Originally published as JCO Early Release 10.1200/JCO.2005.12.052 on January 18 2005

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Witzig, T. E. Articles by Welker, D. A. Search for Related Content PubMed PubMed Citation Articles by Witzig, T. E. Articles by Welker, D. A. Related Articles Related Editorial Social Bookmarking                            What's this?

Rituximab Therapy for Patients With Newly Diagnosed, Advanced-Stage, Follicular Grade I Non-Hodgkin's Lymphoma: A Phase II Trial in the North Central Cancer Treatment Group

From the Department of Internal Medicine, Division of Hematology, and the Division of Hematopathology, Mayo Clinic, Rochester, MN; OHACI, Peoria, IL; Medical Oncology/Hematology, Guthrie Clinic, Milan, PA; Medical Oncology, Allan Blair Cancer Center, Regina, Saskatchewan, Canada; Oncologic Consultants PA, Minneapolis, MN; Hematology/Oncology, Mayo Clinic, Scottsdale, AZ; Medical Oncology and Medical Association, Iowa Oncology Research Association CCOP, Des Moines, IA

Address reprint requests to Thomas E. Witzig, MD, Mayo Clinic 200 First St SW, Rochester, MN 55905; e-mail: witzig{at}mayo.edu

PURPOSE: Patients with newly diagnosed, advanced-stage, follicular grade 1 non-Hodgkin's lymphoma (NHL) are often asymptomatic and can be observed without immediate chemotherapy. The goals of this study were to assess the overall response rate (ORR) to rituximab in this patient population and to determine the time-to-progression (TTP) and time-to-subsequent-chemotherapy (TTSC).

PATIENTS AND METHODS: Eligible patients had untreated follicular grade 1 NHL, and measurable stage III/IV disease. Patients received rituximab 375 mg/m² intravenous weekly x 4 doses and were then followed for response and progression; no maintenance therapy was provided.

RESULTS: Thirty-seven patients were accrued; one patient was ineligible. The median age was 59 years (range, 29 to 83 years). Six patients (18%) had elevated lactate dehydrogenase levels. The ORR was 72%, with 36% complete remissions. Fourteen (39%) of 36 patients remain in unmaintained remission, two died without disease progression, and three died with disease progression. Twenty (56%) of 36 patients have disease progression. The median TTP was 2.2 years (95% CI, 1.3 to not yet reached). Eighteen patients have subsequently been treated with chemotherapy, with a median TTSC of 2.3 years (95% CI, 1.6 to not yet reached). Patients with a high lactate dehydrogenase level had a lower ORR of 33% and a short TTP of only 6 months.

CONCLUSION: Rituximab can be safely administered to patients with advanced-stage follicular grade 1 NHL with efficacy and minimal toxicity. This therapy is highly active and offers an acceptable alternative to observation in this patient population. Patients with high LDH should not be considered for rituximab monotherapy.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

Related Editorial

• Optimizing Rituximab in B-Cell Lymphoma
  Sandra J. Horning
  JCO 2005 23: 1056-1058 [Full Text]

This article has been cited by other articles:

				S. A. Gregory, K. Hohloch, C. Gisselbrecht, K. Tobinai, and M. Dreyling Harnessing the Energy: Development of Radioimmunotherapy for Patients with Non-Hodgkin's Lymphoma Oncologist, October 1, 2009; 14(suppl_2): 4 - 16. [Abstract] [Full Text] [PDF]

				A. Freedman, S. S. Neelapu, C. Nichols, M. J. Robertson, B. Djulbegovic, J. N. Winter, J. F. Bender, D. P. Gold, R. G. Ghalie, M. E. Stewart, et al. Placebo-Controlled Phase III Trial of Patient-Specific Immunotherapy With Mitumprotimut-T and Granulocyte-Macrophage Colony-Stimulating Factor After Rituximab in Patients With Follicular Lymphoma J. Clin. Oncol., June 20, 2009; 27(18): 3036 - 3043. [Abstract] [Full Text] [PDF]

				D. Dayde, D. Ternant, M. Ohresser, S. Lerondel, S. Pesnel, H. Watier, A. Le Pape, P. Bardos, G. Paintaud, and G. Cartron Tumor burden influences exposure and response to rituximab: pharmacokinetic-pharmacodynamic modeling using a syngeneic bioluminescent murine model expressing human CD20 Blood, April 16, 2009; 113(16): 3765 - 3772. [Abstract] [Full Text] [PDF]

				E. Racila, B. K. Link, W.-K. Weng, T. E. Witzig, S. Ansell, M. J. Maurer, J. Huang, C. Dahle, A. Halwani, R. Levy, et al. A Polymorphism in the Complement Component C1qA Correlates with Prolonged Response Following Rituximab Therapy of Follicular Lymphoma Clin. Cancer Res., October 15, 2008; 14(20): 6697 - 6703. [Abstract] [Full Text] [PDF]

				M. Bendandi Aiming at a Curative Strategy for Follicular Lymphoma CA Cancer J Clin, September 1, 2008; 58(5): 305 - 317. [Abstract] [Full Text] [PDF]

				B. D. Cheson and J. P. Leonard Monoclonal Antibody Therapy for B-Cell Non-Hodgkin's Lymphoma N. Engl. J. Med., August 7, 2008; 359(6): 613 - 626. [Full Text] [PDF]

				P. Martin, R. R. Furman, M. Coleman, and J. P. Leonard Phase I to III Trials of Anti B Cell Therapy in Non Hodgkin's Lymphoma Clin. Cancer Res., September 15, 2007; 13(18): 5636s - 5642s. [Abstract] [Full Text] [PDF]

				S. E. Strome, E. A. Sausville, and D. Mann A Mechanistic Perspective of Monoclonal Antibodies in Cancer Therapy Beyond Target-Related Effects Oncologist, September 1, 2007; 12(9): 1084 - 1095. [Abstract] [Full Text] [PDF]

				J. M. Pagel, A. Pantelias, N. Hedin, S. Wilbur, L. Saganic, Y. Lin, D. Axworthy, D. K. Hamlin, D. S. Wilbur, A. K. Gopal, et al. Evaluation of CD20, CD22, and HLA-DR Targeting for Radioimmunotherapy of B-Cell Lymphomas Cancer Res., June 15, 2007; 67(12): 5921 - 5928. [Abstract] [Full Text] [PDF]

				T. E. Witzig, D. J. Inwards, T. M. Habermann, A. Dogan, P. J. Kurtin, J. B. Gross Jr, A. Ananthamurthy, K. M. Ristow, and J. A. Garrity Treatment of Benign Orbital Pseudolymphomas With the Monoclonal Anti-CD20 Antibody Rituximab Mayo Clin. Proc., June 1, 2007; 82(6): 692 - 699. [Abstract] [Full Text] [PDF]

				G. A. Salles Clinical Features, Prognosis and Treatment of Follicular Lymphoma Hematology, January 1, 2007; 2007(1): 216 - 225. [Abstract] [Full Text] [PDF]

				S. S. Neelapu and L. W. Kwak Vaccine Therapy for B-Cell Lymphomas: Next-Generation Strategies Hematology, January 1, 2007; 2007(1): 243 - 249. [Abstract] [Full Text] [PDF]

				M. F. Leahy, J. F. Seymour, R. J. Hicks, and J. H. Turner Multicenter Phase II Clinical Study of Iodine-131-Rituximab Radioimmunotherapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma J. Clin. Oncol., September 20, 2006; 24(27): 4418 - 4425. [Abstract] [Full Text] [PDF]

				S. J. Horning Optimizing Rituximab in B-Cell Lymphoma J. Clin. Oncol., February 20, 2005; 23(6): 1056 - 1058. [Full Text] [PDF]