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A SINGLE CENTRE REAL LIFE EXPERIENCE ON MULTIPLE MYELOMA (MM) PATIENTS: SUBCUTANEOUS ( SUBQ) VERSUS INTRAVENOUS (IV) BORTEZOMIB (BOR).
Author(s): ,
Maria Stefania Infante
Affiliations:
Hospital General Infanta Leonor,madrid,Spain
,
Isabel Gonzalez
Affiliations:
Hospital General Infanta Leonor,madrid,Spain
,
Carolina Muñoz
Affiliations:
Hospital General Infanta Leonor,madrid,Spain
,
Cecilia Heras
Affiliations:
Hospital General Infanta Leonor,madrid,Spain
,
Maria Angeles Foncillas
Affiliations:
Hospital General Infanta Leonor,madrid,Spain
,
Karen Marín
Affiliations:
Hospital General Infanta Leonor,madrid,Spain
Jose Angel Hernandez
Affiliations:
Hospital General Infanta Leonor,madrid,Spain
(Abstract release date: 05/19/16) EHA Library. Infante M. 06/09/16; 134904; PB2004
Dr. Maria Stefania Infante
Dr. Maria Stefania Infante
Contributions
Abstract
Abstract: PB2004

Type: Publication Only

Background
The outcome of multiple myeloma patients (MM) has significantly improved over recent years, mainly due to the discovery of novel antimyeloma agents together with a better knowledge of the biology of the disease [Kumar et al. 2008]. One of these novel agents is bortezomib, the first in the class proteasome inhibitors introduced in the clinical practice approximately one decade ago. However, toxicity, especially peripheral neuropathy, as well as the intravenous route required for its administration are the two most significant bortezomib-related issues. To try to reduce the peripheral neuropathy, new guidelines for its management and the introduction of weekly schedules of administration have contributed to significantly decrease its incidence and the subcutaneous (subQ) administration has been recently introduce to avoid the intravenous (IV) route. Results obtained in phase I/II and III studies have confirmed that subcutaneous administration is feasible and represents an additional step towards the optimization of bortezomib use, resulting in a probably more convenient method than the IV route that is at least as effective.

Aims
To evaluate efficacy and tolerability of Bortezomib ( IV vs subQ) in standard combination myeloma regimens. Moreover, we compared the incidence of peripheral neuropathy. 

Methods
We reviewed data of 50 consecutive MM patients treated at our Hematologic division between October 2008 to November 2015.Standard criteria were applied to evaluate response rate and neurotoxicity (NCI CTCAE national Cancer institute common terminology criteria for adverse events version 4.0)

Results
Our case serie is composed by 50 patients diagnosed with MM and treated in 1º line with combination regimen including Bortezomib (subQ or IV). Median age 75 years (range 39-89). 17/50 (34%) were administered VD regimen ( 7 subQ vs 10 IV), 27/50 (54%) patients were administered VMP ( 15 subQ vs 12 IV), 2/50 patients (4%) received poliQT  VMCP/VBAD ( IV Bortezomib) while 4 patients (8%) received VDT regimen as induction to transplant consolidation with subQ Bortezomib.Overall survival (OS) of the serie was 84 months (47-120 range) (Figure 1) with a free progression survival (FPS) of 23 months ( 19-30 range): no difference was found between subQ or IV Bortezomib regimen in terms of survival.There were 12 cases (24%) of neurotoxicity in our serie: 2/12 (16%) patients with VTD ( subQ Bor ) where the role of the inmunomoduladory drug in the toxicitiy must be considered; 6/12 ( 50%) cases with IV Bor and 4/12 ( 33%) cases with  subQ Bor: all 5/6 cases of neurotoxicity in IV Bortezomib were grade III with need of suspension of the drug. In subQ population there were 1 case with grade I toxicity and 3 cases of grade II neurotoxicity with reduction of the dose. 

Conclusion
In our real life experience OS and FPS in our serie is notable, with 84 months and 23 months described.In terms of toxicity there were slightly more cases of neutorotoxicity in IV Bor population with higher grade of toxicity than the subQ population.In conclusion, the subQ formulation of bortezomib represents an additional step towards the optimization of bortezomib use, resulting in a more convenient route that is at least as effective as the IV route. 



Session topic: E-poster

Keyword(s): Bortezomib, Subcutaneous, Toxicity, Treatment
Abstract: PB2004

Type: Publication Only

Background
The outcome of multiple myeloma patients (MM) has significantly improved over recent years, mainly due to the discovery of novel antimyeloma agents together with a better knowledge of the biology of the disease [Kumar et al. 2008]. One of these novel agents is bortezomib, the first in the class proteasome inhibitors introduced in the clinical practice approximately one decade ago. However, toxicity, especially peripheral neuropathy, as well as the intravenous route required for its administration are the two most significant bortezomib-related issues. To try to reduce the peripheral neuropathy, new guidelines for its management and the introduction of weekly schedules of administration have contributed to significantly decrease its incidence and the subcutaneous (subQ) administration has been recently introduce to avoid the intravenous (IV) route. Results obtained in phase I/II and III studies have confirmed that subcutaneous administration is feasible and represents an additional step towards the optimization of bortezomib use, resulting in a probably more convenient method than the IV route that is at least as effective.

Aims
To evaluate efficacy and tolerability of Bortezomib ( IV vs subQ) in standard combination myeloma regimens. Moreover, we compared the incidence of peripheral neuropathy. 

Methods
We reviewed data of 50 consecutive MM patients treated at our Hematologic division between October 2008 to November 2015.Standard criteria were applied to evaluate response rate and neurotoxicity (NCI CTCAE national Cancer institute common terminology criteria for adverse events version 4.0)

Results
Our case serie is composed by 50 patients diagnosed with MM and treated in 1º line with combination regimen including Bortezomib (subQ or IV). Median age 75 years (range 39-89). 17/50 (34%) were administered VD regimen ( 7 subQ vs 10 IV), 27/50 (54%) patients were administered VMP ( 15 subQ vs 12 IV), 2/50 patients (4%) received poliQT  VMCP/VBAD ( IV Bortezomib) while 4 patients (8%) received VDT regimen as induction to transplant consolidation with subQ Bortezomib.Overall survival (OS) of the serie was 84 months (47-120 range) (Figure 1) with a free progression survival (FPS) of 23 months ( 19-30 range): no difference was found between subQ or IV Bortezomib regimen in terms of survival.There were 12 cases (24%) of neurotoxicity in our serie: 2/12 (16%) patients with VTD ( subQ Bor ) where the role of the inmunomoduladory drug in the toxicitiy must be considered; 6/12 ( 50%) cases with IV Bor and 4/12 ( 33%) cases with  subQ Bor: all 5/6 cases of neurotoxicity in IV Bortezomib were grade III with need of suspension of the drug. In subQ population there were 1 case with grade I toxicity and 3 cases of grade II neurotoxicity with reduction of the dose. 

Conclusion
In our real life experience OS and FPS in our serie is notable, with 84 months and 23 months described.In terms of toxicity there were slightly more cases of neutorotoxicity in IV Bor population with higher grade of toxicity than the subQ population.In conclusion, the subQ formulation of bortezomib represents an additional step towards the optimization of bortezomib use, resulting in a more convenient route that is at least as effective as the IV route. 



Session topic: E-poster

Keyword(s): Bortezomib, Subcutaneous, Toxicity, Treatment

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