1161P - Safety and efficacy of vandetanib as systemic treatment for patients with advanced and progressive medullary thyroid cancer (MTC)

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cytotoxic agents
Thyroid Cancer
Therapy
Biological therapy
Presenter Enrique Grande
Citation Annals of Oncology (2014) 25 (suppl_4): iv394-iv405. 10.1093/annonc/mdu345
Authors E. Grande1, J. Martinez-Trufero2, S. Arevalo3, C. Alvarez-Escola4, M. Beltran5, P. Jimenez Fonseca6, T. Alonso-Gordoa1, E. Dalmau7, M. Duran8, I. Gallegos9, J.L. Manzano10, R. Mesia11, I. Pajares12, J. Fuentes13, J.J. Grau14, O. Reig Torras15, J.M. Trigo16, B. Pelaez17, C. Zafon18, J. Capdevila19
  • 1Medical Oncology Department, Ramon y Cajal University Hospital, 28034 - Madrid/ES
  • 2Medical Oncology, H U Miguel Servet, zaragoza/ES
  • 3Medical Oncology Department, Hospital de Donostia, 28080 - San Sebastian/ES
  • 4Department Of Endocrinology, La Paz University Hospital, 28046 - Madrid/ES
  • 5Medical Oncology, ICO Girona, 28034 - Gerona/ES
  • 6Servicio De Oncologia Medica, Hospital Universitario Central de Asturias, ES-33006 - Oviedo/ES
  • 7Medical Oncology, Corporación Hospitalaria Parc Tauli, 08208 - Sabadell/ES
  • 8Cirugía General, Hospital Rey Juan Carlos, Mostoles/ES
  • 9Servicio De Oncología Médica, Hospital General de Segovia, Segovia/ES
  • 10Medical Oncology, ICO Hospital Germans Trias i Pujol, Barcelona/ES
  • 11Medical Oncology Department. Idibell. Head And Neck Cancer Unit., Institut Català d'Oncologia (ICO)-Hospitalet, 08098 - Hospitalet de Llobregat, Barcelona/ES
  • 12Medical Oncology, Hospital Clinico Lozano Blesa, Zaragoza/ES
  • 13Oncology, hospital valme, 41014 - seville/ES
  • 14Medical Oncology, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 15Oncología Médica, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 16Medical Oncology, Hospital Universitario Virgen de la Victoria, Malaga/ES
  • 17Medical Oncology, University Hosptial de Valladolid, valladolid/ES
  • 18Endocrinology Department, Vall de Hebron University Hospital, 08080 - Barcelona/ES
  • 19Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES

Abstract

Aim

Vandetanib has demonstrated efficacy in advanced MTC in a large phase III trial (NCT00410761). However, little evidence is available on safety and efficacy of vandetanib in daily-practice patients. This is a retrospective multicenter analysis of the safety and activity of vandetanib in the community setting.

Methods

Pts with advanced, unresectable MTC and documented radiological disease progression were included in a compassionate use program in Spain. Pts received vandetanib 300 mg qd as the initial dose, allowing dose reductions as per toxicity. Primary endpoint was response rate (RR) by RECIST and secondary endpoints were safety, progression-free survival (PFS) and correlation between RR and biomarkers. The program was validated by regulatory authorities and all patients signed an informed consent form.

Results

27 pts were enrolled (med age: 48 yo; male: 52%). Vandetanib was given as first-line MKI in 59%, second-line in 22% and third-line in 19% of pts. Dose reductions were needed in 44% of pts to manage toxicity. Most common grade 1-2 adverse events were rash (33%), fatigue (33%), diarrhea (33%), hand-foot syndrome (19%), AST/ALT elevation (19%), mucositis (15%), nausea and vomiting (15%), anorexia (15%) and hypertension (11%). The most frequent grade 3-4 side effects were rash (22%), hypertension (4%), mucositis (4%) and cardiac toxicity (<3%). 25 pts were evaluable for efficacy. Overall RR was 24% (including one complete response), disease stabilization was 60% (44% for more than 6 months) and 16% had progressive disease. Median percentage of tumor shrinkage was 30% (range, 4-100%). No significant differences were found regarding treatment lines and previous exposure to MKIs. Median PFS was 17.6 months (95%CI, 8.3-26.9 months) with 66% of events at the time of analysis. No correlation was found between calcitonin and/or CEA reduction and disease control rate (RR + SD).

Conclusions

Vandetanib showed meaningful activity with an acceptable safety profile inadvanced and progressive MTC in a cohort of patients with a worse prognosis than previously reported. Activity is seen regardless of treatment line.

Disclosure

All authors have declared no conflicts of interest.