Double Autografts Improve Progression-
Myeloma
Researchers from Italy have reported that newly diagnosed patients
with multiple myeloma have improved responses and relapse-free and
event-free survivals following double autologous transplants compared
to a single autologous transplant, but there was no improvement in
overall survival. The details of this study were published in the
June 10, 2007 issue of the Journal of Clinical Oncology.
Many transplant centers are treating patients with multiple myeloma
with two sequential transplants. There is evidence that this prolongs
the time to disease recurrence, but there is little evidence that
this approach improves survival, especially if a second transplant is
carried out at the time of disease progression. A previous French
randomized trial reported that double autologous transplantation
improved overall survival among patients with myeloma who did not
have at least a very good partial response after one transplant. This
has led, in some centers, to the practice of restricting a second
elective transplant to those who fail to achieve a CR or near CR
following a first transplant. Other centers routinely administer a
second transplant only at the time of disease progression following
the first transplant. In addition to transplants, there has been a
marked increase in the number of active drugs for the treatment of
multiple myeloma. Thus, the optimal initial therapy of newly
diagnosed patients with multiple myeloma is still evolving.
The current Italian study treated all patients with vincristine,
adriamycin and dexamethasone (VAD) and mobilized peripheral blood
stem cells with cyclophosphamide and Neupogen® followed by melphalan
200 mg/m2 with stem cell infusion. Patients were aged 60 years or
younger. Upon recovery, patients were randomly allocated to receive a
second transplant with busulfan and melphalan (n-158) within 3-6
months or no transplant (n=163). Patients in both arms of the study
received alfa interferon maintenance. 80-85% of patients received a
first transplant and 65% of those randomly allocated to a second
transplant actually received the assigned treatment. Data is
presented on an intent-to-treat basis with a median follow-up of 55
months.
Table 1: Single Transplants vs. Double Transplants in Multiple Myeloma
One Transplant
Two Transplants
CR or Near CR
37%
47%
Treatment related mortality
3%
4%
Median Relapse-Free Survival
24 months
42 months
Median event-free survival
23 months
35 months
Median overall survival
65 months
71 months
7 year overall survival
46%
43%
One third of the patients allocated to one transplant received an
autologous transplant after disease progression. Ten percent of
patients receiving two transplants received a third transplant. Fifty
percent of patients in both arms were treated with thalidomide or
bortezomib as salvage therapy. As in the French study, the primary
beneficiaries of a second transplant were those with less than a very
good partial response to the first transplant. Patients who had a CR
or near CR after the first transplant did not have improved
outcomes. There was a trend for improvement in overall survival
(p=10) in patients not achieving a near CR to the first transplant
and receiving a second transplant.
Comments: This study confirms the results of the French trials
showing that a second transplant benefits primarily those who are not
in at least a near CR after the first transplant. This indicates that
patients who achieve a CR with the first transplant can delay the
second transplant. This study also points out the power of new drugs
to prolong survival after progression following an autologous
transplant.
Reference: Cavo M, Tosi P, Zamagni E, et al. Prospective, randomized
study of single compared with double autologous stem-cell
transplantation for multiple myeloma: Bologna 96 Clinical Study.
Journal of Clinical Oncology. 2007; 25:2434-2441.
Related News:
Study Confirms Effectiveness of Double Autografts in Multiple Myeloma
(12/17/2004)
Thalidomide is Effective Maintenance after Double Autografts for
Multiple Myeloma (12/15/2004)
Thalidomide is Effective Maintenance after Double Autografts for
Multiple Myeloma (12/15/2004)
Double Autograft Improves Survival of Patients with Multiple Myeloma
(12/11/2002)
© 1998-2007 OncoEd.com All Rights Reserved.
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the accuracy of the information or consequences from the use or
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All Rights Reserved.
These materials may discuss uses and dosages for therapeutic products
that have not been approved by the United States Food and Drug
Administration. All readers should verify all information and data
before administering any drug, therapy or treatment discussed herein.
Neither the editors nor the publisher accepts any responsibility for
the accuracy of the information or consequences from the use or
misuse of the information contained herein.
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