PMID- 20394651
OWN - NLM
STAT- MEDLINE
DCOM- 20100817
LR  - 20211020
IS  - 1600-0609 (Electronic)
IS  - 0902-4441 (Print)
IS  - 0902-4441 (Linking)
VI  - 85
IP  - 2
DP  - 2010 Aug
TI  - Management and supportive care measures for adverse events in patients with 
      myelodysplastic syndromes treated with azacitidine*.
PG  - 130-8
LID - 10.1111/j.1600-0609.2010.01456.x [doi]
AB  - OBJECTIVE: Myelodysplastic syndrome (MDS) treatment can initially worsen 
      patients' clinical condition and they may discontinue therapy before achieving 
      benefit. We present previously unpublished data from two large phase III trials 
      describing common adverse events (AEs) associated with azacitidine and methods to 
      manage them. METHODS: In the Cancer and Leukemia Group B (CALGB) 9221 study, 
      patients with any French-American-British (FAB) subtype of MDS were randomized to 
      azacitidine or best supportive care (BSC). After 56 d, patients randomized to BSC 
      with disease progression could cross over to receive azacitidine. In the AZA-001 
      study, patients with higher-risk MDS (FAB-defined refractory anemia with excess 
      blasts (RAEB), RAEB in transformation, or chronic myelomonocitic leukaemia and 
      IPSS int-2 or high) were randomized to azacitidine or to conventional care 
      regimens (CCR), which included low-dose ara-C, BSC, or intensive chemotherapy. In 
      both studies, azacitidine dose was 75 mg/m(2)/d SC for 7 d every 28 d. AEs were 
      graded per National Cancer Institute's Common Toxicity Criteria version 2.0 
      (AZA-001) or CALGB Expanded CTC (CALGB 9221). RESULTS: In safety-evaluable 
      patients in AZA-001 (N = 175) or CALGB 9221 (N = 150), the most common AEs with 
      azacitidine included hematologic (eg, cytopenias) and non-hematologic 
      administration-related events (eg, injection-site reactions and gastrointestinal 
      disorders). Most AEs were transient and resolved during ongoing therapy (> 83%). 
      Hematologic AEs, most frequently observed during early treatment cycles, 
      decreased during subsequent cycles and were usually managed with dosing delays 
      (23-29%). Gastrointestinal symptoms were primarily managed with anti-emetics and 
      laxatives. CONCLUSION: Hematologic and non-hematologic AEs with azacitidine 
      decreased in frequency as treatment continued. Awareness of the onset, duration 
      and management of AEs can facilitate treatment, permitting patients to continue 
      therapy for maximum benefit.
FAU - Santini, Valeria
AU  - Santini V
AD  - Azienda Ospedaliera Universitaria Careggi, Florence, Italy. 
      valeria.santini@unifi.it
FAU - Fenaux, Pierre
AU  - Fenaux P
FAU - Mufti, Ghulam J
AU  - Mufti GJ
FAU - Hellstrom-Lindberg, Eva
AU  - Hellstrom-Lindberg E
FAU - Silverman, Lewis R
AU  - Silverman LR
FAU - List, Alan
AU  - List A
FAU - Gore, Steven D
AU  - Gore SD
FAU - Seymour, John F
AU  - Seymour JF
FAU - Backstrom, Jay
AU  - Backstrom J
FAU - Beach, Charles L
AU  - Beach CL
LA  - eng
GR  - CA 31946/CA/NCI NIH HHS/United States
GR  - U10 CA033601/CA/NCI NIH HHS/United States
GR  - CA 33601/CA/NCI NIH HHS/United States
GR  - U10 CA031946/CA/NCI NIH HHS/United States
GR  - K24 CA111717/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20100412
PL  - England
TA  - Eur J Haematol
JT  - European journal of haematology
JID - 8703985
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - M801H13NRU (Azacitidine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anemia, Refractory
MH  - Anemia, Refractory, with Excess of Blasts
MH  - Antimetabolites, Antineoplastic
MH  - Azacitidine/*adverse effects
MH  - Disease Management
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myelodysplastic Syndromes/*complications/drug therapy
MH  - Treatment Outcome
PMC - PMC4000014
MID - NIHMS490297
EDAT- 2010/04/17 06:00
MHDA- 2010/08/18 06:00
PMCR- 2014/04/25
CRDT- 2010/04/17 06:00
PHST- 2010/04/17 06:00 [entrez]
PHST- 2010/04/17 06:00 [pubmed]
PHST- 2010/08/18 06:00 [medline]
PHST- 2014/04/25 00:00 [pmc-release]
AID - EJH1456 [pii]
AID - 10.1111/j.1600-0609.2010.01456.x [doi]
PST - ppublish
SO  - Eur J Haematol. 2010 Aug;85(2):130-8. doi: 10.1111/j.1600-0609.2010.01456.x. Epub 
      2010 Apr 12.