Novità e controversie ASCO 2015:H&N
Elisa BelliniSC Oncologia Medica 2
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
• Phase III randomized trial of SFX with concurrent CDDP vs. AFX with Panitumumab in patients with LA-SCCHN (L. Siu, Oral Presentation ASCO 2015).
• Antitumor activity of the anti-PD-1 Antibody Pembrolizumab in biomarkers unselected patients with R/M H&N cancer: Preliminary results of the KEINOTE-012 Expansion Cohort (T. Seiwert, Oral Presentation ASCO 2015).
• UNC Phase II De-intensification Study (B. Chera, Oral Presentation ASCO 2015)
• PET-NECK a multi-centre randomized phase III controlled trial comparing PETCT guided active surveillance with planned ND for locally advanced (N2/N3) nodal metastases in patients with HNSCC treated with CRT (H. Mehanna, Symposium, ASCO 2015).
Novità e controversie ASCO 2015 H&N: obiettivi
Lillian L. Siu, John N. Waldron, Bingshu E. Chen, Eric Winquist, Jim R. Wright, Abdenour Nabid, John H Hay, Jolie Ringash, Geoffrey Liu, Ana Johnson, George Shenouda, Martin Chasen, Andrew Pearce, James B. Butler, Stephen Breen, Eric Xueyu Chen, T J Childs, Alexander Montenegro, Brian O'Sullivan, Wendy R. Parulekar<br /><br /> NCT00820248<br />
Presented By Lillian Siu at 2015 ASCO Annual Meeting
Slide 5
Presented By Lillian Siu at 2015 ASCO Annual Meeting
Slide 11
Presented By Lillian Siu at 2015 ASCO Annual Meeting
Slide 13
Presented By Lillian Siu at 2015 ASCO Annual Meeting
Antitumor Activity of the anti-PD-1 Antibody Pembrolizumab in biomarker-unselected Patients with R/M Head and Neck Cancer: <br />Preliminary Results from the KEYNOTE-012 Expansion Cohort
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
Basis for Immune Therapy- Immune Escape
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
Pembrolizumab (MK-3475)
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
HNSCC expansion cohort of the KEYNOTE-012 Nonrandomized, Phase 1b Multi-cohort trial*
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
Baseline Demographics
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
Overall Response Rate [Site Radiology Review]*
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
Adverse Events of Special Interest
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
UNC Phase II De-Intensification Study
Presented By Bhishamjit Chera at 2015 ASCO Annual Meeting
UNC Phase II De-Intensification Study
Presented By Bhishamjit Chera at 2015 ASCO Annual Meeting
Patient Characteristics
Presented By Bhishamjit Chera at 2015 ASCO Annual Meeting
Results
Presented By Bhishamjit Chera at 2015 ASCO Annual Meeting
PET-NECK - a multi-centre randomized phase III controlled trial (RCT) comparing <br />PETCT guided active surveillance with <br />planned neck dissection (ND) for <br />locally advanced (N2/N3) nodal metastases (LANM) in patients with head and neck squamous cell cancer (HNSCC) <br />treated with primary radical chemoradiotherapy (CRT). <br />
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
Evidence for Planned Neck Dissection
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
18 FDG - PET CT scans
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
PET-Neck Trial schema
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
Study Endpoints
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
Patient demographics
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
Results – OS and p16 status
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
TAKE HOME MESSAGE
• With a median follow-up of 46 months PFS of PMab+PFX was not superior to Cis+SFX in LA-SCCHN.
• Pembrolizumab active both in HPV+ and HPV- patients– Largest experience of immunotherapy in HNSCC; N=132– Active in heavely preatreted population– RR=25%
• Deintensification treatment effective in best prognosis HPV oropharynxs cancer– pCR rate is very high– Small trial – Short follow-up– Requires confirmation
TAKE HOME MESSAGE
• PET-TC surveillance Arm results is equivalent (non inferior) in OS.
• PET-TC Surveillance was cost-effective over the two years trial period compared to planned ND.
• PET-TC become the standard of care compared to planned ND.