Davis, Thomas A.;
Kaminski, Mark S.;
Leonard, John P.;
Hsu, Frank J.;
Wilkinson, Mary;
Zelenetz, Andrew;
Wahl, Richard L.;
Kroll, Stewart;
Coleman, Morton;
Goris, Michael;
Levy, Ronald;
Knox, Susan J.
The Radioisotope Contributes Significantly to the Activity of Radioimmunotherapy
Sie können Bookmarks mittels Listen verwalten, loggen Sie sich dafür bitte in Ihr SLUB Benutzerkonto ein.
Medientyp:
E-Artikel
Titel:
The Radioisotope Contributes Significantly to the Activity of Radioimmunotherapy
Beteiligte:
Davis, Thomas A.;
Kaminski, Mark S.;
Leonard, John P.;
Hsu, Frank J.;
Wilkinson, Mary;
Zelenetz, Andrew;
Wahl, Richard L.;
Kroll, Stewart;
Coleman, Morton;
Goris, Michael;
Levy, Ronald;
Knox, Susan J.
Erschienen:
American Association for Cancer Research (AACR), 2004
Beschreibung:
<jats:title>Abstract</jats:title><jats:p>Purpose: A multicenter, randomized study was undertaken to estimate the single agent activity of Tositumomab and to determine the contribution of radioisotope-labeling with 131I to activity and toxicity by comparing treatment outcomes for Tositumomab and Iodine I 131 Tositumomab (BEXXAR) to an equivalent total dose of unlabeled Tositumomab.</jats:p><jats:p>Experimental Design: Seventy-eight patients with refractory/relapsed non-Hodgkin’s lymphoma were randomized to either unlabeled Tositumomab or Iodine I 131 Tositumomab. Patients progressing after unlabeled Tositumomab could cross over to receive Iodine I 131 Tositumomab. The median follow-up at analysis was 42.6 months (range 1.9 to 71.5 months).</jats:p><jats:p>Results: Responses in the Iodine I 131 Tositumomab versus unlabeled Tositumomab groups: overall response 55% versus 19% (P = 0.002); complete response 33% versus 8% (P = 0.012); median duration of overall response not reached versus 28.1 months (95% confidence interval: 7.6, not reached); median duration of complete response not reached in either arm; and median TTP 6.3 versus 5.5 months (P = 0.031), respectively. Of the patients who had a complete response after initial Iodine I 131 Tositumomab therapy, 71% (10 of 14) continued in complete response at 29.8 to 71.1 months. Two patients who achieved a complete response after unlabeled Tositumomab had ongoing responses at 48.1 to 56.9 months. Nineteen patients received Iodine I 131 Tositumomab crossover therapy. Responses after crossover versus prior response to unlabeled Tositumomab were as follows: complete response rates of 42% versus 0% (P = 0.008); overall response 68% versus 16% (P = 0.002); median durations of overall response 12.6 versus 7.6 months (P = 0.001); and median TTP 12.4 versus 5.5 months (P = 0.01), respectively. Hematologic toxicity was more severe and nonhematologic adverse events were more frequent after Iodine I 131 Tositumomab than after Tositumomab alone. Elevated thyrotropin occurred in 5% of patients. Seroconversion to human antimurine antibody after Iodine I 131 Tositumomab, unlabeled Tositumomab, and Iodine I 131 Tositumomab-crossover was 27%, 19%, and 0%, respectively.</jats:p><jats:p>Conclusions: Unlabeled Tositumomab showed single agent activity, but in this direct comparison, all of the therapeutic outcome measures were significantly enhanced by the conjugation of 131I to Tositumomab.</jats:p>