Τίτλος:
Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
This phase II study explored the effects of bortezomib consolidation versus observation on myeloma-related bone disease in patients who had a partial response or better after frontline high-dose therapy and autologous stem cell transplantation. Patients were randomized to receive four 35-day cycles of bortezomib 1·6 mg/m2 intravenously on days 1, 8, 15 and 22, or an equivalent observation period, and followed up for disease status/survival. The modified intent-to-treat population included 104 patients (51 bortezomib, 53 observation). There were no meaningful differences in the primary endpoint of change from baseline to end of treatment in bone mineral density (BMD). End-of-treatment rates (bortezomib versus observation) of complete response/stringent complete response were 22% vs. 11% (P = 0·19), very good partial response or better of 80% vs. 68% (P = 0·17), and progressive disease of 8% vs. 23% (P = 0·06); median progression-free survival was 44·9 months vs. 21·8 months (P = 0·22). Adverse events observed ≥15% more frequently with bortezomib versus observation were diarrhoea (37% vs. 0), peripheral sensory neuropathy (20% vs. 4%), nausea (18% vs. 0) and vomiting (16% vs. 0). Compared with observation, bortezomib appeared to have little impact on bone metabolism/health, but was associated with trends for improved myeloma response and survival. © 2017 John Wiley & Sons Ltd
Συγγραφείς:
Sezer, O.
Beksac, M.
Hajek, R.
Sucak, G.
Cagirgan, S.
Linkesch, W.
Meltem Akay, O.
Gülbas, Z.
Nahi, H.
Plesner, T.
Snowden, J.A.
Timurağaoğlu, A.
Dechow, T.
Lang, A.
Tuğlular, T.
Drach, J.
Armbrecht, G.
Potamianou, A.
Couturier, C.
Olie, R.A.
Feys, C.
Allietta, N.
Terpos, E.
Περιοδικό:
British Journal of Haematology
Εκδότης:
Wiley-Blackwell Publishing Ltd
Λέξεις-κλειδιά:
alkaline phosphatase; bortezomib; carboxy terminal telopeptide; dickkopf 1 protein; osteocalcin; antineoplastic agent; biological marker; bortezomib, acute liver failure; adult; aged; anxiety disorder; Article; autologous stem cell transplantation; backache; bacterial pneumonia; bone density; bone disease; bone health; bone metabolism; cancer radiotherapy; cancer survival; consolidation chemotherapy; controlled study; depression; diarrhea; drug effect; drug fatality; drug safety; drug withdrawal; fatigue; female; fever; health; herpes zoster; human; hypercalcemia; infection; intention to treat analysis; major clinical study; male; monotherapy; multicenter study; multiple cycle treatment; multiple myeloma; nausea; neuralgia; neutropenia; observation; ossification; osteolysis; outcome assessment; overall survival; pathologic fracture; peripheral neuropathy; phase 2 clinical trial; polyneuropathy; priority journal; progression free survival; randomized controlled trial; reinfection; rhinopharyngitis; sensory neuropathy; spinal cord compression; survival rate; survival time; thrombocytopenia; treatment response; trend study; upper respiratory tract infection; virus reactivation; vomiting; blood; clinical trial; complication; consolidation chemotherapy; drug administration; etiology; follow up; Kaplan Meier method; middle aged; multiple myeloma; pathophysiology; procedures; stem cell transplantation; treatment outcome, Adult; Aged; Antineoplastic Agents; Biomarkers; Bortezomib; Consolidation Chemotherapy; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multiple Myeloma; Osteolysis; Stem Cell Transplantation; Treatment Outcome
