DiagnosticsLandmark Kidney Cancer Data Published By The Journal Of Clinical Oncology
Results from a landmark study published by the Journal
of Clinical Oncology (JCO) show that treatment with Sutent® (sunitinib) achieved a median
overall survival greater than two years in patients with metastatic renal cell carcinoma (mRCC),
commonly known as advanced kidney cancer.1 The publication of this important data in the JCO
reinforces the strength of sunitinib"s clinical benefits and further supports final guidance
published by the National Institute for Health and Clinical Excellence (NICE) in March this year,
which recommends the use of sunitinib for the first-line treatment of advanced kidney cancer.
Sunitinib is the only oral treatment to show median overall survival greater than two years in
advanced kidney cancer patients.
"These data herald a new era in the treatment of metastatic kidney cancer in this country and
throughout the world," commented Professor John Wagstaff, Professor and Honorary Consultant
in Medical Oncology, South Wales Cancer Institute, Swansea and Director of the Wales Cancer
Trials Network. He continued, "With the dawn of new life-extending treatments such as sunitinib,
we are now able to give patients with this difficult-to-treat cancer more hope for the future."
Results of this study show median overall survival for patients who received sunitinib vs
interferon-alpha (IFN-í±) was 26.4 months vs. 21.8 months respectively (p=0.051). However, an
exploratory analysis of patients who received only one line of treatment (i.e. no subsequent
treatments after stopping their sunitinib or IFN-í± therapies) showed that sunitinib almost doubled
the median overall survival compared to IFN-í± (28.1 months vs 14.1, HR = 0.647 (p=0.003, logrank))
1. This is a reflection of clinical practice in the UK where generally patients are only funded
for one line of treatment at most.
Until recently, treatment options were mostly limited to IFN-í±, the current NHS funded standard
of care. It is estimated that more than 7,000 people are diagnosed with kidney cancer in the UK
each year and approximately 3,600 people die from the disease.2
Before NICE guidance only a third (33%) of PCTs (primary care trusts) were funding sunitinib to
some extent. Since the guidelines were published 90% of PCTs have committed to full funding
of sunitinib in accordance with NICE guidance. Across Western Europe eligible patients with
advanced kidney cancer are routinely prescribed sunitinib, where it is now recognised as a
standard of care.3
Sunitinib, an oral medicine, received marketing authorisation in July 2006 and was approved as
a first-line treatment for mRCC in January 2007. It is a novel addition to a new class of "multitargeted"
anti-cancer drugs. It targets the tumour with a dual action approach, by stopping the
cancer cells from multiplying and also cutting off the tumour"s blood supply.
Sunitnib for the treatment of GIST
Sunitinib is also indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal
stromal tumour (GIST) after failure of imatinib mesylate. Updated results from the sunitinib phase III study
in GIST patients who failed on imatinib therapy showed a greater than fourfold increase in time to
progression (TTP) in sunitinib patients (27.3 weeks) compared with those treated with placebo (6.4
weeks).4 Sunitinib treatment yielded significant improvement in survival rates versus placebo at three and
six months although with 88% of patients in the placebo arm ultimately crossing over to sunitinib, the
overall survival was similar between groups.5
Currently, sunitinib is licensed for the first and second line treatment of mRCC and the second-line
treatment of GIST
About Sunitinib
Sunitinib is a novel, oral, multi-targeted cancer therapy that selectively targets multiple receptor tyrosine
kinases (RTKs) involved in tumour growth, angiogenesis and the progression of cancer. By inhibiting
these RTKs, sunitinib targets multiple signaling pathways resulting in a dual action anti-proliferative and
anti-angiogenic effect, which may lead to tumour regression and disease stabilisation.
The recommended starting dose for sunitinib is 50mg once daily for four weeks followed by two weeks off.
The dose can be modified in 12.5mg increments not to exceed 75mg or decrease below 25mg. Sunitinib is
available in 12.5 mg, 25mg, and 50mg capsules. Please refer to the Summary of Product Characteristics
(SPC) for additional dosing recommendations regarding co-administration with cytochrome 3A4 inducers
or inhibitors.
In 2007, Pfizer cut the price of sunitinib by five per cent and committed to providing one cycle/course of the
treatment free of charge to every eligible patient in the UK, in an effort to increase patient access. This
move amounts to an average saving of between 19 per cent and 29 per cent per patient for the cost of treatment, depending upon the type and stage of their tumour. The average annual cost for a patient
taking sunitinib is á£24,168.
Adverse events (AEs) were generally mild to moderate. Most adverse events were reversible, and
generally did not result in discontinuation. In clinical trials, the most common treatment related adverse
events (>20%) included fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis,
dyspepsia, and vomiting; skin discolouration; dysgeusia (loss of taste); and anorexia. Fatigue,
hypertension and neutropenia were the most common grade 3 treatment related adverse events.
Increased lipase (2%) was the most common grade 4 treatment related adverse event. Hepatitis and
hepatic failure occurred in About Pfizer
Pfizer Inc, the world"s largest research-based pharmaceutical company, discovers, develops,
manufactures and markets prescription medicines in 11 therapeutic areas including oncology,
cardiovascular, pain, neuroscience and infectious diseases, including HIV/AIDS. Pfizer is also the world"s
largest animal health company.
Pfizer Inc employs approximately 90,000 colleagues worldwide, all of whom are devoted to working for a
healthier world. Pfizer conducts more biomedical research than any other organisation, and has 12,000
professionals working in six major R&D sites worldwide, including Sandwich in Kent. Pfizer"s annual UK
R&D investment is more than á£550 million - more than á£10 million a week.
In the UK, Pfizer has its European R&D headquarters at Sandwich and its UK business headquarters in
Surrey, and is the major supplier of medicines to the NHS.
References
1. Journal of Clinical Oncology http://jco.ascopubs.org/ Accessed 18 May 2009
2. Cancer Research UK. Available here. Accessed 14
May 2008.
3. Ljungberg B, Hanbury D.C, Kuczyk A.S, et al. Guidelines on Renal Cell Carcinoma. European Association of
Urology 2007 (Page 22)
4. Dmitri GD et al. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure
of imatinib: a randomised controlled trial. Lancet 2006; 368: 1329-1338.
5. Demitri GD et al. Novel statistical analysis of long-term survival to account for cross over in a phase III trial of
sunitinib vs. placebo in advanced GIST after imatinib failure. Presented at ASCO in 2008.
Pfizer Oncology