Vol. 30 No.

6 December 2005 Journal of Pain and Symptom Management 563

Clinical Note

Long-Acting Octreotide for the Treatment

and Symptomatic Relief of Bowel Obstruction
in Advanced Ovarian Cancer
Ursula A. Matulonis, MD, Michael V. Seiden, MD, PhD, Maria Roche, NP,
Carolyn Krasner, MD, Arlan F. Fuller, MD, Tina Atkinson, B.A.,
Alice Kornblith, PhD, and Richard Penson, MD
Division of Medical Oncology (U.A.M., T.A., A.K.), Dana-Farber Cancer Institute, Boston; and the
Divisions of Hematology and Oncology (M.V.S., M.R., C.K., A.F.F., R.P.) and Gynecologic Oncology
(M.V.S., M.R., C.K., A.F.F., R.P.), Massachusetts General Hospital, Boston, Massachusetts, USA

Abstract
Symptoms of malignant bowel obstruction in patients with recurrent ovarian cancer lead to
a poor quality of life. Sandostatin LAR Ò Depot (LAR) (Novartis Pharmaceuticals Corp.,
East Hanover, NJ) is an intramuscular, monthly administered, long-acting form of
octreotide. LAR’s safety and utility were evaluated in a pilot study enrolling 15 advanced
ovarian cancer patients with bowel dysfunction. Once safety with subcutaneous (SQ)
octreotide was assessed, patients were given 30 mg LAR on Day 1 and octreotide SQ for 2
weeks. Of 13 evaluable patients, three patients had a major response to LAR treatment with
reduction in bowel obstruction symptoms, two had a minor response, four had no response,
and four had progressive symptoms. Three patients remained on LAR for more than 9
months. No significant toxicities were attributable to octreotide or LAR. Because three
patients received nine or more monthly injections of LAR, possible direct antitumor effects of
LAR or synergy with chemotherapy needs to be explored. J Pain Symptom Manage
2005;30:563--569. Ó 2005 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc.
All rights reserved.

Key Words
Long-acting octreotide, ovarian cancer, bowel obstruction

Introduction a malignant bowel obstruction (MBO) occurs,

median survival is approximately 3 months.3
Bowel obstruction and symptoms of chronic
Etiologies of MBO in ovarian cancer include
intermittent obstruction or ileus are common
extrinsic occlusion of the lumen, malignant in-
complications in patients with recurrent can-
filtration of mesentery and intestinal muscle
cer of the ovary and peritoneum, and are
and serosal surfaces, and intraluminal obstruc-
reported in up to 42% of patients.1,2 Once
tion.4--6 Secondary intestinal immobility result-
ing from opioids and certain antiemetics also
plays a role in MBO. Bowel obstruction results
Address reprint requests to: Ursula A. Matulonis, MD, in an accumulation of gastric, pancreatic, and
Dana-Farber Cancer Institute, 44 Binney Street, biliary secretions; reduced absorption of water
Boston, MA 02115, USA. and sodium; and an increase in water and sodi-
Accepted for publication: May 26, 2005. um secretion because of increased gastric

Ó 2005 U.S. Cancer Pain Relief Committee 0885-3924/05/$--see front matter

Published by Elsevier Inc. All rights reserved. doi:10.1016/j.jpainsymman.2005.05.018
564 Matulonis et al. Vol. 30 No. 6 December 2005

distension.7--9 This pathophysiology results in acting subcutaneous (SQ) form.15 Steady-state

vomiting, nausea, pain, esophagitis, constipa- octreotide levels were reached by Week 8 for
tion, and/or diarrhea. The clinical picture of the 20 and 30 mg doses of LAR, and by Week
MBO can vary greatly from patient to patient 12 for the 10 mg group. The drug was well
depending on the location of the obstruction, tolerated, regardless of the dose of LAR, and
whether there are single versus multiple points efficacy (control of flushing) was better con-
of obstruction, the mechanism of obstruction, trolled at doses above 20 mg.
exacerbating medications, and the extent and This is the first study to use LAR in patients
sites of tumor recurrence. with recurrent ovarian cancer who have signs
Many patients with ovarian cancer will not and/or symptoms of inoperable bowel ob-
be eligible for surgery because of the presence struction. The objectives of this pilot study
of diffuse intraperitoneal carcinomatosis, mul- were to assess the effectiveness of LAR in im-
tiple partial bowel obstruction points, ascites, proving the symptoms of inoperable bowel ob-
and/or previous radiotherapy, or because of struction and to measure toxicities.
their overall functional status.10,11 Palliative
therapies to treat bowel obstruction in patients
who are deemed nonsurgical candidates in- Methods
clude gastric venting via placement of a naso- Patients were enrolled from the Dana-Farber
gastric or gastrostomy tube, or medications Cancer Institute, Massachusetts General Hospi-
such as anticholinergic drugs; analgesics; ste- tal, and the Brigham and Women’s Hospital, all
roids; antiemetics; smooth muscle relaxants in Boston, Massachusetts, between 2002 and
such as atropine, scopolamine, or loperamide; 2004. All patients signed a written, informed
and somatostatin and its analogs.6,12--15 consent approved by the Dana-Farber/Harvard
Somatostatin and its analogs (octreotide and Cancer Center Institutional Review Board,
vapreotide) have been used either alone or in which has authority over all cancer studies at
combination to alleviate the symptoms from the above-mentioned institutions.
an MBO in ovarian cancer and other malignan- Eligibility criteria included a diagnosis of
cies.13,16,17 Somatostatin inhibits hormones documented recurrence of epithelial ovarian
such as glucagon and insulin, reduces acid se- cancer, primary peritoneal cancer, or fallopian
cretion, slows intestinal mobility, decreases bile tube cancer and the presence of a bowel ob-
flow, and reduces splanchnic blood flow.18 Oc- struction or a chronic intermittent bowel ob-
treotide exerts actions similar to somatostatin, struction based on a compilation of clinical
but has a longer half-life and more potently in- signs, symptoms, and/or radiographic evi-
hibits growth hormone, glucagon, and insulin. dence. The obstruction could not be surgically
Octreotide suppresses luteinizing hormone correctable, as assessed by the patient’s gyneco-
(LH) response to gonadotropin-releasing hor- logic oncology surgeon. Furthermore, patients
mone (GnRH) and inhibits release of gastrin, could not have had prior use of somatostatin or
secretin, vasoactive intestinal peptide, motilin, its analogs and must have had a total bilirubin
and pancreatic polypeptide.18--20 #1.5 g/dL, life expectancy greater than 2
Sandostatin LARÒ Depot (LAR) (Novartis months, and ability to give written informed
Pharmaceuticals Corp., East Hanover, NJ), consent. Radiographic confirmation of ob-
a long-acting depot form of octreotide that is ad- struction was not required for entry into the
ministered intramuscularly once per month, study. If radiographic evidence of bowel ob-
consists of microspheres of the biodegradable struction was made, this was either performed
polymer, poly(DL-lactide-co-glycolide glucose).21 through plain radiography or CT scan. Patients
One intramuscular (IM) injection of LAR leads could concomitantly receive systemic chemo-
to an initial octreotide peak one hour later, therapy; patients were also eligible if they were
followed by decreased concentrations over the on hospice. Patients were not allowed to partic-
next one to two weeks and an increase from ipate if they had a current history of diabetes
Days 14 to 42, with levels falling thereafter.22 mellitus requiring insulin or antihyperglycemic
LAR has not been evaluated in MBO but has agents, clinically significant EKG (electrocar-
been tested at different dose levels in carci- diogram) abnormalities, a family history of a
noid syndrome as an alternative to the short- prolonged QT-interval syndrome, history of
Vol. 30 No. 6 December 2005 Long-Acting Octreotide Use in Bowel Obstruction 565

carcinoid, pancreatitis, or active biliary disease, reduction or resolution of symptoms (i.e., sig-
receipt of other investigational agents on a pro- nificant or complete resolution of nausea/
tocol within 30 days of study entry, or untreated vomiting and/or ability to remove nasogastric
hypothyroidism. tube); minor response, minor reduction in symp-
After informed consent was obtained, pa- toms that fell between a major reduction and
tients were immediately given a single test dose no change; no change, symptoms were neither
of 100 mg of octreotide delivered subcutaneous- significantly clinically improved nor worse;
ly and then observed for 60 minutes. If signs of and progression, symptoms of nausea/vomiting
intolerance such as hypotension, hypertension, worsened following LAR treatment.
chest pain, shortness of breath, or anaphylactic
reaction occurred, patients were removed from
the study and received no further octreotide or Results
LAR. If the patient tolerated SQ octreotide, he/ Fifteen patients were enrolled into this pilot
she immediately received 30 mg LAR delivered study. All patients had a diagnosis of recurrent
intramuscularly in the buttock. In addition, epithelial ovarian cancer. Table 1 lists the pa-
during the initial two weeks of therapy, patients tients’ ages at the time of study entry, number
self-administered 100 mg of octreotide subcuta- of lines of prior chemotherapy, whether the pa-
neously three times per day to achieve immedi- tient was on chemotherapy, predominant sites
ate therapeutic levels. Patient logs and unused of ovarian cancer as assessed by CT scanning,
octreotide were used to confirm octreotide symptoms by patient report, and radiographic
use. Patients were allowed to use lidocaine/pri- findings if radiography was performed. The
locaine cream (AstraZeneca Pharmaceuticals mean age of patients was 61 years. The mean
LP, Wilmington, DE) preinjection to ameliorate number of prior chemotherapies at the time of
injection pain. If patients were on home hos- entry into the study was 5.6, with a range of 3--
pice, they were allowed to receive LAR at home, 9. Patient 8 is not included in any assessments
with the injection being performed by a regis- since she withdrew consent prior to receiving
tered nurse. any treatment because of rapidly progressing
Patients continued on IM LAR at a dose of cancer. One patient (no. 1) developed hives after
30 mg until one of the following occurred: 1) receiving the test dose of SQ octreotide; this reac-
clear progression of symptoms or intolerability tion cleared quickly with oral diphenhydramine.
of LAR or octreotide, 2) the patient opted out This patient was removed from the trial, and she
of the study or the physician opted to remove received no further SQ octreotide or LAR.
the patient from the study, or 3) any Grade 3 Of the 14 patients enrolled in the study who
or 4 toxicity by Common Toxicity Criteria received some treatment, seven patients had
(CTC) directly related to either octreotide or a documented small bowel obstruction (SBO)
LAR. or partial SBO radiographically. One of these
Patients were asked to complete the Euro- patients did not receive LAR because of an aller-
pean Organization for Research and Treat- gic reaction to octreotide (no. 1). The remain-
ment of Cancer Quality of Life Questionnaire ing seven patients either had no radiographic
(EORTC QLQ)-C30 and the OV28 pretreat- evidence of a bowel obstruction (five patients)
ment and once monthly at the time of the or did not have radiographic studies done
LAR injection visit. The EORTC QLQ-C30 (two patients). Sites of cancer recurrence were
and the OV28 are validated surveys used to determined by CT scanning, and most patients
measure quality of life in cancer patients had peritoneal metastases as the predominant
(QLQ-C30) and specifically in ovarian cancer site of disease (Table 1). Nausea and vomiting
patients (OV28).23,24 were the most common complaints, and pa-
tients’ symptoms are listed in Table 1.
Measurement on Therapy Table 2 reviews the treatment history, best
Symptom responses to octreotide and LAR symptom response to LAR therapy on study,
use were measured by the most significant and survival (measured from day of starting
change in symptoms while on study and were treatment on study).
scored as follows: major response, significant Of the 13 patients who received at least one
clinical benefit resulting in significant dose of LAR, four patients received only one
566 Matulonis et al. Vol. 30 No. 6 December 2005

Table 1
Patient Characteristics
# of Lines
of Prior Was Patient
Chemotherapy Receiving
Age at (Including at Chemotherapy Predominant
Patient Time of Time of While on Sites Predominant Radiographic
No. Study Entry Enrollment) Study? of Cancer Symptoms Findings

1 55 7 Yes Pl, per N/V/abd pain SBO

2 62 5 Yes Per, asc N/V No SBO
3 71 4 Yes Pl, omen, per N/V/abd pain No SBO
4 54 8 Yes Pl, per V/con/early sat No SBO
5 57 4 Yes Pl, per N/V/bl/abd pain No SBO
6 31 9 Yes Pl, per N/V/abd pain No SBO
7 56 7 Yes Per N/V/abd pain SBO
9 59 5 Yes Liver mets V/abd pain/bl/con Partial SBO
10 70 3 Yes Pl, per N/V/bl X-ray not performed
11 46 3 Yes Per, asc, nodal V/con/abd pain Partial SBO
12 75 3 No Pl, per, nodal Alternating diarrhea/con SBO
13 54 5 Yes Pl, per N/V/abd pain, bl X-ray not performed
14 56 9 No Per V/bl/abd pain SBO
15 64 7 No Per Int N/V SBO
Pl ¼ pleural; per ¼ peritoneal; asc ¼ ascites; omen ¼ omental; N ¼ nausea; V ¼ vomiting; bl ¼ bloating; con ¼ constipation; int ¼ intermittent;
abd ¼ abdominal; sat ¼ satiety; SBO ¼ small bowel obstruction.

injection of LAR. One of those four patients four patients who received only a single LAR
(no. 15) received all 42 injections of SQ oc- injection discontinued study treatment be-
treotide, while the others received 30 (no. 5), cause of progression of their original symp-
seven (no. 13), and four (no. 10) doses. The toms, suggesting lack of efficacy of octreotide

Table 2
Length of Time on Study, Response to Treatment, and Survival
# of Days
Best Clinical between Study
Patient Months on # of SQ # of LAR Reasons for Removal Response to SQ Entry
No. Study Injections Injections from Study Octreotide/LAR and Death

1 0 1 0 Reaction to SQ Not assessable 853þ

octreotide
2 9 42 9 Progression of Minor 273
symptoms
and cancer
3 3 42 3 Progression of cancer Major 82
4 4 42 4 Progression of cancer No response 103
5 1 30 1 Progression of Progression 72
symptoms
6 2 42 3 Progression of cancer/ Minor 91
symptoms
7 4 42 4 Progression of No response 115
symptoms
and cancer
9 12 42 15 (12 on study Still on trial Major 484þ
and 3 off study)
10 1 4 1 Progression of Progression 30
symptoms
11 10 42 10 Still on trial Major 321þ
12 2 40 2 Progression of No change 74
symptoms
13 1 7 1 Progression of Progression 89
symptoms
14 2 42 2 Progression of No change 69
symptoms
15 1 42 1 Progression of Progression 15
disease/symptoms
Vol. 30 No. 6 December 2005 Long-Acting Octreotide Use in Bowel Obstruction 567

and LAR. Patient 15 had the shortest survival no significant differences among the QOL
on study and had therapy stopped because of scores, specifically the QLQ-C30, OV28, and
rapidly progressing ovarian cancer. the abdominal subscale of the OV28, regard-
Nine patients received more than one injec- less of response to LAR.
tion of LAR. All of these patients received two
full weeks (42 doses) of SQ octreotide. Of
these nine patients, three patients (nos. 3, 9, Discussion
and 11) had a major response to treatment, This pilot study represents the first use of
and two of these patients remain on LAR for LAR in recurrent ovarian cancer patients with
15þ months (no. 9) and 10þ months (no. surgically inoperable bowel obstruction or
11). Of these three patients, two (nos. 9 and symptoms of chronic bowel obstruction. Al-
11) had a partial SBO on radiography. Two pa- though the mean survival on therapy was only
tients had a minor response to therapy, and 3 months and thus comparable to prior litera-
one patient remained on study for 9 months ture, it is notable that three patients were on
before significant cancer progression. Four pa- LAR for 9 months or greater, and two of these
tients had no change in their symptoms. Of patients still remain on study, with one patient
the 13 patients who received LAR, three pa- receiving 15 months of therapy. Of the 13
tients were not actively receiving chemotherapy evaluable patients, three patients had a major
during study treatment. None of the three pa- response to study treatment, two had a minor
tients who were not receiving chemotherapy response, four experienced no change in
had a response to LAR. symptoms, and four patients worsened on
Among the 13 patients who received at least treatment. There were no Grade 3 or 4 toxic-
one dose of LAR, mean survival was 226 days, ities directly related to LAR, and the most fre-
median survival was 89 days, and two patients quently reported side effect was pain at the
are alive at 853þ and 484þ days. injection site.
Toxicities were graded from 1 through 4 by Several studies, both prospective non-
CTC. Table 3 lists toxicities that were deter- randomized and randomized, have docu-
mined to definitely, probably, or possibly relate mented the efficacy of octreotide in patients
to LAR. No Grade 3 or 4 toxicities thought to with MBO.6,16,17 Mangili et al.16 tested octreo-
be related to LAR occurred. Two patients who tide from 300 to 600 mg per day as either an
remain on long-term LAR reported pain at the SQ bolus or a continuous infusion. Thirteen
injection site often extending into the buttock patients were enrolled, and all had obstruction
that lasted several days. present based on clinical signs and confirmed
Quality-of-life scores as measured by the by plain abdominal radiography. Some pa-
EORTC QLQ-C30 and the OV2823,24 were tients were given nasogastric tube drainage
measured pretreatment and once monthly at (eight patients), and others were given addi-
the time of the LAR injection visit. There were tional drugs such as metoclopramide, mor-
phine, and haloperidol. Complete relief of
symptoms occurred within 3.07 days, and vom-
Table 3
Toxicities Related to LAR or SQ Octreotide per iting stopped within 2--3 days of starting treat-
Cycle per Patient ment in most patients. Mean survival from
Toxicity Grade 1 (n) Grade 2 (n) discharge was 15 days (range 4--32 days).
Mercadante17 examined octreotide in 14 pa-
Pain at injection site 2 0
Constipation 1 0
tients with MBO secondary to various cancers
Dyspepsia 1 0 and also used octreotide from 0.3 to 0.6 mg
Flatulence 0 1 per day via SQ bolus or continuous SQ infusion.
GI (other) 1 0
Elevation of alkaline 0 1
Vomiting was controlled in 12 patients and re-
phosphatase duced in two. The drug was well tolerated. Pa-
Elevation of SGOT 1 1 tients also received additional medications to
Abdominal pain/cramping 1 1
Headache 1 0
reduce symptoms of bowel obstruction, such
Myalgia 1 0 as haloperidol and analgesics.
Dyspnea 0 3 In the largest study of the use of octreotide in
Gallstones 0 0
MBO, Riley and Fallon25 examined 24 patients
568 Matulonis et al. Vol. 30 No. 6 December 2005

with various cancers who had intractable vomit- absorbed. Because LAR does not reach thera-
ing as a result of bowel obstruction that was un- peutic levels until at least 14 days after injec-
responsive to a combination of antiemetics, tion, patients will require SQ short-acting
steroids, and/or nasogastric tube drainage for octreotide to provide adequate drug levels un-
24 hours. Fourteen of the 24 had no further til LAR levels become therapeutic. This initial
vomiting, and four patients showed improve- SQ course may also provide an expeditious
ment. Six patients did not respond. Larger stud- mechanism for discerning which patients will
ies thus demonstrate that not all patients will be octreotide responsive since most studies
respond to octreotide even in the setting of ra- confirm that symptoms improve in responding
diographically-proven obstruction. patients within 3 days of initiation of
A 68-patient trial that randomized patients octreotide.
with MBO to either chlorpromazine and hyo- Octreotide and, more recently, LAR have
scine butylbromide or octreotide revealed sig- been associated with cancer regression, includ-
nificant improvement in nausea and vomiting ing ovarian cancer.27 Three patients on our tri-
within 3 days of starting treatment in the pa- al received nine or more doses of monthly
tients receiving octreotide.26 Patients also re- LAR, raising the possibility that LAR may have
ceived opioids in addition to chlorpromazine. contributed to cancer regression. Somatostatin
There was no difference in pain control be- and its five receptors have been found in brain,
tween the two groups. pancreatic D cells, intestinal/gastric epithe-
Our study differed from previously pub- lium, salivary glands, intestinal myenteric
lished studies of octreotide use in MBO in that neurons, and a variety of human cancers in-
bowel obstruction was defined by the clinical cluding adenocarcinomas of the breast, ovary,
constellation of nausea, vomiting, constipa- prostate, kidney, colon, islet tumors, carci-
tion, abdominal pain, and decreased oral in- noids, and lymphomas.28 Other roles for oc-
take regardless of whether bowel obstruction treotide have yet to be examined fully, such
was documented radiographically. In our as direct antitumor effects, modulation of the
study, only seven of 13 evaluable patients had GnRH and LH-releasing hormone pathways, and
documented partial or complete bowel ob- possible synergy with chemotherapy. In addi-
struction. Response to octreotide and LAR tion, whether or not improved chemotherapy-
may vary depending on sites of obstruction management and/or prophylactic use of
(diffuse bowel obstruction or ileus versus acute octreotide may prevent or delay bowel ob-
SBO), primary cancer type, route of adminis- structions is not known.
tration of octreotide and LAR, and the mecha- Because our trial has demonstrated the safety
nism of obstruction. Patients who have acute and tolerability of LAR in patients with ad-
bowel obstruction that is documented on radi- vanced and recurrent ovarian cancer with
ography may respond better to octreotide be- documented bowel obstruction or symptoms
cause of the drug’s ability to reduce secretion of bowel obstruction, a larger Phase II trial is
of water, sodium, and chloride, and increase needed to test the effects of LAR on palliation
absorption of water, than patients with inter- of symptoms of MBO. Evaluating the potential
mittent symptoms of bowel slowing that mimic of LAR to add to the effectiveness of chemo-
a partial, intermittent obstruction. Larger trials therapy will likely require a large Phase III trial
of octreotide are needed in patients with MBO in a carefully defined patient population.
to define which patient subgroups can derive
maximum benefit from LAR and for what rea-
sons. Furthermore, it is not known whether the
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