Thursday, January 26, 2012

Transcription

1 Thursday, January 26, 2012 News Briefing One 7:00 a.m. Mountain time Val J. Lowe, MD Mayo Clinic Rochester, Minn.

2 Fast Facts Co-sponsored by ASTRO, AHNS, ASCO, and SNM. More than 550 attendees are expected. The embargo for the science presented at the Multidisciplinary Head and Neck Cancer Symposium has been lifted. Please save all questions for the end.

3 Prevalence of oral HPV infection in the United States, Maura Gillison, MD, PhD The Ohio State University Columbus, Ohio

4 BACKGROUND HPV is the cause of a distinct form of oropharynx cancer that is rising in incidence in the US, largely among young men Oral HPV16 infection confers an ~14-fold increase in risk of oropharynx cancer Little is known about the epidemiology of oral HPV infection This study was designed to estimate the prevalence of oral HPV infection in the US population and to determine factors associated with infection

5 STUDY DESIGN Cross-sectional study in NHANES by NCHS/CDC Represent the civilian, non-institutionalized U.S. population 5,579 men and women aged years Oral rinse and gargle collected Demographic and behavioral data collected by interview and computer-based questionnaire

6 FINDINGS Seven percent of the U.S. population aged years have an oral HPV infection One percent had an oral HPV16 infection - corresponding to ~2.13 million infected people Infection was more common among older men and current smokers and was more common as number of sexual partners increased. Infection was 3-fold more common among men

7 IMPLICATIONS The 3-fold higher prevalence among men likely explains the 3-fold higher rates for HPV-caused oropharynx cancers among men The strong link observed between sexual behavior and infection indicates non-sexual transmission is likely unusual This study is the first step toward development of prevention and screening strategies for this type of cancer Studies to evaluate the ability of HPV vaccines to prevent oral HPV infection would further inform potential benefits of HPV vaccination among men

8 Pilot study to evaluate the effect of erlotinib administered before surgery in operable patients with squamous cell carcinoma of the head and neck (SCCHN) Mercedes Porosnicu, MD Wake Forest Baptist Medical Center Winston Salem, N.C.

9 Clinical trial Design Window Trial TISSUE BIOPSY Neoadjuvant ErlotinibTreatment Treatment duration: at least 14 days SURGICAL SPECIMEN CT/MRI PET Scan Erlotinib dose: Non-smokers:150 mg orally once a day Smokers: 300 mg orally once a day CT/MRI PET Scan SURGERY: performed at pre-scheduled date PET Scan day 4-6 of treatment Secundary 1) PET as predictor of response to Erlotinib Objectives: 2) Role of PET scan in evaluation of response Secundary Objective: Evaluation of Response Rate to Erlotinib Primary Objective: 1) Identify tissue biomarkers predictors of response to Erlotinib 2) Identify correlation between changes in EGFR-P and downstream pathways activation

10 RESULTS 12 patients have been treated to date Duration of treatment: average of 18.2 days 9 patients received erlotinib 300 mg. Of the 10 evaluable patients, 7 showed partial response (defined as at least 20% reduction in maximum tumor diameter) and 3 patients showed stable disease 2 of the 12 treated patients received shorter duration treatment and displayed very good response All 4 female patients treated presented good response, independent of the erlotinib dose received No grade 3 or 4 toxicities Early (4-6 days)18[f]-fdg PET scan showed a decrease in SUV max to 98.75% +/- 22% in patients with stable disease and to 48.06% +/- 26% in patients with partial response

11 Case Presentation 1 Treatment day 0 Treatment day 6 Treatment day 14

12 Conclusions This is a pilot study of a limited number of SCCHN patients treated with a short course of erlotinib before definitive surgery. We conclude: This is the first study to point out that treatment with erlotinib in a dose adjusted per smoking status is very active in previously untreated patients with SCCHN. All four female patients treated with erlotinib adjusted per smoking status displayed excellent response. Early changes in the 18[F]-FDG PET scan uptake should be further investigated as a marker predictive of response to EGFR inhibition. This pilot trial will continue to enroll patients to address the primary laboratory research correlative aim. Pre-and post-treatment tumor tissue is available in all patients.

13 Outcome of HIV head and neck squamous cell carcinoma treated with RT and chemotherapy Walter Mourad, MD, MSc, PhD Beth Israel Medical Center New York

14 Site #Pts. (%) Pathology Stage LC LRF 2nd Primary OPX 23 (32%) SCCa III/IV 16 (70%) 7 (30%) 3 LX 25 (35%) SCCa I-IV 19 (76%) 6 (24%) 1 Oral Cavity 9 (13%) SCCa I-IV 7 (78%) 2 (22%) 3 HPX 5 (7%) SCCa IV 0 5 (100%) 0 NPX 3 (4%) SCCa III/IV 2 (67%) 1 (33%) 0 Occult Primary 3 (4%) SCCa IV 3 (100%) 0 0 Nasal Cavity 2 (3%) SCCa III/IV 1 (50%) 1 (50%) 0 SMD 1 (1%) Salivary D. II 1 (100%) 0 0 Total 71 (100%) 49 (69%) 22 (31%) 7

15 Median follow up: 47 months (7-140). No RT/Chemo related fatalities. Treatment breaks in excess of 10, 7, 5 days were 5.6, 13, 14%. Median weight loss 20 pounds (6-40) {grades 1, 2, 3 were 11,13, 11%} Acute dysphagia and odynophagia grades 1, 2, 3 were 31, 52, 17%

16 100% dysgeusia, dysphagia, and xerostomia (grades 1-3). Acute skin desquamation grades 1, 2, 3 were 66, 20, 14%. Mucositis grades 1,2, 3 were 10,30, 40% 1 hospitalization for grade 4 (mucositis and dysphagia) and fever and 1 ORN during CCRT due to lower jaw abscess. Late dysphagia grades (1, 2, 3, 4 e.g. PEG dependent) were 46, 28, 15, and 11%. Late Xerostomia grades 1, 2, 3 were 45, 32, 23%.

17

18

19 Conclusions Definitive RT +/- chemotherapy and surgery for HIV seropositive patients with HNSCC appears to be less tolerated and less effective compared to the observed rates of other HNSCC without HIV. Due to the advances in the HAART which prolongs the HIV patients survival, the likelihood to develop HIV related malignancy increases. It is of paramount importance to establish better tolerated treatment strategies to improve tolerance, toxicity and outcomes in this growing patient population.

20 Q and A