A study of toxicity and comparative therapeutic efficacy of vindesine-prednisone vs. vincristine-prednisone in children with acute lymphoblastic leukemia in relapse |
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Authors: | Tribhawan Vats George Buchanan Paulette Mehta Abdal Ragab Eva Hvizdale Ruprecht Nitschke Michael Link G Peter Beardsley David Maybee Jeffrey Krischer |
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Institution: | (1) University of Kansas Medical Center, Kansas City, KS, USA;(2) Southwestern Medical School, Dallas, TX, USA;(3) Shands Teaching Hospital, University of Florida, Gainesville, FL, USA;(4) Emory University School of Medicine, Atlanta, GA, USA;(5) University of South Florida, Tampa, FL, USA;(6) Oklahoma University Health Sciences Center, Oklahoma City, OK, USA;(7) Stanford University Medical Center, Palo Alto, CA, USA;(8) Yale University School of Medicine, New Haven, CT, USA;(9) Walter Reed Army Medical Center, Washington, DC, USA;(10) Pediatric Oncology Group Statistical Office, Gainesville, FL, USA;(11) Pediatric Oncology Group, 4949 West Pine Boulevard, Suite 2A, 63108 St. Louis, MO, USA |
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Abstract: | Summary Vindesine (des-acetyl Vinblastine) is a synthetic derivative of vinblastine, and was produced with the hope that it would have less neurotoxicity and hematopoietic toxicity than other vinca alkaloids.Phase I and II studies also demonstrated significant activity in lymphoid malignancies, especially Acute Lymphoblastic Leukemia (ALL). The present study was designed to compare therapeutic effectiveness of twice weekly vindesine (2 mg/M2/dose) plus Prednisone (60 mg/M2/dose) (Treatment 1) to weekly Vincristine (2 mg/M2/dose) plus Prednisone (60 mg/M2/day) (Treatment 2). All patients were less than 21 years of age, and had documented bone marrow relapse (blast count>25%). In 39 patients presumed sensitive to vincristine, there were 11 complete responses out of 20 patients (55%) randomized to receive vindesine/ prednisone and 7 complete responses out of 19 patients (37%) treated with Vincristine/Prednisone. In 37 patients resistant to vincristine, there were 7 complete responses (19%). Vindesine was more toxic than Vincristine. Major toxicities of vindesine included paraesthesias, peripheral neuropathy and ileus. Vindesine hematological toxicity appeared greater, but such toxicity is hard to assess in patients with bone marrow disease. In this study, vindesine and vincristine had similar efficacy, but vindesine use was associated with more toxicity. |
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Keywords: | vindesine vincristine acute lymphoblastic leukemia relapse |
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