Τίτλος:
Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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
Συγγραφείς:
Terpos, E.
Katodritou, E.
de la Rubia, J.
Hungria, V.
Hulin, C.
Roussou, M.
Delforge, M.
Bries, G.
Stoppa, A.-M.
Aagesen, J.
Sargin, D.
Belch, A.
Ahlberg, L.
Diels, J.
Olie, R.A.
Robinson, D., Jr.
Spencer, M.
Potamianou, A.
van de Velde, H.
Dimopoulos, M.A.
Περιοδικό:
European Journal of Haematology
Εκδότης:
Wiley-Blackwell Publishing Ltd
Λέξεις-κλειδιά:
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
