Role of Bortezomib in the Treatment of Multiple Myeloma - First Results from a Representative Multicentre Treatment Survey in Germany (GER).

Background: Over the past decade new treatment options and drugs significantly altered the treatment paradigm and treatment guidelines for patients with Multiple Myeloma have been established (e.g. ASCO). Bortezomib (Velcade^®) (Vel) was first approved in GER for Multiple Myeloma in April 2004 based on phase II data in treatment after 2^nd relapse. A representative multicentre treatment survey was performed to detect treatment behaviour in GER. The survey performed in 4^th quarter 2004, based on data of 3^rd quarter 2004 was done about one quarter after approval of Vel in GER. As an example of how a new treatment option is integrated into clinical practice, we describe the use of Vel at this certain time point.

Methods: The methods of this representative analysis was provided elsewhere (Freund et al). The data presented here are a subset of this analysis based on 59 sites and 500 patients.

Results: 278 male and 222 female patients, 56% at the time of analysis for decision on primary therapy, 25% for secondary treatment and 19% for further treatment were included in this analysis. The centres participating were 15% university hospitals (UH), 27% non-university hospitals with specialized (SH) and 19% without specialized (NSH) haematology department, and 39% office-based haematologists (OBH). Vel was selected as therapy in 10.4% of patients in total, (14% UH, 52% SH, 2% NSH and 32% OBH) mainly for treatment of > 3^rd relapse (21%), followed by 2^nd relapse (15%) and 1^st relapse (8%). No use of Vel was detected as primary treatment. Within treatment ≥ 3^rd relapse, Vel was the 2^nd most frequently used drug after dexamethasone (dex) (21% and 47% respectively). Vel was most frequently planned as next therapy (53%) followed by dex (23%) and thalidomide (thal) (12%). Only 5% of this population was treated within a clinical study. After 2^nd relapse (approved label at that time), Vel was used as 7^th most frequent drug (15%) after dex, cyclophosphamide, melphalan, thal, adriamycine and vincristine. Planned further therapy for these patients was most frequently Vel (51%) followed by dex (19%), thal (20%) and bendamustine (14%). According to multivariate analysis Vel was mostly used by OBH following thal, cyclophosphamide and dex treatment. After 1^st relapse (not approved at time of survey), Vel played a minor role (8% of chemotherapy used, ranked 10^th) mainly in SH in younger patients below age 40 yrs. with concurrent diseases not qualifying for high dose chemotherapy after melphalan treatment.

Conclusion: New treatment options like Vel are quickly integrated into treatment behaviour in GER, mainly by use in OBH and within approved indication. According to planned treatment, Vel was seen at this early time point as most frequently planned further therapy in ≥ 2^nd relapse indicating this drug’s possibility to become a future treatment standard in heavily pretreated patients. In order to detect the dynamic of change of treatment of Multiple Myeloma, a comparable survey is worth to be repeated in an adequate time period.