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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: scaram(o)uche who wrote (1543)3/15/1999 12:56:00 AM
From: Bob L   of 1762
 
Richard, here is another piece of the article we were discussing on the cltr thread. Czuczman et al in Treatment of Patients with Low-Grade B-Cell Lymphoma with the Combination of Chimeric anti-CD20 Mab and CHOP Chemotherapy, Journal of Clinical Oncology Vol.17,No.1(Jan) 1999 pp268-276. Mention of chemo at end. I'll see what I can do with the tables in a separate post.

Response to Therapy

Median time to response was 47 days (range, 15 to 236 days). The overall response rate to the combination of CHOP and Rituxan treatment was 95% (95% confidence interval, 88% to 100%) in the intent-to-treat patient population (Table 3). Twenty-two patients (55%) experienced a CR, and 16 patients (40%) had a PR. Thus, only the two patients who were withdrawn from the study before the initiation of trial therapy were classified as nonresponders (one with an IWF histologic classification of A and the other, B). Response rates were also evaluated for patient subpopulations, including those with extranodal disease, an elevated serum lactate dehydrogenase concentration, bone marrow involvement, an age of 60 years or more, or bulky disease (Table 3). Combination Rituxan and CHOP therapy achieved at least a partial response in all of the patients, and the complete response rate was less than 45% only for those patients with bulky disease. Twenty-eight (74%) of 38 assessable patients continued in remission after a median observation time of 29 months (Fig 2).
There were 24 assessable (plus one unassessable) newly diagnosed patients with follicular histology, and they all responded to therapy (16 CR and eight PR). The median duration of response was yet to be reached at 27.8+ months. There was no significant difference in duration of response between naive and previously treated patients. There were nine patients with IWF type A histology. Of these, one patient was unassessable, and the other eight patients were responders (three CR and five PR). The median duration of response for the IWF type A patients had not been yet reached at 17+ months. Five of the eight patients were in ongoing remissions. At that time, there was no significant difference in rate or duration of response when these patients were compared with the rest of the study patients.
Eight of the nine patients who had received chemotherapy treatments before study entry responded to therapy with Rituxan and CHOP (Table 4). Five of these responses were complete; two of the complete responses occurred in patients who had experienced either progressive disease or a partial response with their last prior chemotherapy regimen (cyclophosphamide, vincristine, prednisone and chlorambucil, prednisone, respectively).
[End of Response to Therapy section]
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