ISSN:
1569-8041
Keywords:
clinical trials
;
non-Hodgkin's lymphoma
;
response criteria
Source:
Springer Online Journal Archives 1860-2000
Topics:
Medicine
Notes:
Abstract Background:Oncologic literature cites many different definitionsof critical response measurements. Patients and methods:Response criteria (RC) for non-Hodgkin'slymphoma (NHL) were developed by lymphoma experts, endorsed by internationallymphoma clinicians, and applied to a 166-patient rituximab (Rituxan®,MabThera®) trial by a third-party, blinded panel of NHL experts (LEXCOR).Retrospectively, we analyzed this data using variations of the original RC andcomparing with recently published RC. Results:The definition of a ‘normal’ lymph node affected thecomplete response (CR) rate (≤1.0 × 1.0 cm, 6%; ≤1.5× 1.5 cm, 18%; ≤2.0 × 2.0 cm, 28%); overallresponse rate (ORR) was not affected. CR rates increased progressively without≥28 days response confirmation: 12% vs. 6% (≤1.0 ×1.0 cm), 26% vs. 18% (≤1.5 × 1.5 cm), and 36%vs. 28% (≤2.0 × 2.0 cm). CR rate and duration of response (DR)were unaffected when only the six largest, rather than all lesions, weremeasured. When the new RC were applied, CR rate (32%) was higher andDR (13.9 months) and time to progression (15.6 months) were shorter incomplete responders. Conclusions:Standard RC must be consistently and rigorouslyapplied for accurate comparisons between studies.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1008332713631
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