Journal article

Publication year: 2010

Pages: 3115-3121

Journal: Journal of Clinical Oncology

Volume number: 28

Issue number: 19

ISSN: 0732-183X

eISSN: 1527-7755

Open access status: Bronze

DOI Link: https://doi.org/10.1200/JCO.2009.26.6791

Publisher: American Society of Clinical Oncology

Abstract: 

Purpose

The activity of rituximab in pediatric B-cell non-Hodgkin's lymphoma (B-NHL) has not yet been determined. We conducted a phase II window study to examine activity and tolerability of rituximab in newly diagnosed pediatric B-NHL.

Patients and Methods

Patients younger than age 19 years with CD20(+) B-NHL with at least one measurable site were eligible. Treatment consisted of rituximab at 375 mg/m(2) administered intravenously on day 1; concomitant therapy consisted of rasburicase, intrathecally (IT) triple drug (methotrexate, cytarabine, and prednisolone) on days 1 and 3 for CNS-positive patients and steroids only for anaphylaxis. Response criterion was the product of the two largest perpendicular diameters of one to three lesions and/or the percentage of blasts in bone marrow (BM) or peripheral blood (PB) within 24 hours before rituximab and on day 5. Responders had >= 25% decrease of at least one lesion or BM or PB blasts and no disease progress at other sites. Response rate (RR) was set at 45% for unfavorable activity or at 65% for favorable activity.

Results

From April 2004 to August 2008, 136 patients were enrolled. National Cancer Institute Common Toxicity Criteria 3/4 toxicities attributable to rituximab were general condition, 15%; fatigue, 13%; anaphylaxis, 7%; infection, 3%; glutamic-oxaloacetic transaminase/glutamic-pyruvic transaminase, 8%; no capillary leakage; and no toxic death. Forty-nine patients were not evaluable for response because of withdrawal from the study (n = 16), IT therapy in CNS-negative patients (n = 8), corticosteroid treatment (n = 3), technical inadequacy of response evaluation (n = 21), or no evaluable lesion (n = 1). Of 87 evaluable patients, 36 were responders (RR, 41.4%; 95% CI, 31% to 52%); among them, 27 of 67 with Burkitt lymphoma and seven of 15 with diffuse large B-cell lymphoma. A response was more frequently observed in BM (12 of 18) compared with solid tumor lesions (36 of 108; P = .007).

Conclusion Rituximab is active as a single-agent in pediatric B-NHL even though the RR was lower than requested in the phase II plan.

Harvard Citation style: Meinhardt, A., Burkhardt, B., Zimmermann, M., Borkhardt, A., Kontny, U., Klingebiel, T., et al. (2010) Phase II Window Study on Rituximab in Newly Diagnosed Pediatric Mature B-Cell Non-Hodgkin's Lymphoma and Burkitt Leukemia, Journal of Clinical Oncology, 28(19), pp. 3115-3121. https://doi.org/10.1200/JCO.2009.26.6791

APA Citation style: Meinhardt, A., Burkhardt, B., Zimmermann, M., Borkhardt, A., Kontny, U., Klingebiel, T., Berthold, F., Janka-Schaub, G., Klein, C., Kabickova, E., Klapper, W., Attarbaschi, A., Schrappe, M., & Reiter, A. (2010). Phase II Window Study on Rituximab in Newly Diagnosed Pediatric Mature B-Cell Non-Hodgkin's Lymphoma and Burkitt Leukemia. Journal of Clinical Oncology. 28(19), 3115-3121. https://doi.org/10.1200/JCO.2009.26.6791