title: SALTO: a randomized, multicenter study assessing octreotide LAR in inoperable bowel obstruction.
abstract: 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 μg 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.
authors.affiliation: CHU de Grenoble, clinique de soins palliatifs et de coordination en soins de support, pôle de cancérologie, BP 217, 38043 Grenoble, France.
authors.forename: Guillemette
authors.initials: G
authors.lastname: Laval
authors.forename: Hubert
authors.initials: H
authors.lastname: Rousselot
authors.forename: Sophie
authors.initials: S
authors.lastname: Toussaint-Martel
authors.forename: Françoise
authors.initials: F
authors.lastname: Mayer
authors.forename: Eric
authors.initials: E
authors.lastname: Terrebonne
authors.forename: Eric
authors.initials: E
authors.lastname: François
authors.forename: Hédia
authors.initials: H
authors.lastname: Brixi
authors.forename: Thierry
authors.initials: T
authors.lastname: Nguyen
authors.forename: Isabelle
authors.initials: I
authors.lastname: Bourdeix
authors.forename: Ségolène
authors.initials: S
authors.lastname: Bisot-Locard
authors.forename: Laurent
authors.initials: L
authors.lastname: Zelek
mesh_terms: D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D002277:Carcinoma / Q000150:complications*; D020878:Device Removal; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005602:France; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007415:Intestinal Obstruction / Q000188:drug therapy* / Q000209:etiology; D007441:Intubation, Gastrointestinal / Q000295:instrumentation; D017567:Karnofsky Performance Status; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D010534:Peritoneal Neoplasms / Q000150:complications*; D010865:Pilot Projects; D014839:Vomiting / Q000517:prevention & control
chemical_list: D000932:Antiemetics; D005765:Gastrointestinal Agents; D015282:Octreotide; D008775:Methylprednisolone