MBO. JPSM. FEB 2009

Clinical Note
Efficacy of Granisetron in the Antiemetic
Control of Nonsurgical Intestinal Obstruction
in Advanced Cancer: A Phase II Clinical Trial
Albert Tuca, MD, Rosa Roca, MD, Carme Sala, MD, Josep Porta, MD, PhD,
Gala Serrano, MD, Jesu´ s Gonza´lez-Barboteo, MD,
and Xavier Go´mez-Batiste, MD, PhD
Instituto Catala´n de Oncologı´a (A.T., J.P., G.S., J.G.-B., X.G.-B.), L’Hospitalet, Barcelona; Hospital
de Santa Caterina (R.R.), Girona; and Hospital de Sant Lla`tzer (C.S.), Terrassa, Barcelona, Spain
Abstract
The objective of this study was to assess antiemetic efficacy of granisetron in inoperable
intestinal obstruction caused by advanced cancer. The study was open, prospective, and multicentered.
We assessed 24 patients (mean age: 61.3 years; 10 males, 14 females) with intestinal
obstruction who were refractory to previous antiemetics. Obstruction involved the upper
intestine in six patients, the lower intestine in three, and was at multiple levels in 15. Daily
treatment included intravenous granisetron (3 mg) and dexamethasone (8 mg); nasogastric
drainage was not allowed. Subcutaneous haloperidol was available as rescue therapy. A
numeric scale was used to evaluate nausea, pain, asthenia, and anorexia at baseline visit and
every 24 hours up to the completion of four days of treatment (final visit). Treatment failure
was defined as nausea >4 on the numeric scale, vomiting 2/day or more, and rescue therapy
with haloperidol at 5 mg/day or more. Of the 24 patients, 23 were evaluable for efficacy.
Evaluation pre- vs. post-treatment indicated a significant decrease in the severity of nausea
(score 6.9 vs. 0.8; P < 0.001), number of episodes of vomiting (5.3 vs. 1.0; P < 0.001), and
abdominal pain (score 4.4 vs. 1.2; P < 0.001). Nausea and vomiting control was achieved in
86.9% of patients. Although there was a trend toward greater efficacy in the lower and multiple
levels of obstruction, the differences were not statistically significant owing, probably, to small
sample size. We conclude that granisetron may be highly efficacious in the control of emesis
resulting from intestinal obstruction caused by metastatic cancer, and can be used effectively in
patients refractory to other antiemetics.

J Pain Symptom Manage 2009;37:259e270.
 2009 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Key Words
Advanced cancer, intestinal obstruction, antiemetics, 5-HT3 receptor antagonists, granisetron
The study was supported, in part, by a grant from
Roche Farma SA. The funding body was not
involved in the collection and interpretation of
data, or in the decision to publish.
Address correspondence to: Albert Tuca, MD, Servei de
Cures Palliatives, Hospital Duran y Reynals, Institut
Catalan de Oncologı´a, Av. Gran Vı´a s/n, Km 2,
708907 L’Hospitalet, Barcelona, Spain. E-mail:
atuca@iconcologia.net
Accepted for publication: February 1, 2008.
 2009 U.S. Cancer Pain Relief Committee
Published by Elsevier Inc. All rights reserved.
0885-3924/09/$esee front matter
doi:10.1016/j.jpainsymman.2008.01.014
V