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Assessing response rates in clinical trials of treatment for relapsed or refractory multiple myeloma: a study of bortezomib and thalidomide

Leukemia volume 21, pages 818–820 (2007)Cite this article

We read with interest the International Uniform Response Criteria for multiple myeloma (MM) by Durie et al.,1 and congratulate the authors on this important step toward a more standardized approach to assessing response in MM. We believe that such an approach will help gauge the relative value of the newer biological therapies for MM. Indeed, response rates are often the first demonstration of clinical activity of new anti-cancer therapies, which are then further assessed by progression and survival outcomes. Although the concept of unifying response criteria appears intuitive, we were unable to find any literature that actually compares response rates using different criteria in the same cohorts of patients. In this report, we explore and illustrate the impact and influence of methods of response assessment using published studies of thalidomide and bortezomib for the treatment of MM. These data emphasize the need to introduce the standardized criteria proposed by Durie et al. as soon as possible.

As discussed by Durie et al., there are three primary sets of criteria that are used for determining response in MM (Table 1): (1) M-protein reduction alone, based on criteria developed by the Chronic Leukemia and Myeloma Task Force of the National Cancer Institute;2 of note, although these guidelines did not define the degree of response in terms of complete response (CR) or partial response (PR), the extent of M-protein reduction has since been incorporated into clinical trial designs to develop protocol-specific definitions of CR, PR and minimal response (MR). (2) Southwest Oncology Group (SWOG) criteria,3 identifying only a single category of response: CR, sometimes referred to as ‘objective response’. (3) Bladé criteria,4 also known as European Group for Blood and Marrow Transplantation criteria, which are more rigorous and stringent than the aforementioned criteria sets. Using the Bladé criteria, complete responders must have 100% reduction in both serum and urine M-protein and all responses must be maintained for ⩾6 weeks. The M-protein reduction alone criteria comprise the same number of response categories as the Bladé criteria (i.e., CR, PR and MR), but do not require the same number of diagnostic indicators (i.e., plasmacytoma level, percentage of plasma cells in the bone marrow and extent of bone disease) or a minimum response duration.

Table 1 Response criteria utilized in multiple myeloma clinical trials
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Authors and Affiliations

  1. Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Victoria, Australia

    H M Prince & L Mileshkin

  2. Global Health Economics, Janssen Pharmaceutica NV, Beerse, Belgium

    B Schenkel

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  1. H M Prince
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Correspondence to H M Prince.

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Prince, H., Schenkel, B. & Mileshkin, L. Assessing response rates in clinical trials of treatment for relapsed or refractory multiple myeloma: a study of bortezomib and thalidomide. Leukemia 21, 818–820 (2007). https://doi.org/10.1038/sj.leu.2404573

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