Haematologica 2003 - Supplements

currently accepted initial chemotherapy management at 6 months
when compared with baseline QOL. QOL was measured in
consecutive newly diagnosed MM patients using the EORTC
QLQ-C30 questionnaire. Patients completed questionnaires at
diagnosis (baseline) 3 & 6 months during treatment. Results
from 52 evaluable patients with baseline and 6 -month QOL
scores are reported . Analysis was based on two groups; (i)
VAD/C-CAMP regimens directed towards stem cell
transplantation, 20 patients and (ii) standard chemotherapy, 32
patients; (ABCM or alkylating agents directed towards
“plateau”.
QOL scores for Physical, Emotional and Social Functioning
improved in each patient group; the degree of improvement was
greater for those patients ingroup (i). Cognitive functioning
improved for group (i) but showed a decline for patients in group
(ii). Pain and fatigue scores also showed improvements in each
group at 6 months.
Global health scores improved by a mean of 15 points for group
(i) and only by 0.8 points for group (ii) patients. In analysing
QOL data using EORTC QLQ C30 hanges of >10 points in
scores are considered clinically relevant. In this study it was not
possible to show statistical significance for this observation
because of the relatively small numbers of patrients in each
group.
Management of MM with chemotherapy improves QOL. The
degree of improvement appears more marked at 6 months using
VAD/C-CAMP based chemotherapy approaches when compared
with standard chemotherapy. Although the patient groups are not
directly comparable in this prospective, non-randomised study,
the findings make a case for VAD/C-CAMP based regimes as
initial treatment for MM in terms of more rapid symptomatic
benefit and consequent QOL gain. Further studies are needed to
explore treatment effects over longer time scales and larger
numbers of patients are needed.
232
Vinorelbine Plus Dexamethasone For Relapsed Or
Refractory Multiple Myeloma
Figueroa ME∗, Corrado C∗/∗∗, Fischer ML∗, Engelberger
I∗, Pavlovsky S∗∗.
∗Instituto de Investigaciones Hematológicas "Mariano R. Castex",
Academia Nacional de Medicina de Buenos Aires; ∗∗Centro de
Internación e Investigación Clínica "Angélica Ocampo", Fundaleu.
Buenos Aires, Argentina.
Multiple myeloma is a malignant hematological neoplasm that
remains incurable despite the use of modern treatment options.
Even after high-dose chemotherapy and autologous PBSC
transplantation, a high percentage of patients still relapse and
eventually die of progressive disease; therefore, new treatment
options for relapsed or refractory patients need to be investigated.
Vinorelbine has been evaluated in vitro in myeloma cell lines,
displaying proapoptotic and antiproliferative effects.
A prospective clinical trial in relapsed multiple myeloma patients
was conducted in order to evaluate the efficacy of vinorelbine 25
mg/m2 iv, given on days 1 and 4 of each cycle, together with
dexamethasone 40 mg iv on days 1- 4, and 9 -12; treatment
cycles were administered every 21 days.
Seventeen patients were included (7 male, 10 female) from
March 1998 to January 2003, 13 of which were evaluable.
Median age at diagnosis was 52 years (range: 39-69). Median
number of previous treatments was 3 (range: 2-4), 9 patients had
relapsed following autologous PBSC transplantation, and 4
patients had progressed after thalidomide. Median time from
diagnosis was 38 months (range: 16-288). Patients received a
median of 9 treatment cycles (range: 2-18). Two patients died of
progressive disease after receiving two cycles of treatment.
Results: Overall response rate was 77% (10/13), CR 1/13 (7.6%),
PR 7/13 (54%) and minor response ("M" protein reduction
greater than 25% but less than 50%, 2/13 (15.4%). One patient
had stable disease. Median time to best response was 6 months,
and median duration of remission was 7.5 months. Only seven
patients were alive at the time of evaluation, with an median
overall survival of 18 months.
Toxicity was mainly haematological, with 57% of patients
developing grade III/IV neutropenia, and 28% of patients
requiring transfusions.
Conclusion: the combination of vinorelbine plus dexamethasone
is active in relapsed multiple myeloma patients, with an overall
response rate of 77%, and an acceptable toxicity profile.
233
Vinorelbine for relapsed and refractory multiple
myeloma (MM) treated with a combination of
vinorelbine and corticotherapy
Lescaut W, Peyrade F, Foa C, Bondiau PY, Otto J,
Gutnecht J, Thyss A.
Centre Antoine Lacassagne, Nice
Background: After treatment with MP, VAD or thalidomide,
almost all patients with MM will suffer relapses.Vinorelbine has
been shown to have activity on myelomatous cells cultures with
potentialization by dexamethasone ( Ochiai N and al. Leuk res
2002;26:731-738).
Objective: Feasability and evaluation of vinorelbine in the
treatment of refractory or relapsed multiple myeloma. Between
december 1998 and February 2000, 9 patients with MM were
treated (3 M-6W), mean age 68 years; P.S 50%, 3 stables diseases, 2
improvements)
Conclusions: The combination of vinorelbine and corticotherapy
is well tolerated and seems to have moderate efficacy in pretreated
myeloma. Further experience with this drug is warranted.
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