PMID- 21808994
OWN - NLM
STAT- MEDLINE
DCOM- 20121022
LR  - 20220318
IS  - 1433-7339 (Electronic)
IS  - 0941-4355 (Linking)
VI  - 20
IP  - 7
DP  - 2012 Jul
TI  - A phase III open-label study to assess safety and efficacy of palonosetron for 
      preventing chemotherapy-induced nausea and vomiting (CINV) in repeated cycles of 
      emetogenic chemotherapy.
PG  - 1507-14
LID - 10.1007/s00520-011-1239-0 [doi]
AB  - PURPOSE: Prevention of chemotherapy-induced nausea and vomiting (CINV) is of 
      great importance for the completion of multiple cycles of cancer chemotherapy. 
      Palonosetron is a second-generation 5-HT(3) receptor antagonist with proven 
      efficacy for both acute and delayed CINV. This study was designed to assess the 
      safety and efficacy of 0.75 mg palonosetron in repeated cycles of highly 
      emetogenic chemotherapy or anthracycline-cyclophosphamide combination (AC/EC). 
      METHODS: We gave 0.75 mg palonosetron to 538 patients 30 min prior to >/= 50 
      mg/m(2) cisplatin or AC/EC on day 1. Prophylactic dexamethasone was administered 
      on days 1-3. The primary endpoint was the incidence rate of adverse events (AEs). 
      The secondary endpoint was complete response rate (CR, defined as no emesis and 
      no rescue medication) throughout the study period. RESULTS: Treatment-related AEs 
      were seen in 44% (237 of 538 patients). Serious AEs were seen in 4% (23 of 538 
      patients), all considered unrelated or unlikely to be related to palonosetron. 
      Only one patient discontinued the study due to a treatment-related AE. No trend 
      toward worsening of AEs was observed in subsequent cycles of chemotherapy. 
      Complete response rates were maintained throughout repeated cycles. CONCLUSION: 
      The extraordinary safety profile and maintenance of efficacy of 0.75 mg 
      palonosetron combined with dexamethasone were demonstrated throughout repeated 
      chemotherapy cycles.
FAU - Aogi, Kenjiro
AU  - Aogi K
AD  - Department of Breast Oncology, National Hospital Organization Shikoku Cancer 
      Center, 160 Ko, Minami-Umemoto, Matsuyama, Ehime 791-0280, Japan. 
      kaogi@shikoku-cc.go.jp
FAU - Sakai, Hiroshi
AU  - Sakai H
FAU - Yoshizawa, Hirohisa
AU  - Yoshizawa H
FAU - Masuda, Norikazu
AU  - Masuda N
FAU - Katakami, Nobuyuki
AU  - Katakami N
FAU - Yanagita, Yasuhiro
AU  - Yanagita Y
FAU - Inoue, Kenichi
AU  - Inoue K
FAU - Kuranami, Masaru
AU  - Kuranami M
FAU - Mizutani, Mitsuhiro
AU  - Mizutani M
FAU - Masuda, Noriyuki
AU  - Masuda N
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110802
PL  - Germany
TA  - Support Care Cancer
JT  - Supportive care in cancer : official journal of the Multinational Association of 
      Supportive Care in Cancer
JID - 9302957
RN  - 0 (Antiemetics)
RN  - 0 (Isoquinolines)
RN  - 0 (Quinuclidines)
RN  - 0 (Serotonin 5-HT3 Receptor Antagonists)
RN  - 5D06587D6R (Palonosetron)
RN  - 7S5I7G3JQL (Dexamethasone)
SB  - IM
MH  - Aged
MH  - Antiemetics/adverse effects/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Dexamethasone/adverse effects/therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Isoquinolines/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced/*prevention & control
MH  - Neoplasms/drug therapy
MH  - Palonosetron
MH  - Quinuclidines/adverse effects/*therapeutic use
MH  - Serotonin 5-HT3 Receptor Antagonists/adverse effects/therapeutic use
MH  - Treatment Outcome
MH  - Vomiting/chemically induced/*prevention & control
EDAT- 2011/08/03 06:00
MHDA- 2012/10/23 06:00
CRDT- 2011/08/03 06:00
PHST- 2010/11/15 00:00 [received]
PHST- 2011/07/17 00:00 [accepted]
PHST- 2011/08/03 06:00 [entrez]
PHST- 2011/08/03 06:00 [pubmed]
PHST- 2012/10/23 06:00 [medline]
AID - 10.1007/s00520-011-1239-0 [doi]
PST - ppublish
SO  - Support Care Cancer. 2012 Jul;20(7):1507-14. doi: 10.1007/s00520-011-1239-0. Epub 
      2011 Aug 2.