Bortezomib in relapsed multiple myeloma: results of a non-interventional study by office-based haematologists.
BACKGROUND
In Germany, bortezomib is approved for the therapy of relapsed multiple myeloma since 2004. The data which had led to the approval were based on strictly selected patients. However, no data had been recorded on bortezomib in routine practice.


METHODS
In this non-interventional study, bortezomib was studied under routine conditions by office-based haematologists. Data were obtained prospectively following a protocol approved by the responsible Ethics Committee. Treatment followed the prescribing information and was documented for a maximum of 8 cycles. Any therapeutic or diagnostic intervention was left to the discretion of the attending physician. The primary endpoints were efficacy and safety.


RESULTS
Overall remission rate was 61% in patients evaluable for efficacy. Response rates were not significantly different between patients < or = 70 and >70 years of age, nor between patients with and without renal impairment. The median time to best response was 3 cycles. Serious adverse events included thrombocytopenia (grade 3: 6%; grade 4: 8%), peripheral neuropathy (grade 3: 8%), fatigue, and bone pain (grade 3: 6% each; grade 4: 2% each) and anaemia (grade 3: 4%).


CONCLUSIONS
The efficacy and tolerability of bortezomib observed in daily practice are consistent with the results obtained in large-scale clinical trials.
Onkologische Gemeinschaftspraxis, Krankenhaus Bethanien, Frankfurt, Germany. wolfgang.knauf@telemed.de
Wolfgang Ulrich
WU
Knauf
Burkhard
B
Otremba
Friedrich
F
Overkamp
Martin
M
Kornacker
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage; D001897:Boronic Acids / Q000008:administration & dosage*; D000069286:Bortezomib; D005260:Female; D005858:Germany / Q000453:epidemiology; D006405:Hematology / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000453:epidemiology* / Q000517:prevention & control; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology* / Q000517:prevention & control*; D010824:Physicians' Offices / Q000706:statistics & numerical data; D011719:Pyrazines / Q000008:administration & dosage*; D055502:Secondary Prevention; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib