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Novità e controversie ASCO 2015:H&N
Elisa BelliniSC Oncologia Medica 2
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
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• 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
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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
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Slide 5
Presented By Lillian Siu at 2015 ASCO Annual Meeting
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Slide 11
Presented By Lillian Siu at 2015 ASCO Annual Meeting
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Slide 13
Presented By Lillian Siu at 2015 ASCO Annual Meeting
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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
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Basis for Immune Therapy- Immune Escape
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
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Pembrolizumab (MK-3475)
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
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HNSCC expansion cohort of the KEYNOTE-012 Nonrandomized, Phase 1b Multi-cohort trial*
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
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Baseline Demographics
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
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Overall Response Rate [Site Radiology Review]*
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
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Adverse Events of Special Interest
Presented By Tanguy Seiwert at 2015 ASCO Annual Meeting
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UNC Phase II De-Intensification Study
Presented By Bhishamjit Chera at 2015 ASCO Annual Meeting
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UNC Phase II De-Intensification Study
Presented By Bhishamjit Chera at 2015 ASCO Annual Meeting
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Patient Characteristics
Presented By Bhishamjit Chera at 2015 ASCO Annual Meeting
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Results
Presented By Bhishamjit Chera at 2015 ASCO Annual Meeting
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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
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Evidence for Planned Neck Dissection
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
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18 FDG - PET CT scans
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
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PET-Neck Trial schema
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
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Study Endpoints
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
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Patient demographics
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
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Results – OS and p16 status
Presented By Hisham Mehanna at 2015 ASCO Annual Meeting
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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
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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.