Osu 2014 asco review savvides pres head & neck

ASCO Review: H&N Cancer

Panos Savvides, MD PhD MPH

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute 2

ASCO 2014 Review: What’s new in H&N?

Results of SELECT, a lenvatinib phase III clinical trial in Radioactive Iodine Refractory Thyroid Cancer: A new treatment standard? Role of induction chemotherapy in locally advanced

head and neck cancer Italian Induction phase III clinical trial Induction in Nasopharyngeal cancer Treatment de-intensification in Oropharyngeal Cancer

Predictive and prognostic markers to therapy Cetuximab and HPV

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT)

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Slide 17

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Study Rationale

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Study 303: Study Schema

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Patient Characteristics

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Primary Endpoint:<br />Kaplan-Meier Estimate of PFS

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

PFS by Previous VEGF-Targeted Therapy

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

PFS Subgroup Analyses

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Response Rates

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Best Tumor Response

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Overall Survival, ITT population

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Study Medication Exposure

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Treatment-emergent Adverse Events (TEAEs)

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Most Frequent Treatment-related Adverse Events (> 20%)

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

TEAEs of Special Interest

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Clinical trial comparison DECIDE v SELECT

Presented By A. Colevas at 2014 ASCO Annual Meeting

tumor reduction

Presented By A. Colevas at 2014 ASCO Annual Meeting

Primary endpoint: PFS

Presented By A. Colevas at 2014 ASCO Annual Meeting

Survival: Neither sorafenib nor lenvatinib improve survival in these trials

Presented By A. Colevas at 2014 ASCO Annual Meeting

Toxicity and dosing issues

Presented By A. Colevas at 2014 ASCO Annual Meeting

Lingering questions

Presented By A. Colevas at 2014 ASCO Annual Meeting

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute 24

ASCO 2014 Review: What’s new in H&N?

Results of SELECT, a lenvatinib phase III clinical trial in Radioactive Iodine Refractory Thyroid Cancer: A new treatment standard? Role of induction chemotherapy in locally

advanced head and neck cancer Italian Induction phase III clinical trial Induction in Nasopharyngeal cancer Treatment de-intensification in Oropharyngeal Cancer

Predictive and prognostic markers to therapy Cetuximab and HPV

History of Induction Chemotherapy

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

ICT vs. CRT

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute 27

ASCO 2014 Review: What’s new in H&N?

Results of SELECT, a lenvatinib phase III clinical trial in Radioactive Iodine Refractory Thyroid Cancer: A new treatment standard? Role of induction chemotherapy in locally

advanced head and neck cancer Italian Induction phase III clinical trial Induction in Nasopharyngeal cancer Treatment de-intensification in Oropharyngeal Cancer

Predictive and prognostic markers to therapy Cetuximab and HPV

Slide 7

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Slide 8

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Slide 9

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Trial Comparison

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Slide 11

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Slide 12

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Questions Pertained to the Italian Study

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Overall Survival based on RT quality/volume

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

What can we conclude about ICT?

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute 37

ASCO 2014 Review: What’s new in H&N?

Results of SELECT, a lenvatinib phase III clinical trial in Radioactive Iodine Refractory Thyroid Cancer: A new treatment standard? Role of induction chemotherapy in locally advanced

head and neck cancer Italian Induction phase III clinical trial Induction in Nasopharyngeal cancer Treatment de-intensification in Oropharyngeal Cancer

Predictive and prognostic markers to therapy Cetuximab and HPV

Chemotherapy in NPC

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

NCCS Trial Treatment Schema

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

NCCS Outcomes

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Why is NCCS Trial Negative

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute 42

ASCO 2014 Review: What’s new in H&N?

Results of SELECT, a lenvatinib phase III clinical trial in Radioactive Iodine Refractory Thyroid Cancer: A new treatment standard? Role of induction chemotherapy in locally advanced

head and neck cancer Italian Induction phase III clinical trial Induction in Nasopharyngeal cancer Treatment de-intensification in Oropharyngeal

Cancer Predictive and prognostic markers to therapy Cetuximab and HPV

Risk Group Definition base on HPV, Tobacco use & T/N status – Possible role for dose de-escalation in a patient subgroup

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Slide 28

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Results of E1308

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Endpoint: 2yr PFS and OS

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

Questions to address in good risk HPV+ patients

Presented By Quynh-Thu Le at 2014 ASCO Annual Meeting

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute 48

ASCO 2014 Review: What’s new in H&N?

Results of SELECT, a lenvatinib phase III clinical trial in Radioactive Iodine Refractory Thyroid Cancer: A new treatment standard? Role of induction chemotherapy in locally advanced

head and neck cancer Italian Induction phase III clinical trial Induction in Nasopharyngeal cancer Treatment de-intensification in Oropharyngeal Cancer

Predictive and prognostic markers to therapy Cetuximab and HPV

Biomarkers

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting

HPV and cetuximab

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting

Cetuximab + Chemotherapy in SCCHN

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting

SPECTRUM: OS and PFS by arm and p16

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting

RT + cetuximab significantly improves LRC and 5-year OS

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting

Slide 10

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting

Slide 11

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting

Interactions between HPV and the EGFR signaling pathway

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting

Slide 14

Presented By Vassiliki Papadimitrakopoulou at 2014 ASCO Annual Meeting