Updated survival analysis of a randomized phase III study of subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma.
The phase III MMY-3021 study compared safety and efficacy of subcutaneous versus intravenous administration of the proteasome inhibitor bortezomib in patients with relapsed myeloma. The initial report demonstrated non-inferior efficacy with subcutaneous versus intravenous bortezomib for the primary end point: overall response rate after four cycles of single-agent bortezomib. We report updated outcome analyses after prolonged follow up. Best response rate (after up to ten cycles of bortezomib ± dexamethasone) remained 52% in each arm, including 23% and 22% complete or near-complete responses with subcutaneous and intravenous bortezomib, respectively. Time to progression (median 9.7 vs. 9.6 months; hazard ratio 0.872, P=0.462), progression-free survival (median 9.3 vs. 8.4 months; hazard ratio 0.846, P=0.319), and overall survival (1-year: 76.4% vs. 78.0%, P=0.788) were comparable with subcutaneous versus intravenous bortezomib. Peripheral neuropathy rates remained significantly lower with subcutaneous versus intravenous bortezomib, with increased rates of improvement/resolution at the time of this analysis.
Immuno-Hématologie Department, Hôpital Saint-Louis/Centre d'Investigations Cliniques, Hôpital Saint-Louis, Assistance Publique–Hôpitaux de Paris, France.
Bertrand
B
Arnulf
Halyna
H
Pylypenko
Sebastian
S
Grosicki
Ievgenii
I
Karamanesht
Xavier
X
Leleu
Helgi
H
van de Velde
Huaibao
H
Feng
Andrew
A
Cakana
William
W
Deraedt
Philippe
P
Moreau
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001897:Boronic Acids / Q000627:therapeutic use*; D000069286:Bortezomib; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality*; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality*; D011379:Prognosis; D011719:Pyrazines / Q000627:therapeutic use*; D012074:Remission Induction; D015996:Survival Rate
D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib