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Phase II study of denileukin diftitox for relapsed/refractory B-Cell non-Hodgkin's lymphoma.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2004 Oct 15; Vol. 22 (20), pp. 4095-102. Date of Electronic Publication: 2004 Sep 07. - Publication Year :
- 2004
-
Abstract
- Purpose: Denileukin diftitox is a fusion protein combining diphtheria toxin and interleukin-2 (IL-2) that targets tumor cells expressing the IL-2 receptor. Its efficacy has been shown in CD25+ cutaneous T-cell lymphoma, but not in B-cell non-Hodgkin's lymphoma (NHL). A phase II study was performed to evaluate the efficacy and tolerability of denileukin diftitox for relapsed or refractory B-cell NHL.<br />Patients and Methods: Patients with relapsed or refractory B-cell NHL were eligible. Tumor CD25 expression was determined by immunohistochemistry or flow cytometry. Denileukin diftitox was administered intravenously at a dose of 18 microg/kg once daily for 5 days every 3 weeks, up to eight cycles.<br />Results: Of the 45 patients assessable for response, 32 (71%) were refractory to the last chemotherapy treatment, and all were previously treated with rituximab. Three complete responses (6.7%) and eight partial responses (17.8%) were observed, for an overall response rate of 24.5%. Nine patients (20%) had stable disease. Objective response rates were similar in CD25+ (22%) and CD25- histologies (29%), as were stable disease rates (22% and 18%, respectively). For responding patients, the median time to treatment failure was 7 months, with a median follow-up in survivors of 18 months (range, 9 to 28 months), and the projected progression-free survival at 20 months was 24% (95% CI, 0% to 60%). Most toxicities were low-grade and transient.<br />Conclusion: Denileukin diftitox seems to be effective in relapsed or refractory, CD25+ and CD25- B-cell NHL and is well-tolerated at the dosage evaluated. Evaluation of denileukin diftitox in combination with other agents may be warranted.
- Subjects :
- Adult
Aged
Antineoplastic Agents adverse effects
CD4 Antigens analysis
CD8 Antigens analysis
Diphtheria Toxin adverse effects
Diphtheria Toxin therapeutic use
Disease-Free Survival
Drug Administration Schedule
Female
Humans
Hypoalbuminemia chemically induced
Interleukin-2 adverse effects
Interleukin-2 therapeutic use
Lymphoma, B-Cell mortality
Male
Middle Aged
Neoplasm Recurrence, Local
Receptors, Interleukin-2 analysis
Recombinant Fusion Proteins adverse effects
Recombinant Fusion Proteins therapeutic use
Treatment Outcome
Antineoplastic Agents therapeutic use
Lymphoma, B-Cell drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 22
- Issue :
- 20
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 15353540
- Full Text :
- https://doi.org/10.1200/JCO.2004.03.071