986P - Pazopanib in patients with progressive recurrent or metastatic (R/M) salivary gland carcinoma (SGC): Further evaluation of efficacy including tumor...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Head and Neck Cancers
Presenter Joël Guigay
Citation Annals of Oncology (2016) 27 (6): 328-350. 10.1093/annonc/mdw376
Authors J. Guigay1, F. Bidault2, J. Fayette3, C. Even4, D. Cupissol5, F. Rolland6, F. Peyrade1, B. Laguerre7, C. Le Tourneau8, S. Zanetta9, L. Bozec Le Moal10, C. Borel11, L. Digue12, J. Delaye13, S. Diffetocq2, V. Costes14, A. Auperin15, L. Faivre15
  • 1Medical Oncology Departement, Centre Antoine Lacassagne, 06100 - Nice/FR
  • 2Medical Imaging, Institut Gustave Roussy, Villejuif/FR
  • 3Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 4Department Of Head And Neck Cancer, Institut Gustave Roussy, 94805 Villejuif Cedex - Villejuif/FR
  • 5Medicine, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 6Medical Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - St. Herblain/FR
  • 7Medical Oncology, Centre Eugene - Marquis, Rennes/FR
  • 8Dept Of Medical Oncology, Institut Curie, 75005 - Paris/FR
  • 9Oncology Department, Centre Georges-François Leclerc (Dijon), 21000 - Dijon/FR
  • 10Hôpital René Huguenin, Dept Of Medical Oncology, Institut Curie, 75005 - Paris/FR
  • 11Medical Oncology, Centre Paul Strauss Centre de Lutte contre le Cancer, Strasbourg/FR
  • 12Department Of Medical Oncology, CHU Bordeaux Hopital St. André, Bordeaux/FR
  • 13H&n Group, UNICANCER, Paris/FR
  • 14Pathology, CHU Hôpital Gui de Chauliac, Montpellier/FR
  • 15Biostatitics And Epidemiology, Institut Gustave Roussy, Villejuif/FR

Abstract

Background

SGC of head and neck (SGCHN) are rare tumors including adenoid cystic carcinoma (ACC) and non-ACC, with no standard treatment for R/M patients (pts). Pazopanib (Pb) is an oral inhibitor of VEGFR, PDGFR and KIT. We conducted a phase II trial to assess Pb efficacy in SGCHN, and present here results of the ancillary GR study.

Methods

Pts with confirmed progressive R/M SGCHN received Pb 800 mg daily until progression (PD). Primary endpoint was 6-mo PFS rate, with inacceptable and promising rates of 20% and 40%. Tumor volumes were assessed with a medical imaging workstation (Advantage Workstation, GE Healthcare) Assuming exponential growth, GR was defined as log10(Vt/V0)/dt, where V0 and Vt are tumour volumes at time 0 and t and dt the time in months between time 0 and t. Two time periods: pretrial period, from 3-6 mo before inclusion to inclusion (GRpre) and trial period, from inclusion to 3 mo later (GRpost). GR variation was defined as the difference GRpost minus GRpre., a negative difference means a GR break (GRpost 

Results

From 2013 to 2015, 72 pts were enrolled: 49 ACC and 20 non-ACC (3 ineligible excluded), M:F = 32:37, median age 59 yrs (range 27-84), PS 0-1 = 42:27. Pb tolerance was as expected. Among 63 pts (45 ACC, 18 non-ACC) evaluable for efficacy (6 non progressive excluded), 6-mo PFS rate was 47% (95%CI = 36;60) with 30 pts without PD at 6 mo, median PFS was 5.9 mo. Median OS was 17 mo. The 6-mo PFS met the criteria for efficacy conclusion of the trial. GR study was performed among 31 patients (24 ACC, 7 non-ACC). 6-mo PFS was 61% [IC95%:43;76] with 19 pts without PD at 6 mo. Median PFS was 8.2 mo. GR variation analysis showed a significant GR break 3 mo after Pb start (median -0.06 (range -0.37; + 0.10) p 

Conclusions

There is a significant decrease in GR between evaluations done before inclusion and 3 months after Pb start, i.e. a break in tumor growth rate, in agreement with the PFS based conclusion of promising efficacy of Pb in R/M SGCHN.

Clinical trial identification

NCT02393820

Legal entity responsible for the study

UNICANCER

Funding

UNICANCER Ligue Contre le Cancer GSK/Novartis

Disclosure

J. Guigay: Advisory Boards: BMS, Merck Research Grants: BMS, Chugai, GSK, Merck. J. Fayette: Leadership: Glycotope Gmbh. C. Even: Advisory role: MSD Travel expenses: Merck, Astra Zeneca. B. Laguerre: Honoraria and travel expenses: Novartis. C. Le Tourneau: Honoraria: Novartis, BMS, Debiopharm, MERCK, Caris. L. Digue: Travel expenses: MSD. A. Auperin: Travel expenses: Merck. All other authors have declared no conflicts of interest.