January 14, 1999 FOR IMMEDIATE RELEASE
Deborah Pettibone (716) 845-8593 [email protected]
NEW TREATMENT COMBINATION EFFECTIVE FOR NON-HODGKINS LYMPHOMA
BUFFALO, NY - A multi-institutional clinical study led by Roswell Park Cancer Institute (RPCI) has demonstrated the safety and effectiveness of a chemoimmunotherapy treatment for patients with non-Hodgkin's lymphoma. The overall response rate was 95% for patients who received treatment with a combination of Rituxan, a monoclonal antibody, and the systemic standard dose chemotherapy regimen used for this disease. The results were published in the January 1999, Journal of Clinical Oncology.
Under the direction of principal investigator, Myron Czuczman, MD, Division of Medicine, RPCI, 40 patients with low-grade or follicular B-cell non-Hodgkin's lymphoma from RPCI, Northwestern University (Chicago), University of Alabama at Birmingham, and Sidney Kimmel Cancer Center (San Diego) were treated with six infusions of Rituxan, a monoclonal antibody, in combination with six doses of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy. Twenty-two patients had complete responses (55%), 16 patients had partial response (40%), and two patients, who received no treatment, were nonresponders.
Rituxan, the first monoclonal antibody licensed for treatment of cancer in the United States in 1997, harnesses the body's own immune system to focus on and destroy cancer cells and has come to the forefront of an innovative biological approach to treating cancer called biotherapy.
"The rationale for combining the two therapies were non-overlapping toxicities, non-cross resistant mechanisms of action and an in vitro synergy with certain cytotoxic drugs, including doxorubicin," said Dr. Czuczman.
Low-grade NHL generally is associated with a high initial response rate to treatment with standard chemotherapeutic regimens, but has a pattern of repeated relapses. Patients eventually succumb to the disease or its complications, with a median survival of approximately 6.2 years. "For these reasons novel therapeutic agents and strategies need to be evaluated in this group of patients," according to Czuczman.
In this study, medians for duration of response and time to progression had not been reached after a median observation time of 29+ months. Twenty-eight of the 38 assessable patients (74%) continued in remission during this median follow-up period.
Attending physicians attributed 75% of toxicity associated with this treatment to the CHOP chemotherapy. The most frequently experienced adverse events were neuropenia, alopecia (hair loss), nausea, and fever. Rituxan was associated with fever and chills.
"These clinical findings suggest that Rituxan adds therapeutic benefit to CHOP therapy without causing significant additional toxicity," said Dr. Czuczman. "The promising results from this chemoimmunotherapy trial have opened the door to a variety of clinical trials of Rituxan in combination with other cytotoxic agents."
The non-Hodgkin's lymphomas (NHLs) are a diverse group of lymphoid neoplasms that collectively rank fifth in cancer incidence and mortality. The prevalence of NHL has been increasing during the last two decades, and it is estimated that approximately 55,400 new cases and 24,900 deaths will occur in 1998.
Roswell Park Cancer Institute, founded in 1898, is the nation's first and one of its largest cancer research, treatment and education centers, and is the only National Cancer Institute-designated comprehensive cancer center in Western New York.
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