Sutent
From Kidney Cancer Resource
Overview
Sutent is also known as (sunitinib)
Pfizer the manufacturer of Sunitinib interchange the name with Sutent in the public domain for marketing. As do Bayer who similarly interchange their equivalent cancer drug Sorafenib with the name Nexavar.
To view Pfizer's web site for Sutent Click Here
To view Pfizer's Web Site Click Here
To view Pfizer's Health Care Professionals' web site for Sutent Click Here
To view Pfizer's Health Care Professionals' web site on the efficacy of Sutent for RCC Click Here
A first-line treatment for Kidney Cancer Sutent is one of Pfizer's more expensive drugs.
Sutent is an alternative to the current form of immunotherapy ( Interferon-Alpha) available, but trials have shown that it is more effective. Sutent can shrink tumours by as much as 30%, whereas Interferon Alpha is only associated with a 6% shrinkage
You can find all the up to date information and data on Sutent at Pfizer's site.
If you wish to view Pfizer's Web Site Click Here & enter either Renal or Sutent in the Search Box.
OR
Sutent is a medicine that treats cancer. It comes in 12.5-mg, 25-mg, and 50-mg capsules. You take Sutent once per day by mouth. Do not open the capsules.
Sutent is used to treat an advanced form of Kidney Cancer, known as renal cell carcinoma (RCC). Sutentmay slow or stop the growth of cancer. It may also help shrink Tumours.
Sutentis available by prescription only. Your doctor has prescribed Sutent because he or she believes it is the most appropriate treatment for you. Sutent may not be appropriate for all patients with RCC and has not been studied in children. Sutent may not work the same in every person.
OR
To go direct to the page Click Here
When was it licensed
Sutent was licensed for use as a first-line treatment in January 2007, and as a second-line treatment in July 2006
UK Status
When will it be appraised by NICE: No date set
How many patients in Wales could benefit: Approximately 300
Cost: £2,000 per patient per month (approx.)
To view articles relevant to Kidney Cancer & the status of Sutent in Scotland as at 09-Jul-2007 Click Here
There is an Early Day Motion #1050 lodged in the House of Commons by an MP regarding Sutent
South Central Priorities Committees
- (Berkshire PCTs)
Interim Policy Statement 118:
Sunitinib for first or second line treatment of metastatic/advanced renal cell cancer
Ref TV120
Date of Issue: January 2008
The South Central Priorities Committees recommend that Sunitinib for first or second line treatment of metastatic/advanced renal cell cancer is a LOW PRIORITY due to limited evidence of clinical effectiveness and lack of evidence of cost-effectiveness.
There are around 300 new renal cell cancers diagnosed per year in South Central.
Around 65% (i.e. 195 patients) will either present with or eventually progress to metastatic/advanced RCC.
Median survival for advanced/metastatic disease is only 6-12 months.
2 year survival is 10-20% and 5 year survival 10%. Previously, treatment options for advanced disease have been limited.
Immunotherapy with interferon alpha or interleukin 2 has a low response rate and is poorly tolerated.
Summary
One ongoing RCT comparing Sunitinib with interferon in first line treatment has published interim analysis in January 2007.
Data so far show Sunitinib achieved longer progression free survival than interferon (11 months vs 4 months) and although more patients responded to Sunitinib than Interferon, this was still only a 30% response rate.
However, South Central Priorities Committees noted that Sunitinib has not yet been shown to increase overall survival.
Two uncontrolled trials have shown sunitinib to be active in second line use in patients who had progressed after interferon.
42% of patients responded, median progression free survival (PFS) was 8 months.
However, as there was no control group, the progression free survival advantage due to Sunitinib cannot be quantified, nor can its effects on overall survival.
There are no published studies of cost-effectiveness.
The modelling carried out by the manufacturers for submission to Scottish Medicines Consortium, and funding bodies in Canada and Australia led these bodies to conclude that it was not cost effective.
The South Central Priorities Support Unit noted that this modeling was not available for PCTs to evaluate.
NICE Guidance is expected in January 2009.
NOTES:
1. Exceptional circumstances may be considered where there is evidence of significant health impairment and there is also evidence of the intervention improving health status. 2. This policy will be reviewed in the light of new evidence or guidance from NICE. 3. Berkshire Priorities Committee policy statements and minutes can be viewed at www.berkshire.nhs.uk/priorities
Detail from Click Here
Further General Data
NetDoctor on Sutent
- Broad Overview Data of Sutent
Articles
South Wales Argus (KC) 06-Oct-08-02
- Website founders give support
South Wales Argus (KC) 06-Oct-08
South Wales Argus (KC) 24-Sep-08
- Grandad's fight for cancer drug
HEATON-HARRIS, Chris 26-Aug-08
- PRESS RELEASE - Chris HEATON-HARRIS MEP continued support....
DAVIES, David (KC) 26-Aug-08
- PRESS RELEASE - David T.C. DAVIES MP (Monmouthshire) continued support....
Yours Magazine (KC) 26-Aug-08
- The Living Nightmare 'I'm not ready to die'....
BBC (KC) 26-Aug-08
The Times (KC) 26-Aug-08
James Whale Press Release 25-Aug-08
- James Whale Press Release....
Echo (KC) 26-Aug-08
- Backlash over axe for specialist drugs cash....
Oxford Mail (KC) 26-Aug-08
- Doctors back cancer drug protest....
Renal & Urology News (KC) 25-Aug-08
- Difficult RCC Cases Respond to New Drug....
Telegraph (KC) 25-Aug-08
- Senior doctor accuses Government of destroying NHS....
The Guardian (KC) 25-Aug-08
- Specialists question decision not to fund drugs for kidney cancer....
LINDER MYERS SOLICITORS 24-Aug-08 Press Release
- Kidney Cancer Jean Murphy - press release....
BBC (KC) 24-Aug-08
- Experts in drug 'ration' warning....
Sunday Times (KC) 24-Aug-08
- Cancer drugs due a review....
BBC (KC) 24-Aug-08
- Experts in drug 'ration' warning
Belfast Telegraph (KC) 12-Aug-08
- NHS should not save lives if it costs too much: watchdog
MedicalNewsToday (KC) 10-Aug-08
The Times (KC) 08-Aug-08
Swansea Evening Post (KC) 08-Aug-08
- 'HOW CAN THEY PUT A PRICE ON LIFE?'
The Times (KC) 07-Aug-08 / 01
- Case Study: ‘After three tablets, my tumour shrank’
Bristol Evening Post (KC) 07-Aug-08
- NHS advised not to fund kidney cancer drugs
The Times (KC) 07-Aug-08
- £35,000-a-year kidney cancer drugs too costly for NHS
BBC (KC) 07-Aug-08
Daily Mail KC 07-Aug-08-02
- Nasty truth about NICE: It's the body that rations NHS drugs. But this leading cancer specialist says its decisions are deeply flawed
Daily Mail (KC) 07-Aug-08
The Sun (KC) 07-Aug-08
- 4 kidney cancer drugs are axed
Telegraph(KC) 06-Aug-08
- This drug Sutent has let me live to see my grandchildren born....
Telegraph (KC) 06-Aug-08 /02
MEN - TV (KC) 06-Aug-08
- Jean Murphy has an anonymous benefactor who is paying for her Sutent....
Daily Mail (KC) 06-Aug-08
- Cancer victim denied life-prolonging drug Sutent on NHS is given hope with £10,000 anonymous donation
Telegraph (KC) 05-Aug-08
Manchester Evening News (KC) 05-Aug-08
- Mystery donor to gran's rescue with Sutent....
Witney Gazette (KC) 04-Aug-08
Daily Mail (KC) 01-Aug-08
- 'CONDEMNED TO DIE' BY NHS
BBC (KC) 31-Jul-08
- Man in cancer drug health threat
Telegraph (KC) 30-Jul-08
- Retired nurse's former employer denies her life saving cancer drug Sutent
Bristol Evening Post (KC) 26-Jul-08/02
- EDITORIAL: For reasons known only to the government the NHS has become a platform for INequality.
Bristol Evening Post (KC) 26-Jul-08
Telegraph (KC) 13-Jul-08
- Tens of thousands of cancer victims denied drugs which could extend their lives
Salford Advertiser (KC) 11-Jul-08
- Jean Murphy loses cancer drug battle for Sutent despite The High Court!
Norwich Evening News (KC) 11-Jul-08
- Mother Gail Balding loses cancer drug appeal for Sutent again
Salford Advertiser (KC) 03-Jul-08
- Crunch time for Jean as courts decide her fate
Bristol Evening Post (KC) 03-Jul-08
Bristol Evening Post (KC) 02-Jul-08
Telegraph (KC) 24-Jun-08
The Times (KC) 15-Jun-08
The Mirror (KC) 09-Jun-08
- Boob jobs put before cancer cases
Norwich Evening News (KC) 09-Jun-08
- Mum still being denied cancer drug Sutent
Kidney Cancer Sufferer Meets MP at Parliament 02-Jun-08
- David Blackett Kidney Cancer Care Fund Cycles for Sutent from Norfolk to Westminster
UroToday (KC) 02-Jun-08
- Pfizer Presents Overall Survival Data for Sutent™ Versus Interferon-Alfa
Daily Mail (KC) 01-Jun-08
- New drug gives thousands of kidney cancer sufferers new hope at £2,000 a month
CNW Group (KC) 30-May-08
- Side Effects of Sunitinib in Kidney Cancer are 2 to 3 Times More Expensive to Manage Than Those of Avastin Plus Interferon
Salford Advertiser (KC) 15-May-08
- Hundreds back Jean's fight....
Diss Mercury (KC) 23-May-08
- Friends of David Blackett denied Sutent on their bikes to boost charity....
Salford Advertiser (KC) 08-May-08
- Campaign for drug steps up
Salford Advertiser (KC) 01-May-08
- My agony of cancer drug fund refusal....
Eastbourne Herald (KC) 29-Apr-08
- A terminally ill man took his life after being refused medication from the Primary Care Trust.
The Northern Echo (KC) 16-Apr-08
- Fighting corner of people denied time-giving drugs
Forbes 13-Apr-08
Fight For Life Announcement 31-Jan-08
- Sutent Blister Packs
Norwich Evening News (KC) 17-Nov-2007
- My wife is being denied vital drug
29-Jul-2006 - Description from Pub. Meds.
Sunitinib malate for the treatment of metastatic renal cell carcinoma and gastrointestinal stromal Tumours.Adams VR, Leggas M.
Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, Kentucky 40536, USA. vadam0@email.uky.edu
BACKGROUND: Sunitinib was approved by the US Food and Drug Administration (F&DA) on January 26, 2006, for the treatment of metastatic renal cell carcinoma (mRCC) and gastrointestinal stromal tumor (GIST) in patients who have failed to respond to imatinib or were unable to tolerate it. OBJECTIVE: This article reviews the pharmacology, pharmacokinetics, and pharmacodynamics of sunitinib; potential drug interactions; and the results of clinical trials evaluating its efficacy and tolerability.
METHODS: Pertinent literature was identified by searches of MEDLINE (1966-January 31, 2007), the American Society of Clinical Oncology abstracts database (2000-2007 annual meetings/symposia and previous meetings), and the FDA Web site (October 2006). Search terms included, but were not limited to, sunitinib, SUl1248, renal cell carcinoma, gastrointestinal stromal tumor, pharmacology, pharmacokinetic, adverse events, and clinical trial. Additional publications were found by scanning the reference lists of the identified articles.
RESULTS: Sunitinib is a potent inhibitor of multiple tyrosine kinase receptors. Its Tmax is reached within 6 to 12 hours, and food does not appear to affect its bioavailability. Sunitinib is metabolized by cytochrome P450 (CYP) 3A4 to an active metabolite, SU12662, which is further metabolized by CYP3A4 to an inactive moiety. The parent compound and active metabolite have similar biochemical activity and potency and reach similar plasma concentrations. Sunitinib and SU12662 have a tl/2 of 40 to 60 hours and 80 to 110 hours, respectively. Steady-state concentrations of both active entities are reached after 10 to 14 days of therapy.
In a Phase III trial comparing sunitinib with interferon-alfa (IFN-00 as first-line therapy for mRCC, sunitinib was associated with a median progression-free survival of 11 months, compared with 5 months with IFN-cz (P < 0.001). A randomized, double-blind, placebo-controlled trial evaluating sunitinib as second-line therapy for GIST found a median time to progression of 28.9 weeks in the sunitinib arm, compared with 7 weeks in the placebo arm (hazard ratio = 0.28; P < 0.001).
In Phase II trials, sunitinib also had anti-tumor activity in patients with breast cancer, neuroendocrine tumors, and non-small cell lung cancer. Further evaluation in these tumors, as well as in patients with acute myelogenous leukemia, may lead to expanded indications.
The approved dose of sunitinib is 50 mg/d PO for 4 weeks, followed by a 2-week rest; this pattern is repeated until tumor progression or the occurrence of intolerable adverse effects.
The most common clinical toxicities attributable to sunitinib include diarrhea, mucositis/stomatitis, hypertension, rash, skin discoloration, and altered taste, whereas commonly occurring laboratory abnormalities have been seen in association with gastrointestinal toxicity, renal toxicity, and hematologic toxicity.
Of grade 3/4 toxicities occurring with sunitinib (which are relatively uncommon [<10%]), those that are clinically important include hypertension, diarrhea, fatigue, and hand-foot syndrome.
CONCLUSIONS: Sunitinib is a multiple tyrosine kinase receptor inhibitor approved for the treatment of mRCC and GIST. Evidence for long-term clinical benefit in renal cell cancer and other tumors awaits the results of ongoing trials.
To view the original of this article Click Here
Nov-Dec-2006 - Description from Pub. Meds.
Urol Oncol. 2006 Nov-Dec;24(6):553-4.
Sunitinib: in patients with metastatic renal cell carcinoma Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY.Blute ML.
CONTEXT: Current treatment options for metastatic renal cell carcinoma (RCC) are limited and there is a need to identify novel and effective therapies. Sunitinib malate is an oral multitargeted tyrosine kinase inhibitor, which has shown activity in an initial study of cytokine-refractory metastatic RCC patients.
OBJECTIVE: To confirm the antitumor efficacy of sunitinib as second-line treatment in patients with metastatic clear-cell RCC, the predominant cell type of this malignancy.
DESIGN, SETTING, AND PATIENTS: Open-label, single-arm, multicenter clinical trial. Patients were enrolled between February and November 2004, with follow-up continuing until disease progression, unacceptable toxicity, or withdrawal of consent. The reported data apply through August 2005. Patients (N = 106) had metastatic clear-cell RCC, which had progressed despite previous cytokine therapy.
INTERVENTION: Repeated 6-week cycles of sunitinib, 50 mg per day given orally for 4 consecutive weeks followed by 2 weeks off per treatment cycle.
MAIN OUTCOME MEASURES: Assessment of clinical response, degree of tumor regression on imaging studies using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Primary end point was overall objective response rate (complete plus partial). Secondary end points were progression-free survival and safety. Response was evaluated by independent third-party core imaging laboratory and by treating physicians (investigator assessment).
RESULTS: All 106 patients received sunitinib and were included in the intent-to-treat population for safety analyses. Of these, 105 patients were evaluable for efficacy analyses. The objective response rate according to an independent third-party assessment resulted in 36 patients with partial response (34%; 95% confidence interval, 25%-44%), and a median progression-free survival of 8.3 months (95% confidence interval, 7.8-14.5 months). The most common adverse events experienced by patients were fatigue in 30 (28%) and diarrhea 21 (20%). Neutropenia, elevation of lipase, and anemia were the most common laboratory abnormalities observed in 45 (42%), 30 (28%), and 27 (26%) patients, respectively. C
CONCLUSION: The results of this trial demonstrate the efficacy and manageable adverse-event profile of sunitinib as a single agent in second-line therapy for patients with cytokine-refractory metastatic clear-cell RCC.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00077974.
PMID: 17138136 [PubMed - in process]
To view the original of this article Click Here
Anyone with experience of using/taking Sunitinib or knows of UK Trials, usage, availability and efficacy can they please post their experiences as a new Comment in this section.
Side Effects
CAVEAT
Not everyone gets side effects from Sutent and those who do may only experience a slight side effect in one aspect or more - we merely pass on tips we have received from various patients who did experience a side effect.
Tiredness
This is a common side effect of any powefull drug such as this.
It's worth taking a look at this link
Hands &/or Feet soreness
Reflux
Mouth & Throat Soreness
Yellow Skin
This can occur after about a week of using Sutent and can occur in about 1/3rd of users. It usually goes away, however as it can be a sign of other things it would be worth taking medical advice from your doctor.
Personal Experiences
Sutent - 12 days into 2nd. Cycle
- A brief personal review of Sutent....
Sutent - After 6 Cycles
- A brief personal review & Video Clip....
Sutent - After 8 Cycles
- A brief personal review....
Sutent Trials
To view the listing of Click Here
References
Disclaimer
Kidney Cancer Resource (KCR) is not influenced by sponsors. The information contained herein is not intended as a substitute for the advice of an appropriately qualified and licensed physician or other licensed health care provider. The information provided here is for educational and information purposes only. Early accurate Diagnosis (Dx.) saves lives. Please check with a physician if you suspect you are ill, never ignore Symptoms. To help your health care specialist make an accurate Diagnosis please keep notes of dates, times and details of your Symptoms. We are not offering medical advice nor do we consider links, individuals or articles accessed through this site to be offering medical advice.
E&OE - Errors & Omissions Excepted
As much of the information posted on this Web Site for peoples convenience is of a medical or technical nature, and may be a matter of life or death the E&OE is a Disclaimer showing that to the best of our ability information is accurate and correctly written or transcribed. Before acting on information on this site you are responsible for checking it with your relevant medical team. We can not be held responsible for any Errors & Omissions made; nor for information on links and articles provided in good faith.
