Haematologica 2003 - Supplements

Neutropenia, previously reported as a rare adverse effect in this
setting, was not seen to date in our cohort. We have not observed
progression of disease, although the median follow up is still
short (10 months; range 5-30 months).
Conclusions and Comments: Cuadruple maintenance treatment
with bisfosfonates + INF + Dexamethasone + Thalidomide
presents an acceptable tolerance. The different effects of each
drug could induce a theorical multiple control over MRD by
acting at different levels on the pathogenesis of MM.
Thalidomide seems to be a safe drug in the post-transplant
setting, perhaps adding effect to the response achieved posttransplant
without major toxicity. Longer follow up and future
randomized trials will be needed to validate the role of
thalidomide and its long-term effect when used as maintenance
therapy in the post-transplant setting and in prolonging the
plateau phase of MM.
References:
A Alegre et al. Triple Maintenance Therapy (Pamidronate +
Interferon + Dexamethasone) Post- Autologous Peripheral Blood
Stem Cell Transplant ion (APBSCT) in Multiple Myeloma (MM)
VII International Myeloma Workshop, Banff, Canada, 2001,145,
P57
346
Maintenance or Salvage Therapy with Thalidomide
Enhances Overall Survival following Autologous
Hematopoietic Progenitor Cell Transplantation for
Multiple Myeloma.
S Lonial, B. Brinker, E.K Waller, A.A. Langston, I Redei, K
Smith, S Bucur, E Winton, R. Lyles, L.T. Heffner
Winship Cancer Institute, Emory University School of Medicine
Autologous hematopoietic progenitor cell transplant (HPCT) has
been proven to prolong survival for patients with multiple
myeloma, and is a standard part of therapy for most newly
diagnosed patients. While this therapy is well tolerated,
ultimately it is palliative, as nearly all patients will eventually
relapse. We have retrospectively analyzed the impact of
maintenance therapy (planned) or salvage therapy with
thalidomide (Thal) and its impact on overall survival following
HPCT. Methods: 54 patients received busulfan,
cyclophosphamide, and etoposide (Bu/Cy/VP-16) and 58
received melphalan 200mg/m2 (MEL 200). All of the patients
who received MEL 200 also received PBSC grafts, while 25 of
the 54 recipients of Bu/Cy/VP-16 received BM grafts. . Patients
were evaluated for disease status, overall survival, and relapse
free survival based upon the last known documented follow up or
restaging (for disease status). 12 patients received the
combination of Thal/INF, 22 patients received Thal alone, 27
patients received interferon alone, and 45 patients chose to
receive no maintenance therapy at all. Thal doses ranged between
100 and 400mg/day (median dose of 200mg/d) for a median
duration of 8.5 months. Interferon doses were 3 million units SQ
TIW for between 6 and 12 months post transplant as tolerated.
Results: Statistical comparisons of both overall survival and
progression free survival demonstrated no difference between
patients who received either conditioning regimen. Median
follow-up for the group as a whole was 18.5 months, 13.1 months
for the group receiving MEL200, and 35 months for the group
receiving Bu/Cy/VP-16. Median survival for the group as a whole
was 51 months, with a predicted 5 year OS of 49%. We then
evaluated the impact of post transplant therapy on overall
survival. Median survival for the group receiving Thal or
Thal/INF was 113 months, INF alone was 51 months, and the
group that received neither Thal nor INF was 29 months
(P=.0003 log rank test). In a multivariate analysis, factors which
were significant for overall survival included response to
transplant (p=.001), age