title: Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial.
abstract: We investigated the impact of subcutaneous versus intravenous bortezomib in the MM5 trial of the German-Speaking Myeloma Multicenter Group which compared bortezomib, doxorubicin, and dexamethasone with bortezomib, cyclophosphamide, and dexamethasone induction therapy in newly diagnosed multiple myeloma. Based on data from relapsed myeloma, the route of administration for bortezomib was changed from intravenous to subcutaneous after 314 of 604 patients had been enrolled. We analyzed 598 patients who received at least one dose of trial medication. Adverse events were reported more frequently in patients treated with intravenous bortezomib (intravenous=65%; subcutaneous=56%, P=0.02). Rates of grade 2 or more peripheral neuropathy were higher in patients treated with intravenous bortezomib during the third cycle (intravenous=8%; subcutaneous=2%, P=0.001). Overall response rates were similar in patients treated intravenously or subcutaneously. The presence of International Staging System stage III disease, renal impairment or adverse cytogenetic abnormalities did not have a negative impact on overall response rates in either group. To our knowledge this is the largest study to present data comparing subcutaneous with intravenous bortezomib in newly diagnosed myeloma. We show better tolerance and similar overall response rates for subcutaneous compared to intravenous bortezomib. The clinical trial is registered at eudract.ema.europa.eu as n. 2010-019173-16.
authors.affiliation: University Hospital, Heidelberg; Germany.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Merz
authors.affiliation: Asklepios Hospital Hamburg Altona; Germany.
authors.forename: Hans
authors.initials: H
authors.lastname: Salwender
authors.affiliation: Klinikum Chemnitz; Germany.
authors.forename: Mathias
authors.initials: M
authors.lastname: Haenel
authors.affiliation: University Hospital, Heidelberg; Germany.
authors.forename: Elias K
authors.initials: EK
authors.lastname: Mai
authors.affiliation: University Hospital, Heidelberg; Germany National Center for Tumor Diseases, Heidelberg; Germany.
authors.forename: Uta
authors.initials: U
authors.lastname: Bertsch
authors.affiliation: German Cancer Research Center, Heidelberg; Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Kunz
authors.affiliation: German Cancer Research Center, Heidelberg; Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hielscher
authors.affiliation: Charité Universitätsmedizin, Berlin; Germany.
authors.forename: Igor W
authors.initials: IW
authors.lastname: Blau
authors.affiliation: University Hospital, Köln; Germany.
authors.forename: Christof
authors.initials: C
authors.lastname: Scheid
authors.affiliation: University Hospital, Heidelberg; Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Hose
authors.affiliation: University Hospital, Heidelberg; Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Seckinger
authors.affiliation: University Hospital, Heidelberg; Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Jauch
authors.affiliation: University Hospital, Heidelberg; Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Hillengass
authors.affiliation: University Hospital, Heidelberg; Germany.
authors.forename: Marc S
authors.initials: MS
authors.lastname: Raab
authors.affiliation: University Hospital, Heidelberg; Germany.
authors.forename: Baerbel
authors.initials: B
authors.lastname: Schurich
authors.affiliation: University Medical Center, Mainz; Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Munder
authors.affiliation: University Hospital, Bonn; Germany.
authors.forename: Ingo G H
authors.initials: IG
authors.lastname: Schmidt-Wolf
authors.affiliation: Helios Hospital, Berlin Buch; Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Gerecke
authors.affiliation: Kath. Krankenhaus, Hagen; Germany.
authors.forename: Hans-Walter
authors.initials: HW
authors.lastname: Lindemann
authors.affiliation: Asklepios Hospital St. Georg, Hamburg; Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Zeis
authors.affiliation: University Hospital, Tübingen; Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Weisel
authors.affiliation: University Hospital Essen, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Duerig
authors.affiliation: University Hospital, Heidelberg; Germany National Center for Tumor Diseases, Heidelberg; Germany hartmut.goldschmidt@med.uni-heidelberg.de.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Goldschmidt
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols; D000069286:Bortezomib / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods*; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007668:Kidney / Q000187:drug effects / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000473:pathology; D011446:Prospective Studies; D012074:Remission Induction; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D000069286:Bortezomib; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide
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