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Prepublished online as a Blood First Edition Paper on November 27, 2002; DOI 10.1182/blood-2002-03-0889.
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Blood, 15 March 2003, Vol. 101, No. 6, pp. 2144-2151
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Overall and event-free survival are not improved by the use of
myeloablative therapy following intensified chemotherapy in previously
untreated patients with multiple myeloma: a prospective randomized
phase 3 study
Christine M. Segeren,
Pieter Sonneveld,
Bronno van der Holt,
Edo Vellenga,
Alexandra J. Croockewit,
Gregor E. G. Verhoef,
Jan J. Cornelissen,
Martijn R. Schaafsma,
Marinus H. J. van
Oers,
Pierre W. Wijermans,
Wim E. Fibbe,
Shulamit Wittebol,
Harry C. Schouten,
Marinus van Marwijk Kooy,
Douwe H. Biesma,
Joke W. Baars,
Rosalyn Slater,
Monique M. C. Steijaert,
Ivon Buijt, and
Henk M. Lokhorst
From the Erasmus Medical Center Rotterdam (Erasmus MC)
and University Medical Center Utrecht (UMCU) for the Dutch-Belgian
Hemato-Oncology Cooperative Study Group (HOVON), The
Netherlands.
We compared the efficacy of intensified chemotherapy followed by
myeloablative therapy and autologous stem cell rescue with intensified
chemotherapy alone in patients newly diagnosed with multiple myeloma.
There were 261 eligible patients younger than 66 years with
stage II/III multiple myeloma who were randomized after remission
induction therapy with vincristine, adriamycin, dexamethasone (VAD) to
receive intensified chemotherapy, that is, melphalan 140 mg/m2 administered intravenously in 2 doses of 70 mg/m2 (intermediate-dose melphalan [IDM]) without stem
cell rescue (n = 129) or the same regimen followed by
myeloablative therapy consisting of cyclophosphamide, total body
irradiation, and autologous stem cell reinfusion (n = 132).
Interferon- -2a was given as maintenance. Of the eligible
patients, 79% received both cycles of IDM and 79% of allocated
patients actually received myeloablative treatment. The response rate
(complete remission [CR] plus partial remission [PR]) was 88% in
the intensified chemotherapy group versus 95% in the myeloablative
treatment group. CR was significantly higher after myeloablative
therapy (13% versus 29%; P = .002). With a median
follow-up of 33 months (range, 8-65 months), the event-free survival
(EFS) was not different between the treatments (median 21 months versus
22 months; P = .28). Time to progression
(TTP) was significantly longer after myeloablative treatment (25 months versus 31 months; P = .04). The overall survival (OS) was
not different (50 months versus 47 months; P = .41).
Intensified chemotherapy followed by myeloablative therapy as
first-line treatment for multiple myeloma resulted in a higher CR and a
longer TTP when compared with intensified chemotherapy alone. However,
it did not result in a better EFS and OS.
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