Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer

Lars Bastholt, Michael C. Kreissl, Dagmar Führer, Ana Luiza Maia, Laura D Locati, Léa Maciel, Yi Long Wu, Kevin N Heller, Alan Webster, Rossella Elisei

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)187-194
Number of pages8
JournalEuropean Thyroid Journal
Volume5
Issue number3
DOIs
Publication statusPublished - Sep 2016

Fingerprint

Safety
Diarrhea
Exanthema
Nausea
Appointments and Schedules
Hypertension
Medullary Thyroid cancer
N-(4-bromo-2-fluorophenyl)-6-methoxy-7-((1-methylpiperidin-4-yl)methoxy)quinazolin-4-amine
Physiologic Monitoring
Dermatitis
Ambulatory Care
Telephone
Vomiting
Fatigue
Headache
Creatinine
Control Groups

Keywords

  • Journal Article

Cite this

Bastholt, L., Kreissl, M. C., Führer, D., Maia, A. L., Locati, L. D., Maciel, L., ... Elisei, R. (2016). Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer. European Thyroid Journal, 5(3), 187-194. https://doi.org/10.1159/000448919

Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer. / Bastholt, Lars; Kreissl, Michael C.; Führer, Dagmar; Maia, Ana Luiza; Locati, Laura D; Maciel, Léa; Wu, Yi Long; Heller, Kevin N; Webster, Alan; Elisei, Rossella.

In: European Thyroid Journal, Vol. 5, No. 3, 09.2016, p. 187-194.

Research output: Contribution to journalArticle

Bastholt, L, Kreissl, MC, Führer, D, Maia, AL, Locati, LD, Maciel, L, Wu, YL, Heller, KN, Webster, A & Elisei, R 2016, 'Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer', European Thyroid Journal, vol. 5, no. 3, pp. 187-194. https://doi.org/10.1159/000448919
Bastholt, Lars ; Kreissl, Michael C. ; Führer, Dagmar ; Maia, Ana Luiza ; Locati, Laura D ; Maciel, Léa ; Wu, Yi Long ; Heller, Kevin N ; Webster, Alan ; Elisei, Rossella. / Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer. In: European Thyroid Journal. 2016 ; Vol. 5, No. 3. pp. 187-194.
@article{ece924cb0d3b4010a91bb8ef873203a3,
title = "Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer",
abstract = "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.",
keywords = "Journal Article",
author = "Lars Bastholt and Kreissl, {Michael C.} and Dagmar F{\"u}hrer and Maia, {Ana Luiza} and Locati, {Laura D} and L{\'e}a Maciel and Wu, {Yi Long} and Heller, {Kevin N} and Alan Webster and Rossella Elisei",
year = "2016",
month = "9",
doi = "10.1159/000448919",
language = "English",
volume = "5",
pages = "187--194",
journal = "European Thyroid Journal",
issn = "2235-0640",
publisher = "S. Karger AG",
number = "3",

}

TY - JOUR

T1 - Effect of an Outreach Programme on Vandetanib Safety in Medullary Thyroid Cancer

AU - Bastholt, Lars

AU - Kreissl, Michael C.

AU - Führer, Dagmar

AU - Maia, Ana Luiza

AU - Locati, Laura D

AU - Maciel, Léa

AU - Wu, Yi Long

AU - Heller, Kevin N

AU - Webster, Alan

AU - Elisei, Rossella

PY - 2016/9

Y1 - 2016/9

N2 - 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.

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.

KW - Journal Article

U2 - 10.1159/000448919

DO - 10.1159/000448919

M3 - Article

C2 - 27843809

VL - 5

SP - 187

EP - 194

JO - European Thyroid Journal

JF - European Thyroid Journal

SN - 2235-0640

IS - 3

ER -