title: Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer.
abstract: OBJECTIVE
  Effective management of adverse events (AEs) following vandetanib treatment is important to maximize clinical benefits. We examined whether more frequent contact with vandetanib-treated patients reduced AEs of CTCAE grade 2 or higher.
  
  
  METHODS
  In this open-label, multicentre, phase III study, patients with locally advanced or metastatic medullary thyroid cancer were randomized to a patient outreach programme (outreach) or a standard AE monitoring schedule (vandetanib control) for 52 weeks. In addition to standard AE monitoring, patients in the outreach arm were contacted every 2 weeks by telephone/during their clinic visit for specific AE questioning related to diarrhoea, nausea, vomiting, fatigue, headache and rash. Patients received vandetanib at 200 or 300 mg/day, depending on the creatinine levels at screening.
  
  
  RESULTS
  Altogether, 205 patients were randomized (outreach, n = 103; vandetanib control, n = 102). This study did not meet its primary objective; the mean percentage of time patients experienced at least one AE of grade 2 or higher was higher for the outreach group (51.65%) than for the vandetanib control group (45.19%); the difference was not statistically significant (t statistic: 1.29; 95% CI -3.44 to 16.37%; p = 0.199). The most frequently reported AEs were diarrhoea (56.9% for the outreach group vs. 46.6% for the vandetanib controls), hypertension (36.3 vs. 31.1%), rash (25.5 vs. 24.3%) and nausea (25.5% vs. 18.4%), and the most frequently reported AEs of grade 2 or higher were hypertension (33.3 vs. 23.3%), diarrhoea (26.5 vs. 24.3%) and dermatitis acneiform (11.8 vs. 9.7%).
  
  
  CONCLUSIONS
  Additional outreach to patients treated with vandetanib had no impact on the rate or severity of AEs compared to the standard AE monitoring schedule. AEs were consistent with the known safety profile of vandetanib.
authors.affiliation: Department of Oncology R, Odense University Hospital, Odense, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Bastholt
authors.affiliation: Department of Nuclear Medicine, Augsburg Hospital, Augsburg, Germany; Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Kreissl
authors.affiliation: Department of Endocrinology and Metabolism, University Hospital Essen, Essen, Germany.
authors.forename: Dagmar
authors.initials: D
authors.lastname: Führer
authors.affiliation: Serviço de Endocrinologia, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
authors.forename: Ana L
authors.initials: AL
authors.lastname: Maia
authors.affiliation: Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Laura D
authors.initials: LD
authors.lastname: Locati
authors.affiliation: Hospital das Clínicas de Ribeirăo Preto, Ribeirăo Preto, Brazil.
authors.forename: Léa
authors.initials: L
authors.lastname: Maciel
authors.affiliation: Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Wu
authors.affiliation: AstraZeneca, Gaithersburg, Md., USA.
authors.forename: Kevin N
authors.initials: KN
authors.lastname: Heller
authors.affiliation: AstraZeneca, Macclesfield, UK.
authors.forename: Alan
authors.initials: A
authors.lastname: Webster
authors.affiliation: Endocrinology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Elisei
keywords: Adverse events; Medullary thyroid cancer; Patient outreach; Safety; Vandetanib