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

1. Berrino F, et al. Survival for eight major cancers and all cancers combined for European adults diagnosed

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.