Product Focus
Campto® effective and flexible
chemotherapy for advanced
colorectal cancer
Helen Ferns
Abstract
T he use of chemotherapy with patients with advanced colorec-
tal cancer is increasing. There is a growing appreciation of the
potential of traditional and newer treatments to improve quality of
life, and of their value in the palliation of symptoms, in addition to
providing modest gains in overall survival. Possible benefits have
to be weighed up against the risk of side effects and patients
need to be supported in making difficult decisions. This article
provides a brief overview of chemotherapy agents for advanced
colorectal cancer and focuses on one new agent, Campto®. The
evidence supporting its use, common side effects and manage-
ment recommendations are discussed. The role of the oncology
team and the implications for nurses are outlined.
olorectal cancer is the fourth most
C common form of cancer worldwide
and the second most common cause
of death in Western countries (Parker et al,
1997). It accounts for 10–15% of all can-
cers and has a much higher incidence in
Western countries than in others
(Cunningham and Findlay, 1993). A com-
parison of survival rates from different
countries in the Western world illustrates
significant differences in 5-year survival:
USA 63.5%, Europe 47%, UK 40.9%
(Cancer Research Campaign, 1999).
The management of colorectal cancer
involves various treatment modalities,
with surgery being predominant.
Chemotherapy and radiotherapy are used
in both the adjuvant and metastatic setting.
In order to achieve the best possible
chance of cure, early diagnosis and appro-
priate surgical therapy is essential.
Unfortunately diagnosis is often delayed
because of the vagueness of symptoms and
a delayed realization of their significance.
Survival is related to the spread of the
disease at diagnosis. Around 29% of
Helen Ferns is Cancer
patients who present with colorectal can-
Research UK Lead cer have distant metastasis at the time of
Research Nurse, Christie presentation, usually to the liver or lungs
Hospital NHS Trust,
Manchester, M20 4BX, UK (Smithies and Stein, 1999). Few of these
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290
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patients will survive 3 years from the time
of diagnosis (NHS Clinical Outcomes
Group, 1997). About 80% of patients
diagnosed with colorectal cancer undergo
surgery (Effective Health Care, 1997).
Many have potentially good survival out-
comes following surgery, however, over
50% of those who have undergone
surgery with apparently complete excision
of the primary tumour will eventually
relapse and die of the metastatic disease
(Cunningham, 1996).
This article gives an overview of
chemotherapy agents used in the manage-
ment of advanced colorectal cancer, with
particular focus on one agent, Campto ®.
Implications for nurses are discussed.
Palliative chemotherapy for
advanced colorectal cancer
Advanced colorectal cancer has been
defined as colorectal cancer that at presen-
tation or recurrence is either metastatic or
so locally advanced that surgical resection
is unlikely to be carried out with curative
intent (Young and Rea, 2001). Palliative
chemotherapy is now offered to an
increasing proportion of patients with
advanced colorectal cancer. The aims of
chemotherapy in this group of patients are
to prolong survival, control symptoms
and maintain or improve quality of life
(Seymour et al, 1997).
The decision about whether to start pal-
liative chemotherapy requires input from
an oncologist experienced in the treatment
of colorectal cancer and from any specialist
or oncology nurses involved in a patient’s
care. The individual and their significant
others need all the relevant information if
they are to make an informed choice about
whether to pursue further treatment.
The potential benefits of palliative
chemotherapy must be weighed against
potential treatment toxicity. The effect on
quality of life is paramount and should
 Campto® effective and flexible chemotherapy for advanced colorectal cancer

always be discussed with the individual. symptom control, performance status and
The continuing assessment of treatment- quality of life (Scheithauer et al, 1993).
related side effects and correct manage- From 2000 new chemotherapy agents used
ment is essential in determining the after, or in combination with, 5-FU have
acceptability of palliative chemotherapy. been introduced, giving oncologists and
Poor performance status (World Health individuals more scope to personalize
Organization (WHO) grade 3 or 4, Table treatment regimens.
1) low serum albumin, high alkaline phos- Massacesi et al (2002) have published
phatase and liver involvement are indepen- outcomes from an observational study that
dent predictors of progression. Low serum looked at predictors of 5-FU failure. With
albumin, high glutamyl transferase and this data oncologists are better able to pro-
high carcino-embryonic antigen are predic- file patients that may have a predisposition
tors for poor survival. Patients with these to 5-FU failure and thus consider alterna-
markers are less likely to benefit from tive agents or no chemotherapy at all,
chemotherapy (Fountzilas et al, 1996). depending on patient choice (Massacesi et
al, 2002).
5-fluorouracil and folinic acid Controversy exists around the world as
Up until the mid 1990s, 5-fluorouracil (5- to the optimal 5-FU regimen. This is an
FU) was the only active drug available in important issue when evaluating the results
the management of colorectal cancer. A of clinical trials conducted with various 5-
combination of 5-FU with a biochemical FU regimens as the standard arm (Cassidy,
modulator, such as folinic acid (FA), was 2001). Clinical trials conducted or led from
the standard treatment for advanced colo- the USA tend to use the bolus 5-FU regi-
rectal cancer, increasing survival by about mens. In Europe infusional regimens
3–6 months, as well as improving both (Table 2) are generally preferred and used
as standard therapy. Current evidence sug-
Table 1. World Health Organization (WHO) performance gests that 5-FU administered in an infu-
status sional form (at least 24 hours duration)
doubles response rate, increases median
WHO grade Characteristics
survival and reduces toxicity over bolus
0 Able to carry out all normal activity without restriction regimens (Meta-Analysis Group in
1 Restricted in physically strenuous activity but Cancer, 1998).
ambulatory and able to carry out light work The toxicities of infusional 5-FU with or
2 Ambulatory and capable of all self-care but unable to without FA (Table 2) are usually manage-
carry out any work; up and about more than 50% of able and both regimens are well tolerated,
waking hours with minimal disruption to functional sta-
3 Capable only of limited self-care; confined to bed or tus. Educating individuals about common
chair more than 50% of waking hours side effects and prompt management can
4 Completely disabled; cannot carry out any self-care;
reduce the grade of toxicity. Both regimens
totally confined to bed or chair require an indwelling central or peripheral
line and individuals must be made aware of
(WHO, 1979)
the limitations of living with an indwelling
line and of potential complications. These
Table 2. Infusional 5-FU regimens for the treatment of can range from clots, infection and
advanced colorectal cancer phlebitis, to the breaking of lines, which
can delay treatment. Oral 5-FU pro-drugs
Method of are now emerging that have been shown to
Regimen administration Common side effects have similar efficacy to bolus 5-FU (Hoff,
de Gramont Infused over 48 hours Mucositis, neutropenia, 2000) but without the complications asso-
(5-FU/FA) every 2 weeks nausea and vomiting, ciated with line insertion. There is much
(usually requires diarrhoea, plantar palmar debate about the optimum duration of
indwelling central or erythrodysaethesia (hand and
peripheral line) foot syndrome) and fatigue
chemotherapy. Common practice is to
vary between 12 and 24 weeks or until
disease progression.
Lokich Continuous infusion Mucositis, neutropenia,
(5-FU) (requires ambulatory nausea and vomiting,
It has been shown that in advanced dis-
pump and indwelling diarrhoea, plantar palmar ease, starting chemotherapy early, before
central or peripheral erythrodysaethesia (hand and clinical deterioration, can improve response
line) foot syndrome) and fatigue rate of treatment and overall survival by
5-FU=5-fluorouracil, FA=folinic acid (NHS Clinical Outcomes Group, 1997) 3–6 months without any adverse effect on
quality of life (Scheithauer et al, 1993).

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 Campto® effective and flexible chemotherapy for advanced colorectal cancer
Campto
In recent years several new agents with
different mechanisms of action have
shown improved activity in the treatment
of advanced colorectal cancer, both in
chemotherapy naive individuals and those
with disease refractory to 5-FU. Campto
(irinotecan) is one of these drugs and is
the first new agent in nearly 40 years to
have shown consistent and reproducible
activity in advanced colorectal cancer
(Rothenberg, 1998).
Campto represents a novel class of cyto-
toxic drug, the camptothecins. The active
component of Campto is a selective
inhibitor of topoisomerase I, an enzyme
that plays a pivotal role in DNA transcrip-
tion, replication and repair. Colorectal can-
cer cells have high levels of topoisomerase I.
Several randomized controlled trials
(RCTs) with Campto have shown a sur-
vival benefit in individuals with advanced
colorectal cancer (Cunningham et al, 1998;
Rougier et al, 1998; Douillard et al, 2000;
Saltz et al, 2000).
Six RCTs looking at first-line treatment
with Campto in combination with 5-
FU/FA in comparison with other 5-FU
based regimens have been published. The
patient profile for these studies is given in
Table 3. The number of patients in these
studies ranged from 90 to 457 (Pozzo et al,
1999; Saltz et al, 2000; Graeven et al, 2000;
Douillard et al, 2000; Maiello et al, 2000;
Tournigand et al, 2000). Improvements
were statistically significant in the larger
phase III studies (Douillard et al, 2000:
Saltz et al, 2000). Improvements were
demonstrated in response rates (a response
rate of 31% was seen in the standard arm
(5-FU/FA) and 49% in the Campto arm
Table 3. First-line treatment with Campto® in combination
with 5-fluorouracil/folinic acid (5-FU/FA)
Patient profile Dose
Performance status ≤2 180 mg/m2 every 2 weeks
Metastatic colorectal cancer with infusional 5-FU/FA
Bilirubin ≤1.5 times the upper limit of normal regimen
Treatment administered via a centrally placed or peripherally placed line.
Table 4. Dosage adjustments for patients undergoing
second-line single agent treatment with Campto®
Patient profile Dose
Fit as in first-line indication 350mg/m2 every 3 weeks
≥70 years performance status =2 300mg/m2 every 3 weeks
Bilirubin 1.5-3 times upper limit of normal 200mg/m2 every 3 weeks
Patients at risk or who may need 125mg/m2 every week for
a closer follow up. 4 weeks followed by 2 weeks rest
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(Campto/5-FU/FA)), median time to pro-
gression (4.4 months in the standard arm
and 6.7 months in the Campto arm) and
overall survival (median survival
14.1 months in the standard arm and
17.4 months in the Campto arm). No
other regimen has twice demonstrated has
a survival advantage in this setting
(Douillard et al, 2000; Saltz et al, 2000).
Various RCTs have looked at Campto as
a single agent in the second-line treatment
of advanced colorectal cancer, whether
compared with best supportive care
(Cunningham et al, 1998) or 5-FU/FA
(Rougier et al, 1998). These studies evalu-
ated 279 and 267 patients respectively.
They demonstrated statistically significant
overall improvements in survival for the
experimental arm from 6.5 months to
9.2 months (Cunningham et al, 1998) and
from 8.5 months to 10.8 months (Rougier
et al, 1998). Significant improvements in
quality of life were seen in both studies.
Quality of life was assessed in all RCTs
with the validated questionnaire of the
European Organisation for Research and
Treatment of Cancer, QLQ-C30, which
includes five functioning scales, one global
health status scale and nine symptom scales
(Aaranson et al, 1993).
Indications for treatment are first line, in
combination with 5-FU/FA, in individu-
als who have no prior chemotherapy for
advanced disease and as a second-line sin-
gle agent therapy in individuals who have
progressed after an established 5-FU regi-
men. Treatment with Campto is flexible
and adaptable depending on a patient’s
performance status and the extent of the
disease. Dose adjustments for various
groups of individuals in second-line treat-
ment are given in Table 4.
Campto treatment management
Side effects from cytotoxic drug treatment
for advanced cancer have to be effectively
managed if quality of life gains are to be
maximized. The side effects of Campto are
generally manageable and non-cumulative.
The most common dose-limiting toxicity
is delayed diarrhoea. Other important side
effects include cholinergic syndrome, neu-
tropenia and alopecia. Nurses should be
aware that chemotherapy can cause neu-
tropenia, which may occur with or with-
out fever. Prompt medical attention is
required, especially if associated with diar-
rhoea. Nurses should refer to the guide-
lines for loperamide and oral fluoro-
quinolones as described in Table 5 and as
 Campto® effective and flexible chemotherapy for advanced colorectal cancer
Table 5. Common side effects and management of Campto® therapy
Side effect
Acute cholinergic syndrome
Defined as early diarrhoea,
sweating, abdominal cramps,
lacrimation, myositis, salivation,
visual disturbances, malaise
and decrease in blood pressure
Occurs within 24 hours
of treatment administration
Early diarrhoea
Watery loose stools occurring
within first 24 hours of
treatment administration
Nausea and vomiting
Can occur after each
administration of treatment
Delayed diarrhoea
Occurring >24 hours after
treatment administration
Predictable at around 5 days
after administration
Neutropenia
Median day to nadir is 8 days
Alopecia
Occurs gradually as cycles
continue
*Grade 3 diarrhoea – increase of ≥7 stools/day or need for parental support for dehydration. Grade 4 diarrhoea – physiological consequences
requiring intensive care or haemodynamic collapse, †Grade 1 alopecia – mild hair loss. Grade 2 alopecia – pronounced hair loss, S/C=subcuta-
neous, IV=intravenous, (Adapted from Aventis Pharma, 2003)
294
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Comments
● Short lasting
● Never life threatening
● Unpleasant for the individual
● Treatable and preventable
● Should not led to treatment
discontinuation
● Controllable with effective
anti-emetic therapy.
● Usually administered IV
before each cycle.
● Oral treatment to take home
● Usually short lived
(12–72 hours)
● Most common dose-limiting
toxicity of Campto treatment
● Education of patient and staff
in the appropriate management
can reduce severity
● Severe grade 3–4* diarrhoea
seen in 13% of individuals
treated first-line
(combination) and in
20% of individuals treated
second-line (single agent)
● Second most dose-limiting
toxicity
● Non-cumulative
● Febrile neutropenia in 1–2% of
patients treated first line
(combination) and in 5% treated
second line (single agent)
● Reversible when treatment is
discontinued
● Grade 1–2† occurs in 51% of
individuals treated first line
(combination) and in >90%
treated second line
(single agent)
Management
S/C injection of atropine sulphate 0.25 mg
Subsequent injections should be administered
before each cycle
Treatment should be with atropine and not
Loperamide
Pre-treatment infusion:
IV bolus granisetron 3 mg or ondansetron 8 mg
IV bolus dexamethasone 8 mg
Day 2: Oral dexamethasone 4 mg three times daily
Day 3: Oral dexamethasone 4 mg twice daily
Day 4: Oral dexamethasone 4 mg once daily
Domperidone or metoclopramide as required
As soon as delayed diarrhoea occurs the individual
must take 2 loperamide capsules,
then take 2 capsules every 2 hours for 12 hours
If diarrhoea persists patients should keep taking
capsules every 2 hours until there has been
no diarrhoea for 12 hours
An individual must inform the hospital
● if diarrhoea persists after 24 hours on
loperamide capsules
● if they have a temperature as well as diarrhoea
● if they have nausea and vomiting
as well as diarrhoea
Antibiotic therapy will need to be commenced
after 24 hours of diarrhoea
If diarrhoea has not settled after 48 hours despite
medication an individual will need to be seen at
hospital to ensure they are not dehydrated or have
a bowel infection.
Patients should be given a prescription for
loperamide, and may also be given a prescription
for an oral fluoroquinolone, when they leave hospital.
Patients should be given instructions on their use
and physician contact details, and be advised
to contact their physician if they experience
prolonged diarrhoea, with or without fever
Weekly blood counts recommended
Treatment delay if blood counts have not
recovered to local policy satisfactory values
Education of patient as to incidence
Provision of a wig if desired
International Journal of Palliative Nursing, 2003, Vol 9, No 7
 Campto® effective and flexible chemotherapy for advanced colorectal cancer

prescribed by the physician. Table 5 out- generate 5-FU preferentially in tumour

lines the common side effects and guid-
ance for management (Aventis Pharma,
2003). The Summary of Product
Characteristics for Campto (Aventis
Pharma, 2001) recommends a 15–20%
dose reduction in patients who experience
severe toxicity. Manufacturer’s general
management recommendations are given
in Box 1.
Other new drugs
In addition to Campto, a number of other
new compounds have been introduced for
the treatment of advanced colorectal cancer.
Oxaliplatin
Oxaliplatin is a new platinum derivative
analogue and is a potent inhibitor of DNA
synthesis. It is thought to act as an alkylat-
ing agent making DNA lesions that the
cell cannot repair, leading to cell death
(Cvitkovic and Bekradda, 1999). It shows
synergism with 5-FU and is administered
intravenously with infusional 5-FU/FA.
Raltitrexed
Raltitrexed is a selective thymidylate syn-
thase inhibitor. It is licensed in the UK
for the palliative treatment of colorectal
cancer for patients in whom 5-FU is not
tolerated or is inappropriate. It is a conve-
nient 15-minute infusion every 3 weeks
and although evidence suggests compara-
ble survival data with 5-FU. Toxicity is
unpredictable as highlighted in the
Medical Research Council CRO6 trial,
which reported an increase in the toxic
death rate of four patients in the
raltitrexed arm to none in 5-FU/FA arms
(Maughan et al, 2001).
Oral 5-fluorouracil prodrugs and
modulators
Capecitabine: Capecitabine is the first of
a new class of oral fluoropyrimidines, a
prodrug of 5-FU. It was designed to
mimic continuous infusion 5-FU and to
tissue. The tumour selective activity of
capecitabine is achieved through the
exploitation of the high concentrations
of thymidine phosphorylase present in
colorectal cancer cells.
UFT: Tegafur (Ftorafur) is another oral
prodrug of 5-FU, which has been available
since the 1960s. Uracil is added to Tegafur
to form UFT. Uracil inhibits the break-
down and extends the half-life of 5-FU.
Role of newer agents
Newer agents are rightly gaining a place in
the first- and second-line treatment of
advanced colorectal cancer, some showing
an improvement in progression-free sur-
vival and, in the case of Campto, improved
overall survival (Young and Rea, 2001).
Optimum sequencing and combination
of 5-FU/FA, Campto and oxaliplatin are
the subject of an ongoing trial, the MRC
CRO8 (FOCUS) which is currently
recruiting in the UK. A study by
Tournigand et al (2000) has addressed a
similar question.
In Europe a randomized trial of FOLFIRI
(Campto 180mg/m2 + 5-FU/FA de
Gramont schedule) followed by FOLFOX
(oxaliplatin 100mg/m2 + 5-FU/FA de
Gramont schedule) versus the reverse
sequence in the first-line treatment of
metastatic colorectal cancer has shown that
both sequences have similar overall survival
(Douillard et al, 2003).
Chemotherapy prolongs the time
to tumour progression and the overall
survival of individuals with advanced col-
orectal cancer. Even though chemother-
apy is potentially toxic, the increase in
overall survival and the palliative benefits
make them more acceptable. There is
mounting evidence that all individuals
with advanced colorectal cancer should be
offered chemotherapy, depending on
physical functioning. Individuals should
be allowed to make informed decisions,
balancing the relatively small gains in

Box 1. General management recommendations for Campto®

Campto should be administered in designated units specialized in the administration of cytotoxic
chemotherapy and supervised by a suitable trained oncologist. Specialist oncology teams are used
to managing the unwanted side effects of Campto therapy.
Education of the individual receiving Campto as to management of potential toxicities is essential.
Verbal and written information must be provided with a 24-hour contact number.
Education of staff involved ensures that the incidence and severity of side effects are minimized.
Standard management guidelines have been developed to promote good practice and quality
patient care.
(Aventis Pharma, 2003)

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 Campto® effective and flexible chemotherapy for advanced colorectal cancer
‘Quality of life in overall survival and improvement in qual-
cancer care is ity of life against the potential treatment
toxicities (Simmonds, 2000).
increasingly
recognized as a Oncology team
valuable The management of patients with colorec-
supplement to tal cancer is multifaceted, including
tumour response treatment, symptom management, and
and survival emotional and psychosocial support.
The multidisciplinary team encompasses
data... ’
oncologist, radiographers, chemotherapy
nurse, specialist nurses, trials team, dieti-
cians, medical social worker and rehabilita-
tion team. The general management
recommendations given earlier for Campto
can also be applied to other agents (Box 1).
The pathway of care for an individual
with colorectal cancer is continually
moving between primary, secondary and
tertiary care settings, increased communi-
cation and the sharing of information can
only improve the whole package of care
to the individual resulting in improved
outcomes.
With the increased used of ambulatory
chemotherapy in advanced colorectal can-
cer, increased links have been established
with the primary health-care team, who
can be responsible for the disconnection of
infusers and the care of central and periph-
eral lines. The oncology team must ensure
that district nurses are kept up to date in
the management of individuals receiving
ambulatory chemotherapy and practice
using local guidelines, as well as providing
support and advice.
Over recent years, individuals with
advanced colorectal cancer have seen an
increase in overall survival, with the use of
palliative chemotherapy and the availabil-
ity of new agents. But that survival is, on
average, about 18 months (Douillard et al,
2000), therefore, liaison with local pallia-
tive care teams is advisable early on, to
ensure good palliation of symptoms and
psychosocial support.
Implications for nurses
In considering the cure/care dichotomy
in advanced colorectal cancer emphasis
must be placed on individual care and opti-
mal quality of life. Families, nurses and
other health-care professionals share an
interest in maximizing positive outcomes
of any treatment intervention by support-
ing the patient in making the best decision
for their particular situation. The oncology
nurse is in an ideal position to help the
individual obtain information about vari-
ous treatment options in order to make an
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informed choice and give consent.
Information on quality of life outcomes
can assist in the decision-making process.
There is evidence of significant variation
in the management and outcomes of col-
orectal cancer nationally and internation-
ally (Cancer Research Campaign, 1999).
Current guidelines (The Association of
Coloproctology of Great Britain and
Ireland, 2001) advocate the use of
chemotherapy in advanced and recurrent
disease. Whether the decision is to treat
or palliate in order to extend life in
advanced or recurrent disease, quality of
life issues should be the main focus.
Quality of life in cancer care is increas-
ingly recognized as a valuable supplement
to tumour response and survival data, pro-
viding the individual’s perspective on
therapies and evaluating whether small
gains in life span come at too high a cost.
Taking into account the individual’s
assessment of quality of life during treat-
ment might give a different perception of
toxicity and efficacy than that of the clini-
cian. The nurse has a practical role in
assessing the ongoing quality of life with
individual patients throughout any treat-
ment regimen during his/her nursing
assessment and is in a prime position to
support patients in decisions about treat-
ment continuation or discontinuation.
Future
Fluoropyrimidine-based therapies have
been the main component of first-line
treatment for individuals with colorectal
cancer. With the current data showing sig-
nificantly prolonged survival when indi-
viduals are treated with first-line Campto
combined with infusional 5-FU/FA, first-
line Campto based regimens should be
offered as a first-line treatment in
advanced colorectal cancer.
Phase I and II trials are currently
underway exploring the value of combin-
ing Campto with other oral 5-FU pro-
drugs It may be that Campto in
combination with 5-FU/FA, or an oral 5-
FU pro-drug, in the adjuvant setting will
prove of greater use in the treatment of
colorectal cancer than 5-FU/FA alone.
Summary
In recent years new cytotoxic agents have
become available for the treatment of
colorectal cancer, hopefully, during the
next few years, the use of different com-
binations of these agents will be seen in
both the adjuvant and palliative setting,
 Campto® effective and flexible chemotherapy for advanced colorectal cancer
improving survival and maximizing
quality of life.
Key words Although 50% of patients with bowel
● Colorectal cancer can expect to be cured with
cancer surgery, 50% go on to develop metastatic
● Palliative
disease. Historically treatment options
have been limited for this group of indi-
chemotherapy
viduals. The development and availability
● Campto® of new treatment options offers encour-
agement and extends the range of options
● Increased
available to oncologists.
survival
It is vital for individuals and oncologists
● Quality of life to have choice when considering treatment
for advanced bowel cancer, as no single
treatment will be suitable for all individuals
when balancing stage of disease, perfor-
mance status, treatment responses and
quality of life. Providing information to
patients about all aspects of treatment is an
important role of nurses and other mem-
bers of the oncology te am.
The author has been involved in the production of
informational and educational material for patients
and staff in the use of Campto and has received
support to attend conferences from Aventis Pharma.
Aaranson NK, Ahmedzai S, Bergman B et al (1993)
The European Organisation for Research and
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Aventis Pharma (2003) A Nurses Guide to Treatment
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