Haematologica 2003 - Supplements

cytogenetics and β2 microglobulin to guide alternative
chemotherapy regimens in patients identified as high risk. Future
strategies might include alternative preparatory regimens or posttransplant
therapies, such as consolidation with nonmyeloablative
allogeneic transplantation or interferon
maintenance.
241
Single Agent Dexamethasone for Induction in Patients
with Multiple Myeloma Undergoing Autologous Stem
Cell Transplants
Shaji Kumar, Martha Q Lacy, Angela Dispenzieri, S.Vincent
Rajkumar, Rafael Fonseca, Susan Geyer, Nancy Iturria ,
Cristine Allmer, Thomas E Witzig, John A Lust, Philip R
Greipp, Robert A Kyle, Mark R Litzow, and Morie A Gertz.
Divisions of Hematology, and Biostatistics, Mayo Clinic, Rochester,
MN, 55905
Background: Randomized clinical trials have demonstrated that
autologous stem cell transplantation (SCT) offers a survival
advantage for patients with multiple myeloma (MM). Outside of
SCT, none of the combination chemotherapy regimens have
shown any survival advantage compared to standard
melphalan/prednisone combination. The combination of
vincristine, doxorubicin, and dexamethasone (VAD) is the most
commonly utilized induction therapy for myeloma prior to stem
cell collection and SCT. Within this combination, dexamethasone
(Dex) is probably the most active agent. It is not clear, if the
addition of vincristine and Adriamycin to Dex offers benefit to
patients proceeding to PBSCT after induction therapy. We
retrospectively evaluated our experience using Dex as a single
agent for pre-SCT induction therapy, to address this question.
Patients and Methods: 108 patients with MM, who underwent
SCT between April 1995 and April 2002, with at least 3 months
post-transplant follow up, form the subjects for this study. 36
patients who received dexamethasone (Dex) as a single agent for
induction therapy are compared to a historical group of 72
patients who received initial therapy with VAD. Patient data was
obtained from a prospectively maintained database and from
patient clinical records. Single agent dexamethasone was given at
40 mg/day on days 1-4, 9-12, and 17-20 for four cycles.
Responses were defined using standard criteria.
Results: The study cohort of 108 patients had a median age of
59 years (range 29-72), 58% were males. Baseline demographic
and clinical characteristics were similar in the two groups except
for higher β2M in the VAD group. 74% of patients in the VAD
group had a PR to the induction therapy compared to 63% in the
Dex group (P=0.25). Overall response rates including minimal
responses (25-49% reduction in M-protein) were 86% for the
VAD group and 74% for the Dex group (P=0.13). Patients in the
Dex group collected more CD34 cells (median 10.8 X 106/Kg vs
8.5 X 106/Kg, P=0.004). All patients in the Dex group received
melphalan only conditioning compared to 57% in the VAD
group, the rest receiving Melphalan/TBI. Time to engraftment for
neutrophil (>500) and platelets (>50K) was shorter for the VAD
group, P < 0.01. All patients in the VAD group and 33 patients
(94%) in the Dex group achieved an objective response at the
completion of the transplant.
Conclusion: The response to induction therapy with dexamethasone
alone results in similar response rates to those seen with VAD. When
combined with the fact that response to transplant is no different
between these groups, it makes a case for using Dexamethasone
alone as initial therapy for patients planning to proceed to transplant.
This regimen obviates the need for catheter placement for
chemotherapy as well as decreases the risk of neutropenic infections
and thrombotic events seen with cytotoxic chemotherapy as well as
avoids the inconvenience of continuous infusion chemotherapy
which often needs inpatient care.
242
An Open, Randomized, Controlled, Phase II, single
centre, two-period cross over study to compare the
quality of life (QoL) and toxicity experienced on PEG
Interferon (P-IFN) with interferon-alpha2b (IFN) in
patients with multiple myeloma (MM) maintained on a
steady dose of IFN
B Sirohi, R Powles, D Lawrence, H Hollis, E Salmon, D
Heming, G Patel, M Das, S Kulkarni
Royal Marsden NHS Trust
Subject compliance with IFN dosing during the prolonged
treatment courses of maintenance therapy for patients with MM is
an important factor for achieving the intended clinical benefit.
The significantly longer half-life of P-IFN (Schering-Plough)
allows once-weekly dosing rather than thrice weekly Consenting,
eligible MM patients who had been receiving IFN maintenance
therapy for at least six weeks were randomly (1:1) allocated to
receive P-IFN for three months followed by IFN for 3 months, or
to continue with IFN for 3 months followed by P-IFN for 3
months (crossover design). Patients were assessed for toxicity
using the NCI-Common Toxicity Criteria throughout the study
and were asked to complete an EORTC QLQ-C30 and EORTC-
QLQ MY24 (Stead et al; Br J Haematol, 1999;104:605-611)
questionnaire to assess their QoL before receiving the first
randomised treatment and at 3 and 6 months. The dose of P-IFN
was equivalent to IFN. The main aim of the study was to compare
the Global QoL score from QLQ-C30 on P-IFN and IFN. The
study enrolled 60 patients (Median age, 51 years (31-70)17F,
43M, 80% stage III). At the time of enrolment, 55% patients were
in complete remission and 23% in partial remission and 22%
were minimal responders to previous therapy . 54 (90%) patients
completed all the three QoL questionnaires (baseline, 3 and 6
month) and all patients completed at least 2 questionnaires. The
data from the EORTC-QLQ-C30 has been analysed Scores for
each scale in the EORTC-QLQ-C30 questionnaire were
calculated as suggested in the scoring manual. A higher score on
functional scores i.e positive difference indicates P-IFN is better
and a lower score on symptom scales i.e negative difference
indicates P-IFN is better. P-IFN was associated with a
statistically significantly better global QoL score (mean
difference 8.33; 95%CI 4.2-14.98; P