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The literate patient and access to
information
At a workshop held in conjunction with
ASCO, experts discussed access to care
and shared decision-making for people
with cancer from a European and global
perspective. Milka Krapež (Patient
Coalition of Slovenia, Ljubljana,
Slovenia) discussed improved patient
access to information and how that
affects cancer care.
Several trends have led to changes in
cancer care over the past few decades.
Now many types of cancers are diseases
people live, and more people are
survivors. Cancers are detected earlier in
the course of disease, partly because of
advances in screening, improved
education of physicians, and a better
informed public. Even though cancer is
no longer a universal death sentence, the
diagnosis of cancer often brings fear,
anxiety, hopelessness, loneliness,
devastation and shock.
These days, patients can find information
about cancer on the Internet, from various
types of media and in bookstores. Well-
informed patients can share in decision-
making. Many patients are becoming
more demanding about health care, but
not all doctors pay heed to their demands.
Most people rate their health as very
important, but in many countries, only a
small percentage of government funds is
devoted to health care. Several studies
have shown that national health care
expenditures on cancer are correlated
with survival [1,2].
NEWS FLASHES FROM ASCO
METASTASECTOMY
PROLONGS SURVIVAL IN
PATIENTS WITH METASTATIC
RENAL-CELL CARCINOMA
Michael Staehler. Ludwig-Maximilians-University, Munich,Germany.
SCORED VALUE AND
CHRONIC-KIDNEY-DISEASE
NEPHRECTOMY FOR RENAL
MASS
Geoffrey R. Nuss. University of TexasSouthwestern Medical School, Dallas,TX, USA.
IMPLICATIONS OF BRAIN
METASTASES IN RENAL-CELL
CARCINOMA
Brian Shuch. University of Californiaat Los Angeles, Los Angeles, CA,USA.
AGE A PROGNOSTIC FACTOR
IN WOMEN WITH RENAL-CELL
CARCINOMA
Daniel J. George. Duke University,Durham, NC, USA.
LONG-TERM SURVIVAL
FOLLOWING NEPHRECTOMY
Melissa D. Laudano. ColumbiaPresbyterian Medical Center, NewYork, NY, USA.
THYROID DYSFUNCTION A
POTENTIAL MARKER FOR
EFFICACY OF SUNITINIB IN
RENAL-CELL CARCINOMA
Pascal Wolter. Catholic UniversityLeuven, Belgium.
MEDUNET CONGRESS NEWS
FROM DATA PRESENTED AT THE
44TH ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO ‘08)
30 MAY–3 JUNE 2008, CHICAGO, IL, USA
REAL-WORLD ONCOLOGY AND NEW HOPE
FOR PATIENTS WITH METASTATIC RENAL-CELL
CARCINOMA
Over the past few decades, inroads have been made in screening,
diagnosing and treating cancer. These advances have led to a growth
in survivorship. However, access to cancer care remains a problem in
many parts of the world. Experts at a workshop held in conjunction
with ASCO discussed global issues related to access to care and shared
decision-making between physicians and patients. Novel treatments
are becoming available for many types of cancers, but before these
drugs are widely adopted, evidence is needed to demonstrate that they
improve outcomes. At ASCO, for the first time, a drug was reported to
extend overall survival beyond two years in metastatic renal-cell
carcinoma; the novel oral multikinase inhibitor sunitinib showed a
survival advantage over standard therapy with interferon-alfa.
Please visit www.medical-ip.com to discuss this report with your colleagues and leave your comments on other articles!
NEW HOPE FOR PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA
METASTASECTOMY PROLONGS SURVIVAL INPATIENTS WITH METASTATICRENAL-CELL CARCINOMA
Metastasectomy significantly improved
the five-year overall survival rate in
patients with metastatic renal-cell
carcinoma (RCC), according to a review
of ten years of experience that included
240 patients. The study was reported at a
poster session at ASCO by Michael
Staehler (Grosshadern Clinics,
Department of Urology, Ludwig-
Maximilians-University, Munich,
Germany).
The study included 240 patients with
potentially resectable metastatic RCC
treated between 1995 and 2006 at the
Grosshadern Clinics in Munich. All
patients underwent nephrectomy.
Metastasectomy was performed in 183
patients. The control group was the
remaining 57 patients who did not
undergo metastasectomy.
Sites of surgery for metastatic disease
were: liver in 68 patients, lung in 121
patients, lymph nodes in 87 patients, and
other metastatic lesions in 141 patients.
In the control group, 20 had liver
metastases, 41 had lung metastases,
29 had lymph node metastases, and
36 patients had lesions at other sites.
Median follow-up was 26 months.
Five-year overall survival rate in all
patients was 52.6%. Five-year survival
rate was significantly higher in the group
of patients who underwent metastasecto-
my: 57.8% versus 35.3% in controls
(p < 0.001). The survival benefit was
determined to be independent of site of
metastatic disease. The only negative
prognostic factor for surgery was grade;
patients with grade 3 and grade 4 RCC
in their initial nephrectomy specimen did
not have a survival benefit from
metastasectomy.
Reference:Staehler M, et al. J Clin Oncol2008;26(Suppl.):Abstr. 5107.
2
Cost of cancer therapy from a global
perspective
Although cancer is responsible for 27%
of all deaths and 38% of deaths in
people under the age of 65, cancer
accounts for only 11% of government
expenditure on health care, 0.8% of
government funds for anti-neoplastic
drugs and 0.45% of government
expenditure for innovative anti-cancer
drugs [3], explained Nils Wilking
(Department of Oncology, Karolinska
Institute, Stockholm, Sweden).
Several important issues related to
costs of cancer therapy need to be
addressed, he continued. Better data are
needed to show that anti-neoplastic
drugs improve outcomes in cancer
patients; even if anti-neoplastic agents
do improve outcomes, funds are needed
not only for drugs, but also for
detection and prevention. Dr. Wilking
stated that the impact of prevention and
early detection is still limited and
highly dependent on access.
Dr. Wilking said that another factor is
that clinicians are under intense
pressure to satisfy demands of patients,
with at least 50 new oncology products
expected by 2013. However, no major
increase in the numbers of oncologists
is expected over the same time period
in Europe or in the USA.
Over the next five years, an estimated
ten new drugs will be come available
per year, and costs of these drugs are
expected to increase 15% to 20%
annually, Dr. Wilking continued. The
total oncology market is estimated to
increase eight- to ninefold between
1999 and 2011, he said.
Better data are needed on
incidence/mortality/survival and the
effect of therapy. Access to cancer
therapy, including drugs, needs to be
addressed in developing countries.
Research on outcome of improved
access to therapy is an important part
of assessing the value of innovation in
cancer, Dr. Wilking concluded.
Empowering patients: a novel
approach to cost-effective health care
Patients can contribute to cost-effective
cancer management at several levels,
said Reinhard Angelmar (INSEAD,
Paris, France). Adopting a healthy
lifestyle can prevent cancer and
outcomes can be improved by
participating in screening programs,
becoming aware of cancer symptoms,
and presenting to a health care
professional when symptoms emerge.
Once a person is diagnosed with cancer,
judicious choices of hospitals and doctors
and treatment adherence can improve the
chances of survival and quality of life.
Ideally, health care decision-making
would be shared by physicians and
informed consumers. However, not all
cancer patients want power over health
care decisions. Prof. Angelmar suggested
that patients in the USA are more likely
to want shared decision-making than
those from some European countries,
where a large proportion of patients
depend on their doctors for health care
decisions.
Renal-cell carcinoma: new hope for
patients with metastatic disease
Five-year survival for patients diagnosed
with metastatic renal-cell carcinoma is
about 20% [4]. Until 2005, treatment
options for metastatic renal-cell
carcinoma were limited. Interleukin-2 or
interferon-alfa (IFN-alfa) was used as
first-line treatment, but these treatments
had a great deal of toxicity, and median
overall survival with these therapies was
only about 12 months [5]. The advent of
novel targeted agents over the past few
years has improved the outlook for
patients with metastatic renal-cell
carcinoma.
Whereas in the past, the drugs used to
treat this stage of disease did not improve
survival, oncologists can now offer their
patients newer therapies that prolong the
time to disease progression and improve
progression-free survival (PFS).
SCORED VALUE AND CHRONIC-KIDNEY-DISEASENEPHRECTOMY FOR RENALMASS
Geoffrey R. Nuss (Department of
Urology, University of Texas
Southwestern Medical School, Dallas,
TX, USA) examined a validated
predictive model (SCORED) that could
help stratify the risk of chronic kidney
disease (CDK) in patients with renal
masses after nephrectomy. Patients with
CDK are at higher risk for cardiac
morbidity and mortality.
The study enrolled 293 consecutive
patients who underwent radical
nephrectomy for a suspicious renal
mass; patients had no evidence of
metastatic disease and they had a normal
contralateral kidney. Patients were
stratified prior to surgery using low
(<4) and high (>4) SCORED values.
Glomerular filtration rates were
estimated using the MDRD
(Modification of Diet in Renal Disease)
equation.
Median size of kidney mass was 6 cm
(range 2–24 cm). A higher SCORED
value was associated with a significantly
greater risk of having stage III CDK
prior to surgery compared with a low
SCORED value: 38% versus 18%,
respectively (p < 0.004). The difference
between the two groups with regard to
developing CDK post-operatively was
more pronounced among patients with a
preoperative GFR � 60 mL/min/1.73 m2.
A comparative analysis with another
cohort of 171 patients who underwent
nephron-sparing approaches instead of
nephrectomy showed that the
nephron-sparing approach protected
patients from developing post-operative
CDK. Dr. Nuss and colleagues
recommended the use of nephron-
sparing approaches whenever possible,
since stage III CDK is an independent
risk factor for cardiovascular morbidity
and mortality.
Reference: Nuss GR, et al. J Clin Oncol2008;26(Suppl.):Abstr. 5117.
3
NEW HOPE FOR PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA
approval of sunitinib as first-line
therapy. Thereafter, patients on the INF-
alfa arm of the study were allowed cross
over to sunitinib for disease progression.
The study enrolled 750 patients with
clear-cell histology and no prior
systemic treatment. Patients were
randomised in a 1:1 ratio to sunitinib
(50 mg orally daily for four weeks and
two weeks off treatment) or IFN-alfa
(9 MU subcutaneously three times
weekly on non-consecutive days). At
baseline, the two treatment arms were
well balanced for demographic and
disease characteristics. Median age was
62 in the sunitinib arm and 59 in the
IFN-alfa arm. About 62% and 38% of
the patients had an Eastern Cooperative
Oncology Group (ECOG) Performance
Status (PS) of 0 and 1, respectively;
about 90% had prior nephrectomy.
About 78% had lung metastases, 26%
liver metastases and 30% bone
metastases. Nineteen per cent of the
sunitinib group and 24% of the IFN-
alfa group had one metastatic site, and
81% and 76%, respectively, had two or
more. More than a third had favourable
prognosis, based on MSKCC
(Memorial Sloan Kettering Cancer
Center) risk factor assessment; more
than 50% were intermediate risk; and
about 6% were poor risk.
Median treatment duration was 11
months for sunitinib and four months
for IFN-alfa. Fourteen per cent of
At ASCO, final results of an
international, phase III, randomised,
controlled trial confirmed a survival
advantage for sunitinib over IFN-alfa in
patients with metastatic renal-cell
carcinoma [6]. Sunitinib consistently
demonstrated improved PFS and overall
response rate compared with IFN-alfa,
and is now considered the reference
standard for first-line treatment of
metastatic renal-cell carcinoma and for
future trials for this disease.
Sunitinib, an angiogenesis inhibitor
targeted to the vascular endothelial
growth factor (VEGF) and platelet-
derived growth factor receptor,
represents an advance over previous
treatments for this poor-prognosis
disease. This is the first time overall
survival of more than two years has
been achieved in the first-line setting of
metastatic renal-cell carcinoma.
“Sunitinib is a major accomplishment
compared to past treatments. Now we
can tell a patient with metastatic renal-
cell carcinoma that he or she may gain
two more years to live,” stated Robert
A. Figlin (Division of Medical
Oncology and Therapeutics Research,
City of Hope, Duarte, CA, USA).
In 2005, an interim analysis of this
study showed a statistically significant
improvement in PFS (median PFS 11
months vs. 5 months, respectively,
p < 0.000001) [7], leading to FDA
Figure 1 FINAL OVERALL SURVIVAL
Source: Figlin RA, et al. J Clin Oncol 2008;26(Suppl.):Abstr. 5024.
CI = confidence interval
Hazard ratio 0.821 (95% CI 0.673–1.001; log-rank p = 0.051)
Sunitinib (n = 375). Median 26.4 months
(95% CI 23.0–32.9)
IFN-alfa (n = 375). Median 21.8 months
(95% CI 17.9–26.9)
Time (months)
Surv
ival
pro
bab
ilit
y (
%)
3 6 9 12 15 18 21 24 27 30 33 36| | | | | | | | | | | |
100
90
80
70
60
50
40
30
20
10
0
IMPLICATIONS OF BRAINMETASTASES IN RENAL-CELLCARCINOMA
Isolated brain metastases are a rare
occurrence in patients with metastatic
renal-cell carcinoma (RCC; 5.2%) and
are most commonly observed in
clear-cell RCC (92.7%), according to a
retrospective analysis from 1991 to 2006
presented at a poster session by Brian
Shuch (Department of Urology, David
Geffen School of Medicine, University
of California at Los Angeles, Los
Angeles, CA, USA).
Dr. Shuch said that central nervous
system (CNS) surveillance should be
routine in all patients with metastatic
RCC, especially those with clear-cell
histology, regardless of the presence
of symptoms.
Size, but not number of metastases, was
associated with CNS symptoms and risk
of craniotomy. Improved survival was
associated with ECOG performance
status and systemic therapy after CNS
treatment (i.e., craniotomy, stereotactic
radiosurgery or whole-brain radiation).
ECOG performance status was an
independent predictor of survival. The
number of lesions (>1) was an indepen-
dent predictor of CNS recurrence after
therapy; median CNS recurrence was
13 months in patients with one lesion
and four months in those with more
than one lesion.
The study was based on 138 patients
with metastatic RCC with brain metasta-
sis; 97 were male (70.3%), mean age at
cancer diagnosis was 57 years, mean age
at diagnosis of brain metastasis was 60
years, and 92.7% had clear-cell
histology. Nephrectomy was performed
in 120 patients (87%).
Only 87 patients (67.4%) had CNS
symptoms at the time of diagnosis of
brain metastasis. About one third
(31.9%) had more than one lesion. Size
of lesion was fairly evenly distributed:
<1 cm (28.6%), 1–2 cm (37%), and
>2 cm (34.5%).
Reference:Shuch B, et al. J Clin Oncol2008;26(Suppl.):Abstr. 5097.
4
NEW HOPE FOR PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA
(p < 0.0001), time to diagnosis less
than or more than one year (p < 0.0001),
haemoglobin level below lower limit of
normal (p < 0.0001), corrected calcium
level above or below 10 mg/dL
(p < 0.0001), and LDH above versus
below 1.5 times upper limit of normal
(p = 0.0006).
International open-label access trial
Phase II and III clinical trials of
sunitinib in metastatic renal-cell
carcinoma provide safety data on short-
term treatment in the first-line setting.
Assessment of long-term tolerability is
needed, especially since an
exposure–response analysis showed
that higher exposure (dose and
duration) of sunitinib was directly
related to greater efficacy [8].
At ASCO, a poster presentation
detailed short (<6 months) and longer-
term (�6 months) safety of sunitinib
in 4,622 patients enrolled in an
ongoing, international, open-label,
expanded-access trial as of December,
2007 [9]. Safety and efficacy data were
available for 4,185 patients (44% were
short-term and 56% were long-term).
The study, sponsored by Pfizer, Inc.,
was presented by Camillo Porta
(Medical Oncology, IRCCS San
Matteo University Hospital, Pavia,
Italy).
sunitinib-assigned patients were still on
treatment compared with 2% of those
on IFN-alfa. The most common reason
for drug discontinuation was
progressive disease (more than 60%;
about 20% withdrew for adverse
events).
Final overall survival was a median of
26.4 months for sunitinib and 21.8
months for IFN-alfa (p = 0.051;
Figure 1). When overall survival was
censored for the 25 patients who
crossed over to the sunitinib arm for
progressive disease, median overall
survival was 26.4 months versus 20.0
months respectively (p = 0.0362).
In the sunitinib arm, 182 patients
(56%) were on any post-study
treatment compared with 213 (59%) on
IFN-alfa. Thirty-six patients (11%) in
the sunitinib arm and 117 (33%) in the
IFN-alfa arm were on post-study
sunitinib. For patients not on any post-
study treatment, median overall
survival was 28.1 months in the
sunitinib arm and 14.1 months in the
IFN-alfa arm (p = 0.0033; Figure 2).
Prof. Figlin said that the benefits of
sunitinib were seen in all subgroups.
According to multivariate analysis,
factors significantly related to overall
survival (in addition to treatment with
sunitinib vs. IFN-alfa, p = 0.0096)
were ECOG 0 versus ECOG 1
Figure 2 OVERALL SURVIVAL IN PATIENTS WHO DID
NOT RECEIVE ANY POST-STUDY TREATMENT
Source: Figlin RA, et al. J Clin Oncol 2008;26(Suppl.):Abstr. 5024.
CI = confidence interval; NA = not available
Hazard ratio 0.647 (95% CI 0.482–0.870; log-rank p = 0.0033)
Sunitinib (n = 193). Median 28.1 months
(95% CI 19.5–NA)
IFN-alfa (n = 162). Median 14.1 months
(95% CI 9.7–21.1)
Time (months)
3 6 9 12 15 18 21 24 27 30 33 36| | | | | | | | | | | |
Surv
ival
pro
bab
ilit
y (
%)
100
90
80
70
60
50
40
30
20
10
0
AGE A PROGNOSTIC FACTORIN WOMEN WITH RENAL-CELLCARCINOMA
In women, but not men, age was an
independent risk factor of disease-
specific survival (DSS), with the risk of
renal-cell carcinoma (RCC)-specific
death increased by 1% for each
additional year of age. Women
presented with less advanced tumours
compared with men, leading to a
significant 19% reduced risk of RCC-
specific death compared with men
(p < 0.001). The gender-related survival
difference was greatest in people under
the age of 40 years (p = 0.0136),
intermediate in women aged 40–59
(p < 0.001), and the difference between
genders disappeared in patients over
age 60.
The international study was presented at
a poster session by Daniel J. George
(Duke Comprehensive Cancer Center,
Duke University, Durham, NC, USA).
The study population included 5,654
patients who underwent nephrectomy at
10 international academic centres; 3,777
(67%) were men and 1,877 (33%) were
women. Women generally presented
with significantly lower tumour stages
(p < 0.001), had distant metastases less
frequently (p < 0.001) and had lower-
grade tumours (p < 0.001); they were
more likely to have clear-cell histology
(87% vs. 82%, respectively) and less
likely to have papillary RCC (7% vs.
12%, respectively, p < 0.001, for both
comparisons with men).
The authors speculated that the role of
oestrogen in the development and
progression of RCC should be studied,
since age was a prognostic factor and
the difference in survival between men
and women was not associated with
tumour characteristics or ECOG
performance status. If a true oestrogen
effect on RCC does exists then the
potential for hormone-targeted therapy
in women will also need to be
investigated.
Reference: Pantuck AJ, et al. J Clin Oncol2008;26(Suppl.):Abstr. 5091.
5
NEW HOPE FOR PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA
Patients treated with sunitinib for a
longer period of time had a
comparative increase in the overall
incidence of treatment-related adverse
events, as would be expected, but no
new safety signals emerged in this
study. Fifty-six per cent of short-term
patients and 88% of long-term patients
reported any treatment-related adverse
event. Of those patients who
discontinued therapy, 89% of short-
term and 96% of long-term patients
reported any treatment-related adverse
events.
Importantly, no new or unexpected
long-term toxicities emerged, and no
increase in grade 3 or higher cardiac
disorders was reported with longer
exposure to the drug; the safety profile
of sunitinib in this diverse group of
unselected patients was similar to that
reported in phase II and III trials. Half
as many long-term patients
discontinued sunitinib treatment as
short-term patients, suggesting that
there is no cumulative toxicity
associated with the drug.
The authors said that patients were kept
on sunitinib for a longer period of time
by the liberal use of dosing adjustments,
which are possible because most
adverse events that occur on the drug
are manageable or reversible. Median
duration of sunitinib exposure for long-
term patients was approximately four
times as long as the duration of
treatment for short-term patients. Twice
as many long-term patients as short-
term patients experienced dose
reductions to 37.5 mg. Approximately
five to six times as many long-term
patients as short-term patients had their
dose reduced to 25 mg. Six per cent of
long-term patients versus 13% of short-
term patients discontinued treatment due
to adverse events.
The most common non-haematologic
grade 3 or 4 treatment-related adverse
events in ongoing patients were fatigue
(1% and 6% of short- and long-term
patients, respectively); hand–foot
syndrome (3% and 6%, respectively);
and diarrhoea (1% and 6%,
respectively). In discontinued patients,
the most common grade 3 or 4 non-
haematologic adverse events were
fatigue (9% of short-term and 8% of
long-term patients) and asthenia (6%
and 8%, respectively).
The most common grade 3 or 4
haematologic treatment-related adverse
events are seen in Table 1 and Table 2.
Table 1
Table 2
GRADE 3 OR 4 HAEMATOLOGIC TREATMENT-RELATED ADVERSE
EVENTS OCCURRING IN ��15% OF ONGOING PATIENTS
Source: Houk BE, et al. Data presented at the 99th Annual Meeting of the American Association for Cancer Research(AACR). San Diego, CA, USA, 2008 (Abstr. 5828).
Adverse event <6 months of sunitinib ��6 months of sunitinib
Thrombocytopenia 6 (4 %) 71 (7 %)
Neutropenia 6 (4 %) 80 (7 %)
GRADE 3 OR 4 HAEMATOLOGIC TREATMENT-RELATED ADVERSE
EVENTS OCCURRING IN ��15% OF DISCONTINUED PATIENTS
Adverse event <6 months of sunitinib ��6 months of sunitinib
Thrombocytopenia 120 (7%) 111 (9%)
Anaemia 52 (3%) 62 (5%)
Neutropenia 51 (3%) 105 (8%)
LONG-TERM SURVIVAL FOLLOWING NEPHRECTOMY
The number of years of survival
following nephrectomy is a strong
predictor of survival in patients with
renal-cell carcinoma (RCC) — the more
years out from nephrectomy, the better
the survival. The probability of survival
is related to the development of local
recurrence and metastasis, explained
Melissa A. Laudano (Columbia
University Medical Center, New York,
NY, USA) who presented this study at a
poster session.
The authors used the Columbia Clinical
Database of Urologic Oncology to
identify 1,114 partial and radical
nephrectomy patients treated for RCC
from 1998 to 2007. Conditional proba-
bilities were calculated for each year of
survival after surgery, adjusting for
variables such as age at surgery,
Fuhrman grade, pathologic stage,
tumour size, lymph node status, vascular
invasion and necrosis.
Landmark analysis showed that the
baseline probability of five-year survival
was 0.78. Conditional on surviving one
year post-surgery , the probability
increased to 0.81 and reached 0.96 for
those who survived four years. Disease-
specific survival increased from baseline
over the same time period from 0.87 to
0.90 at one, and 0.99 at four years.
Baseline 10-year survival was 0.54; after
one year of survival, the probability
increased to 0.56; after three years of
survival, to 0.63; and after seven years
of survival, to 0.78.
For patients who remained disease-free,
five-year survival ranged from 0.88 to
0.95 if patients survived one to four
years after nephrectomy, respectively.
With local recurrence, the five-year
survival ranges from 0.53 to 0.89 after
surviving from one to four years,
respectively. Of three patients who had
both metastasis and local recurrence,
none were alive at five years. The
authors concluded that determining
conditional survival estimates has
implications for counselling patients.
Reference: Laudano, MA. J Clin Oncol2008;26(Suppl.):Abstr. 5120.
6
NEW HOPE FOR PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA
References
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in 1995–1999: Results of the EUROCARE-4 study. Lancet Oncology 2007;8:773–783.
2. Wilking N, Jönsson B. A pan-European comparison regarding patient access to cancer drugs. Karolinska
Institute, Stockholm, Sweden, 2005.
3. Khayat D. Cost of cancer care in France: Toward a new regulation model. Data presented the 2007 Annual
Meeting of the American Society of Clinical Oncology (ASCO). Chicago, IL, USA, 2007.
4. Lam JS, et al. Evolving principles of surgical management and prognostic factors for outcome in renal cell
carcinoma. J Clin Oncol 2006;24:5565–5575.
5. Motzer RJ, et al. Sunitinib versus interferon alfa in metastic renal-cell carcinoma. N Engl J Med2007;356:115–124.
6. Figlin RA, et al. Overall survival with sunitinib versus interferon (IFN)-alfa as first-line treatment of
metastatic renal cell carcinoma (mRCC). J Clin Oncol 2008;26(Suppl.):Abstr. 5024.
7. Motzer RJ, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med2007;356:115–124.
8. Houk BE, et al. Comparative efficacy of sunitinib administered on an intermittent or a continuous daily
dosing schedule in metastatic renal cell carcinoma (mRCC) and gastrointestinal stromal tumor (GIST)
patients predicted using population PK approaches. Data presented at the 99th Annual Meeting of the
American Association for Cancer Research (AACR). San Diego, CA, USA, 2008 (Abstr. 5828).
9. Porta C, et al. Short- and long-term safety with sunitinib in an expanded access trial in metastatic renal cell
carcinoma (mRCC). J Clin Oncol 2008;26(Suppl.):Abstr. 5114.
NEW HOPE FOR PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA
7
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THYROID DYSFUNCTION APOTENTIAL MARKER FOREFFICACY OF SUNITINIB INRENAL-CELL CARCINOMA
Several studies have shown that thyroid
function test (TFT) abnormalities are
present in approximately two thirds of
patients with advanced renal-cell
carcinoma (RCC) while on sunitinib. A
prospective study presented at a poster
session by Pascal Wolter (Department of
General Medical Oncology, University
Hospital Gasthuisberg, Catholic
University Leuven, Belgium) suggests
that TFT may be a marker for efficacy of
the drug in patients with RCC.
The study evaluated thyroid function
prospectively in 53 patients with
advanced RCC carcinoma who were
taking sunitinib at a daily oral dose of
50 mg for four weeks on, two weeks off
(one cycle); patients were evaluated on
day 1 and day 28 of each cycle. Thyroid
function was evaluable in 40 patients
(30 males, with a median age of 59).
Twenty-eight of 40 patients (70%)
developed TFT abnormalities. Median
progression-free survival was 3.6
months in those with no TFT abnor-
malities versus 10.3 months when bio-
chemical TFT abnormalities were
identified. Median overall survival was
6.6 months when there were no TFT
abnormalities and 18.2 months when
TFT abnormalities were present.
Understanding the biology and etiology
of sunitinib-induced thyroid dysfunction
and clinical outcome should be studied
further, the authors stated. These studies
will help define the role of thyroid
dysfunction as a surrogate marker for
efficacy of sunitinib in patients with
advanced RCC.
Reference: Wolter P, et al. J Clin Oncol2008;26(Suppl.):Abstr. 5126.