PMID- 27843809
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2235-0640 (Print)
IS  - 2235-0802 (Electronic)
IS  - 2235-0640 (Linking)
VI  - 5
IP  - 3
DP  - 2016 Sep
TI  - Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer.
PG  - 187-194
AB  - OBJECTIVES: 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. STUDY DESIGN: 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.
FAU - Bastholt, Lars
AU  - Bastholt L
AD  - Department of Oncology R, Odense University Hospital, Odense, Denmark.
FAU - Kreissl, Michael C
AU  - Kreissl MC
AD  - Department of Nuclear Medicine, Augsburg Hospital, Augsburg, Germany; Department 
      of Nuclear Medicine, University Hospital Wurzburg, Wurzburg, Germany.
FAU - Fuhrer, Dagmar
AU  - Fuhrer D
AD  - Department of Endocrinology and Metabolism, University Hospital Essen, Essen, 
      Germany.
FAU - Maia, Ana L
AU  - Maia AL
AD  - Servico de Endocrinologia, Hospital de Clinicas de Porto Alegre, Porto Alegre, 
      Brazil.
FAU - Locati, Laura D
AU  - Locati LD
AD  - Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan, Italy.
FAU - Maciel, Lea
AU  - Maciel L
AD  - Hospital das Clinicas de Ribeirao Preto, Ribeirao Preto, Brazil.
FAU - Wu, Yi
AU  - Wu Y
AD  - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
FAU - Heller, Kevin N
AU  - Heller KN
AD  - AstraZeneca, Gaithersburg, Md., USA.
FAU - Webster, Alan
AU  - Webster A
AD  - AstraZeneca, Macclesfield, UK.
FAU - Elisei, Rossella
AU  - Elisei R
AD  - Endocrinology Unit, Department of Clinical and Experimental Medicine, University 
      of Pisa, Pisa, Italy.
LA  - eng
PT  - Journal Article
DEP - 20160910
PL  - England
TA  - Eur Thyroid J
JT  - European thyroid journal
JID - 101604579
PMC - PMC5091223
OTO - NOTNLM
OT  - Adverse events
OT  - Medullary thyroid cancer
OT  - Patient outreach
OT  - Safety
OT  - Vandetanib
EDAT- 2016/11/16 06:00
MHDA- 2016/11/16 06:01
PMCR- 2017/03/01
CRDT- 2016/11/16 06:00
PHST- 2016/03/03 00:00 [received]
PHST- 2016/07/18 00:00 [revised]
PHST- 2017/03/01 00:00 [pmc-release]
PHST- 2016/11/16 06:00 [entrez]
PHST- 2016/11/16 06:00 [pubmed]
PHST- 2016/11/16 06:01 [medline]
AID - etj-0005-0187 [pii]
AID - 10.1159/000448919 [doi]
PST - ppublish
SO  - Eur Thyroid J. 2016 Sep;5(3):187-194. doi: 10.1159/000448919. Epub 2016 Sep 10.