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.