Haematologica 2003 - Supplements

Support Unit (CTSU) with flexibility in adding standardized data
elements to address the specific objectives of a study. The CDEs
will serve as a foundation for data forms generation in all NCIsponsored
clinical trials across all diseases. A process has also
been established to systematically review and revise data
collection standards as necessary. The standardized data elements
and forms generated for multiple myeloma, amyloidosis, and
Waldenstrom’s macroglobulinemia will be presented, and the
CDEs and forms will be made publicly available on the NCI web
site:
http://cii-server5.nci.nih.gov:8080/pls/cde_public/cde_java.show
198
A PROSPECTIVE ANALYSIS OF A POPULATION
STUDY 622 UNSELECTED PATIENTS PRESENTING
WITH MULTIPLE MYELOMA IN HAEMATOLOGY UNITS
IN A LARGE UNITED KINGDOM, NATIONAL HEALTH
SERVICE REGION
Phekoo K, MØller H, Richards M, Bevan D, Gillett D,
Streetly M, Bell S, Fields P, Schey S on behalf of of the
South Thames Haematology Specialist Committee
Guys & St Thomas` NHS Trust, The Thames Cancer Registry,
Guy`s & St Thomas` NHS Trust, St George`s NHS Trust, Kent &
Sussex NHS Trust, Guys` & St Thomas` NHS Trust, Thames
Cancer Registry, Guys` & St Thomas` NHS Trust, Guy`s & St
Thomas` NHS Trust
A major limitation of randomised controlled trials is selection
bias. We present a population-based analysis of patients
diagnosed with Multiple Myeloma (MM).
The setting of the study was the South Thames area (7.0 million
inhabitants), managed by 66 haematologists covering 27 Acute
NHS Trusts. Haematologists confirmed cases of MM
prospectively between 1999-2000, and recorded the paraprotein
and the Salmon-Durie stage. Haematology data officers from the
Thames Cancer Registry (TCR) collected data on haematological
and biochemical laboratory results. The cause and date of death
(patients followed-up until September 2002) were obtained from
the Office of National Statistic by the TCR. Survival analysis was
based on Kaplan-Meier estimates. Statistical analysis was
performed using the Wilcoxon test and the Cox Regression
model.
622 cases of MM were newly diagnosed. The crude incidence
rate was 4.5/100,000. The median age was 73 years (range 20-
97), 72% were >65 years. The male to female ratio was 1:1. IgG
paraprotein occurred in 52% of cases, IgA 22%, IgD 1.3%, IgM
1.1% and 8% were unspecified. Four patients were non-secretory
and 12% had light chain disease. 65% were staged, 33% were I,
27% II and 40% stage III. 37% had a Hb 2mg/L. 26% had serum creatinine > 180
umol/L. 10% had calcium levels >3mmol/L. Only 22 patients
had cytogenetic analysis, no abnormalities were detected in 19
cases and there were insufficient cells for analysis in 3 samples.
65% had the WHO-PS documented on presentation, 74% were
active (score 0, 1 and 2) and 26% were confined or disabled
(score 3 and 4). 2.2% were entered into clinical trials at
presentation. 332 deaths were reported to the ONS and of these
83% were attributable to MM.
The median overall survival for the whole group was 30 months
whist in the 65 years it was 41.6 and 24.9 months
respectively (p=0.0000). Pre-treatment performance status
(p=0.0000), stage (p=0.0025), creatinine >180 umol/L
(p=0.0000), Hb 2mg/L (p=0.0054), were predictors for survival. Cox
multivariate analysis of age and the above parameters showed
that stage was the only independent significant factor.
We report an incidence of 4.5/100,000 per year. This may reflect
improved ascertainment rates in the elderly population by
engaging haematologists in the reporting process. Median
survival in this series compares favourably (30 vs. 31 months)
with a single centre study (Lacy et al. 1999) at the Mayo clinic
conducted between 1985-1998. Whilst only 2.2% of patients were
entered into clinical trials the overall survival reported in the