National Horizon Scanning Centre. Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer. December 2007

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1 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 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 Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer Target group Medullary thyroid cancer (MTC) - locally advanced or metastatic. Technology description Vandetanib (Zactima, ZD6474, AZD6474) is a once-daily, oral antiangiogenic vascular endothelial growth factor (VEGF) receptor-2, epidermal growth factor receptor (EGFR) and rearranged during transfection (RET) tyrosine kinase inhibitor. Vandetanib works by inhibiting both the development of the tumour's blood supply and the growth and survival of the tumour itself. Vandetanib is administered orally at 300mg once daily. Vandetanib is also in phase III development for non-small cell lung cancer and phase II trials are ongoing in patients with myeloma, breast, brain and prostate cancer. Innovation and/or advantages Vandetanib is the first in a new drug class of combined tyrosine kinase inhibitors. There are no specifically licensed chemotherapy agents for thyroid cancer. Developer AstraZeneca Place of use Home care e.g. home dialysis Secondary care e.g. general, nonspecialist 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: In phase II clinical trials. Vandetanib has been granted orphan drug status in the US and Europe for this indication. NHS or Government priority area: This topic is relevant to the NHS Cancer Plan. Relevant guidance NICE clinical guideline. Improving outcomes in head and neck cancers: the manual, British Thyroid Association, Royal College of Physicians. Guidelines for the management of thyroid cancer in adults. Second edition The Royal College of Pathologists. Standards and datasets for reporting cancers. Dataset for thyroid cancer histopathology reports British Thyroid Association. UK guidelines for the use of thyroid function tests British Association of Endocrine Surgeons. Guidelines for the surgical management of endocrine disease and training requirements for endocrine surgery The Northern Cancer Network. Guidelines for the management of thyroid cancer

3 Clinical need and burden of disease In 2004 approximately 1,400 new cases, and 300 deaths from thyroid cancer were recorded in England and Wales 7. Thyroid cancer is the most common malignant endocrine tumour, but represents less than 0.5% of all malignancies 8. Unlike other cancers, approximately 50% of cases occur in patients under 60 years. Medullary thyroid carcinoma (MTC) originates from the parafollicular cells (also called C cells) in the thyroid, and represents about 5-9% of all thyroid cancers (between 70 and 126 new cases per year). MTC can be sporadic or familial if gene mutations run in families. The five-year age standardised relative survival for thyroid cancer in England and Wales was 80% for women and around 75% for men 7. MTC has a poorer survival rate than papillary or follicular thyroid cancer. Existing comparators and treatments Treatment of thyroid cancer includes: Surgical removal of the thyroid with lymph node dissection. Chemotherapy (disappointing results). Radionuclide therapy (palliative care). Prophylactic thyroidectomy with additional radioactive therapy is considered for: Close family members of people with familial MTC and Carriers of a rearranged during transfection (RET) germ line mutation Efficacy and safety Trial name or code NCT phase II 9 NCT phase II 10 NCT phase I/II 11 NCT phase II 12 Sponsor AstraZeneca AstraZeneca National Cancer AstraZeneca Institute Status Conference abstract Ongoing Ongoing Ongoing Location USA, France North and South America, Europe, Australia, India USA USA, Australia, Canada, Europe Design Non-randomised, open label, uncontrolled. Participants n=30; unresectable, locally advanced or metastatic hereditary MTC, RET mutation. vandetanib 300 mg/day until disease progression. Follow-up Primary outcome Median duration of treatment 172 days. Response Evaluation Criteria in Solid Tumors (RECIST). Randomised, double-blind, placebo-controlled n=232 (planned); adults. Unresectable, locally advanced or metastatic hereditary or sporadic MTC. vandetanib 300 mg/day. Open-label, single-arm. n=21 (planned); 5 to 18 years; recurrent or metastatic, unresectable, hereditary MTC, RET mutation. vandetanib in 28- day cycles. Non-randomised, open label, uncontrolled n=15 (planned); adults. Locally advanced or metastatic hereditary MTC. vandetanib 100 mg/day monotherapy. 7 months Not known 8 months Progression-free RECIST; Tumour markers (calcitonin and CEA); Tumour- Objective response rate. 3

4 Secondary outcomes Key results Adverse effects Disease control rate; Tumour markers (calcitonin); safety. 20% partial response (duration of response days); 30% stable disease at 24 weeks. 19 patients had a 50% decrease in calcitonin for at least 6 weeks. Adverse events in >50%: rash (73%), diarrhoea (67%), fatigue (57%) and nausea (53%). Most were grade 1 or 2; grade 3 included asymptomatic QTc prolongation (n=5), rash and diarrhoea (n=3). Overall objective response rate; disease control rate; duration of response; overall related diarrhoea; safety; pharmacokinetics. Progression-free and overall survival; expression of RET, EGFR, VEGFR. Safety and tolerability; progression-free Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Estimated cost and cost impact The cost of vandetanib is currently unkown. Potential or intended impact speculative Patients Reduced morbidity Reduced mortality or increased survival Quicker, earlier or more accurate Other: diagnosis or identification of disease Improved quality of life for patients and/or carers Non identified Services Increased use Service reorganisation required Staff or training required Decreased use Other: Non identified Costs Increased unit cost compared to alternative Increased costs: more patients coming for treatment Increased costs: capital investment needed New costs: Savings: Other: References 1 National Institute for Health and Clinical Excellence. Improving outcomes in head and neck cancers: the manual British Thyroid Association, Royal College of Physicians. Guidelines for the management of thyroid cancer. Perros P, ed. 2nd edition. Report of the Thyroid Cancer Guidelines Update Group. London: Royal College of Physicians,

5 3 The Royal College of Pathologist. Standards and datasets for reporting cancers. Dataset for thyroid cancer histopathology reports. February British Thyroid Association. UK guidelines for the use of thyroid function tests. July The British Association of Endocrine Surgeons. Guidelines for the surgical management of endocrine disease and training requirements for endocrine surgery. January The Northern Cancer Network Guidelines for the management of thyroid cancer: Clinical Oncology 2000;12: Cancer Research UK. UK Thyroid cancer statistics, National Standards for Thyroid Cancer Services. NHS Wales. Cancer Services Co-ordinating Group. January Wells SA, Gosnell JE, Gagel RF, Moley DG, Pfister DG, Sosa JA, et al. Vandetanib in metastatic hereditary medullary thyroid cancer: follow-up results of open-label phase II trial. J Clin Oncol ASCO Annual Meeting Proceedings Part I. 2007; Vol 25; 18S (abstract 6018). 10 Clinicaltrial.gov. An efficacy study comparing ZD6474 to placebo in medullary thyroid cancer. Reference: NTC Accessed 14/11/2007. Available at: Hhttp://clinicaltrials.gov/ct2/show/NCT ?term=vandetanib+thyroid&rank=1H 11 National Cancer Institute. Phase I/II study vandetanib in young patients with hereditary medullary thyroid carcinoma. Reference: NTC Accessed 13/11/2007. Available at: Hhttp:// 12 Clinicaltrial.gov. A study to assess ZD6474 (ZACTIMA ) monotherapy in locally advanced or metastatic hereditary medullary thyroid cancer. Reference: NTC Accessed 14/11/2007. Available at: Hhttp://clinicaltrials.gov/ct2/show/NCT ?term=vandetanib+thyroid&rank=3H 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)

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