New Era of Precision Medicine for Head and Neck Cancer
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1 New Era of Precision Medicine for Head and Neck Cancer Carol R. Bradford, MD Executive Vice Dean for Academic Affairs Chief Academic Officer, Michigan medicine Charles J. Krause, MD, Collegiate Professor of Otolaryngology Seventh Annual Symposium September 26-27, 2017
2 Disclosures I have no disclosures.
3 Treatments for Head and Neck Cancer Surgery? Radiation Chemotherapy Biologic Therapy Which treatment offers our patients the best chance for cure with the least treatment-related morbidity?
4 Clinical Trials and Biomarkers HPV Epidemic Immunotherapy Precision Medicine
5 Clinical Trials and Biomarkers HPV Epidemic Immunotherapy Precision Medicine
6 Clinical Trials and Biomarkers Can response to a single cycle of induction chemotherapy predict the ability to cure larynx cancer with chemoradiation?
7 University of Michigan Clinical Trial for Advanced Larynx Cancer E Induction Chemotherapy N D O S Responders Chemoradiation C O P Y Non- Responders Laryngectomy + XRT 87% 3-year survival rates Urba, et al. J Clin Oncol, 24:593-8, 2006
8 Clinical Trials in Larynx Cancer Photo courtesy of Norman Hogikyan, MD This approach allowed us to cure the cancer while preserving the larynx in 71% of patients
9 Improved Survival Compared to Historic Control U-M Larynx Trial VA Larynx Trial
10 Larynx Tumors with High Bcl-xL are Cisplatin-Resistant (Bcl-xL blocks programmed cell death) Low Bcl-xL Rate of Larynx Preservation High Bcl-xL? opportunity to target Bcl-xL Kumar B et al, Archives of Otolaryngol 2007 Time of Laryngeal Preservation
11 (-)-Gossypol (AT101) Component of ancient Chinese herbal medicine derived from cottonseeds Binds to BH3 pocket of Bcl-xL and blocks antiapoptotic effect Efficiently targets cisplatinresistant tumor cells for apoptosis in vitro and in vivo Oliver C et al Clinical Cancer Research 2004 Bauer J et al Molec Cancer Ther 2005 Bcl-x L (-)-gossypol Collaboration with Shaomeng Wang; AT-101 lead compound in Phase II Trials with Ascenta Therapeutics
12 Anti-apoptosis Inhibitor AT101 in Advanced Laryngeal Cancer Untreated Stage III, IV Larynx Cancer CR = complete response PR = partial response NR = no response TP CR XRT + Chemo TP PR,NR TP CR,PR NR XRT + Chemo Surgery AT101 Day 1,2,3 AT101 Day 1,2,3 This clinical trial is designed to test whether AT101 decreases the need for laryngectomy by improving response to a single cycle of induction chemotherapy TP = Docetaxel and Platinum
13 Clinical Trials and Biomarkers Which patients will benefit from surgery for advanced oral cavity/oropharynx cancer?
14 Clinical Trials in Oral Cavity and Oropharynx Cancer We used a single cycle of induction chemotherapy to stratify patients for chemoradiation versus surgery/xrt Worden F et al. JCO, 2008 Kumar B et al. JCO, 2008
15 Clinical Factors and Biomarkers Entered into Database p53 p16 BCLxL smoking gender HPV Test Tissue Microarray and cores for DNA EGFR Immunohistochemistry p53 mutation analysis Database Site treatment response age stage
16 Survival: Oropharynx Versus Oral Cavity Oropharynx p<.001 Oral Cavity The results were much better in oropharynx cancer than in oral cavity cancer
17 HPV is a Favorable Biomarker for Survival in Oropharynx Cancer HPV + HPV- HPV in situ hybridization p16 Expression: a Surrogate for HPV p16 = p=<0.0001
18 The New University of Michigan Paradigm for Oropharynx Cancer Carboplatin/docetaxel/intensity modulated radiation IMRT spares contralateral parotid gland and pharyngeal constrictors Excellent local/regional control and survival Improved swallowing results
19 Oropharynx Cancer Clinical Trial Design Registration Tumor Staging Molecular Markers Imaging QOL E N D O S C O P Y IMRT + Weekly: (Carboplatin AUC 1) (Paclitaxel 30 mg/m 2 ) 12 weeks E V A L U A T I O N Salvage Surgery Follow Up Median Follow-up Time: 36 months (95% CI [31,39] mo)
20 Intensity Modulated Radiation Therapy Can target tumor more precisely Can spare adjacent normal tissues, like pharyngeal constrictors and reduce toxicity Better swallowing outcomes Feng, F et al., J Clin Oncol 2010
21 Results for Chemoradiation for Stage III/IV Oropharynx Cancer 73 patients Excellent survival rates 96% local regional control Dysphagia was absent or minimal in 95% 88% 3yr Disease Free Survival 90% HPV+ Feng, F et al., J Clin Oncol 2010
22 Biomarkers and Clinical Trials HPV Epidemic Immunotherapy Precision Medicine
23 High-risk Human Papillomaviruses: A Highly Contagious Cause of Cancer
24 Two distinct diseases comprise OPSCC p53 mut p16 E7 prb p16 3p, 4q, 5q, 8p, 13q del HPV E6 p53
25 HPV-Related Throat Cancer In the News Michael J. Douglas disclosed that he was diagnosed with a T4N2bM0 HPV-related throat cancer in He is a former smoker. He spoke at the 2014 American Head and Neck Cancer Society Meeting as a keynote speaker He received chemoradiation and remains free of evidence of disease Photo taken June 4, 2016 at Jatin Shah s Festschrift and Celebration
26 HPV-related Oropharynx Cancer is a Sexually Transmitted Disease Oropharyngeal cancer risk is increased with High lifetime number of sexual partners (3.1 odds ratio) High lifetime number of oral-sex partners (3.4 odds ratio) Marijuana use D Souza et al, NEJM 2007, 356:
27 Which head and neck cancers are likely to be HPV-related in U.S.A.? Nasopharynx: HPV-related in 30% of cases Oropharynx: HPV-related in 90% of cases Oral cavity, larynx, and hypopharynx: HPV-related in 5% of cases
28 HPV is a Favorable Prognostic Marker in Many Clinical Trials
29 Future Directions Future clinical trials should address whether treatment for HPV-positive, non-smoking patients can be de-intensified to limit morbidity of treatment without affecting success of treatment and role of transoral approaches in cohort Similarly, trials should address whether intensification of treatment and/or surgical intervention for HPV-negative smoking patient can effect better survival
30 Role of HPV Vaccination Gardasil, quadrivalent (types 6, 11, 16, 18) vaccine, recombinant Indicated for use in young women and men age 9-26 Vaccine is highly likely to prevent the development of HPV-related head and neck cancer Will take at least 30 years for vaccination strategy to impact incidence of throat cancer
31 Biomarkers and Clinical Trials HPV Epidemic Immunotherapy Precision Medicine
32 PD-1/PD-L1 Inhibitors Overcome Local Immunosuppression PD-1: programmed cell death inhibitor 1 present on T cells When PD-1 binds to its ligand, PD-L1 (on tumor cells), the ability of the T cell to produce an effective immune response is down-regulated Nivolumab and Pembrolizumab are PD-1 antibodies that show remarkable and durable anti-tumor activity in certain malignancies
33 Immunotherapy in Head and Neck Cancer Among patients with platinum-refractory, recurrent squamous-cell carcinoma of the head and neck, treatment with nivolumab resulted in longer overall survival than treatment with standard, single-agent therapy. (CheckMate 141). Ferris R et al. NEJM Oct 2017 tail on the curve is an important observation
34 Biomarkers and Clinical Trials HPV Epidemic Immunotherapy Precision Medicine
35 Medicine of the Present: One Treatment Fits All
36 Medicine of the Future: Personalized Diagnostics and Therapies
37 Mi-Oncoseq Schema: Recurrent/Refractory Tumor Patient mtor HPV NOTCH Recurrent Tumor Patient Whole Genome Screen Cyclin D1 Targeted Therapeutic Clinical Trials p53 P13K
38 Precision Medicine Case Study #1 D.R. is a pediatrician who presented with highly aggressive sarcoma of the mandible. Distant metastasis were present at diagnosis Tumor progressed despite aggressive XRT and chemotherapy and frequent debulking
39 Precision Medicine Case Study #1 Applying the Mi-Oncoseq Schema Patient enrolled in Mi-Oncoseq No druggable targets identified Patient diagnosed with Lynch syndrome, familial colon cancer and sarcomas Family members actively screened for malignancies
40 Mi-OTOseq Schema: Newly Diagnosed Tumor Patient mtor HPV NOTCH Future Newly Diagnosed Tumor Patient Whole Genome Screen Cyclin D1 Targeted Therapeutic Clinical Trials p53 P13K
41 Precision Medicine Case Study #2 Young woman; non-smoker, non-drinker, HPVnegative recurrent tongue cancer (predicted to be a less genetically complex patient) Amplification of FGFR1 on chromosome 8 FGFR1 FISH Western blot shows FGFR1 overexpression in HNSCC_1 If patient should relapse, she could be enrolled in a clinical trial with an FGFR inhibitor Tillman
42 MiOTOSeq Progress To Date 67 patients enrolled Clinical Oncology Linked with all ongoing clinical trials 250 related or actionable genes in panel Pathology MiOTOSeq Genomics and Bioinformatics Matched circulating tumor DNA monitoring on all patients Clinical Genetics Bioethics
43 Numerous Gene Alterations Identified in Head and Neck Cancers
44 We are at the forefront of personalized therapy where we can and must deliver the RIGHT treatment for the RIGHT patient at the RIGHT time
45 Acknowledgements The University of Michigan Head and Neck Oncology Program within the Comprehensive Cancer Center at the University of Michigan The University of Michigan Head and Neck Cancer Specialized Program of Research Excellence (NIH)
46 Head and Neck Oncology Program Team Avraham Eisbruch, M.D. Radiation Oncology Frank Worden, M.D. Medical Oncology Tammi Miller, BSN, R.N. Nursing Teresa Lyden, M.A., CCC-Sp Speech Pathology J. Chad Brenner, Ph.D. Tumor Biology Jonathan McHugh, M.D. Pathology Tom Carey, Ph.D. Tumor Biology Silvana Papagerakis, Ph.D. Tumor Biology Timothy Johnson, M.D., Dermatology
47 Head and Neck Oncology Program Team Carol Bradford Doug Chepeha Scott McLean Matt Spector Andy Shuman Keith Casper Mark Prince Kelly Malloy Greg Wolf Chaz Stucken
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