PMID- 32083996
OWN - NLM
STAT- MEDLINE
DCOM- 20210201
LR  - 20210609
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 38
IP  - 13
DP  - 2020 May 1
TI  - Bendamustine With Dexamethasone in Relapsed/Refractory Systemic Light-Chain 
      Amyloidosis: Results of a Phase II Study.
PG  - 1455-1462
LID - 10.1200/JCO.19.01721 [doi]
AB  - PURPOSE: No established treatments exist for relapsed/refractory systemic 
      light-chain (AL) amyloidosis. Bendamustine has shown potential in the treatment 
      of multiple myeloma. We conducted a phase II, multicenter trial to assess the 
      efficacy and safety of bendamustine with dexamethasone (ben-dex) in patients with 
      persistent or progressive AL amyloidosis after >/= 1 prior therapy. METHODS: The 
      trial enrolled 31 patients who received bendamustine on days 1 and 2 (100 mg/m(2) 
      intravenously) with 40 mg of weekly dexamethasone in 28-day cycles until disease 
      progression or up to 6 cycles after complete hematologic response. The primary 
      objective was the rate of partial hematologic response (PR) or better. RESULTS: 
      Patients received a median of 4 cycles (range, 2-12 cycles) with 57% of patients 
      achieving a PR or better (11% complete response, 18% very good PR). The overall 
      organ response was 29% among the 24 patients who had measurable organ 
      involvement. Treatment was well tolerated with no grade 5 treatment-related 
      adverse events (AEs). Sixty-five percent of patients had a therapy-related grade 
      3-4 AE. The most common AEs included myelosuppression, fatigue, and 
      nausea/vomiting. The median overall survival was 18.2 months (95% CI, 11.3 to 
      43.8 months), and hematologic response was associated with prolonged survival (P 
      = .0291). The median progression-free survival was 11.3 months (95% CI, 5.0 to 
      15.4 months). CONCLUSION: Overall, ben-dex is a viable treatment option with 
      substantial efficacy and limited toxicity for patients with pretreated AL 
      amyloidosis who have limited therapeutic options. This trial was registered at 
      (ClinicalTrials.gov identifier: NCT01222260).
FAU - Lentzsch, Suzanne
AU  - Lentzsch S
AD  - Division of Hematology/Oncology, Columbia University Medical Center, New York, 
      NY.
FAU - Lagos, Galina G
AU  - Lagos GG
AD  - Division of Hematology/Oncology, Columbia University Medical Center, New York, 
      NY.
FAU - Comenzo, Raymond L
AU  - Comenzo RL
AD  - Division of Hematology/Oncology, Tufts Medical Center, Boston, MA.
FAU - Zonder, Jeffrey A
AU  - Zonder JA
AD  - Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI.
FAU - Osman, Keren
AU  - Osman K
AD  - Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY.
FAU - Pan, Samuel
AU  - Pan S
AD  - Division of Hematology/Oncology, Columbia University Medical Center, New York, 
      NY.
FAU - Bhutani, Divaya
AU  - Bhutani D
AD  - Division of Hematology/Oncology, Columbia University Medical Center, New York, 
      NY.
FAU - Pregja, Silva
AU  - Pregja S
AD  - Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI.
FAU - Sanchorawala, Vaishali
AU  - Sanchorawala V
AD  - Amyloidosis Center, Boston University School of Medicine and Boston Medical 
      Center, Boston, MA.
FAU - Landau, Heather
AU  - Landau H
AD  - Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center, New 
      York, NY.
LA  - eng
SI  - ClinicalTrials.gov/NCT01222260
GR  - P30 CA008748/CA/NCI NIH HHS/United States
GR  - P30 CA013696/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20200221
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - 981Y8SX18M (Bendamustine Hydrochloride)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Bendamustine Hydrochloride/administration & dosage/adverse effects
MH  - Dexamethasone/administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Drug Resistance, Neoplasm/*drug effects
MH  - Fatigue/chemically induced
MH  - Female
MH  - Humans
MH  - Immunoglobulin Light-chain Amyloidosis/*drug therapy/pathology
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Neoplasm Recurrence, Local
MH  - Treatment Outcome
MH  - Vomiting/chemically induced
PMC - PMC7193746
EDAT- 2020/02/23 06:00
MHDA- 2021/02/02 06:00
PMCR- 2021/05/01
CRDT- 2020/02/22 06:00
PHST- 2020/02/23 06:00 [pubmed]
PHST- 2021/02/02 06:00 [medline]
PHST- 2020/02/22 06:00 [entrez]
PHST- 2021/05/01 00:00 [pmc-release]
AID - 1901721 [pii]
AID - 10.1200/JCO.19.01721 [doi]
PST - ppublish
SO  - J Clin Oncol. 2020 May 1;38(13):1455-1462. doi: 10.1200/JCO.19.01721. Epub 2020 
      Feb 21.