PMID- 34481658
OWN - NLM
STAT- MEDLINE
DCOM- 20220418
LR  - 20220531
IS  - 1535-6345 (Electronic)
IS  - 0147-0272 (Linking)
VI  - 46
IP  - 1
DP  - 2022 Feb
TI  - Limited benefits of thalidomide and dexamethasone maintenance after autologous 
      stem cell transplantation in newly diagnosed multiple myeloma patients: a 
      prospective phase II multi-center study in Korea.
PG  - 100786
LID - S0147-0272(21)00103-3 [pii]
LID - 10.1016/j.currproblcancer.2021.100786 [doi]
AB  - Although the clinical outcome of newly diagnosed multiple myeloma has improved 
      with maintenance therapy, maintenance with novel agents is not always available 
      depending on medical expenses or drug accessibility. We intended to investigate 
      the efficacy and toxicity of thalidomide/dexamethasone maintenance in Korean 
      patients. In this multicenter phase 2 study, patients with newly diagnosed 
      myeloma who underwent induction chemotherapy followed by autologous stem cell 
      transplantation (ASCT) were enrolled to receive maintenance treatment of 100mg 
      thalidomide daily for 28 days and 40mg dexamethasone daily for 4 days each cycle. 
      Maintenance was given up to 12 cycles. The primary endpoint was a 1-year event 
      free survival (EFS) rate. It was assumed that EFS at 1-year would be 91% with 
      thalidomide and 1-year EFS below 82% would be of no effect. A total of 43 
      patients were consecutively enrolled (median age, 58 years [range, 34 - 65]; 
      male, n = 31). With a median follow-up duration of 17.3 months (range, 1.1 - 
      32.2), EFS at 1 year was 65.1% (95% confidence interval [CI], 48.9 - 77.3). PFS 
      and OS at 1 year was 85.6% (95% CI, 70.7 - 93.3) and 90.4 (95% CI, 76.3 - 96.3), 
      respectively. In terms of side effects, 39 patients (90.7%) experienced adverse 
      events (AEs) of any grade, and 14 patients (32.6%) experienced grade 3 or 4 
      adverse events. 15 patients (34.9%) failed to complete 12 cycles of maintenance, 
      and the most common reason for premature termination was AEs (n = 6). In Korean 
      patients the benefits of thalidomide maintenance does not seem to outweigh the 
      toxicity of thalidomide, especially in high-risk MM. Considering the long 
      clinical course of MM, preservation of quality of life and finances might be more 
      beneficial for subsequent MM treatment.
CI  - Copyright (c) 2021. Published by Elsevier Inc.
FAU - Byun, Ja Min
AU  - Byun JM
AD  - Department of Internal Medicine, Seoul National University College of Medicine, 
      Seoul National University Hospital, Seoul, Korea; Cancer Research Institute, 
      Seoul National University College of Medicine, Seoul, Korea.
FAU - Kim, Sang-A
AU  - Kim SA
AD  - Department of Internal Medicine, Seoul National University College of Medicine, 
      Seoul National University Hospital, Seoul, Korea.
FAU - Koh, Youngil
AU  - Koh Y
AD  - Department of Internal Medicine, Seoul National University College of Medicine, 
      Seoul National University Hospital, Seoul, Korea; Cancer Research Institute, 
      Seoul National University College of Medicine, Seoul, Korea.
FAU - Shin, Dong-Yeop
AU  - Shin DY
AD  - Department of Internal Medicine, Seoul National University College of Medicine, 
      Seoul National University Hospital, Seoul, Korea; Cancer Research Institute, 
      Seoul National University College of Medicine, Seoul, Korea.
FAU - Kwon, Ji Hyun
AU  - Kwon JH
AD  - Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, 
      Korea.
FAU - Kim, Jin Seok
AU  - Kim JS
AD  - Division of Hematology, Department of Internal Medicine, Yonsei University 
      College of Medicine, Severance Hospital, Seoul, Korea.
FAU - Kim, Kihyun
AU  - Kim K
AD  - Division of Haematology-Oncology, Department of Medicine, Samsung Medical Centre, 
      Sungkyunkwan University School of Medicine, Seoul, Korea.
FAU - Min, Chang-Ki
AU  - Min CK
AD  - Department of Hematology, Seoul St Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, Korea.
FAU - Eom, Hyeon-Seok
AU  - Eom HS
AD  - Hematology-Oncology Clinic, National Cancer Center, Goyang, Korea.
FAU - Lee, Je-Jung
AU  - Lee JJ
AD  - Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 
      Hwasun, Korea.
FAU - Bang, Soo-Mee
AU  - Bang SM
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seongnam, Korea.
FAU - Yoon, Sung-Soo
AU  - Yoon SS
AD  - Department of Internal Medicine, Seoul National University College of Medicine, 
      Seoul National University Hospital, Seoul, Korea; Cancer Research Institute, 
      Seoul National University College of Medicine, Seoul, Korea. Electronic address: 
      ssysmc@snu.ac.kr.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210820
PL  - United States
TA  - Curr Probl Cancer
JT  - Current problems in cancer
JID - 7702986
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 7S5I7G3JQL (Dexamethasone)
SB  - IM
MH  - *Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Dexamethasone/therapeutic use
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Multiple Myeloma/diagnosis/drug therapy
MH  - Prospective Studies
MH  - Quality of Life
MH  - Thalidomide/therapeutic use
MH  - Transplantation, Autologous
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Autologous stem cell transplantation
OT  - Maintenance
OT  - Multiple myeloma
OT  - Thalidomide
EDAT- 2021/09/06 06:00
MHDA- 2022/04/19 06:00
CRDT- 2021/09/05 20:28
PHST- 2020/12/14 00:00 [received]
PHST- 2021/06/21 00:00 [revised]
PHST- 2021/07/27 00:00 [accepted]
PHST- 2021/09/06 06:00 [pubmed]
PHST- 2022/04/19 06:00 [medline]
PHST- 2021/09/05 20:28 [entrez]
AID - S0147-0272(21)00103-3 [pii]
AID - 10.1016/j.currproblcancer.2021.100786 [doi]
PST - ppublish
SO  - Curr Probl Cancer. 2022 Feb;46(1):100786. doi: 
      10.1016/j.currproblcancer.2021.100786. Epub 2021 Aug 20.