PMID- 20935058
OWN - NLM
STAT- MEDLINE
DCOM- 20110923
LR  - 20220318
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 22
IP  - 4
DP  - 2011 Apr
TI  - Three palonosetron regimens to prevent CINV in myeloma patients receiving 
      multiple-day high-dose melphalan and hematopoietic stem cell transplantation.
PG  - 939-946
LID - S0923-7534(19)38560-6 [pii]
LID - 10.1093/annonc/mdq457 [doi]
AB  - BACKGROUND: Explore safety and efficacy of three palonosetron-containing regimens 
      for emesis prevention over 7 days in multiple myeloma (MM) patients receiving 
      melphalan (100 mg/m(2)) and hematopoietic stem cell transplantation (HSCT). 
      PATIENTS AND METHODS: Randomized, double-blind pilot study in MM patients (n=73) 
      receiving 1, 2, or 3 days of 0.25 mg palonosetron (30-s i.v. bolus) 30 min before 
      melphalan (days -2 and -1) and HSCT (day 0). Patients received dexamethasone (20 
      mg i.v., days -2 and -1) immediately before or after study drug/placebo. Daily 
      diaries recorded emesis, rescue medication, nausea duration, and adverse events 
      (AEs). RESULTS: Seven-day complete protection (no emesis) occurred in 41.7% [95% 
      confidence interval (CI) 22.1% to 63.4%], 41.7% (95% CI 22.1% to 63.4%), and 
      44.0% (95% CI 24.2% to 65.1%) of patients receiving 1, 2, or 3 days of 
      palonosetron, respectively (P=0.43). Complete response (emesis free without 
      rescue medication) occurred in 8.3%, 20.8%, and 20.0% (P=0.14). Common AEs (>/=10%) 
      were mild-to-moderate diarrhea, constipation, headache, insomnia, and flatulence. 
      No serious AEs occurred. CONCLUSIONS: Palonosetron with dexamethasone was safe 
      and effective in preventing emesis in MM patients receiving melphalan and HSCT. 
      This pilot study with a limited number of patients suggests that multiple doses 
      of palonosetron could be more effective than a single dose in making patients 
      emesis free without need for rescue medication. However, even multiple doses of 
      palonosetron resulted in only 20% of patients being emesis free without rescue 
      medication, suggesting that further improvement will require development of more 
      effective combination antiemetic therapy.
CI  - (c) The Author 2010. Published by Oxford University Press on behalf of the European 
      Society for Medical Oncology.
FAU - Giralt, S A
AU  - Giralt SA
AD  - Adult BMT Service, Memorial Sloan Kettering Cancer Center, New York. Electronic 
      address: GiraltS@mskcc.org.
FAU - Mangan, K F
AU  - Mangan KF
AD  - Fox Chase Temple BMT Program, Philadelphia.
FAU - Maziarz, R T
AU  - Maziarz RT
AD  - Oregon Health and Science University, Portland.
FAU - Bubalo, J S
AU  - Bubalo JS
AD  - Oregon Health and Science University, Portland.
FAU - Beveridge, R
AU  - Beveridge R
AD  - Fairfax-Northern Virginia Hematology-Oncology P.C., Fairfax.
FAU - Hurd, D D
AU  - Hurd DD
AD  - Wake Forest University School of Medicine, Winston-Salem.
FAU - Mendoza, F L
AU  - Mendoza FL
AD  - Adult BMT Service, Memorial Sloan Kettering Cancer Center, New York.
FAU - Rubenstein, E B
AU  - Rubenstein EB
AD  - Medical & Scientific Affairs, Eisai Inc., Woodcliff Lake.
FAU - DeGroot, T J
AU  - DeGroot TJ
AD  - Medical & Scientific Affairs, Eisai Inc., Woodcliff Lake.
FAU - Schuster, M W
AU  - Schuster MW
AD  - Hematopoietic Stem Cell Transplantation Program, Stony Brook University, Stony 
      Brook, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20101008
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents, Alkylating)
RN  - 0 (Isoquinolines)
RN  - 0 (Quinuclidines)
RN  - 5D06587D6R (Palonosetron)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - Q41OR9510P (Melphalan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents, Alkylating/administration & dosage/*adverse 
      effects/therapeutic use
MH  - Dexamethasone/administration & dosage/adverse effects/therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - Isoquinolines/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Melphalan/administration & dosage/*adverse effects/therapeutic use
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy/surgery
MH  - Nausea/chemically induced/*prevention & control
MH  - Palonosetron
MH  - Quinuclidines/administration & dosage/adverse effects/*therapeutic use
MH  - Vomiting/chemically induced/*prevention & control
EDAT- 2010/10/12 06:00
MHDA- 2011/09/29 06:00
CRDT- 2010/10/12 06:00
PHST- 2010/10/12 06:00 [entrez]
PHST- 2010/10/12 06:00 [pubmed]
PHST- 2011/09/29 06:00 [medline]
AID - S0923-7534(19)38560-6 [pii]
AID - 10.1093/annonc/mdq457 [doi]
PST - ppublish
SO  - Ann Oncol. 2011 Apr;22(4):939-946. doi: 10.1093/annonc/mdq457. Epub 2010 Oct 8.