Andreas Schneeweiss1, Frank Förster2, Hans Tesch3, Bahriye Aktas4, Oleg Gluz5, Matthias Geberth6, Martin M Hertz-Eichenrode7, Winfried Schönegg8, Claudia Schumacher9, Andreas Kutscheidt10, Claudia Kiewitz11, Sandra Klawitter11, Marcus Schmidt12. 1. National Center for Tumor Diseases, University Hospital, Heidelberg, Germany andreas.schneeweiss@med.uni-heidelberg.de. 2. Outpatient Department of Gynecologic Oncology Chemnitz & University of Applied Sciences Zwickau, Chemnitz, Germany. 3. Center for Hematology and Medical Oncology at Bethanien Hospital, Frankfurt/Main, Germany. 4. Department of Gynecology and Obstetrics, University of Duisburg-Essen, Essen, Germany. 5. West German Study Group, Mönchengladbach, Germany. 6. Department for Gynecooncology Mannheim, Mannheim, Germany. 7. Praxis Hertz-Eichenrode/N. Kolloch, Remscheid, Germany. 8. Praxis Winfried Schönegg, Berlin, Germany. 9. St Elisabeth Hospital, Breast Centre Köln-Hohenlind, Köln, Germany. 10. WiSP Research Institute, Langenfeld, Germany. 11. Roche Pharma AG, Grenzach, Germany. 12. Department of Obstetrics and Gynecology, University Hospital Mainz, Mainz, Germany.
Abstract
AIM: The German ML21165 study evaluated bevacizumab-containing therapy for metastatic breast cancer (mBC) in routine oncology practice. PATIENTS AND METHODS: Patients received bevacizumab with chemotherapy until disease progression, unacceptable toxicity or consent withdrawal. Pre-specified end-points were safety and efficacy [response rate, progression-free survival (PFS) and overall survival (OS)]. RESULTS: Between May 2007 and September 2009, 865 patients received first-line bevacizumab plus paclitaxel for mBC, of whom 16% were aged ≥70 years and 9% had ECOG performance status of 2 or more. At data cut-off (median of 15.9 months' follow-up), the median PFS was 9.6 months [95% confidence interval (CI)=9.0-10.4 months] and the median OS was 21.6 months (95% CI=19.4-23.5 months). The most common non-haematological adverse drug reactions of grade 3 or more were pain (9%), hypertension (5%), sensory neuropathy (3%) and proteinuria (3%). Prolonged bevacizumab was well-tolerated. CONCLUSION: The efficacy and safety of first-line bevacizumab-paclitaxel in routine oncology practice is consistent with results from randomized trials. Copyright
AIM: The German ML21165 study evaluated bevacizumab-containing therapy for metastatic breast cancer (mBC) in routine oncology practice. PATIENTS AND METHODS: Patients received bevacizumab with chemotherapy until disease progression, unacceptable toxicity or consent withdrawal. Pre-specified end-points were safety and efficacy [response rate, progression-free survival (PFS) and overall survival (OS)]. RESULTS: Between May 2007 and September 2009, 865 patients received first-line bevacizumab plus paclitaxel for mBC, of whom 16% were aged ≥70 years and 9% had ECOG performance status of 2 or more. At data cut-off (median of 15.9 months' follow-up), the median PFS was 9.6 months [95% confidence interval (CI)=9.0-10.4 months] and the median OS was 21.6 months (95% CI=19.4-23.5 months). The most common non-haematological adverse drug reactions of grade 3 or more were pain (9%), hypertension (5%), sensory neuropathy (3%) and proteinuria (3%). Prolonged bevacizumab was well-tolerated. CONCLUSION: The efficacy and safety of first-line bevacizumab-paclitaxel in routine oncology practice is consistent with results from randomized trials. Copyright