PMID- 32892275
OWN - NLM
STAT- MEDLINE
DCOM- 20201013
LR  - 20210129
IS  - 1432-0584 (Electronic)
IS  - 0939-5555 (Print)
IS  - 0939-5555 (Linking)
VI  - 99
IP  - 11
DP  - 2020 Nov
TI  - Ixazomib-based frontline therapy in patients with newly diagnosed multiple 
      myeloma in real-life practice showed comparable efficacy and safety profile with 
      those reported in clinical trial: a multi-center study.
PG  - 2589-2598
LID - 10.1007/s00277-020-04234-9 [doi]
AB  - The induction therapy containing ixazomib, an oral proteasome inhibitor, has 
      shown favorable efficacy and safety in clinical trials, but its experience in 
      real-life remains limited. In routine practice, few patients received 
      ixazomib-based induction therapy due to reasons including (1) patients' 
      preference on oral regimens, (2) concerns on adverse events (AEs) of other 
      intravenous/subcutaneous regimens, (3) requirements for less center visits, and 
      (4) fears of COVID-19 and other infectious disease exposures. With the aim of 
      assessing the real-life effectiveness and safety of ixazomib-based induction 
      therapy, we performed this multi-center, observational study on 85 newly 
      diagnosed multiple myeloma (NDMM) patients from 14 medical centers. 
      Ixazomib-based regimens included ixazomib-lenalidomide-dexamethasone (IRd) in 
      44.7% of patients, ixazomib-dexamethasone (Id) in 29.4%, and Id plus another 
      agent (doxorubicin, cyclophosphamide, thalidomide, or daratumumab) in 25.9%. 
      Different ixazomib-based therapies were applied due to (1) financial burdens or 
      limitations on local health insurance coverage, (2) concerns on treatment 
      tolerance, and (3) drug accessibility issue. Ten patients received ixazomib 
      maintenance. The median age was 67 years; 43.5% had ISS stage III disease; 48.2% 
      had an Eastern Cooperative Oncology Group performance score >/= 2; and 17.6% with 
      high-risk cytogenetic abnormalities. Overall response rate for all 85 patients 
      was 95.3%, including 65.9% very good partial response or better and 29.5% 
      complete responses. The median time to response was 30 days. The response rate 
      was similar across different ixazomib-based regimens. Median progression-free 
      survival was not reached. Severe AEs (>/= grade 3) were reported in 29.4% of 
      patients. No grade 3/4 peripheral neuropathy (PN) occurred. Patients received a 
      median of 6 (range 1-20) cycles of ixazomib treatment; 56.6% remained on 
      treatment at data cutoff; 15.3% discontinued treatment due to intolerable AEs. 
      These results support that the ixazomib-based frontline therapy was highly 
      effective with acceptable toxicity in routine practice and the ixazomib oral 
      regimens could be good alternative options for NDMM patients.
FAU - Li, Jing
AU  - Li J
AD  - Department of Hematology, Zhongshan Hospital, Fudan University, 180 Fenglin Road, 
      Shanghai, 200032, People's Republic of China.
FAU - Bao, Li
AU  - Bao L
AD  - Department of Hematology, Beijing Jishuitan Hospital, Beijing, China.
FAU - Xia, Zhongjun
AU  - Xia Z
AD  - Department of Hematologic Oncology, Sun Yat-sen University Cancer Center, 
      Guangzhou, China.
FAU - Wang, Sili
AU  - Wang S
AD  - The First Affiliated Hospital of Xiamen University, Xiamen, China.
FAU - Zhou, Xin
AU  - Zhou X
AD  - Wuxi People Hospital, WuXi, China.
FAU - Ding, Kaiyang
AU  - Ding K
AD  - Anhui Provincial Cancer Hospital, Hefei, China.
FAU - Zhang, Wenhao
AU  - Zhang W
AD  - Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 
      Shanghai, China.
FAU - Yang, Wei
AU  - Yang W
AD  - Shengjing Hospital of China Medical University, Shengjing, China.
FAU - Li, Bingzong
AU  - Li B
AD  - The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
FAU - Fu, Chengcheng
AU  - Fu C
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Jiangsu Institute of Hematology, Suzhou, China.
FAU - Chen, Bing
AU  - Chen B
AD  - Department of Hematology, The Affiliated Nanjing Drum Tower Hospital, Nanjing 
      University Medical School, Nanjing, China.
FAU - Hua, Luoming
AU  - Hua L
AD  - The Affiliated Hospital of Hebei University, Baoding, China.
FAU - Wang, Liang
AU  - Wang L
AD  - Department of Hematology, ZhuJiang Hospital of Southern Medical Univeristy, 
      Guangzhou, China.
FAU - Luo, Jun
AU  - Luo J
AD  - The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 
      China.
FAU - Yang, Yang
AU  - Yang Y
AD  - Department of Hematology, Zhongshan Hospital, Fudan University, 180 Fenglin Road, 
      Shanghai, 200032, People's Republic of China.
FAU - Xu, Tianhong
AU  - Xu T
AD  - Department of Hematology, Zhongshan Hospital, Fudan University, 180 Fenglin Road, 
      Shanghai, 200032, People's Republic of China.
FAU - Wang, Weida
AU  - Wang W
AD  - Department of Hematologic Oncology, Sun Yat-sen University Cancer Center, 
      Guangzhou, China.
FAU - Huang, Yun
AU  - Huang Y
AD  - The First Affiliated Hospital of Xiamen University, Xiamen, China.
FAU - Wu, Guolin
AU  - Wu G
AD  - Anhui Provincial Cancer Hospital, Hefei, China.
FAU - Liu, Peng
AU  - Liu P
AUID- ORCID: 0000-0002-9639-6606
AD  - Department of Hematology, Zhongshan Hospital, Fudan University, 180 Fenglin Road, 
      Shanghai, 200032, People's Republic of China. liu.peng@zs-hospital.sh.cn.
LA  - eng
GR  - 2017ZX09304-021/National Key New Drug Creation Special Programs/
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20200906
PL  - Germany
TA  - Ann Hematol
JT  - Annals of hematology
JID - 9107334
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Boron Compounds)
RN  - 4Z63YK6E0E (daratumumab)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 71050168A2 (ixazomib)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - 80168379AG (Doxorubicin)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - F0P408N6V4 (Lenalidomide)
RN  - TE7660XO1C (Glycine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse 
      effects
MH  - Boron Compounds/*administration & dosage/adverse effects
MH  - Cyclophosphamide/administration & dosage/adverse effects
MH  - Dexamethasone/administration & dosage/adverse effects
MH  - Doxorubicin/administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Female
MH  - Glycine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Humans
MH  - Lenalidomide/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy/mortality/pathology
MH  - Neoplasm Staging
MH  - Peripheral Nervous System Diseases/*chemically induced/diagnosis/physiopathology
MH  - Remission Induction
MH  - Survival Analysis
MH  - Thalidomide/administration & dosage/adverse effects
MH  - Treatment Outcome
PMC - PMC7474576
OTO - NOTNLM
OT  - Frontline
OT  - Ixazomib
OT  - Myeloma
OT  - Real-world
COIS- The authors declare that they have no conflict of interest.
EDAT- 2020/09/07 06:00
MHDA- 2020/10/21 06:00
PMCR- 2020/09/06
CRDT- 2020/09/06 20:36
PHST- 2020/06/09 00:00 [received]
PHST- 2020/08/24 00:00 [accepted]
PHST- 2020/09/07 06:00 [pubmed]
PHST- 2020/10/21 06:00 [medline]
PHST- 2020/09/06 20:36 [entrez]
PHST- 2020/09/06 00:00 [pmc-release]
AID - 10.1007/s00277-020-04234-9 [pii]
AID - 4234 [pii]
AID - 10.1007/s00277-020-04234-9 [doi]
PST - ppublish
SO  - Ann Hematol. 2020 Nov;99(11):2589-2598. doi: 10.1007/s00277-020-04234-9. Epub 
      2020 Sep 6.