National Horizon Scanning Centre. Sunitinib (Sutent) for advanced and/or metastatic breast cancer. December 2007
|
|
- Hugh Little
- 5 years ago
- Views:
Transcription
1 Sunitinib (Sutent) for advanced and/or metastatic breast cancer December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes. The Research Programme is part of the National Institute for Health Research
2 Sunitinib (Sutent) for advanced and/or metastatic breast cancer Target group: Breast cancer - advanced and/or metastatic: o First line in combination with paclitaxel/docetaxel o Second line monotherapy o Second line in combination with capecitabine after failure of taxanes and anthracyclines due to resistance or intolerance. Technology description Sunitinib malate (Sutent, SU11248) is an oral multi-targeted tyrosine kinase inhibitor with anti-tumour and anti-angiogenic activity in development for first and second line treatment of advanced and/or metastatic breast cancer. Sunitinib inhibits the plateletderived growth factor (PDGF), vascular endothelial growth factor (VEGF), KIT and FLT3 receptors on cancer cells, vascular endothelial cells and pericytes. Sunitinib is administered orally in a six week cycle; 50mg per day for four weeks, followed by a break of two weeks before repeating the cycle until disease progression. Trials are also investigating a continuous dose of 37.5mg. Sunitinib (Sutent) is currently licensed for the treatment of: advanced and/or metastatic renal cell carcinoma. unresectable and/or metastatic malignant gastro-intestinal stromal tumours (GIST) after failure of imatinib mesylate due to resistance or intolerance. Sunitinib is currently in phase II trials for neoadjuvant treatment of newly diagnosed resectable stage II-IIIA breast cancer as a monotherapy and in combination with chemotherapy in stage II-IIIB breast cancer. Sunitinib is also in phase III trials for nonsmall cell lung cancer, and metastatic colorectal cancer refractory to 5FU, irinotecan and oxaliplatin. Innovation and/or advantages Sunitinib may increase response rates and progression free survival in patients with metastatic breast cancer. It will add another treatment option for patients with advanced disease, and as an oral treatment, it may be possible to manage patients on an outpatient basis if used as a monotherapy. Developer Pfizer Ltd. Place of use Home care e.g. home dialysis Secondary care e.g. general, non-specialist hospital General public e.g. over the counter Community or residential care e.g. district nurses, physio Tertiary care e.g. highly specialist services or hospital Other: Primary care e.g. used by GPs or practice nurses Emergency care e.g. paramedic services, trauma care Availability, launch or marketing dates, and licensing plans: Suntinib is in phase III clinical trials for first and second line advanced and/or metastatic breast cancer. 2
3 NHS or Government priority area: This topic is relevant to the NHS Cancer Plan Relevant guidance NICE clinical guidelines in progress (due January 2009): o Advanced breast cancer diagnosis and treatment o Early breast cancer diagnosis and treatment SIGN clinical guideline. Management of breast cancer in women, NICE cancer service guidance - Improving outcomes in breast cancer, NICE Technology Appraisals Advanced breast cancer: trastuzumab ( ), taxanes (docetaxel and paclitaxel, ), vinorelbine ( ), gemcitabine ( ) and capecitabine ( ). Early stage breast cancer: adjuvant hormonal therapies ( ), and for adjuvant treatment - trastuzumab ( ), docetaxel ( ) and paclitaxel ( ). Clinical need and burden of disease Breast cancer is the most common malignancy affecting women in the UK. There were 39,301 women newly diagnosed with breast cancer in England and Wales during and in 2005 there were 10,969 deaths, a rate of 40 deaths per 100,000 females 13. Advanced and metastatic breast cancer are defined by clinical staging based on the tumour, node and metastasis staging system, falling within stage III and stage IV. Between 16% and 20% of women (an estimated 6,288 to 7,860 women) presenting with breast cancer have advanced disease with distant metastases 3, and in 2002 NICE estimated that around 50% of those presenting with early or localised breast cancer will eventually develop metastatic breast cancer 3. Existing comparators and treatments The role of current treatments for advanced and metastatic breast cancer is to palliate symptoms, prolong survival and maintain a good quality of life. The choice of treatment is based on previous therapy, oestrogen receptor status, HER2 status and the extent of the disease. Current options include: First line systemic therapy for oestrogen receptor-negative disease is chemotherapy (usually an anthracycline based regimen a or a combination of cyclophosphamide, methotrexate and fluorouracil). Hormone manipulation therapy for oestrogen receptor positive tumours. Following disease progression on an anthracycline, other chemotherapy options include single-agent taxanes, capecitabine (in combination with docetaxel or as monotherapy), bevacizumab (in combination with paclitaxel), vinorelbine and gemcitabine in combination with paclitaxel. Trastuzumab in combination with taxanes is given to those with HER2+ metastatic disease. It may also be given on its own in women with advanced breast cancer who have already received at least two courses of chemotherapy 14. a Anthracycline based regimens include AC (doxorubicin and cyclophosphamide), EC (epirubicin and cyclophosphamide), CAF (cyclophosphamide, doxorubicin and fluorouracil), FEC (fluorouracil, epirubicin and cyclophosphamide) 3
4 Efficacy and safety One phase I conference abstract 15 has reported on the use of sunitinib in combination with paclitaxel for first-line treatment of metastatic breast cancer. There are several ongoing phase II trials of sunitinib as either a monotherapy, or in combination for first and second line treatment of metastatic breast cancer: First line in combination with bevacizumab and paclitaxel (SABRE-B trial) Second line in combination with trastuzumab Second line monotherapy in triple receptor negative disease Consolidation therapy after response to taxanes Trial name or code Second line monotherapy - phase II 16 SUN 1094: First line in combination: sunitinib + paclitaxel vs. bevacizumab + paclitaxel phase III 17 SUN 1064: First line in combination: sunitninib + docetaxel vs. docetaxel phase III 18 Sponsor Pfizer Pfizer Pfizer Status Conference abstract Ongoing Ongoing Location USA USA USA, Europe (incl UK) Design Open-label, single-arm. Randomised, open-label, active-control. Randomised, open-label, active-control. Participants in trial n=64; anthracycline and taxane refractory metastatic breast cancer. Received Sunitinib 50mg daily for 4 weeks in repeating 6 week cycles. n=740 (planned); no prior chemotherapy for advanced disease. Randomised to sunitinib once daily and paclitaxel i.v. once weekly for 3 out of 4 weeks; or bevacizumab i.v. once every 2 weeks and paclitaxel (as above). n=550; no prior chemotherapy for advanced disease. Administered in 3 week cycles, randomised to: Arm A - docetaxel i.v. on day 1, sunitinib on day 2-15, no treatment days 16-21, or Arm B - docetaxel on day 1 every 3 weeks. Follow-up Until disease progression. Until disease progression. Until disease progression. Primary Objective response rate Progression free survival PFS outcome Secondary outcomes Safety Key results Interim analysis on 51 patients: partial response = 7 (14%); stable disease >6 months = 1 (2%). Expected reporting date Adverse effects (PFS) Safety; tumour control; survival; patient reported outcomes Not known. Study commenced November Grade 3 adverse events included neutropenia (39%), anaemia (2%), thrombocytopenia (15%), fatigue (5%), diarrhoea (7%), hand-foot syndrome (7%) and hypertension (5%). Dose reductions required in 17%. - - Overall response rate; duration of response; overall survival; patient reported outcomes; safety. Not known. Study commenced February
5 Trial name or code SUN 1107: Second line monotherapy: Sunitinib vs. capecitabine phase III 19 SUN 1099: Second line in combination: Sunitinib + capecitabine vs. capecitabine phase III 20 Sponsor Pfizer Pfizer Status Ongoing Ongoing Location Europe, Australia USA, Europe (incl UK) Design Randomised, open-label, active-control. Randomised, open-label, active control. Participants in trial n=700 (planned); anthracycline and taxane refractory. Administered as a 37.5mg continuous dose. n=430 (planned); anthracycline and taxane refractory. Administered as a 37.5mg continuous dose. Follow-up Until disease progression. Until disease progression. Primary PFS. PFS. outcome Secondary outcomes Expected reporting Time to tumour progression, overall response rate, duration of response, overall survival, patient reported outcomes, safety. Not known. Study commenced November Overall response rate; duration of response; overall survival; 2 and 3 yr survival; patient reported outcomes; overall safety profile. Not known. Study commenced February Estimated cost and cost impact The cost of sunitinib is estimated at approximately 3,140 per six-week cycle, giving an annual cost (based on 8 cycles) of around 25,110 per patient b. At a continuous dose of 37.5mg, the annual cost would be approximately 32,300 per patient. This cost would be in addition to current chemotherapy if used in combination, but as an oral monotherapy, there is the potential for savings through outpatient treatment. Potential or intended impact speculative Patients Reduced morbidity Quicker, earlier or more accurate diagnosis or identification of disease Reduced mortality or increased survival Other: Improved quality of life for patients and/or carers Non identified Services Increased use Service reorganisation required Staff or training required Decreased use: oral administration Other: Non identified Costs Increased unit cost compared to alternative: Additional therapy New costs: Increased costs: more patients coming for treatment Savings: oral monotherapy may enable outpatient use. Increased costs: capital investment needed Other: b Costs from BNF 54, September
6 References 1 Management of breast cancer in women. Scottish Intercollegiate Guideline Network. Guideline 84, December Improving outcomes in breast cancer. Cancer service guidance. National Institute for Health and Clinical Excellence. August National Institute for Health and Clinical Excellence. Guidance on the use of trastuzumab for advanced breast cancer: The clinical effectiveness and cost effectiveness of trastuzumab for breast cancer, March 2002; Technology Appraisal Guidance number National Institute for Health and Clinical Excellence. Guidance on the use of taxanes for advanced breast cancer: Taxanes for the treatment of breast cancer, September 2001; Technology Appraisal Guidance number National Institute for Health and Clinical Excellence. Guidance on the use of vinorelbine for advanced breast cancer: The clinical effectiveness and cost effectiveness of vinorelbine for breast cancer, December 2002; Technology Appraisal Guidance number National Institute for Health and Clinical Excellence. Gemcitabine for the treatment of metastatic breast cancer, January Technology Appraisal Guidance number National Institute for Health and Clinical Excellence. Guidance on the use of capecitabine for advanced breast cancer: The clinical effectiveness and cost effectiveness of capecitabine for breast cancer, May 2003; Technology Appraisal Guidance number National Institute for Health and Clinical Excellence. Guidance on the use of hormonal treatments for early stage breast cancer: Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer, November 2006, Technology Appraisal Guidance number National Institute for Health and Clinical Excellence. Guidance on the use of trastuzumab for early-stage breast cancer: Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer, August 2006; Technology Appraisal Guidance number National Institute for Health and Clinical Excellence. Docetaxel for the adjuvant treatment of early nodepositive breast cancer, September Technology Appraisal Guidance number National Institute for Health and Clinical Excellence. Paclitaxel for the adjuvant treatment of early nodepositive breast cancer, September Technology Appraisal Guidance number Cancer Research UK. UK breast cancer incidence statistics. Accessed 15/11/2007. Available online at: Hhttp://info.cancerresearchuk.org/cancerstats/types/breast/incidence/H. 13 Cancer Research UK. UK breast cancer mortality statistics. Accessed 15/11/2007. Available online at: Hhttp://info.cancerresearchuk.org/cancerstats/types/breast/mortality/H. 14 Cancerbackup. Accessed 15/11/2007. Hhttp:// 15 Kozloff MF, Chuang E, Roy J et al. Preliminary results of a phase I study of sunitinib plus paclitaxel for firstline treatment of advanced breast cancer. ASCO Breast Cancer Symposium 2007 (abstract 163). 16 Miller KD, Burstein HJ, Elias AD et al. Phase II study of SU11248, a multitargeted tyrosine kinase inhibitor (TKI) in patients with previously treated metastatic breast cancer. Breast Cancer Res Treat. 2005; 94 (suppl 1): S61 (abstract 1066). 17 Clinicaltrials.gov. A phase III study of SU plus paclitaxel verus bevacizumab plus paclitaxel in patients with advanced breast cancer. Accessed 9/11/2007. Available online at: Hhttp://clinicaltrials.gov/ct2/show/NCT ?term=sunitinib+paclitaxel&rank=2H.. 18 Clinicaltrials.gov. Study of sunitinib in combination with docetaxel in patients with advanced breast cancer. Accessed 9/11/2007. Available online at: Hhttp://clinicaltrials.gov/ct2/show/NCT ?term=Sunitinib+docetaxel&rank=1H. 19 Clinicaltrials.gov. A clinical trial comparing efficacy and safety of sunitinib and capecitabine. Accessed 9/11/2007. Available online at: Hhttp://clinicaltrials.gov/ct2/show/NCT ?term=sunitinib+capecitabine&rank=1H. 20 Clinicaltrials.gov. A study of sunitinib in combination with capecitabine compared with capecitabine in patients with breast cancer. Accessed 9/11/200. Available online at: Hhttp://clinicaltrials.gov/ct2/show/NCT ?term=sunitinib+capecitabine&rank=2H. 6
7 The National Institute for Health Research Research Programme is funded by the Department of Health. The views expressed in this publication are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health The, Department of Public Health and Epidemiology University of Birmingham, Edgbaston, Birmingham, B15 2TT, England Tel: +44 (0) Fax +44 (0)
8 8
National Horizon Scanning Centre. Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy
Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy December 2007 This technology summary is based on information available at the time of research and
More informationHorizon Scanning Technology Briefing. Sutent (Sunitinib) for first-line and adjuvant treatment of renal cell carcinoma
Horizon Scanning Technology Briefing National Horizon Scanning Centre Sutent (Sunitinib) for first-line and adjuvant treatment of renal cell carcinoma August 2006: Updated October 2006 This technology
More informationNational Horizon Scanning Centre. Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer. December 2007
Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer December 2007 This technology summary is based on information available at the time of research and a limited literature
More informationEribulin for locally advanced or metastatic breast cancer third line; monotherapy
Eribulin for locally advanced or metastatic breast cancer third line; monotherapy April 2009 This technology summary is based on information available at the time of research and a limited literature search.
More informationNational Horizon Scanning Centre. Erlotinib (Tarceva) in combination with bevacizumab for advanced or metastatic non-small cell lung cancer
Erlotinib (Tarceva) in combination with bevacizumab for advanced or metastatic non-small cell lung cancer This technology summary is based on information available at the time of research and a limited
More informationHorizon Scanning Technology Briefing. Cetuximab (Erbitux) for metastatic colorectal cancer. National Horizon Scanning Centre.
Horizon Scanning Technology Briefing National Horizon Scanning Centre Cetuximab (Erbitux) for metastatic colorectal cancer December 2006 This technology summary is based on information available at the
More informationNational Horizon Scanning Centre. Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer. December 2007
Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer December 2007 This technology summary is based on information available at the time of research and a limited literature
More informationNational Horizon Scanning Centre. Imatinib (Glivec) for adjuvant therapy in gastrointestinal stromal tumours. August 2008
Imatinib (Glivec) for adjuvant therapy in gastrointestinal stromal tumours August 2008 This technology summary is based on information available at the time of research and a limited literature search.
More informationDenosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma
Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma September 2008 This technology summary is based on information available at the time of research and a limited literature
More informationNational Horizon Scanning Centre. GV1001 for advanced and/or metastatic pancreatic cancer. April 2008
GV1001 for advanced and/or metastatic pancreatic cancer April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended
More informationErlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy
Erlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy September 2008 This technology summary is based on information available at the time of research and a
More informationNational Horizon Scanning Centre. Temsirolimus (Torisel) for mantle cell lymphoma - relapsed and/or refractory. January 2008
Temsirolimus (Torisel) for mantle cell lymphoma - relapsed and/or refractory January 2008 This technology summary is based on information available at the time of research and a limited literature search.
More informationHorizon Scanning Centre November Vinflunine (Javlor) monotherapy for advanced breast cancer SUMMARY NIHR HSC ID: 7887
Horizon Scanning Centre November 2012 Vinflunine (Javlor) monotherapy for advanced breast cancer SUMMARY NIHR HSC ID: 7887 This briefing is based on information available at the time of research and a
More informationNational Horizon Scanning Centre. Bevacizumab (Avastin) for glioblastoma multiforme - relapsed. August 2008
Bevacizumab (Avastin) for glioblastoma multiforme - relapsed August 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended
More informationNational Horizon Scanning Centre. Rituximab (MabThera) for chronic lymphocytic leukaemia. September 2007
Rituximab (MabThera) for chronic lymphocytic leukaemia This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive
More informationCabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel
Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel April 2009 This technology summary is based on information available at the time of research and a
More informationNational Horizon Scanning Centre. Azacitidine (Vidaza) for myelodysplastic syndrome. September 2007
Azacitidine (Vidaza) for myelodysplastic syndrome September 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
More informationHorizon Scanning Technology Summary. Temozolomide (Temodal) for advanced metastatic melanoma. National Horizon Scanning Centre.
Horizon Scanning Technology Summary National Horizon Scanning Centre Temozolomide (Temodal) for advanced metastatic melanoma April 2007 This technology summary is based on information available at the
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health Technology Appraisal Trastuzumab, as monotherapy and in combination with a taxane, for the treatment of metastatic breast cancer (to include
More informationNational Horizon Scanning Centre. Ampligen for chronic fatigue syndrome. December 2007
Ampligen for chronic fatigue syndrome December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive
More informationNational Horizon Scanning Centre. Ipilimumab (MDX-010) for unresectable stage III or IV metastatic melanoma - first or second line treatment
Ipilimumab (MDX-010) for unresectable stage III or IV metastatic melanoma - first or second line treatment April 2008 This technology summary is based on information available at the time of research and
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Proposed Health Technology Appraisal Everolimus in combination with exemestane for the treatment of advanced or metastatic HER2 negative, oestrogen
More informationHorizon Scanning Technology Summary. Cyanocobalamin nasal spray (Nascobal) for vitamin B12 deficiency. National Horizon Scanning Centre.
Horizon Scanning Technology Summary National Horizon Scanning Centre Cyanocobalamin nasal spray (Nascobal) for vitamin B12 deficiency April 2007 This technology summary is based on information available
More informationNational Horizon Scanning Centre. Dronedarone (Multaq) for atrial fibrillation and atrial flutter. December 2007
Dronedarone (Multaq) for atrial fibrillation and atrial flutter December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not
More informationHorizon Scanning Technology Summary. Tenofovir disoproxil fumarate for hepatitis B. National Horizon Scanning Centre. April 2007
Horizon Scanning Technology Summary National Horizon Scanning Centre Tenofovir disoproxil fumarate for hepatitis B April 2007 This technology summary is based on information available at the time of research
More informationHorizon Scanning Technology Summary. Liraglutide for type 2 diabetes. National Horizon Scanning Centre. April 2007
Horizon Scanning Technology Summary National Horizon Scanning Centre Liraglutide for type 2 diabetes April 2007 This technology summary is based on information available at the time of research and a limited
More informationHorizon Scanning Technology Summary. Methylnaltrexone for opioid induced constipation in advanced illness and palliative care
Horizon Scanning Technology Summary National Horizon Scanning Centre Methylnaltrexone for opioid induced constipation in advanced illness and palliative care April 2007 This technology summary is based
More informationNational Horizon Scanning Centre. Pregabalin (Lyrica) for fibromyalgia. September 2007
Pregabalin (Lyrica) for fibromyalgia September 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive
More informationCabozantinib for medullary thyroid cancer. February 2012
Cabozantinib for medullary thyroid cancer February 2012 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive
More informationHorizon Scanning Technology Summary. Adalimumab (Humira) for juvenile idiopathic arthritis. National Horizon Scanning Centre.
Horizon Scanning Technology Summary National Horizon Scanning Centre Adalimumab (Humira) for juvenile idiopathic arthritis June 2007 This technology summary is based on information available at the time
More informationTrastuzumab (Herceptin) for HER2 positive early, locally advanced and inflammatory breast cancer neoadjuvant treatment
Trastuzumab (Herceptin) for HER2 positive early, locally advanced and inflammatory breast cancer neoadjuvant treatment August 2010 This technology summary is based on information available at the time
More informationHorizon Scanning Technology Briefing. Zoledronic Acid (Aclasta) once yearly treatment for postmenopausal. National Horizon Scanning Centre
Horizon Scanning Technology Briefing National Horizon Scanning Centre Zoledronic Acid (Aclasta) once yearly treatment for postmenopausal osteoporosis December 2006 This technology summary is based on information
More informationNational Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008
Saxagliptin (BMS 477118) for type 2 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement
More informationNational Horizon Scanning Centre. Irbesartan (Aprovel) for heart failure with preserved systolic function. August 2008
Irbesartan (Aprovel) for heart failure with preserved systolic function August 2008 This technology summary is based on information available at the time of research and a limited literature search. It
More informationNational Horizon Scanning Centre. Decitabine (Dacogen) for myelodysplastic syndrome. April 2008
Decitabine (Dacogen) for myelodysplastic syndrome April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be
More informationHorizon Scanning Technology Briefing. Alvimopan (Entrareg ) for opioid-induced bowel disfunction. National Horizon Scanning Centre.
Horizon Scanning Technology Briefing National Horizon Scanning Centre Alvimopan (Entrareg ) for opioid-induced bowel disfunction August 2006 This technology briefing is based on information available at
More informationHorizon Scanning Technology Summary. Abatacept (Orencia) for juvenile idiopathic arthritis. National Horizon Scanning Centre.
Horizon Scanning Technology Summary National Horizon Scanning Centre Abatacept (Orencia) for juvenile idiopathic arthritis June 2007 This technology summary is based on information available at the time
More informationHorizon Scanning Technology Briefing. Prostate cancer gene 3 (Progensa PCA3) assay in the diagnosis of prostate cancer
Horizon Scanning Technology Briefing National Horizon Scanning Centre Prostate cancer gene 3 (Progensa PCA3) assay in the diagnosis of prostate cancer December 2006 This technology summary is based on
More informationNational Horizon Scanning Centre. Tadalafil for pulmonary arterial hypertension. October 2007
Tadalafil for pulmonary arterial hypertension October 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a
More informationCilengitide (Impetreve) for glioblastoma multiforme. February 2012
Cilengitide (Impetreve) for glioblastoma multiforme February 2012 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
More informationHorizon Scanning Technology Briefing. Magnetic resonance spectroscopy for prostate cancer. National Horizon Scanning Centre.
Horizon Scanning Technology Briefing National Horizon Scanning Centre Magnetic resonance spectroscopy for prostate cancer August 2006 This technology briefing is based on information available at the time
More informationHorizon Scanning Centre November Enobosarm (Ostarine) for cachexia in patients with advanced non-small cell lung cancer first line
Horizon Scanning Centre November 2012 Enobosarm (Ostarine) for cachexia in patients with advanced non-small cell lung cancer first line SUMMARY NIHR HSC ID: 5206 This briefing is based on information available
More informationLiraglutide (Victoza) in combination with basal insulin for type 2 diabetes
Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes May 2011 This technology summary is based on information available at the time of research and a limited literature search. It
More informationNational Horizon Scanning Centre. Irbesartan (Aprovel) for prevention of cardiovascular complications in patients with persistent atrial fibrillation
Irbesartan (Aprovel) for prevention of cardiovascular complications in patients with persistent atrial fibrillation August 2008 This technology summary is based on information available at the time of
More informationTRANSPARENCY COMMITTEE OPINION. 29 April 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 29 April 2009 NAVELBINE 20 mg, soft capsules B/1 (CIP: 365 948-4) NAVELBINE 30 mg, soft capsules B/1 (CIP: 365 949-0)
More informationTRANSPARENCY COMMITTEE OPINION. 15 February 2006
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 15 February 2006 Taxotere 20 mg, concentrate and solvent for solution for infusion B/1 vial of Taxotere and 1 vial
More informationCommissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December
Commissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December 17 2010. 32/10 Imatinib for gastrointestinal stromal tumours (unresectable/metastatic) (update on
More informationCertolizumab pegol (Cimzia) for psoriatic arthritis second line
Certolizumab pegol (Cimzia) for psoriatic arthritis second line This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
More informationAbatacept (Orencia) for active rheumatoid arthritis. August 2009
Abatacept (Orencia) for active rheumatoid arthritis August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
More informationRilonacept for cryopyrin associated periodic syndromes
Rilonacept for cryopyrin associated periodic syndromes August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended
More informationB-cell lymphoma vaccine (BiovaxID) for follicular non-hodgkin s lymphoma
B-cell lymphoma vaccine (BiovaxID) for follicular non-hodgkin s lymphoma May 2010 This technology summary is based on information available at the time of research and a limited literature search. It is
More informationAppendix 2. Adjuvant Regimens. AC doxorubin 60 mg/m 2 every 3 weeks x 4 cycles Cyclophosphamide 600 mg/m 2
Appendix 2 Adjuvant Regimens AC doxorubin 60 mg/m 2 every 3 weeks x 4 cycles Cyclophosphamide 600 mg/m 2 CMF IV cyclophosphamide 600 mg/m 2 days 1 & 8 every 4 weeks methotrexate 40 mg/m 2 for 6 cycles
More informationInsulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children
Insulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children December 2008 This technology summary is based on information available at the time of research and a limited literature
More informationHorizon Scanning Technology Briefing National Helical Tomotherapy Horizon Hi-ART System for Scanning external cancer Centre radiotherapy August 2006
Horizon Scanning Technology Briefing National Horizon Scanning Centre Helical Tomotherapy Hi-ART System for external cancer radiotherapy August 2006 This technology briefing is based on information available
More informationNational Horizon Scanning Centre. Mepolizumab (Bosatria) for hypereosinophilic syndrome first line in combination with corticosteroids.
Mepolizumab (Bosatria) for hypereosinophilic syndrome first line in combination with corticosteroids May 2008 This technology summary is based on information available at the time of research and a limited
More informationLacosamide (Vimpat) for partial-onset epilepsy monotherapy. December 2011
Lacosamide (Vimpat) for partial-onset epilepsy monotherapy This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a
More informationNational Horizon Scanning Centre. Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class III. April 2008
Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class April 2008 This technology summary is based on information available at the time of research and a limited literature search.
More informationScottish Medicines Consortium
P Oral) Scottish Medicines Consortium vinorelbine 20 and 30mg capsules (NavelbineP Pierre Fabre Ltd No. (179/05) 06 May 2005 The Scottish Medicines Consortium (SMC) has completed its assessment of the
More informationNational Horizon Scanning Centre. Mannitol dry powder for inhalation (Bronchitol) for cystic fibrosis. April 2008
Mannitol dry powder for inhalation (Bronchitol) for cystic fibrosis April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not
More informationClinical Expert Submission Template
Clinical Expert Submission Template Thank you for agreeing to give us a personal statement on your view of the technology and the way it should be used in the NHS. Health care professionals can provide
More informationCommon disease 175,000 new cases/year 44,000 deaths/year Less than 10% with newly diagnosed at presentation have stage IV disease Chronic disease,
Chemotherapy for Metastatic Breast Cancer: Recent Results HARMESH R. NAIK, MD. Karmanos Cancer Institute and St. Mary Hospital Metastatic breast cancer (MBC) Common disease 175,000 new cases/year 44,000
More informationAdjusting the Crossover Effect in Overall Survival Analysis Using a Rank Preserving Structural Failure Time Model: The Case of Sunitinib GIST Trial
Adjusting the Crossover Effect in Overall Survival Analysis Using a Rank Preserving Structural Failure Time Model: The Case of Sunitinib GIST Trial Xin Huang 1 and Qiang (Casey) Xu 2 1 Pfizer Oncology
More informationNational Horizon Scanning Centre. Methylnaltrexone (MOA-728) for postoperative ileus. April 2008
(MOA-728) for postoperative ileus April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement
More informationInterviews are based on data presented at the 2012 American Society of Clinical Oncology Annual Meeting, June 1-5, 2012, Chicago, Illinois* *PeerVoice is an independent publisher of conference news and
More informationPerjeta (pertuzumab)
Perjeta (pertuzumab) Line(s) of Business: HMO; PPO; QUEST Integration Medicare Advantage Original Effective Date: 10/01/2015 Current Effective Date: 01/01/201809/16/2018 POLICY A. INDICATIONS The indications
More informationHow to carry out health technology appraisals and guidance. Learning from the Scottish experience Richard Clark, Principal Pharmaceutical
The Managed Introduction of New Medicines How to carry out health technology appraisals and guidance. Learning from the Scottish experience Richard Clark, Principal Pharmaceutical Analyst July 10 th 2009,
More informationInsulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes
Insulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended
More informationClinical Management Guideline for Breast Cancer
Initial Evaluation Clinical Stage Pre-Treatment Evaluation Treatment and pathological stage Adjuvant Treatment Less than 4 positive lymph nodes ER Positive HER2 Negative (see page 2 & 3 ) Primary Diagnosis:
More informationBevacizumab added to a taxane for the first-line treatment of metastatic breast cancer
Appendix I Bevacizumab added to a taxane for the first-line treatment of metastatic breast cancer Primary Care Trusts (PCTs) provide a unique perspective on the technology, which is not typically available
More informationThe legally binding text is the original French version
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 29 November 2006 TAXOTERE 20 mg, concentrate and solvent for infusion in single-dose vials of 7 ml, individually packed
More informationBreast Cancer Breast Managed Clinical Network
Initial Evaluation Clinical Stage Pre-Treatment Evaluation Treatment and pathological stage Less than 4 positive lymph nodes Adjuvant Treatment ER Positive HER2 Negative (see page 2 & 3 ) HER2 Positive
More informationAdjuvant Systemic Therapy in Early Stage Breast Cancer
Adjuvant Systemic Therapy in Early Stage Breast Cancer Julie R. Gralow, M.D. Director, Breast Medical Oncology Jill Bennett Endowed Professor of Breast Cancer Professor, Global Health University of Washington
More informationIt is a malignancy originating from breast tissue
59 Breast cancer 1 It is a malignancy originating from breast tissue including both early stages which are potentially curable, and metastatic breast cancer (MBC) which is usually incurable. Most breast
More informationLead team presentation Eribulin for treating locally advanced or metastatic breast cancer after two or more prior chemotherapy regimens STA
For projector and public [noacic] Lead team presentation Eribulin for treating locally advanced or metastatic breast cancer after two or more prior chemotherapy regimens STA 1 st Appraisal Committee meeting
More informationEverolimus (Votubia) for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis first line or post surgery
Everolimus (Votubia) for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis first line or post surgery April 2011 This technology summary is based on information
More informationUstekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs)
Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) January 2010 This technology summary is based on information available at the time of research
More informationSTUDY FINDINGS PRESENTED ON TAXOTERE REGIMENS IN HEAD AND NECK, LUNG AND BREAST CANCER
Contact: Anne Bancillon + 33 (0)6 70 93 75 28 STUDY FINDINGS PRESENTED ON TAXOTERE REGIMENS IN HEAD AND NECK, LUNG AND BREAST CANCER Key results of 42 nd annual meeting of the American Society of Clinical
More informationHorizon Scanning Technology Summary. Magnetic resonance angiography (MRA) imaging for the detection of coronary artery disease
Horizon Scanning Technology Summary National Horizon Scanning Centre Magnetic resonance angiography (MRA) imaging for the detection of coronary artery disease April 2007 This technology summary is based
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline title SCOPE Colorectal cancer: diagnosis and management of colorectal cancer 1.1 Short title Colorectal cancer 2 The remit The Department
More informationCancer du sein métastatique et amélioration de la survie Pr. X. Pivot
Cancer du sein métastatique et amélioration de la survie Pr. X. Pivot Date of preparation: November 2015. EU0250i TTP/PFS Comparaisons First line metastatic breast cancer Monotherapy Docetaxel Chan 1999
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Health Technology Appraisal
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Health Technology Appraisal Nivolumab for previously treated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency
More informationNational Horizon Scanning Centre. Enhanced Liver Fibrosis Test (ELF) for evaluating liver fibrosis. June 2008
Enhanced Liver Fibrosis Test (ELF) for evaluating liver fibrosis June 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended
More information亞東紀念醫院 Breast Cancer 化學治療處方集
亞東紀念醫院 Breast Cancer 化學治療處方集 2008-08 制定 最近修改日期 :2015-01 CMF Breast cancer 化學治療處方參考集 Adjuvant Classic CMF Cyclophosphamide 100mg/m2 PO qd; D1-D14 Methotrexate 40mg/m 2 in N/S 100 ml IV drip 30 mins; D1,
More informationAppendix E - Summary form Oxaliplatin and capecitabine for the adjuvant treatment of colon cancer table of consultee comments
Oxaliplatin and capecitabine for the adjuvant treatment of colon cancer table of consultee comments Section Consultees Comments Action Objective Roche RCP RCP As far as capecitabine is concerned, the objective
More informationGeneral Information, efficacy and safety data
Horizon Scanning in Oncology Horizon Scanning in Oncology 23 rd Prioritization 2 nd quarter 2015 General Information, efficacy and safety data Eleen Rothschedl Anna Nachtnebel Priorisierung XXIII HSS Onkologie
More informationNew Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer
New Evidence reports on presentations given at ASCO 2012 New Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer Presentations at ASCO 2012 Breast
More informationOlesoxime for amyotrophic lateral sclerosis first line
Olesoxime for amyotrophic lateral sclerosis first line May 2011 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
More informationChapter. Contents Breast Cancer Adjuvant Epirubicin weekly. Docetaxel Copy No:
Chapter 2: Breast Cancer Contents Chapter 2: Breast Cancer... 1 Breast Cancer... 2 Adjuvant...... 2 Epi-CMF... 2 FEC / docetaxel... 3 FEC100... 4 AC/EC/TC... 4 (neo) adjuvant... 5... 5 HER2 positive: TCarboH...
More informationNCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Fall Conference Call 23 November 2009 SUMMARY REPORT
NCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Fall Conference Call 23 November 2009 SUMMARY REPORT The NCIC CTG DSMC reviewed the following trials with respect to safety, trial conduct, including
More informationTechnology appraisal guidance Published: 15 March 2002 nice.org.uk/guidance/ta34
Guidance on the use of trastuzumab for the treatment of advanced breast cancer Technology appraisal guidance Published: 15 March 2002 nice.org.uk/guidance/ta34 NICE 2018. All rights reserved. Subject to
More informationInformation for Patients. Guidance on the use of trastuzumab for the treatment of advanced breast cancer
Information for Patients Guidance on the use of trastuzumab for the treatment of advanced breast cancer March 2002 This leaflet is also available in Welsh, (Ref no. N0067). Mae'r daflen hon hefyd ar gael
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Herceptin) Reference Number: ERX.SPA.42 Effective Date: 07.01.16 Last Review Date: 05/17 Line of Business: Commercial [Prescription Drug Plan] Revision Log See Important Reminder at the
More informationScottish Medicines Consortium
Scottish Medicines Consortium cetuximab 2mg/ml intravenous infusion (Erbitux ) (279/06) MerckKGaA No 9 June 2006 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationNCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Friday, 1 May 2009 SUMMARY REPORT
NCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Friday, 1 May 2009 SUMMARY REPORT The NCIC CTG DSMC reviewed the following trials with respect to safety, trial conduct, including accrual, and
More informationPasireotide Long-Acting Repeatable (Signifor) for acromegaly first and second line
Pasireotide Long-Acting Repeatable (Signifor) for acromegaly first and second line December 2010 This technology summary is based on information available at the time of research and a limited literature
More informationContemporary Chemotherapy-Based Strategies for First-Line Metastatic Breast Cancer
Contemporary Chemotherapy-Based Strategies for First-Line Metastatic Breast Cancer Hope S. Rugo, MD Professor of Medicine Director, Breast Oncology and Clinical Trials Education University of California
More informationAfamelanotide for erythropoietic protoporphyria and congenital erythropoietic porphyria
Afamelanotide for erythropoietic protoporphyria and congenital erythropoietic porphyria This technology summary is based on information available at the time of research and a limited literature search.
More informationClinical guideline Published: 23 February 2009 nice.org.uk/guidance/cg81
Advanced breast cancer: diagnosis and treatment Clinical guideline Published: 23 February 2009 nice.org.uk/guidance/cg81 NICE 20. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationTriple Negative Breast Cancer: Part 2 A Medical Update
Triple Negative Breast Cancer: Part 2 A Medical Update April 29, 2015 Tiffany A. Traina, MD Breast Medicine Service Memorial Sloan Kettering Cancer Center Weill Cornell Medical College Overview What is
More informationIndex. Note: Page numbers of article titles are in boldface type.
Index Note: Page numbers of article titles are in boldface type. A Abdominal drainage, after hepatic resection, 159 160 Ablation, radiofrequency, for hepatocellular carcinoma, 160 161 Adenocarcinoma, pancreatic.
More information