BP). Troxacitabine was provided as an intravenous infusion for more than 30 minutes daily for 5 days at a dose of 8.0 mg/m2/d (40 mg/m2 per course). Courses were given every 3 to 4 weeks according to antileukemic efficacy. Results: Forty-two patients (AML, 18 patients; MDS, one patient; ALL, six patients; CML-BP, 17 patients) were treated. Median age was 51 years (range, 23 to 80 years); 22 patients were male. Stomatitis was the most significant adverse event, with three patients (7%) and two patients (5%), respectively, experiencing grade 3 or 4 toxicity. Ten patients (24%) had grade 3 hand-foot syndrome, and two patients (5%) had grade 3 skin rash. One patient (2%) had grade 3 fatigue and anorexia. Marrow hypoplasia occurred between days 14 and 28 in 12 (75%) of 16 assessable patients with AML. Two complete remissions and one partial remission (18%) were observed in 16 assessable patients with AML. None of six patients with ALL responded. Six (37%) of 16 assessable patients with CML-BP experienced a return to chronic-phase disease. Conclusion: Troxacitabine has significant antileukemic activity in patients with AML and CML-BP.

AB - Purpose: To investigate the activity of a novel dioxolane L-nucleoside analog, troxacitabine (L-(-)-OddC, BCH-4556), in patients with refractory leukemia. Patients and Methods: Study participants were patients with refractory or relapsed acute myeloid (AML) or lymphocytic (ALL) leukemia, myelodysplastic syndromes (MDS), or chronic myelogenous leukemia in blastic phase (CML-BP). Troxacitabine was provided as an intravenous infusion for more than 30 minutes daily for 5 days at a dose of 8.0 mg/m2/d (40 mg/m2 per course). Courses were given every 3 to 4 weeks according to antileukemic efficacy. Results: Forty-two patients (AML, 18 patients; MDS, one patient; ALL, six patients; CML-BP, 17 patients) were treated. Median age was 51 years (range, 23 to 80 years); 22 patients were male. Stomatitis was the most significant adverse event, with three patients (7%) and two patients (5%), respectively, experiencing grade 3 or 4 toxicity. Ten patients (24%) had grade 3 hand-foot syndrome, and two patients (5%) had grade 3 skin rash. One patient (2%) had grade 3 fatigue and anorexia. Marrow hypoplasia occurred between days 14 and 28 in 12 (75%) of 16 assessable patients with AML. Two complete remissions and one partial remission (18%) were observed in 16 assessable patients with AML. None of six patients with ALL responded. Six (37%) of 16 assessable patients with CML-BP experienced a return to chronic-phase disease. Conclusion: Troxacitabine has significant antileukemic activity in patients with AML and CML-BP.

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