TY - JOUR
TI - Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice
AU - Terpos, E.
AU - Katodritou, E.
AU - de la Rubia, J.
AU - Hungria, V.
AU - Hulin, C.
AU - Roussou, M.
AU - Delforge, M.
AU - Bries, G.
AU - Stoppa, A.-M.
AU - Aagesen, J.
AU - Sargin, D.
AU - Belch, A.
AU - Ahlberg, L.
AU - Diels, J.
AU - Olie, R.A.
AU - Robinson, D., Jr.
AU - Spencer, M.
AU - Potamianou, A.
AU - van de Velde, H.
AU - Dimopoulos, M.A.
JO - European Journal of Haematology
PY - 2018
VL - 101
TODO - 4
SP - 556-565
PB - Wiley-Blackwell Publishing Ltd
SN - 0902-4441, 1600-0609
TODO - 10.1111/ejh.13147
TODO - 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
TODO - 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
ER -