A new multidrug reinduction protocol with topotecan, vinorelbine, thiotepa, dexamethasone, and gemcitabine for relapsed or refractory acute leukemia Journal Article


Authors: Kolb, E. A.; Steinherz, P. G.
Article Title: A new multidrug reinduction protocol with topotecan, vinorelbine, thiotepa, dexamethasone, and gemcitabine for relapsed or refractory acute leukemia
Abstract: We report the results of a phase 2 nonrandomized single-arm trial of a combination therapy for relapsed or refractory leukemia. From January 1999 to June 2002, 28 patients with multiple relapsed or refractory acute leukemia received a combination of topotecan, vinarelbine, thiotepa, dexamethasone, and, for patients with an M3 marrow on day 7, gemcitabine. A total of 14 patients had pre-B-ALL (acute lymphoblastic leukemia), three had T-cell leukemia, nine acute myeloblastic leukemia (AML), and two biphenotypic leukemia. In all, 13 patients achieved a significant response (10 complete responses and three partial responses). Among the responders, five had pre-B-ALL, two had T-cell leukemias, five had AML, and one had biphenotypic leukemia. In total, 10 of these patients subsequently underwent hematopoletic stem cell transplantation, and four are alive without disease. One patient died, while in remission, of complications resulting from an episode of sepsis and pneumonia that occurred during topotecan, vinorelbine, thiotepa, dexamethasone, and gemcitabine (TVTG) reinduction. Other toxicities included grade 4 neutropenia in all patients and transient grade 2 hepatotoxicity in 10 patients (36%). In summary, we report that 47% of heavily pretreated pediatric patients with multiply relapsed or refractory leukemia achieved a significant response after therapy on the TVTG protocol. Further studies are warranted to evaluate the role of the TVTG combination in the treatment of leukemia.
Keywords: adolescent; adult; child; clinical article; controlled study; preschool child; treatment outcome; child, preschool; leukemia; fludarabine; prednisone; clinical trial; mortality; neutropenia; doxorubicin; gemcitabine; cytarabine; methotrexate; temozolomide; topotecan; drug megadose; antineoplastic agent; unindexed drug; controlled clinical trial; liver toxicity; phase 2 clinical trial; bone marrow suppression; etoposide; antineoplastic combined chemotherapy protocols; drug administration schedule; recurrence; cyclophosphamide; dexamethasone; melphalan; vincristine; clinical protocol; hematopoietic stem cell transplantation; ifosfamide; thiotepa; vinblastine; acute lymphoblastic leukemia; pneumonia; cancer regression; acute leukemia; whole body radiation; infant; mitoxantrone; daunorubicin; acute myeloblastic leukemia; drug derivative; dactinomycin; asparaginase; recurrent disease; sepsis; epirubicin; idarubicin; graft rejection; drug administration; navelbine; cyclosporin a; deoxycytidine; granulocyte colony stimulating factor; t cell leukemia; tioguanine; acute disease; gemtuzumab ozogamicin; cladribine; mercaptopurine; adult respiratory distress syndrome; vinorelbine; humans; human; male; female; priority journal; article
Journal Title: Leukemia
Volume: 17
Issue: 10
ISSN: 0887-6924
Publisher: Nature Publishing Group  
Date Published: 2003-10-01
Start Page: 1967
End Page: 1972
Language: English
DOI: 10.1038/sj.leu.2403097
PUBMED: 14513046
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 12 September 2014 -- Source: Scopus
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  1. Peter G Steinherz
    221 Steinherz
  2. Anders E Kolb
    16 Kolb