In this report, we present our results of the biochemotherapy combination of rituximab (Rituxan), a monoclonal antibody against CD20, with fludarabine (Fludara) and cyclophosphamide (Cytoxan, Neosar).
In this report, we present our results of the biochemotherapy combination ofrituximab (Rituxan), a monoclonal antibody against CD20, with fludarabine (Fludara) and cyclophosphamide(Cytoxan, Neosar). During course 1, rituximab is given at a slow rate at 375mg/m² on day 1 followed by fludarabine at 25 mg/m² and cyclophosphamide at 250mg/m² on days 2-4. During subsequent courses (2-6), rituximab is given at500 mg/m² on day 1 and fludarabine and cyclophosphamide are given at the samedoses but on days 1-3. From November 1999 to July 2001, 167 patients wereregistered, and 102 patients are currently evaluable after more than 6 months offollow-up.
Patient characteristics are as follows: median age, 59 years (range: 36-81years); males, 72.5%; Rai stage IV, 42%; median platelet count, 117 × 109cells/L (range: 15-367 × 109 cells/L); median hemoglobin, 12.1 g/dL (range:6.8-16.5 g/dL); median white blood cell count, 52 × 109 cells/L (range: 1.3-584× 109 cells/L); three or more lymph node sites involved, 59%;beta-2-microglobulin greater than 3 mg/dL, 83%; performance status of ≤ 1, 79%.The median number of prior treatments was 2: 14.7% of the patients had receivedalkylating agents only, 58.8% had been sensitive to fludarabine-containingregimens, and 26.4% had been resistant to fludarabine.
The median follow-up time is 13+ months. Using National Cancer Institutecriteria, the complete response (CR) rate is 23%; nodular partial response, 14%;partial response, 36%; and no response, 20.9%. The total response rate was72.2%. Of 13 patients (38%) in CR, five had immunoglobulin rearrangementsundetectable by polymerase chain reaction. Responses based on prior therapy aresummarized as follows:
Frequent toxicities related to rituximab included chills and fever. Othertoxicities included nausea/vomiting, hypotension, and dyspnea. Serioustoxicities from the treatment included eight episodes of pneumonia, sevenepisodes of neutropenic fever, five of sepsis, and one prolongedmyelosuppression. A total of 26 patients have died.
CONCLUSION: The combination of fludarabine, cyclophosphamide, and rituximabis a very active program for patients with previously treated CLL.