Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Discussion – Head and neck cancer

3463 - Buparlisib (BKM120) in refractory head and neck squamous cell carcinoma harbouring or not a PI3KCA mutation: a phase II multicenter trial


28 Sep 2019


Poster Discussion – Head and neck cancer


Jérome Fayette


Annals of Oncology (2019) 30 (suppl_5): v449-v474. 10.1093/annonc/mdz252


J. Fayette1, L. Digue2, C. Ségura-Ferlay3, I. TREILLEUX4, Q. Wang5, G. Lefebvre6, A. Daste7, C. Even8, S. Couchon Thaunat9, A. Guyennon9, F. Peyrade10, D. Cupissol11, B. You12, C. Le Tourneau13, L. Jaouen3, E. Grinand3, S. Tabone-Eglinger14, G. Garin3, D. Perol3

Author affiliations

  • 1 Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 2 Medical Oncology, CHU Bordeaux Hopital St. André, 33000 - Bordeaux/FR
  • 3 Clinical Research - Drci, Centre Léon Bérard, 69008 - Lyon/FR
  • 4 Pathology Dpt, Centre Léon Bérard, 69008 - Lyon/FR
  • 5 Recherche Translationnelle, Centre Léon Bérard, 69008 - Lyon/FR
  • 6 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 7 Gironde, CHU Bordeaux Hopital St. André, 33000 - Bordeaux/FR
  • 8 Medical Oncology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 9 Radiology Dpt, Centre Léon Bérard, 69008 - Lyon/FR
  • 10 Medical Oncology, Centre Anticancer Antoine Lacassagne, 6100 - Nice/FR
  • 11 Medical Oncology, Laboratoire de Radio-Analyse du C.R.L.C., 34298 - Montpellier/FR
  • 12 Oncology, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR
  • 13 Medical Oncology, Institut Curie, 75005 - Paris/FR
  • 14 Biological Ressources Center, Centre Léon-Bérard, 69008 - Lyon/FR


Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 3463


The PI3K/AKT pathway activation is an independent marker of poor outcome in head and neck squamous-cell carcinoma (HNSCC). It is involved in resistance to cetuximab and PI3KCA mutations (5% of HNSCC) may be a key event of this dysregulation. Buparlisib is an oral, pan-Class I PI3K inhibitor that inhibits tumor growth in HNSCC xenografts.


This phase II evaluated the efficacy of oral buparlisib (100mg/d) in 2 parallel cohorts of refractory HNSCC (progression after platinum and cetuximab) with (PIK3CAmutated, exons 9/20) or without (PIK3CAnon-mutated) PI3KCA activating mutation. The primary endpoint was 2-month Disease Control Rate (DCR2m) as per centrally reviewed RECIST 1.1. Secondary endpoints included ORR, PFS, OS, and safety. Buparlisib would be considered ineffective if DCR2m ≤ 10% and promising if ≥ 30% (Simon’s optimal two-stage design; α: 5% unilateral, power: 90%): 7 successes/35 evaluable patients per cohort were required.


58 HNSCC heavily pre-treated (78% at least 2 prior lines) received at least one dose of buparlisib (PIK3CAnon-mutated, n = 36 and PIK3CAmutated, n = 22) The PIK3CAmutated cohort was prematurely closed because of slow accrual). The DCR2m was 38.9% (95% CI [25.5; + ∞[) for PIK3CAnon-mutated and 36.4% (95% CI [19.5; + ∞[) for PIK3CAmutated. No objective response was observed. Median PFS was 1.8 m (95% CI [1.6; 3.5]) and 1.7 m (95% CI [1.1; 4.1]) for PIK3CAnon-mutated and PIK3CAmutated respectively. Median OS was 5.8 m (95% CI [3.7; 9.2]) and 3.4 m (95% CI [2.6; 7.9]) for PIK3CAnon-mutated and PIK3CAmutated. Most common related AEs (>25%) included hyperglycemia, asthenia, anxiety, depression, lymphopenia, anemia, leucocyte increase, hematocrite decrease, Na decrease, nausea and diarrhea. Most frequent related AE ≥ Grade 3 (>5%) were hyperglycemia, lymphopenia, asthenia, Na decrease, depression, dermatitis. 14 pts (24.1%) discontinued buparlisib due to an AE.


Buparlisib had limited antitumor activity in heavily pre-treated HNSCC patients independent of PI3KCA mutational status.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Centre Léon Bérard.


INCA et Fondation ARC.


J. Fayette: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Honoraria (self): Merck Serono; Advisory / Consultancy: innate pharma; Advisory / Consultancy: Biogen. A. Daste: Honoraria (self), Advisory / Consultancy: BMS. C. Even: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self): Merck Serono. F. Peyrade: Honoraria (self): BMS; Honoraria (self): Merck Serono. C. Le Tourneau: Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: AstraZeneca.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.