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.

1. Julie Nangia, MD
Associate Professor
Medical Director, Breast Oncology
Dan L. Duncan Comprehensive Cancer Center
Baylor College of Medicine
SCALP Clinical Trial Results

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• Clinical trial funding by Paxman Ltd
(to institution)
Disclosures

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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)

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How Scalp Cooling Works
Borrowed/Courtesy of Corina van den Hurk
Netherlands Comprehensive Cancer Organization

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How Scalp Cooling Works

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• 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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• 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

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• 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.

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• 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

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• 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

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Design
Enrollment
Scalp Cooling Device
Retrospectively
Matched
Controls
Assessed for:
• Alopecia
• Quality of Life
• Device Safety
Rugo Et al. JAMA. 2017

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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

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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)

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(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

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Results
Rugo Et al. JAMA. 2017
Dean Score
1
Dean
Score 4

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• 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

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• 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

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• 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

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• 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

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• December 2013 – September 2016
• Open at 7 sites across the US
– 3 academic centers
– 4 community oncology clinics
• 229 women signed consent
SCALP Trial

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Design
Enrollment
Randomization
Scalp Cooling Device Control
Assessed for:
• Alopecia
• Quality of Life
• Device Safety

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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

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Examples of Grading
Baseline
(Grade 0 alopecia)
Grade 1 Alopecia
* 3-4 weeks after using cooling system for 4 cycles of chemo

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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

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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

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• 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.

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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

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Results: Primary Outcome
Nangia, et al. ASCO Poster 2017

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Results: Primary Outcome
Nangia, et al. ASCO Poster 2017

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Results: Adverse Events
Nangia, et al. ASCO Poster 2017

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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

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Secondary Endpoints
Nangia, et al. ASCO Poster 2017

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Secondary Endpoints
Nangia, et al. ASCO Poster 2017

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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)

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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

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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.

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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

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scalpcooling.org

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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?

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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

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• 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

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Who in the picture has cancer?

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“Fighting Cancer on My Own Terms”