San Antonio Breast Cancer Symposium December 6 10

San Antonio Breast Cancer Symposium December 6 -10, 2016 Scalp Cooling Alopecia Prevention Trial (SCALP) Julie Nangia, Tao Wang, Polly Niravath, Kristen Otte, Cynthia Osborne, Steven Papish, Frankie Holmes, Jame Abraham, Shari Goldfarb, Jay Courtright, Richard Paxman, Mari Rude, Susan Hilsenbeck, Kent Osborne, Mothaffar Rimawi

Disclosures San Antonio Breast Cancer Symposium, December 6 -10, 2016 • Dr. Nangia – clinical trial funding Paxman Ltd (to institution) • Relevant Disclosures of other Authors – Tao Wang, Kristen Otte, Susan Hilsenbeck: clinical trial funding (to institution) – Richard Paxman: CEO of Paxman Coolers Ltd (funded this clinical trial) This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute.

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Scalp Cooling Alopecia Prevention Trial • Demonstrate the safety and efficacy of scalp cooling devices in reducing chemotherapyinduced alopecia • SCALP is the first randomized trial in the world to evaluate modern scalp cooling This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Clinicaltrials. gov NCT 01986140 Funded by Paxman Ltd

SCALP San Antonio Breast Cancer Symposium, December 6 -10, 2016 • December 2013 – September 2016 • Open at 7 sites across the US Inclusion Criteria • Stage 1 or 2 breast cancer • • Neoadjuvant or adjuvant • chemotherapy • § This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Exclusion Criteria Migraines Anemia Hypothyroidism Other uncontrolled medical conditions

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Design Enrollment Randomization Scalp Cooling Device Assessed for: • Alopecia • Quality of Life • Device Safety This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Control

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Alopecia Grading: CTCAE Version 4. 0 Grade 0 No hair loss Grade 1 Hair loss of up to 50% of normal, no wig required This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Grade 2 Hair loss of > 50% of normal, wig required CTCAE = Common Terminology Criteria for Adverse Events Version 4. 0 * CTCAE only defines alopecia through Grade 2 © 1998 - 2015 Baylor College of Medicine®

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Design Patient Reported Comfort Scale Very Comfortable Reasonably Comfortable Uncomfortable Very uncomfortable Questionnaires European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C 30 Hospital Anxiety Depression Scale Body Image Scale This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Comfort Scale: Massey. Europen J Onc Nur, 2004; 8: 121 -130

Results San Antonio Breast Cancer Symposium, December 6 -10, 2016 • Enroll 235 participants (85% power to detect a 20% absolute difference in hair preservation) • One interim analysis was planned to allow the study to stop early for efficacy after 142 participants were evaluable for the primary endpoint with an O’Brien-Fleming spending function September 26, 2016 DSMB agreed to stop accrual due to a positive superiority interim analysis This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute.

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Participant Flow Chart 229 Participants Consented 182 Randomized Why ineligible? Anemia Migraines Hypothyroidism Stage 3 Breast Cancer 119 Device 63 Control 95 Modified ITT 47 Modified ITT 60 additional participants not in this analysis This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Why withdrew consent? Changed Mind Randomized to Control 6 in pre-cooling phase • 4 Device (cold/discomfort) • 1 Anxiety • 1 Claustrophobia 1 during chemo (device cold)

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Results: Primary Outcome 100% Success Failure Hair Preservation Fisher's exact test p<0. 0001 75% 50. 5% (40. 7%, 60. 4%) 50% 25% 0% (0%, 7. 6%) 0% Cooling This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Non-cooling

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Results: Adverse Events Adverse Device Effects AADEs (CTCAE V 4. 0) Headache Nausea Dizziness Chills Paresthesia Pruritus Sinus pain Skin & SQ tissue disorders Skin ulceration Cycle 1 n=101 11. 9% 4% 3% 1% 1% 1% Cooling N = 101 Cycle 2 Cycle 3 n=84 n=66 10. 7% 1. 5% 2. 4% 1. 5% 1. 2% 1. 5% 1% 1% This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Cycle 4 n=62 6. 5% 1. 6%

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Results: Quality of Life Patient Reported Comfort Scale Very Comfortable Cycle 1 n=101 11. 9% Cooling (N = 101) Cycle 2 Cycle 3 n=84 n=66 16. 7% Reasonable Comfortable 51. 5% 39. 3% 47% 50% Comfortable Uncomfortable Very Uncomfortable Not Assessed 28. 7% 5. 9% 2% 26. 2% 13. 1% 2. 4% 21. 2% 12. 1% 3% 24. 2% 9. 7% 1. 6% Comfort Scale Cycle 4 n=62 14. 5% Quality of Life Assessments showed no difference This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute.

San Antonio Breast Cancer Symposium, December 6 -10, 2016 Discussion Hair Preservation in the cooling group 100% 80% Success Failure 65. 1% (52. 8%, 75. 7%) 60% 21. 9% (11%, 38. 8%) 40% 20% 0% Taxane This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute. Anthracycline

Conclusion San Antonio Breast Cancer Symposium, December 6 -10, 2016 • Scalp cooling devices are highly effective • Seeking FDA clearance • Need further studies exploring this technology for other types of tumors • More studies for impact of chemotherapy-induced alopecia on psyche and body image • Tailored QOL tools are needed to evaluate the impact of alopecia This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm. edu for permission to reprint and/or distribute.