Journal article
Phase II Study of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated, Aggressive Non-Hodgkin’s Lymphoma
Journal of clinical oncology, Vol.19(2), pp.389-397
01/15/2001
DOI: 10.1200/JCO.2001.19.2.389
PMID: 11208830
Abstract
PURPOSE: To determine the safety and efficacy of the combination of the chimeric anti-CD20 antibody Rituxan (rituximab, IDEC-C2B8; Genentech Inc, South San Francisco, CA) and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy in patients with aggressive non-Hodgkin’s lymphoma (NHL).
PATIENTS AND METHODS: Thirty-three patients with previously untreated advanced aggressive B-cell NHL received six infusions of Rituxan (375 mg/m
2
per dose) on day 1 of each cycle in combination with six doses of CHOP chemotherapy given on day 3 of each cycle.
RESULTS: The ORR by investigator assessment confirmed by the sponsor was 94% (31 of 33 patients). Twenty patients experienced a complete response (CR) (61%), 11 patients had a partial response (PR) (33%), and two patients were classified as having progressive disease. In the 18 patients with an International Prognostic Index (IPI) score ≥ 2, the combination of Rituxan plus CHOP achieved an ORR of 89% and CR of 56%. The median duration of response and time to progression had not been reached after a median observation time of 26 months. Twenty-nine of 31 responding patients remained in remission during this follow-up period, including 15 of 16 patients with an IPI score ≥ 2. The most frequent adverse events attributed to Rituxan were fever and chills, primarily during the first infusion. Rituxan did not seem to compromise the ability of patients to tolerate CHOP; all patients completed the entire six courses of the combination. The bcl-2 translocation of blood or bone marrow was positive at baseline in 13 patients; 11 patients had follow-up specimens obtained (eight CR, three PR), and all had a negative bcl-2 status after therapy. Only one patient has reconverted to bcl-2 positivity, and all patients remain in clinical remission.
CONCLUSION: This is the first report to demonstrate the safety and efficacy of the Rituxan chimeric anti-CD20 antibody in combination with standard-dose CHOP in the treatment of aggressive B-cell lymphoma. The clinical responses are at least comparable to those achieved with CHOP alone with no significant added toxicity. The presence or absence of the bcl-2 translocation did not affect the ability of patients to achieve a CR with this regimen. The ability to achieve sustained remissions in patients with an IPI score ≥ 2 warrants further investigation with a randomized study.
Details
- Title: Subtitle
- Phase II Study of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated, Aggressive Non-Hodgkin’s Lymphoma
- Creators
- J. M. Vose - University of Nebraska Medical CenterB. K. Link - University of Nebraska Medical CenterM. L. Grossbard - University of Nebraska Medical CenterM. Czuczman - University of Nebraska Medical CenterA. Grillo-Lopez - University of Nebraska Medical CenterP. Gilman - University of Nebraska Medical CenterA. Lowe - University of Nebraska Medical CenterL. A. Kunkel - University of Nebraska Medical CenterR. I. Fisher - University of Nebraska Medical Center
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.19(2), pp.389-397
- DOI
- 10.1200/JCO.2001.19.2.389
- PMID
- 11208830
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 01/15/2001
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359887902771
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