@article{3122991,
    title = "Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice",
    author = "Terpos, E. and Katodritou, E. and de la Rubia, J. and Hungria, V. and Hulin, C. and Roussou, M. and Delforge, M. and Bries, G. and Stoppa, A.-M. and Aagesen, J. and Sargin, D. and Belch, A. and Ahlberg, L. and Diels, J. and Olie, R.A. and Robinson, D., Jr. and Spencer, M. and Potamianou, A. and van de Velde, H. and Dimopoulos, M.A.",
    journal = "European Journal of Haematology",
    year = "2018",
    volume = "101",
    number = "4",
    pages = "556-565",
    publisher = "Wiley-Blackwell Publishing Ltd",
    issn = "0902-4441, 1600-0609",
    doi = "10.1111/ejh.13147",
    keywords = "bortezomib;  cyclophosphamide;  dexamethasone;  doxorubicin;  lenalidomide;  melphalan;  prednisone;  thalidomide;  vincristine;  antineoplastic agent;  bortezomib, adult;  aged;  anemia;  Article;  atrial fibrillation;  basal cell carcinoma;  breast carcinoma;  cancer combination chemotherapy;  cancer patient;  cancer recurrence;  chronic hepatitis;  clinical outcome;  death;  diarrhea;  diffuse large B cell lymphoma;  disease exacerbation;  drug dose reduction;  drug efficacy;  drug safety;  drug withdrawal;  female;  fever;  health care utilization;  heart failure;  hepatitis B;  human;  infection;  liver cancer;  major clinical study;  male;  monotherapy;  multiple cycle treatment;  multiple myeloma;  myelodysplastic syndrome;  neuropathy;  neurotoxicity;  observational study;  outpatient care;  overall survival;  peripheral neuropathy;  pneumonia;  priority journal;  progression free survival;  refractory multiple myeloma;  refractory multiple myeloma;  second cancer;  skin cancer;  tachycardia;  thrombocytopenia;  time to treatment;  toxic hepatitis;  treatment duration;  treatment response;  treatment response time;  clinical trial;  comorbidity;  drug resistance;  Kaplan Meier method;  middle aged;  mortality;  multicenter study;  multimodality cancer therapy;  multiple myeloma;  pathology;  recurrent disease;  retreatment;  treatment outcome;  very elderly, Adult;  Aged;  Aged, 80 and over;  Antineoplastic Combined Chemotherapy Protocols;  Bortezomib;  Combined Modality Therapy;  Comorbidity;  Drug Resistance, Neoplasm;  Female;  Humans;  Kaplan-Meier Estimate;  Male;  Middle Aged;  Multiple Myeloma;  Recurrence;  Retreatment;  Treatment Outcome",
    abstract = "Objective: The efficacy and safety of bortezomib-based therapy for relapsed/refractory multiple myeloma (RRMM) in clinical trials may differ from the oncology practice experience. The electronic VELCADE® OBservational Study was designed to prospectively evaluate bortezomib for multiple myeloma (MM) in real-world medical practice. Method: Patients scheduled to receive intravenous bortezomib for MM were eligible. The primary objective was to evaluate clinical outcomes, including response, time to response, time to next therapy, treatment-free interval, progression-free survival (PFS), and overall survival (OS). Secondary objectives included safety and healthcare resource utilization. Results: In total, 873 patients with a median of two therapy lines prior to initiating bortezomib were included. The overall response rate (≥partial response) was 69%, including 37% complete response/near-complete response. Median time to response was 1.8 months, median time to next therapy was 9.7 months, and median treatment-free interval was 7.9 months. After 22.6 months’ median follow-up, median PFS was 12.0 months and median OS was 36.1 months. The most common adverse events (AEs) were neuropathy not otherwise specified (19%), diarrhea NOS, and thrombocytopenia (each 17%); 230 (26%) patients discontinued bortezomib due to AEs. Of 689 (79%) patients without baseline peripheral neuropathy (PN), the rate of new-onset any-grade PN increased to 51% (12% grade 3/4) by cycle 8. Overall, 244 (28%) patients were hospitalized, 372 (43%) attended an outpatient visit, and 341 (39%) underwent a diagnostic/therapeutic procedure during bortezomib treatment. Conclusion: These prospective real-world data demonstrate the effectiveness and safety of bortezomib-based therapy for RRMM and confirm high response rates and long OS for this population. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd"
}