PURPOSE: A phase II trial was performed to evaluate the safety and efficacy of rituximab, a chimeric anti-CD20 monoclonal antibody, in patients with bulky (> 10-cm lesion) relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS: Thirty-one patients received intravenous infusions of rituximab 375 mg/m 2 weekly for four doses. All patients had at least one prior therapy (median, three; range, one to 13) and had progressive disease at study entry. Patients were a median of 4 years from diagnosis. RESULTS: No patient had treatment discontinued because of an adverse event. No patient developed human antichimeric antibody. The overall response rate in 28 assessable patients was 43% with a median time to progression of 8.1 months (range, 4.5 to 18.6+ months) and median duration of response of 5.9 months (range, 2.8 to 12.1+ months). The average decrease in lesion size in patients who achieved a partial response was 76%, and patients with stable disease had a decrease in average lesion size of 26%. Median serum antibody concentration was higher in responders compared with nonresponders, and a negative correlation was shown between antibody concentration and tumor bulk at baseline. CONCLUSION: Rituximab single-agent outpatient therapy is safe and shows significant clinical activity in patients with bulky relapsed or refractory low-grade or follicular B-cell NHL.
6714 Background: Bortezomib is a highly active agent in multiple myeloma. Advanced stages of multiple myeloma are freqeuntly associated with progressive renal failure. We report here 6 cases of acute advanced deterioration of renal function on prior renal insuficiency in chronic MM patients, with complete or near complete reversal of severe renal dysfunction after treatment with Velcade and Dexamethasone. Methods: Pts received Velcade 1.0 mg/m2/d IV d1,4,8,11 and Dexamethasone 20 mg IV d1,4,8,11. Results: Rapid reversal of acute deterioration of renal dysunction was demonstrated after treatment with Velcade and Dexamethasone in this retrospective review of patient cases. Improvement of renal function was generally evident quickly, often less than 2 weeks, earlier than expected from general myeloma tumor response. A review of a trial of treatment with Velcade where Dexamethasone was added in later cycles may address possible evidence of synergy of Velcade and dexamethasone in reversal of renal dysfunction. Animal models suggest NFkB, the target of Bortezomib, is upregulated in acute tubular injury from proteinuria and suggest further study of this drug’s possible role in protecting renal function. Conclusions: In summary, rapid and at times dramatic reversal of severe renal dysfunction is seen with Velcade and Dexamethasone, sparing the 6 patients above from imminent dialysis. Prevention of end stage renal failure is an important clinical goal given the prolonged survivals seen in myleoma patients in the current era, and the known impact of renal failure on their survival. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Millennium Millennium
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