PMID- 22265994
OWN - NLM
STAT- MEDLINE
DCOM- 20120316
LR  - 20131121
IS  - 1769-6917 (Electronic)
IS  - 0007-4551 (Linking)
VI  - 99
IP  - 2
DP  - 2012 Feb 1
TI  - SALTO: a randomized, multicenter study assessing octreotide LAR in inoperable 
      bowel obstruction.
PG  - E1-9
LID - 10.1684/bdc.2011.1535 [doi]
AB  - This phase II, multicenter, randomized, double-blind, non-comparative study 
      assessed the efficacy and safety of immediate-release octreotide and octreotide 
      LAR, in combination with corticosteroids and standard medical care, on the 
      symptoms of inoperable malignant bowel obstruction (MBO) due to peritoneal 
      carcinomatosis. The primary efficacy endpoint was "success" at day 14 defined as 
      a composite endpoint including the absence of a nasogastric tube, and vomiting 
      less than twice per day and no use of anticholinergic agents. Patients in the 
      octreotide arm received octreotide LAR 30 mg intramuscular (im) on days 1, 29 
      and 57, as well as daily immediate-release octreotide 600 mug per day plus 
      methylprednisolone on days 1 to 6. Placebo-treated patients received 
      methylprednisolone and matched placebo instead of octreotide. Difficulties 
      associated with enrolling patients at palliative-care stage meant only 
      64 patients (instead of the planned 102 patients) were randomized, 32 to 
      octreotide and 32 to placebo. Despite randomization, more patients in the 
      octreotide arm (46.4%) than in the placebo arm (21.9%) had a baseline Karnofsky 
      score less than 50. An intention-to-treat analysis showed that in the octreotide 
      and placebo arms, 12 (38%) and nine (28%), respectively, patients were 
      successfully treated at day 14, which increased to 9/15 (60%) and 7/25 (28%), 
      respectively, among patients with a baseline Karnofsky score greater or equal 
      to 50. Octreotide-treated patients reported three drug-related adverse events 
      (AEs), and no drug-related serious AEs or deaths. Octreotide LAR may have a key 
      role in treating patients with a MBO due to peritoneal carcinomatosis, 
      particularly in those with moderately severe disease.
FAU - Laval, Guillemette
AU  - Laval G
AD  - CHU de Grenoble, clinique de soins palliatifs et de coordination en soins de 
      support, pole de cancerologie, BP 217, 38043 Grenoble, France.
FAU - Rousselot, Hubert
AU  - Rousselot H
FAU - Toussaint-Martel, Sophie
AU  - Toussaint-Martel S
FAU - Mayer, Francoise
AU  - Mayer F
FAU - Terrebonne, Eric
AU  - Terrebonne E
FAU - Francois, Eric
AU  - Francois E
FAU - Brixi, Hedia
AU  - Brixi H
FAU - Nguyen, Thierry
AU  - Nguyen T
FAU - Bourdeix, Isabelle
AU  - Bourdeix I
FAU - Bisot-Locard, Segolene
AU  - Bisot-Locard S
FAU - Zelek, Laurent
AU  - Zelek L
CN  - SALTO Study Group
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - France
TA  - Bull Cancer
JT  - Bulletin du cancer
JID - 0072416
RN  - 0 (Antiemetics)
RN  - 0 (Gastrointestinal Agents)
RN  - RWM8CCW8GP (Octreotide)
RN  - X4W7ZR7023 (Methylprednisolone)
SB  - IM
MH  - Aged
MH  - Antiemetics/*therapeutic use
MH  - Carcinoma/*complications
MH  - Device Removal
MH  - Double-Blind Method
MH  - Drug Therapy, Combination/methods
MH  - Female
MH  - France
MH  - Gastrointestinal Agents/adverse effects/*therapeutic use
MH  - Humans
MH  - Intestinal Obstruction/*drug therapy/etiology
MH  - Intubation, Gastrointestinal/instrumentation
MH  - Karnofsky Performance Status
MH  - Male
MH  - Methylprednisolone/*therapeutic use
MH  - Middle Aged
MH  - Octreotide/adverse effects/*therapeutic use
MH  - Peritoneal Neoplasms/*complications
MH  - Pilot Projects
MH  - Vomiting/prevention & control
FIR - Laval, Guillemette
IR  - Laval G
FIR - Toussaint-Martel, Sophie
IR  - Toussaint-Martel S
FIR - Rousselot, Hubert
IR  - Rousselot H
FIR - Chauffert, Bruno
IR  - Chauffert B
FIR - Mayer, Francoise
IR  - Mayer F
FIR - Terrebonne, Eric
IR  - Terrebonne E
FIR - Francois, Eric
IR  - Francois E
FIR - Brixi, Hedia
IR  - Brixi H
FIR - Nguyen, Thierry
IR  - Nguyen T
FIR - Zelek, Laurent
IR  - Zelek L
FIR - Caunes, Nathalie
IR  - Caunes N
FIR - Fibet, Marilene
IR  - Fibet M
FIR - Miglianico, Laurent
IR  - Miglianico L
FIR - Planchet-Barraud, Brigitte
IR  - Planchet-Barraud B
FIR - Lazard, Eric
IR  - Lazard E
FIR - Guirimand, Frederic
IR  - Guirimand F
FIR - Horner-Vallet, Dany
IR  - Horner-Vallet D
FIR - Locher, Christophe
IR  - Locher C
FIR - Nahapetian, Henri
IR  - Nahapetian H
FIR - Priou, Franck
IR  - Priou F
FIR - Moutel, Karine
IR  - Moutel K
EDAT- 2012/01/24 06:00
MHDA- 2012/03/17 06:00
CRDT- 2012/01/24 06:00
PHST- 2012/01/24 06:00 [entrez]
PHST- 2012/01/24 06:00 [pubmed]
PHST- 2012/03/17 06:00 [medline]
AID - S0007-4551(15)30501-4 [pii]
AID - 10.1684/bdc.2011.1535 [doi]
PST - ppublish
SO  - Bull Cancer. 2012 Feb 1;99(2):E1-9. doi: 10.1684/bdc.2011.1535.