Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma.
BACKGROUND
Thalidomide maintenance therapy after stem cell transplantation resulted in increased progression-free survival and overall survival in a few trials, but its role in non-transplant eligible patients with multiple myeloma remains unclear. This study assessed the impact of thalidomide-interferon in comparison to interferon maintenance therapy in elderly patients with multiple myeloma.


METHODS
Of 289 elderly patients with multiple myeloma who were randomized to thalidomide-dexamethasone or melphalan-prednisolone induction therapy, 137 finally completed 9 cycles of induction therapy with stable disease or better and thereby qualified for maintenance treatment. Of these, 128 have been randomized to either thalidomide-interferon or interferon alone. Primary study endpoints were progression-free survival and response rates; secondary endpoints were overall survival, toxicity and quality of life.


RESULTS
Thalidomide-interferon maintenance therapy led to a significantly longer progression-free survival compared to interferon (27.7 vs. 13.2 months, P=0.0068), but overall survival was similar in both groups (52.6 vs. 51.4 months, P=0.81) and did not differ between patients aged 75 years or older, or younger patients (P=0.39). Survival after disease progression tended to be shorter in patients on thalidomide-interferon maintenance therapy (P=0.056). Progression-free survival and overall survival tended to be shorter in patients with adverse cytogenetic (FISH) findings compared to the standard risk group but differences were not significant (P=0.084 and P=0.082, respectively). Patients on thalidomide-interferon presented with more neuropathy (P=0.0015), constipation (P=0.0004), skin toxicity (P=0.0041) and elevated creatinine (P=0.026).


CONCLUSIONS
Thalidomide plus interferon maintenance therapy increased progression-free survival but not overall survival and was associated with slightly more toxicity than maintenance with interferon alone. (ClinicalTrials.gov Identifier: NCT00205751).
Ludwig
Heinz
H
Department of Medicine I, Center for Oncology and Hematology, Wilhelminenspital, Vienna, Austria. heinz.ludwig@wienkav.at
Adam
Zdenek
Z
Tóthová
Elena
E
Hajek
Roman
R
Labar
Boris
B
Egyed
Miklós
M
Spicka
Ivan
I
Gisslinger
Heinz
H
Drach
Johannes
J
Kuhn
Ingrid
I
Hinke
Axel
A
Zojer
Niklas
N
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007155:Immunologic Factors; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality*; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage*
D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D007155:Immunologic Factors; D016898:Interferon-alpha; D013792:Thalidomide