Haematologica 2003 - Supplements

There was done evaluation of intensity of MIBI and known
markers of myeloma disease before and after therapy.
Methods : 96 cosecutive patients with MM and 28 patients with
MGUS were evaluated.. All patients were examined at the time of
diagnosis and 29 patients after chemotherapy. Intensity od MIBI
was scored as N-normal, D-difuse, F-focal.
Results: The uptake score of MIBI correlate with clinical status,
activity of disease as determined by serum beta-2-microglobulin,
monoclonal imunoglobulin level,thymidine-kinase, CRP, LDH,
telopeptide 1CTP, infiltration of bone marrow by plasma cells. (
p< 0,05).
Focal type of MIBI scintigraphy indicated worse prognosis and
was present in more advanced disease stage II and III accordind
Durie –Salmon clasification.. In the group od 28 MGUS patients
was found diffuse patern of MIBI only in 2 patients, they are
stable during two years observation period..In non secretory
myeloma was MIBI reliable method for detection of focal
involvement in soft tisues, which was proved by MRI , CT and
cytological examination.
Conclusion: The use of 99mTc.-MIBI scintigraphy is a reliable
tool for the detecting and staging of MM disease, can detect
multifocal involvement and is very usefull espetially in nonsecretory
and low secretory MM.
Supported by grant IGA Czech Republic ,NC 6724-3/2001.
7.3 Prognostic models.
196
Prognostic factors in Multiple Myeloma
Janet A.Dunn*, Mark T. Drayson , Gulnaz Begum*, Nicola
Barth*,Ade Olujohungbe
*Cancer Research UK Clinical Trials Unit, Department of Immunity
and Infection
Patients with myeloma vary greatly in prognosis at presentation
and those patients entered into different studies are not
necessarily comparable. Lack of comparability particularly
applies if studies using intensive chemotherapy are compared
with trials using less toxic treatment. It is important to
prospectively identify those who could tolerate prolonged
chemotherapy and who may benefit from more aggressive
regimens. Efforts to improve patient management in this disease
have been assisted by identifying a number of prognostic factors,
which are now routinely recorded in the UK Medical Research
Council (MRC) myelomatosis trials. A number of prognostic
indices have been developed in an attempt to divide patients into
clearly defined prognostic groups. The Durie-Salmon index is the
most widely used system but most MRC patients fall into the
poor prognostic group. The Cuzick index and the use of serum
2 microglobulin both provide reliable means for dividing
patients into prognostic strata, each containing a useful number of
patients. However, there are several other potentially useful
prognostic factors that could be incorporated into an improved
staging system.
Prognostic factors have been assessed in the 999 patients
randomised to receive ABCM (adriamycin, BCNU,
cyclophosphamide, and melphalan) combination therapy in the
Vth and VIth MRC myelomatosis trials. The Vth trial compared
ABCM (314 patients) versus melphalan (316 patients) (Lancet,
1992 339: 200-205) between October 1982 and May 1986. The
VIth trial assessed whether reduction in tumour bulk achieved by
corticosteroids was useful given at the start of the ABCM
regimen; 343 patients randomised to ABCM, 342 patients
randomised to ABCMP between June 1986 and March 1991.
Cross-trial survival analysis shows no difference between the
ABCM treatments used in the Vth and VIth trials or with the
addition of prednisolone. Hence the 999 patients can be pooled
for the exploration of prognostic factors.
Log-rank analysis was performed on the twenty-three potential
prognostic factors to identify the importance of each factor. Cox
regression models were then applied to these factors firstly by
grouping them into six main groups: 1) general factors measured
by age, sex, performance status and serum albumin; 2) tumour
burden or activity measured by bone marrow plasma cells,
extramedullary involvement, paraprotein class and serum 2
microglobulin; 3) haemopoietic function measured by anaemia,
thrombocytopenia, lymphopenia and neutropenia; 4) skeletal
disease measured by bone pain, fractures, hypercalcaemia, serum
phosphate, osteolytic lesions and osteoporosis; 5) alkaline
phosphatase and other liver enzymes; 6) renal disease measured
by serum creatinine and blood urea. This allows the importance
of each factor to be considered in a similar group to explore
correlations. This reduced the set down to thirteen potential
factors which were considered in a final overall model. The final
Cox regression model identified serum 2 microglobulin,
corrected serum calcium, age, osteolytic lesions, platelets,
performance status and bone marrow plasma cells as independent
prognostic factors. C-reactive protein was also considered but
was not an independent factor. This model is a useful tool to
divide the patients into good, intermediate and poor prognostic
groups, allowing the prediction of clinically useful prognostic
groups.
197
Common Data Elements Development for Myeloma
Trials: A Joint Project of the National Cooperative
Cancer Clinical Trials Groups and NCI.
Susan Geyer1, Angela Dispenzieri1, David Vesole2, Donna
Reece3, Montserrat Rue4, Pamela West5, Mark White5,
Jeffrey Abrams6, Beverly Meadows6.
1Mayo Clinic, Rochester, MN, USA; 2Blood and Marrow
Transplantation, Medical College of Wisconsin, Milwaukee, WI,
USA; 3University Health Network, Princess Margaret Hospital,
Toronto, ON, Canada; 4Dana Farber Cancer Institute, Boston, MA,
USA; 5EMMES Corporation, Rockville, MD, USA; 6National
Cancer Institute, Bethesda, MD, USA.
Successful monitoring, analysis, and presentation of clinical trials
are largely dependent on the data collected through the generated
study forms set, which identifies the content and timing of
protocol-specific data to be collected for each patient. This is
challenging for trials in hematologic malignancies that use more
than one set of staging and/or response criteria which are ever
changing and differ between investigative groups. In an initiative
sponsored by the National Cancer Institute (NCI) to standardize
and simplify the collection and reporting of data for clinical trials,
a Common Data Elements (CDE) committee was organized to
generate standardized forms for multiple myeloma, amyloidosis,
and Waldenstrom’s macroglobulinemia. This committee included
statisticians, physicians, and data managers with representation
from the major North American cancer cooperative groups
involved in this research (ECOG, NCIC, NCCTG, SWOG,
ABMTR/IBMTR) as well as representatives from NCI and the
EMMES Corporation, an NCI contractor. The charge of the CDE
project and of our committee was two-fold: to review data
collection with the intent of eliminating unnecessary items, and to
propose standardized definitions and uniform valid values for the
required elements. These case report forms will be used in the
phase III trials being implemented through the Cancer Trials
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