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| |  New Treatment Combo For Non-Hodgkin's Lymphoma BUFFALO, NY -- Jan. 15, 1999 -- 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 percent 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 of this study were published in this month’s issue of 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, University of Alabama at Birmingham, and Sidney Kimmel Cancer Center 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 percent), 16 patients had partial response (40 percent) and two patients, who received no treatment, were non-responders. 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," Dr. Czuczman said 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," Czuczman said. 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 percent) continued in remission during this median follow-up period. Attending physicians attributed 75 percent 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," Dr. Czuczman said. "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.
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