Head and neck cancer updates presented at ESMO 2020

EPIC-OPC study: misclassification of OPC patients

The presence of human papillomavirus p16 alone is not sufficient to classify oropharyngeal cancer (OPC) as HPV-positive,1 therefore, it is important to define the proportion, determinants, and prognosis of OPC patients who are p16 positive but HPV DNA–negative (p16+/HPV-). Miren Taberna, MD, PhD, L’Hospitatlet de Llobregat, Barcelona, Spain, presented the findings of the EPIC-OPC study at the virtual 2020 European Society of Medical Oncology (ESMO) Congress.2

The EPIC-OPC study consisted of 7702 patients including 13 cohorts from 9 different countries. The results determined that the percentage of positive cases for p16 was 49.7%, HPV+ cases were 47.9%, HPV+ and p16+/HPV+ were 44.3%, respectively, and among p16+ cases, 10.9% were HPV-.

Additionally, compared to p16-/HPV- tumors, p16+/HPV+ may represent a promising prognostic biomarker with the strongest prognostic value for overall survival (aHR 0.28, 95% CI 0.25-0.31), followed by p16+/HPV- (aHR=0.65, 95% CI 0.56-0.76), and p16-/HPV+ (HR=0.72, 95% CI 0.60-0.86).

This study demonstrated that p16+/HPV+ tumors showed the highest overall survival and disease-free survival. Using p16 immunostaining alone, 11% of OPC patients would be incorrectly classified as having HPV-related OPC disease according to TNM-8 staging, resulting in the risk of misclassification for de-escalation in clinical trials, particularly in regions with lower attributable fractions of HPV.

Cisplatin chemoradiation plus xevinapant improves overall survival in patients with locally advanced squamous cell carcinoma of the head and neck

Also at the meeting, Prof. Jean Bourhis, MD, of the University of Lausanne, Lausanne, Switzerland presented data demonstrating that xevinapant (Debio 1143), provides a significant improvement in the survival of patients with poor prognosis, locally advanced, squamous cell carcinoma of the head and neck.3

In this Phase II study patients were randomized 1:1 to receive xevinapant (n = 48) or matching placebo (n = 47) in addition to standard high-dose cisplatin chemoradiotherapy. After a 33-month follow-up, patients who were randomized to receive xevinapant plus cisplatin chemoradiotherapy, reported a reduction in risk mortality by 51% (HR=0.49, [95%CI: 0.26-0.92], P=0.0261) versus patients who received chemotherapy alone. Furthermore, the 3-year overall survival rate (OS) was 66% (95% CI: 49–78) in the xevinapant arm versus 51% (95% CI: 34–65) in the placebo arm; the median OS was not reached with xevinapant versus 36.1 months.

This study demonstrated significant improvement in progression-free survival (PFS) with xevinapant, which reduced the risk of disease progression or death by 66% (HR=0.34 [95%CI, 0.17-0.68], p=0.0023) and improved probability of PFS at 36 months to 72% in the xevinapant arm compared to 36% in the placebo arm.

The IMCISION trial: promising results for HNSCC

Lotje Zuur, MD, PhD, The Netherlands Cancer Institute, Netherlands at the Virtual 2020 European Society of Medical Oncology (ESMO) Congress, presented promising results from the Phase Ib/II IMCISION trial (NCT03003637) investigating the feasibility, safety, and efficacy of neoadjuvant nivolumab alone or with ipilimumab immune checkpoint blockade in patients with advanced-stage head and neck cell carcinoma (HNSCC) prior to curative surgery.4

In this study, 32 patients indicated for curative (salvage) surgery were treated with nivolumab alone (n = 6) or nivolumab plus ipilimumab (n = 26). 9 out of 29 evaluable patients (31%) achieved a near pathologic complete response (pCR) when treated with nivolumab alone or nivolumab plus ipilimumab. The recurrence-free survival for patients who achieved near pCR was 100% at 14 months, which was significantly better than patients with <90% pR (p=<0.05).

To conclude, this study demonstrated that neoadjuvant immune checkpoint blockade was feasible in treating patients with HNSCC and was not associated with unmanageable adverse events. 

Written by Ayesha Barbar

Edited by Solyana Yohannes


  1. Smeets S, Hesselink A, Speel E, et al. A novel algorithm for reliable detection of human papillomavirus in paraffin-embedded head and neck cancer specimen. Int J Cancer. 2007;121. doi: 10.1002/ijc.22980 
  2. Mehanna H, Taberna Sanz M, Tous S, et al. 911O Performance of dual p16 and HPV testing for determining prognosis in cancer of the oropharynx, the EPIC-OPC Study. Annals of Oncology. 2020;31:S658-S659.
  3. Bourhis J, Sun XS, Le Tourneau C, et al. 3-year follow-up results of the double-blind, randomized phase II trial comparing concurrent high-dose cisplatin chemoradiation plus xevinapant (Debio 1143) or placebo in high-risk patients with locally advanced squamous cell carcinoma of the head and neck. Annals of Oncology. 2020; 31 (suppl_4): S1142-S1215
  4. Zuur L, Vos J, Elbers J, et al. LBA40 Neoadjuvant nivolumab and nivolumab plus ipilimumab induce (near-) complete responses in patients with head and neck squamous cell carcinoma: The IMCISION trial. Annals of Oncology. 2020;31:S1169.