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Scalp Cooling 101

bkling
bkling

In simplified terms, scalp cooling systems are tightly fitting, helmet-like hats filled with a cold gel or liquid that you wear during chemotherapy infusions. It is a device that can help many people keep some or quite a bit of their hair during chemotherapy which can cause hair loss. It has been life-changing for many in the cancer community, but not everyone can afford or has access to it. To help our breast (chest) cancer community understand how it works and its success rates, our guest speaker Julie Nangia, MD, Medical Director, Breast Oncology at Baylor College of Medicine, will discuss her clinical review published called "Quality of Life Matters: It Is Time to Integrate Scalp Cooling in Routine Clinical Practice" in JCO Oncology Practice: An American Society of Clinical Oncology Journal. Come with your questions and join us for this lively discussion.

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Julie Nangia, MD
Associate Professor
Medical Director, Breast Oncology
Dan L. Duncan Comprehensive Cancer Center
Baylor College of Medicine
SCALP Clinical Trial Results
This presentation is the intellectual property of the author/presenter.
Contact them at Nangia@bcm.edu for permission to reprint and/or distribute.
• Clinical trial funding by Paxman Ltd
(to institution)
Disclosures
This presentation is the intellectual property of the author/presenter.
Contact them at Nangia@bcm.edu for permission to reprint and/or distribute.
Background
• Chemotherapy treats micro-metastatic disease &
can decrease the risk of breast cancer recurrence
• It is associated with side effects such as
chemotherapy-induced alopecia. Women rate
this as one of the most severe, distressing and
troublesome side effects
• Many countries use scalp cooling devices to
prevent chemotherapy-induced alopecia with
variable success rates based on non-randomized
trials (25%-100% hair retention)
This presentation is the intellectual property of the author/presenter.
Contact them at Nangia@bcm.edu for permission to reprint and/or distribute.
How Scalp Cooling Works
Borrowed/Courtesy of Corina van den Hurk
Netherlands Comprehensive Cancer Organization
This presentation is the intellectual property of the author/presenter.
Contact them at Nangia@bcm.edu for permission to reprint and/or distribute.
How Scalp Cooling Works
This presentation is the intellectual property of the author/presenter.
Contact them at Nangia@bcm.edu for permission to reprint and/or distribute.
• Devices have more stringent and different approval
processes which the cold caps did not have to go
through
• The FDA had concerns about patient safety and the
possibility of scalp metastasis. There are 2 large
studies from other countries showing no increase in
scalp metastasis or change in overall survival with
device use.
• FDA cleared the first scalp cooling device Dec 2015
– This was a non-randomized trial and only looked at
taxane-based chemotherapy.
– Showed 66% hair retention.
Why Not Used In the US Sooner?
Van den Hurk Breast 2013
Lemieux Breast Can Res 2015
Rugo ASCO poster 6/2015

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Scalp Cooling 101

  • 1. Julie Nangia, MD Associate Professor Medical Director, Breast Oncology Dan L. Duncan Comprehensive Cancer Center Baylor College of Medicine SCALP Clinical Trial Results
  • 2. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • Clinical trial funding by Paxman Ltd (to institution) Disclosures
  • 3. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Background • Chemotherapy treats micro-metastatic disease & can decrease the risk of breast cancer recurrence • It is associated with side effects such as chemotherapy-induced alopecia. Women rate this as one of the most severe, distressing and troublesome side effects • Many countries use scalp cooling devices to prevent chemotherapy-induced alopecia with variable success rates based on non-randomized trials (25%-100% hair retention)
  • 4. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. How Scalp Cooling Works Borrowed/Courtesy of Corina van den Hurk Netherlands Comprehensive Cancer Organization
  • 5. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. How Scalp Cooling Works
  • 6. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • Devices have more stringent and different approval processes which the cold caps did not have to go through • The FDA had concerns about patient safety and the possibility of scalp metastasis. There are 2 large studies from other countries showing no increase in scalp metastasis or change in overall survival with device use. • FDA cleared the first scalp cooling device Dec 2015 – This was a non-randomized trial and only looked at taxane-based chemotherapy. – Showed 66% hair retention. Why Not Used In the US Sooner? Van den Hurk Breast 2013 Lemieux Breast Can Res 2015 Rugo ASCO poster 6/2015
  • 7. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • Retrospective study of 1370 women with stage 1-3 breast cancer from Quebec • 553 women who used scalp cooling and 817 who did not • Median f/u 6.3 years • No difference in Overall Survival in scalp cooled vs no scalp cooling groups Safety: Overall Survival Lemieux. Breast Cancer Res Treat. 2015
  • 8. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • Overview from observational studies, autopsy studies & Munich cancer registry • >33,771 breast cancer patients • 77% treated adjuvantly, mainly with taxanes/anthracyclines • Incidence of scalp metastases was not higher with scalp cooling – Scalp cooling 0.04-1% – No scalp cooling 0.03-3% Safety: Scalp Metastasis/Recurrence Van den Hurk. Breast. Oct 2013.
  • 9. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • Meta-analysis • Identified 24 studies, 10 with long term follow-up which were included in the analysis – 12/1959 cases with scalp cooling (0.61%) – 5/1238 with no scalp cooling (0.4%) No Difference in Rate of Scalp Metastasis p = 0.43 Safety: Scalp Metastasis Rugo et al. Breast Cancer Res Treat . 2017
  • 10. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • August 2013-September 2016 • 5 US medical centers • Taxane-based chemotherapy for early stage breast cancer • 132 subjects consented Prospective US Device Trial Rugo Et al. JAMA. 2017
  • 11. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Design Enrollment Scalp Cooling Device Retrospectively Matched Controls Assessed for: • Alopecia • Quality of Life • Device Safety Rugo Et al. JAMA. 2017
  • 12. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Participant Flow Chart 132 Participants Screened 122 were eligible 106 Device 16 Controls 101 in Primary Analysis 16 in Primary Analysis Why ineligible? Ineligible Chemo (3) Withdrew Consent (4) Stage 3/4 Breast Cancer (2) Treated Elsewhere (1) Why not in the primary analysis? Included 101 • 88 received all chemo • 3 stopped treatment • 1 refused device • 2 could not tolerated the device Excluded 5 • 4 due to chemo side effects • 1 did not have early stage breast cancer Rugo Et al. JAMA. 2017
  • 13. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Results: Primary Endpoint Rugo Et al. JAMA. 2017 Hair Retention Dean Score 0 Dean Score 1 Dean Score 2 Dean Score 3 Dean Score 4 66.3% of participants had successful hair retention (0% in the control arm)
  • 14. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. (1.) TC: Docetaxel/cyclophosphamide x 4-6 (2.) TCarbo: Docetaxel/carboplatin + HER2 targeted therapy x 4-6 (3.) Paclitaxel: Paclitaxel weekly x 12 (4.) Docetaxel + HER2 targeted therapy x 4-6 (5.) AC: Doxorubicin/cyclophosphamide x 4 (6.) Treatment success: Dean score ≤ 2 Results: Success by Chemotherapy Regimen in Treatment and Control Groups Chemotherapy regimen DigniCap Control Treatment success6 Treatment success6 TC1 48/76 (63.2%) 0/10 TCarbo2 10/12 (83.3%) 0/3 Paclitaxel3 12/12 (100%) 0/2 Docetaxel4 1/1 (100%) 0/0 AC5 0/0 0/1 Courtesy of Dr. Rugo Presented at MSKCC 2016
  • 15. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Results Rugo Et al. JAMA. 2017 Dean Score 1 Dean Score 4
  • 16. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • 7 events in 106 participants considered related to the device, all grade 1/2 – Headache (4) – Pruritis (1) – Skin Pain (1) – Head Discomfort (1) • No skin metastases as of median follow- up of 29.5 months Adverse Events Rugo Et al. JAMA. 2017
  • 17. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • 88 of 106 had all their planned chemo – 3 patients could not tolerate the dvice – 11 stopped because of hair loss or chemo adverse effects • Patient Symptom Survey – 104 had a “feeling of chilliness” – 43 had headache – 75 had scalp pain Tolerability Rugo Et al. JAMA. 2017
  • 18. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • The DigniCap System prevented hair loss in 66.3% of patients with breast cancer receiving non-anthracyline based chemotherapy • Treatment was safe and well tolerated • FDA clearance of first scalp cooling device in the US 12/2015 Conclusions Rugo Et al. JAMA. 2017
  • 19. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • Demonstrate the safety and efficacy of scalp cooling devices in reducing chemotherapy- induced alopecia • SCALP is the first randomized trial in the world to evaluate modern scalp cooling SCALP Trial Clinicaltrials.gov NCT01986140 Funded by Paxman Ltd
  • 20. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • December 2013 – September 2016 • Open at 7 sites across the US – 3 academic centers – 4 community oncology clinics • 229 women signed consent SCALP Trial
  • 21. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Design Enrollment Randomization Scalp Cooling Device Control Assessed for: • Alopecia • Quality of Life • Device Safety
  • 22. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Alopecia Grading: CTCAE Version 4.0 Grade 0 No hair loss Grade 1 Hair loss of up to 50% of normal, no wig required Grade 2 Hair loss of > 50% of normal, wig required ©1998 - 2015 Baylor College of Medicine® CTCAE = Common Terminology Criteria for Adverse Events Version 4.0 * CTCAE only defines alopecia through Grade 2
  • 23. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Examples of Grading Baseline (Grade 0 alopecia) Grade 1 Alopecia * 3-4 weeks after using cooling system for 4 cycles of chemo
  • 24. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Examples of Grading Baseline (Grade 0 alopecia) Grade 2 Alopecia * Subject in control group; 3 weeks after 2nd cycle of chemotherapy. * Subject in cooling group; 3 weeks after using cooling system for 2 cycles of chemotherapy
  • 25. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Design Patient Reported Comfort Scale Very Comfortable Reasonably Comfortable Comfortable Uncomfortable Very uncomfortable Comfort Scale: Massey. Europen J Onc Nur, 2004; 8: 121-130 Questionnaires European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 Hospital Anxiety Depression Scale Body Image Scale
  • 26. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • 235 subjects were planned to be enrolled to provide 85% power to detect a 20% difference in hair preservation. • The trial stopped early based on a pre-planned interim analysis for efficacy after 142 participants were evaluable for the primary endpoint with an O’Brien-Fleming spending function* Statistical Analysis Plan Nangia, et al. JAMA, 2017; 317(6):596-605.
  • 27. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Participant Flow Chart 293 Participants Consented 236 Randomized 157 Device 79 Control 130 Modified ITT 54 Modified ITT Why ineligible? Hypothyroidism (11) Anemia (10) Stage 3 Breast Cancer (7) Baseline Alopecia (5) Migraines (4) Age >= 70 (3) Lichens Planus (2) Other (6) Why withdrew consent? 18 Randomized to Control 7 due to hair loss 6 in pre-cooling phase • 4 Device (cold/discomfort) • 1 Anxiety • 1 Claustrophobia 4 during chemo (device cold) 2 alternate treatment 3 withdrew consent 1 chemo related 1 progressive disease Nangia, et al. ASCO Poster 2017
  • 28. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Results: Primary Outcome Nangia, et al. ASCO Poster 2017
  • 29. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Results: Primary Outcome Nangia, et al. ASCO Poster 2017
  • 30. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Results: Adverse Events Nangia, et al. ASCO Poster 2017
  • 31. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Results: Quality of Life Patient Reported Comfort Scale Comfort Scale Cooling (N = 137) Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 Cycle 7 Cycle 8 n=137 n=117 n=90 n=83 n=36 n=31 n=11 n=9 Very Comfortable 10.9% 15.4% 13.3% 15.7% 16.7% 12.9% - - Reasonable Comfortable 51.8% 41.9% 50% 45.8% 50% 54.8% 45.5% 44.4% Comfortable 27.7% 27.4% 22.2% 27.7% 22.2% 29% 36.4% 44.4% Uncomfortable 8% 10.3% 12.2% 9.6% 8.3% 3.2% 9.1% 11.1% Very Uncomfortable - 3.4% - - - - 9.1% - Not Assessed 1.5% 1.7% 2.2% 1.2% 2.8% - - - Quality of Life Assessments showed no difference Nangia, et al. ASCO Poster 2017
  • 32. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Secondary Endpoints Nangia, et al. ASCO Poster 2017
  • 33. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Secondary Endpoints Nangia, et al. ASCO Poster 2017
  • 34. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Penguin Cold Cap Registry Study Rice et al. BCRT. 2018. Regimen % Successful Hair Retention TC x 4 83.8% (31/37) TC x 4-6 50% (5/10) Weekly P  AC 43.4% (10/23) AC  Weekly P 20% (2/10) Taxotere/Carbo +/- Herceptin 100% (2/2) Other 60% (9/15)
  • 35. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Conclusion from SCALP trial • Scalp cooling devices are highly effective • This device received FDA clearance in the US based on these data • 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
  • 36. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Efficacy by Tumor Type: Overall 50% had hair retention n = 1411 Van den Hurk, Netherlands Comprehensive Cancer Org Poster These data led to the FDA expanded approval to patients with solid tumors.
  • 37. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Other chemotherapy agents Van den Hurk, Netherlands Comprehensive Cancer Org Poster • Seems to work with: – Eribulin – Doxil • More effective with: – Epirubicin vs Adriamycin • Ineffective with concurrent taxane/anthracycline • Contraindicated in: – Oxaliplatin due to cold sensitivity – Hematologic malignancies due to risk for scalp metastasis – Cancer of the CNS, H&N, Small Cell Lung, Squamous Lung, Skin Cancers, and any other solid tumors with high likelihood of metastasis in transit
  • 38. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. scalpcooling.org
  • 39. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Decision Aid (scalpcooling.org)
  • 40. • Conclusions: – Scalp cooling during chemotherapy infusion for Japanese patients made their hair recovery faster “Prospective study of hair recovery after chemotherapy with scalp cooling in Japan” – Shozo Ohsumi, poster SABCS Does scalp cooling help with hair regrowth?
  • 41. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Docetaxel: + Small Risk for Permanent Alopecia Martin. Breast Cancer Research and Treatment (2018) 171:627–634 https://doi.org/10.1007/s10549-018-4855-2 Spanish study showed no permanent alopecia with docetaxel when scalp cooling was used
  • 42. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. • Make clear expectations – Most patients have hair thinning and lose 30% of their hair – Define what a success is upfront – Put ownership on the patient and explain to them that the better the fit, the better the chance of success – Sequence chemo with agent with less hair loss first (weekly paclitaxel AC) – Avoid stress to hair • no dye or straightners/curling • use sulfate free shampoo/conditioner • comb hair in shower with conditioner in – https://www.paxmanusa.com/ Tips for Use
  • 43. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. Who in the picture has cancer?
  • 44. This presentation is the intellectual property of the author/presenter. Contact them at Nangia@bcm.edu for permission to reprint and/or distribute. “Fighting Cancer on My Own Terms”

Editor's Notes

  1. My disclosures are funding for this clinical trial from Paxman Ltd to my institution.
  2. Chemotherapy treats micro-metastatic disease & can decrease the risk of breast cancer recurrence. However, it is associated with distressing side effects such as alopecia. Many countries use scalp cooling devices to prevent alopecia with variable success rates based on non-randomized trials
  3. So why does cooling the scalp work? Chemotherapy attacks rapidly dividing cells like cancer cells and hair follicles. 90% of the hair follicles are in the growth phase. Click The thought is that the cold temperature will cause stricture of blood flow to the skin of the scalp and allow less chemo to reach the hair follicles. The cold temperatures also reduce biochemical activity and make the hair follicles less susceptible to the damage from chemo. Click Here is an example of a hair follicle from a patient receiving chemo and you can clearly see the damage chemo caused.
  4. So how do scalp cooling devices work? Here is an example of a scalp cooling machine. There is a refrigeration unit that connects to a cooling cap and circulates coolant. This allows the scalp to be cooled to ~64 degrees. Scalp cooling works by reducing blood flow and chemo exposure to the hair follicles. Click Each patient is fitted to the correct cap size, and there is an inner and outer cap. Proper scalp cooling is crucial to hair retention. Click scalp cooling devices, unlike cold caps, can be worn throughout treatment and patients can disconnect for 10 minutes if needed to go to the restroom or move to a different location. The devices are typically worn for 30 minutes prior to chemo, during chemo and 90 minutes after chemotherapy. Some center will move patients to a “scalp cooling waiting area” for their post-cooling time because they need the chemo chairs for other patients.
  5. So why are these devices not commonly used in the US? This is because devices have more stringent and different approval processes which the cold caps did not have to go through. Intitially the FDA had concerns about patient safety and the possibility of scalp metastasis, but 2 recent studies from other countries showed no increase in scalp metastasis or change in overall survival. The FDA approved the first scalp cooling device in Dec 2015 based on a non-randomized trial with taxane-based chemotherapy which showed a 66% hair retention rate.
  6. The main objective of the study is to demonstrate that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer. This clinical trial is the first randomized trial in the world to evaluate modern scalp cooling.
  7. This trial accrued participants from December 2013 to September 2016. It was open at 7 sites across the US-3 academic centers and 4 community oncology clinics. Baylor College of Medicine was the lead site and performed all the data management, monitoring, and data analysis.
  8. After enrollment, eligible participants were randomized in a 2:1 ratio to scalp cooling or no scalp cooling. Randomization was stratified by site and major type of chemo. The device was worn for 30 minutes prior to chemo, during chemo, and for 90 minutes after chemo. Alopecia assessments were made at baseline and 2-4 weeks after each chemo by a blinded healthcare provider, the clinician and the participant. The participants were also asked if they needed to use a wig.
  9. Here are some examples of alopecia assessments. Alopecia was assessed using the Common Terminology Criteria for Adverse Events Version 4.0. Grade 0 is no hair loss, Grade 1 is up to 50% hair loss not requiring use of a wig of headwrap, and grade 3 is >50% hair loss requiring the use of a wig or headwrap
  10. Here are some examples of alopecia assessments. Both of these participants had grade 1 alopecia after using scalp cooling for 4 cycles.
  11. Here are examples of grade 2 alopecia. The participant on top was in the control group and the participant on the bottom received scalp cooling.
  12. For those wearing the device, a comfort scale was also administered with each use to rate device comfort. Click 3 There were 3 quality of life questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, Hospital Anxiety Depression Scale, and Body Image Scale which were administered at baseline, after 4 cycles of chemo, and at completion of chemo if >4 cycles.
  13. SCALP planned to 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. All analyses for efficacy were based on the intent to treat population. All second analyses are exploratory.
  14. There were 229 participants that signed consent of which 182 met eligibility criteria and were randomized in a 2:1 ratio to the scalp cooling device vs control. The data from the interim analysis is being presented today, and the intent to treat population is those that were randomized and completed at least 1 cycle of chemotherapy. Click The most common reasons for ineligibility were anemia, migraines, hypothyroidism and stage 3 breast cancer. Eligible participants were randomized in a 2:1 ratio to the scalp cooling device vs control. The data from the interim analysis is being presented today, and the modified intent to treat population is those that were randomized and completed at least 1 cycle of chemotherapy. Click The most common reasons for randomized patients not completing at least 1 cycle of chemotherapy were that the participant changed their mind or that they were randomized to the control and wanted to use the cold caps. Of note 6 participants withdrew during the pre-cooling phase: 4 of these because the device was too cold/uncomfortable, 1 due to claustrophobia from the cap. There was also 1 participant who withdrew during chemo because the device was too cold Click There are an additional 60 participants enrolled in SCALP that are not part of the interim analysis
  15. The results of the final analysis showed that in the scalp cooling group 50% of participants retained their hair, and in the control group 0% of participants retained their hair with a p value of 0.0001%.
  16. The results of the interim analysis showed that in the scalp cooling group 50% of participants retained their hair, and in the control group 0% of participants retained their hair with a p value of 0.0001%.
  17. There were a total of 54 adverse events, all grade 1 or 2. Click The most common were headache, nausea and dizziness.
  18. Here is the patient reported comfort scale. Most participants rated the device as reasonable comfortable and very few found the scalp cooling device to be uncomfortable. However, 10 of the 157 randomized patients could not tolerate the device due to cold or discomfort Click Quality of Life Assessments were done using 3 questionnaires. Analysis of the questionnaires showed no significant differences between those in the scalp cooling group versus control or in the successful hair retention group versus alopecia group.
  19. It is known that scalp cooling devices are more effective in preventing hair loss with certain types of chemotherapy such as taxanes. In SCALP the hair retention rate with taxanes was 65% and with anthracyclines was 22%. The other US trial with scalp cooling devices was prospective, but not randomized and only included taxane-based chemotherapy, with a similar hair retention rate of 66% using a slightly different alopecia grading scale.
  20. Here is information about hair retention with specific chemotherapy regimens after completion of chemotherapy. Click With AC and weekly taxol/carboplatin the hair retention rate it was 66%. Click With AC and weekly taxol it was 19%. With ddAC and ddTaxol it was 40%. Click With weekly taxol with or without carboplatin it was 100% Click With TC it was 57%. Click And with TCH +/- pertuzumab it was 75%. This information may be used by oncologists to help select type of chemotherapy. For example in a patient with HER2+ breast cancer an oncologist may elect to give TCH vs AC followed by TH which are considered equivalent regimens due to the higher rates of hair retention
  21. In Conclusion: Scalp cooling devices are highly effective and should become available to women with breast cancer receiving chemotherapy. Based on the results of this study Paxman Ltd will file for FDA clearance of this device. Further studies should be done exploring this technology for other types of tumors and with other chemotherapy regimens. More studies looking at the impact of chemotherapy-induced alopecia on psyche and body image should be performed as well. Tailored Quality of Life tools are needed to evaluate the impact of alopecia on quality of life