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Blood, 15 September 2001, Vol. 98, No. 6, pp. 1985-1986
CORRESPONDENCE
Response:
Myelodysplastic syndromes standardized response criteria:
further definition
We read with interest Dr Raza's letter1 in response
to the International Working Group's (IWG's) proposal to provide
standardized response criteria in myelodysplastic syndromes
(MDSs).2 Developing consistent guidelines for MDSs
presents a challenge since the clinical course of the disease may
fluctuate prior to and during therapeutic intervention. These criteria
were designed to create a standardized format so that results from
different studies could be compared and to minimize the likelihood that
arbitrarily designed response definitions would be used. In addition,
the criteria developed were to be clinically relevant and response
durability defined. There are often a number of subtle issues that do not become apparent
until such guidelines are applied, as has been noted with the newer
guidelines in chronic lymphocytic leukemia (CLL) and non-Hodgkin
lymphomas (NHLs),3,4 and presumably will also be the case
with the new acute myeloid leukemia (AML) guidelines in development.
When clinicians attempt to apply such guidelines either to clinical
practice or to a clinical research study, some degree of judgment must
be used. Regarding Dr Raza's comment about definitions of baseline
values, the values used should accurately represent the laboratory
values at the time the patient is entered into the trial. As we
indicated in Table 1, "all relevant response criteria must be noted
on at least 2 successive determinations at least 1 week apart after an
appropriate period," and such criteria would also be consistently
applied at baseline (eg, at least 2 successive determinations
at least 1 week apart within a 1 month period). Regarding Dr Raza's request for a definition of the term
"transfusion dependence," we consider this term to indicate the
average number of transfusions within a defined period (eg, within
several months prior to therapy). Thus, as stated in Table 1, responses to treatment would reflect decreases in these values over a similar baseline period. Transfusion independence, by definition, would necessitate no requirement for such blood products over the specified period of time. Dr Raza was concerned that too many forms of responses were included.
Rather, we believe the inclusion of the various types of responses is
important because it reflects the clinically relevant intent
of the treatment. For example, an anemic patient with a normal platelet
count receiving low-intensity therapy may experience an increase in
hemoglobin and platelet values following treatment. But the only
clinically relevant response in this case would be erythroid (HI-E). In
contrast, patients receiving high- intensity therapy (attempting to
alter the natural history of the disease) would have their responses
based on levels of remission of the disease. Cytogenetic and
quality-of-life responses would be valuable to determine for both types
of treatment. We concur with Dr Raza's statement about the value of having applied
these criteria previously. In fact, in addition to the extensive
clinical trials experience of the IWG investigators, a number of prior
studies have used these criteria to varying degrees and, thus, provided
a practical model for some of the proposed criteria
guidelines.5-7 Despite these experiences, we do believe
that some modification of these parameters will be needed as we
accumulate new knowledge. As stated in our report, "We anticipate
that these recommendations may require modifications as more is learned
about the molecular biology and genetics of these
disorders."2(p3674) Dr Raza suggests having each of the French-American-British (FAB)
subtypes of MDSs (refractory anemia [RA], RA with ringed sideroblasts
[RARS], RA with excess of blasts [RAEB], chronic myelomonocytic
leukemia [CMML]) treated as separate entities. Such stratification of
MDS patients can certainly be used and is consistent with our
guidelines. We anticipate that, in the coming years, "treatment
choice" and "treatment development" will be guided increasingly
according to molecularly defined subtypes of MDS. An important recent
addition to the FAB morphologic categories has been the International
Prognostic Scoring System (IPSS) for MDSs.8 As we stated,
this approach provides an improved stratification system for
"clarifying outcomes of treatments and for designing clinical trials
... using risk-based criteria for patient entry and
evaluation."2(p3673) Our group strongly advocates that
responses to therapy be evaluated in the context of prognostically
relevant stratification. Our hope is that these response guidelines will help expedite the
development of new and more effective therapies for patients with MDSs.
Bruce D. Cheson, John M. Bennett, Hagop Kantarjian, Charles A. Schiffer, Stephen D. Nimer, Bob Löwenberg, Richard
M. Stone, Moshe Mittelman, Guillermo F. Sanz, Pierre W. Wijermans, and Peter L. Greenberg, for the International Working
Group to Standardize Response Criteria for the Myelodysplastic
Syndromes
Correspondence: Bruce D. Cheson, National Cancer Institute,
Executive Plaza North, Room 741, Bethesda, MD 20892; e-mail:
chesonb{at}ctep.nci.nih.gov
References
1.
Raza A.
Improve or abandon the standardized response criteria for myelodysplastic syndromes recommended by the International Working Group.
Blood.
2001;98:251-252[Free Full Text].
2.
Cheson BD, Bennett JM, Kantarjian H, et al.
Report of an international working group to standardize response criteria for myelodysplastic syndromes.
Blood.
2000;96:3671-3674[Abstract/Free Full Text].
3.
Cheson BD, Bennett JM, Grever M, et al.
National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment.
Blood.
1996;87:4990-4997[Free Full Text].
4.
Cheson BD, Horning SJ, Coiffier B, et al.
Report of an international workshop to standardize response criteria for non-Hodgkin's lymphoma: NCI Sponsored International Working Group.
J Clin Oncol.
1999;17:1244-1253[Abstract/Free Full Text].
5.
Negrin RS, Stein R, Doherty K, et al.
Maintenance treatment of the anemia of myelodysplastic syndromes with recombinant human G-CSF plus erythropoietin: evidence for in vivo synergy.
Blood.
1996;87:4076-4081[Abstract/Free Full Text].
6.
Hellström-Lindberg E, Ahlgren T, Begguin Y, et al.
Treatment of anemia in myelodysplastic syndromes with granulocyte colony-stimulating factor plus erythropoietin: results from a randomized phase II study and long-term follow-up of 71 patients.
Blood.
1998;92:68-75[Abstract/Free Full Text].
7.
List AF, Brasfield F, Heaton R, et al.
Stimulation of hematopoiesis by amifostine in patients with myelodysplastic syndrome.
Blood.
1997;90:3364-3369[Abstract/Free Full Text].
8.
Greenberg P, Cox C, Le Beau MM, et al.
International scoring system for evaluating prognosis in myelodysplastic syndromes.
Blood
1997;89:2079-2088[Abstract/Free Full Text].
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