Objectives: Standard RC exist for solid tumors, AML, CLL, and HD, but not for NHL. A panel of NHL experts (SH, BDC, BP) developed RC for a clinical trial (CT) of the anti-CD20 antibody, IDEC-C2B8. The RC were also reviewed and endorsed by a group of European NHL experts (BC, AH, WH, RM, TAL). Methods: The RC require: Complete response (CR) - 1. no palpable nodes, 2. nodes on CT £1x1 cm, 3. confirmed at > 28 days, 4. asymptomatic with no decrease in performance status, 5. BM negative if initially positive, 6. liver/spleen normal, and 7. no new lesions. Partial response (PR) - 8. sum of the product (SPD) decreased from baseline by ä50% plus 3 & 7. Stable disease (SD) - 9n <50% decrease in SPD from baseline, <SO% increase from baseline/nadir, plus 7, Progressive disease (PD) - 10. SPD increased > 50% from nadir or 11. neW lesions. These RC recognize that anatomical structures, such as lymph nodes, wil( not disappear upon CT scanning but require a substantial reduction for a CR. The requirements for PD are similar or stricter than current cooperative group RC which require a 25% increase in SPD from baseline. A Lymphoma Expert'sj Confirmation of Response panel (LEXCOR), an independent audit group, reviewed all responders' CT scans. All measurable lesions were measured at baseline, firs( efficacy evaluation, and confirmation of response. The panel was blinded other than to pt data necessary to establish a response classification. Results: The RC were applied to an IDEC-C2B8 CT in relapsed LG/F NHL and, SO/166 pts (48%) were classified as responders (10 CR and 70 PR) by LEXCOR. In 74 cases the investigator and the sponsor also classified the pts as responders for A concordance rate of 92.5% (74/80). The classification assigned by LEXCOR superseded that of the investigator (and the sponsor). Conclusions: These RC recognize the anatomical and clinical issues in assessing responses in this disease (molecular remissions may also be important), require the use of CT for evaluations, and arc very conservative (strict) in the requirements for CR and for PD. Their application by a panel of experts results in good concordance, with investigator reported results. These RC apply broadly to all LG/F NHL and may become the basis for development of precise standard criteria for LG/F NHL.
|Original language||English (US)|
|Number of pages||1|
|State||Published - 1997|