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Thyroid locally advanced or metastatic vandetanib DISCONTINUED

 Warning: QT prolongation, torsades de pointes and sudden death:

Vandetanib can prolong the QT interval and may cause fatal or life-threatening ventricular arrhythmias (including torsades de pointes) or sudden death.  Vandetanib should not be commenced in patients with QTc >480 ms, congenital long QT syndrome or a history of arrhythmias (unless all contributing risk factors have been corrected). ECG and electrolytes should be monitored at baseline and regularly throughout treatment. Drugs known to prolong the QT interval should be avoided. Caution is advised if concomitant CYP3A4 inhibitors are used, as vandetanib is metabolised by CYP3A4. Vandetanib has a long half life - the risk of QT prolongation and arrhythmia may remain for a period of weeks after cessation of therapy.

Check for clinical trials in this patient group. Link to Australian Clinical Trials website

The anticancer drug(s) in this protocol have been updated with the ADDIKD guideline recommendations (if applicable). Recommendations may differ from other protocols which have not been updated. For further information refer to the dedicated eviQ ADDIKD guideline webpage.

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This protocol has been discontinued due to superior alternatives available.  

Treatment schedule summary

Drug Dose Route
Vandetanib 300 mg ONCE a day PO

Continuous until disease progression or unacceptable toxicity

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Bibliography

Bose, D., F. Meric-Bernstam, W. Hofstetter, et al. 2010. "Vascular endothelial growth factor targeted therapy in the perioperative setting: implications for patient care." Lancet Oncol 11(4):373-382.

Vascular endothelial growth factor (VEGF) targeted therapy, either alone or in combination with chemotherapy, has become the standard of care in several solid tumours, including colorectal cancer, renal-cell carcinoma, breast cancer, non-small-cell lung cancer, and glioblastoma. VEGF is crucial in the process of angiogenesis and wound healing and, thus, its inhibition has the potential to affect wound healing in patients undergoing surgery. In this review, we summarise the data available on the use of VEGF-targeted therapies, and their effect on perioperative wound complications. Surgery in patients receiving VEGF-targeted therapies seems to be safe when an appropriate interval of time is allowed between surgical procedures and treatment. Recommendations regarding this interval are provided in a disease and agent site-specific manner. We also discuss complications arising from the use of VEGF-directed therapies that might require surgical intervention and the considerations important in their management. At this juncture, safety data on the use of VEGF-targeted therapies in the perioperative period are sparse, and investigators are urged to continue to study this issue prospectively in current and future clinical trials to establish firm guidelines.

Wells, S.A., Jr., B.G. Robinson, R.F. Gagel, et al. 2012 "Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial" J Clin Oncol 30(2):134-41.

PURPOSE: There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. PATIENTS AND METHODS: Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. RESULTS: Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). CONCLUSION: Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC (ClinicalTrials.gov NCT00410761).

Grande, E., M.C. Kreissl, S. Filetti, et al. 2013 "Vandetanib in advanced medullary thyroid cancer: review of adverse event management strategies" Adv Ther 30(11):945-66.

INTRODUCTION: Vandetanib has recently demonstrated clinically meaningful benefits in patients with unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). Given the potential for long-term vandetanib therapy in this setting, in addition to treatment for disease-related symptoms, effective management of related adverse events (AEs) is vital to ensure patient compliance and maximize clinical benefit with vandetanib therapy. METHODS: This expert meeting-based review aims to summarize published data on AEs associated with vandetanib therapy and to provide clinicians with specific practical guidance on education, monitoring, and management of toxicities induced in patients treated with vandetanib in advanced and metastatic MTC. The content of this review is based on the expert discussions from a multidisciplinary meeting held in October 2012. RESULTS: Characteristics, frequency, and risk data are outlined for a number of dermatological, cardiovascular, gastrointestinal, and general AEs related to vandetanib treatment. Preventive strategies, practical treatment suggestions, and points for clinical consideration are provided. CONCLUSIONS: Good patient and team communication is necessary for the prevention, early detection, and management of AEs of vandetanib. Physicians, nurses, and other healthcare providers play a critical role in providing AE management and patient support to optimize outcomes with vandetanib in MTC.

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Version 6

Date Summary of changes
31/03/2023 Protocol reviewed at Medical Oncology reference committee meeting. Protocol discontinued due to the availability of superior alternatives. Version number changed to V.6.

Version 5

Date Summary of changes
30/07/2021 Protocol reviewed at Medical Oncology reference committee meeting. Protocol superseded due to the availability of superior alternatives. Version number changed to V.5. Next review in 2 years.
21/12/2021 Changed antiemetic clinical information block to minimal or low, to align with new categories. See ID 7 Prevention of anti-cancer therapy induced nausea and vomiting (AINV) v5.

Version 4

Date Summary of changes
10/09/2020 Patient information title updated- 'advanced' changed to 'locally advanced'. Version number changed to V.4.

Version 3

Date Summary of changes
21/10/2016 New protocol taken to Medical Oncology Reference Committee meeting 
14/12/2016 Protocol approved and published on eviQ
31/05/2017

Transferred to eviQ site. Version number changed to V.2.

Hepatitis B screening changed to unknown.
22/05/2019 Protocol reviewed by Medical Oncology Reference Committee. Patient information sheet updated. Review 2 years. Version number changed to V.3

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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20 Apr 2024