Scalp Cooling in Preventing Chemotherapy-Induced Alopecia for Early Breast Cancer Patients: Long-Term Outcomes of Real- Life Data

doi:10.21203/rs.3.rs-4830396/v1

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Research Article

Scalp Cooling in Preventing Chemotherapy-Induced Alopecia for Early Breast Cancer Patients: Long-Term Outcomes of Real- Life Data

https://doi.org/10.21203/rs.3.rs-4830396/v1

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Purpose

Chemotherapy-induced alopecia (CIA) negatively impacts quality of life of breast cancer patients. The present observational study was designed to confirm the efficacy and safety of scalp-cooling system to prevent CIA in early breast cancer (BC) patients undergoing (neo)adjuvant chemotherapy.

Methods

We prospectively evaluated all early BC patients undergoing scalp cooling during (neo)adjuvant chemotherapy in our Institution. Primary endpoint was to assess the success of scalp cooling system (hair loss ≤ 50%).

Results

We included 252 early breast cancer patients treated from May 2016 to July 2023; median age was 49 years, 46% had stage II disease. Most of them received adjuvant chemotherapy (77.4%) and anthracycline-based regimens (78.2%). Hair loss ≤ 50% was observed in 72% of overall patients: in all patients treated with paclitaxel weekly-based chemotherapy, and in 63% and 75% of pts treated with anthracycline and docetaxel-cyclophosphamide regimens respectively (anthracycline-based versus anthracycline-free regimens, p ≤ 0.05). Hair thickness, straightening, permanent hair and BMI were factors linked to the risk of hair loss (p ≤ 0.05). Sixty-nine percent of patients had almost one adverse event, coldness the most frequent (62%); 13% of patients early discontinued the use of the scalp cooling system. With a median months of follow-up of 35 months, no scalp metastasis was reported.

Conclusion

These results support the use of scalp-cooling in preventing CIA for early breast cancer patients receiving (neo)adjuvant chemotherapy especially if they underwent anthracycline-free regimens, reducing the negative psychological impact of oncological treatments on their lives.

scalp-cooling

breast cancer

chemotherapy-induced alopecia

quality of life

DigniCap®

Breast cancer (BC) is the most diagnosed cancer in women worldwide excluding non-melanoma of the skin [1]. About 90% of BC are diagnosed at early stages and surgery, systemic therapies and radiotherapy led to a 5-years survival of more than 80% according to the stage and other risk factors for relapse [2]. Despite the options of new drugs in the treatment of early breast cancer, chemotherapy with anthracyclines and/or taxanes is usually proposed to patients in adjuvant or neoadjuvant setting, to reduce the risk of relapse, to increase the possibility of a conservative surgery and to study the aggressiveness of the neoplasm based on the pathological response [3].

An important aim for physicians involved in breast cancer is reducing the burden of adverse events related to cancer treatment. Among them, one of the most shocking for the majority of breast cancer patients is chemotherapy-induced alopecia (CIA) for its impact on body image, sexuality and self-esteem. Hence, up to 8% of all cancer patients decide to refuse chemotherapy to avoid hair loss [4].

Hair loss intensity is related to drug category and the number of administered drugs. Poly-chemotherapy is associated with higher incidences compared to monotherapy.

Epirubicin/Adriamiycin and cyclophosphamide (EC/AC), weekly paclitaxel (TXL) alone or in combination with carboplatin are associated with a risk of alopecia of more than 90%. It usually occurs after the first cycle starting around the fourteenth day for the EC/AC regimen and during the first month of therapy for weekly regimens [5, 6]. Immunomodulatory agents targeting cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death protein-1 (PD-1), and programmed death-ligand-1 (PD-L1) or anti human epidermal growth factor receptor 2 (HER2) such as trastuzumab and pertuzumab alone are not associated with increased risk or hair loss [7].

The most important factor influencing the shedding pattern is the mitotic activity of the hair follicle [8]. Up to 90% of scalp hairs are normally in anagen phase with the highest mitotic rate and so great vulnerability to drugs.

Nowadays, CIA pathobiology is still an unresolved question. Chemotherapy damages the metabolically active, fast-growing scalp hair follicles (HFs) causing massive apoptosis in the maximally proliferating hair matrix, especially of the p53-dependent matrix keratinocyte [9].

Age, comorbidities, the presence of any previous type of alopecia (more frequently androgenetic alopecia) and nutritional and hormonal status are considered risk factors for CIA [10].

Several approaches have been tested for preventing or treating CIA: scalp hypothermia, topical epinephrine or norepinephrine to decrease the amount of drug delivered to the hair bulb as well as pharmacologic and biological interventions able to block the effects of the chemotherapy on the follicle and promote hair growth (topical bimatoprost, topical minoxidil, and topical calcitriol) [11]. A recent meta-analysis showed that scalp cooling is the only approach able to induce a significant reduced risk of CIA [12]. In the last few years, a lot of data has been published about the efficacy and safety of the scalp cooling system with the DigniCap® device.

In 2019 we published a prospective observational study about our experience with the use of the DigniCap® scalp cooling system for preventing CIA in 127 early breast cancer patients undergoing (neo)adjuvant chemotherapy at our Institute “Perrino Hospital” of Brindisi and we found an overall success rate of 71.7% [13].

The present analysis aims to evaluate the long-term outcomes of the scalp cooling system in these patients and to analyze its effectiveness and safety in a larger number of patients.

2.1 Study Design and Participants

In our Oncology Unit, scalp cooling (SC) system with DigniCap® was offered to all early breast cancer patients older than 18 years subjected to neoadjuvant or adjuvant chemotherapy since May 2016 and all the data referred to SC were prospectively collected. Controindication of the DigniCap® SC system were cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy and patient refusal. The local Ethics Committee approved the study and we acquired a written informed consent for every patient.

2.2. Procedures

In our Institution two DigniCap® devices are available to allow the treatment of four patients simultaneously without additional costs for any patient.

Data about the patients' distress, adverse events and scalp cooling outcomes were collected at each cycle by a psycho-oncologist. Researchers anonymized all these informations by putting them in a database, adding information about patient's characteristics (age, menopausal status, BMI.), tumor biology (stage, grading, phenotype) and hair features. Alopecia was evaluated according to Deans’s scale for hair loss: grade 1/excellent (< 25% hair loss), grade 2/good (25%-50% hair loss), grade 3/moderate (50%-75% hair loss), and grade 4/poor (> 75% hair loss). Success was defined as hair loss < 50% according to Dean’s scale (Grade 0–2); failure was defined as > 50% hair loss (Grade 3–4) [14].

2.3 Objectives

Our primary objective was to assess efficacy in preventing CIA, tolerability and long-term outcomes of the scalp cooling system (DigniCap® devices) in early breast cancer patients treated with systemic chemotherapy. Secondary end-point was to test the correlation among some patient’s features and DigniCap® devices outcome.

2.3 Statistical Analysis

Patient demographics and clinical characteristics were reported using descriptive statistics: medians with interquartile range (IQR) were used for continuous variables and absolute counts with relative frequencies for categorical variables. The association between variables was evaluated with Fisher’s exact test and the strength of the association with Cramer’s V. A logistic regression model was implemented with an univariable and a multivariable analysis; odds ratio (OR), 95% confidence intervals (CI) and p-values were reported. The level of significance was set at p < 0.05. Jamovi (version 2.4.8) was used for statistical analyses.

Table 1 Clinicopathologic patients’ characteristics at the time of CT starting

	N (%) of Patients
Age median (range)	49 (42-56)
Menopausal Status
Premenopausal	143 (57%)
Postmenopausal	108 (43%)
Race
Caucasian	193 (76.6%)
Mediterranean	55 (21.8%)
African	3 (1.2%)
Asian	1 (0.4%)
Hystotype
Ductal	233 (92%)
Lobular	9 (4%)
Other	10 (4%)
Phenotype
ER and/or PgR pos	169 (67%)
ER and/or PgR neg	83 (33%)
HER2 pos.	93 (37%)
HER2 neg.	159 (63%)
Ki67 status
Ki67 <20%	70 (28%)
Ki67 ≥ 20%	182 (72%)
Histological Grade
1	4 (2%)
2	97 (38%)
3	148 (59%)
UNK	3 (1%)
cT/pT
1	129 (51%)
2	94 (37%)
3	20 (8%)
4	7 (3%)
UNK	2 (1%)
cN/pN
0	113 (45%)
1	93 (37%)
2	23 (9%)
3	19 (8%)
UNK	4 (2%)
Disease Stage (AJCC)
I	79 (31%)
II	117 (46%)
III	56 (22%)
Body Mass Index
Healthy Weight	132 (52%)
Under Weight	10 (4%)
Over Weight	77 (31%)
Obesity	33 (13%)
Smokers
Yes	26 (10.3%)
No	198 (78.6%)
UNK	28 (11.1%)
Chemotherapy regimens
EC→TXL weekly	75 (29.8%)
EC	72 (28.6%)
TXL + TRAST. Weekly	46 (18.3%)
EC→TXL+TRAST.weekly	35 (13.9%)
EC→TXL + CBDCA weekly	5 (2.0%)
EC→TXL+TRAST.+PERT. weekly	5 (2.0%)
(TXL+CBDCA weekly→EC )+PEMBRO.	5 (2.0%)
TC	5 (2.0%)
EC→CMF	5 (2.0%)
CBDCA+TXL+TRAST. Weekly	1 (0.4%)
EC→CMF+TRAST	1 (0.4%)
Anthracycline based regimens
Yes	197 (78.2%)
No	55 (21.8%)
Chemotherapy setting
Adjuvant	195 (77.4%)
Neoadjuvant	57 (22.6%)

Abbreviations: AJCC, American Joint Committee on Cancer; ER, estrogen receptor; PgR, progesterone receptor; pos., positive; HER2, human epidermal growth factor receptor 2; TXL, paclitaxel; TRAST, trastuzumab; CBDCA, carboplatin; EC, epirubicin – cyclophosphamide; TC, docetaxel - cyclophosphamide; PEMBRO., pembrolizumab; CMF, cyclophosphamide-methotrexate-5-fluorouracil; PERT., pertuzumab; UNK, unknown.

One hundred and seventeen patients had II stages of the disease according to the AJCC system classification (43%), 31% and 22% of patients had stage I and III respectively. Patients received different chemotherapy regimens, mainly anthracyclines containing regimens (78.2%) and in the adjuvant setting (77.4%)

4.2 Scalp Cooling Efficacy

The scalp cooling device success rate (Dean’s alopecia scale score 0-2 equal to a hair loss ≤ 50%) was 72% for all evaluable patients at the end of chemotherapy treatment (248 out of 252). Differences in response to SC device according to the chemotherapy regimens were listed in Table 2.

Table 2 Features related to chemotherapy regimens used and hair loss degree evaluated by medical staff at the end of all cycles of chemotherapy

Chemotherapy regimens	Treatment completed N. (%) of Patients	Hair loss ≤ 50% N. (%) of Patients	Hair loss >50% N. (%) of Patients	Treatment prematurely stopped (%)	Reason (n)
EC→TXL weekly	59 (81.9%)	39 (66.1%)	20 (33.9%)	13 (18.1%)	Alopecia (7), coldness (3), others (3)
EC	64 (88.9%)	41 (64.1%)	23 (35.9%)	8 (11.1%)	Alopecia (2), pain (2), others (2)
TXL + TRAST. Weekly	46 (100%)	46 (100%)
EC→TXL+TRAST.weekly	27 (80%)	18 (66.7%)	9 (33.3%)	8 (22.9%)	Alopecia (5), coldness (1), other (1)
EC→TXL + CBDCA weekly	5 (100%)	2 (40%)	3 (60%)
EC→TXL+TRAST.+PERT. weekly	3 (60%)	3 (100%)		2 (40%)	Others (2)
(TXL+CBDCA weekly→EC )+PEMBRO.	4 (100%)	4 (100%)
TC	5 (80%)	3 (75%)	1 (25%)	1 (20%)	Alopecia
EC→CMF	2 (100%)	1 (50%)
CBDCA+TXL+TRAST. Weekly	1 (100%)	1 (100%)
EC→CMF+TRAST	1 (100%)		1 (100%)

Abbreviation: TXL, paclitaxel; TRAST, trastuzumab; CBDCA, carboplatin; EC, epirubicin – cyclophosphamide; TC, docetaxel - cyclophosphamide; PEMBRO., pembrolizumab; CMF, cyclophosphamide-methotrexate-5-fluorouracil; PERT., pertuzumab;

Efficacy of 100% in preventing hair loss > 50% was observed in all patients undergoing paclitaxel weekly-based chemotherapy. Moreover, among 46 patients treated with weekly paclitaxel-based chemotherapy (forty-five received paclitaxel-trastuzumab and one paclitaxel-carboplatin-trastuzumab regimen) no one has had a hair loss evaluated by Dean's scale more than G1 and the majority (42 out of 46) did not experienced any hair loss (G0 according to Dean's scale). Even if only four patients received chemotherapy with anthracyclines after weekly paclitaxel, all these patients had hair loss ≤ 50% (Figure 1).

Table 3 The hair loss degree related to anthracycline based versus anthracycline free regimes

Variable

Hair loss ≤ 50%

N. (%) of Patients

Hair loss >50% (%)

N. (%) of Patients

p-value

Anthracycline free chemoterapy

49 (98.0%)

1 (2.0%)

<0.001*

(Cramer’s V: 0.310)

Anthracycline free chemoterapy

108 (65.5%)

57 (34.5%)

p-value: Fisher’s exact test; *anthracycline based chemotherapy versus anthracycline free chemotherapy

In our series, hair thickness, hair straightening and hair permanent were related to the risk of hair loss; hair structure, previous alopecia, dyed hair and hair density were not significantly related to scalp-cooling failure (Table 4 and Table 5)

Table 4. The hair loss degree according to the hair’s patient characteristics at baseline.

	N (%) of Patients	Hair loss ≤ 50% N. of Patients (%)	Hair loss > 50% N. of Patients (%)	p-Value
Hair thickness
Fine	76 (30.5%)	59 (77.6%)	17 (22.4%)	0,02*
Medium	94 (37.7%)	72 (76.6%)	22 (23.4%)
Thick	79 (31.7%)	47 (59.5%)	32 (40.5%)
Hair structure
Straight	127 (51%)	97 (76.3%)	30 (23.6%)	0,07*
Wavy	88 (36%)	61 (69.3%)	27 (30.6%)
Curly	32 (13%)	18 (56.2%)	14 (43.7%)
Hair density
Low	156 (63.1%)	109 (69.9%)	47 (30.1%)	0,64*
Medium	88 (35.6%)	64 (72.7%)	24 (27.3%)
High	3 (1.2%)	3 (100%)	0 (0.0%)
Pevious alopecia
Yes	10 (4.1%)	10 (100%)	0 (0.0%)	0,67*
No	237 (95.9%)	166 (70.0%)	71 (30.0%)	0,67*
Dyed hair
Yes	171 (69%)	121 (70.7%)	51 (29.8%)	0,64*
No	76 (31%)	56 (73.6%)	20 (26.3%)	0,64*
Hair straightening
Yes	37 (15%)	144 (68.5%)	66 (31.4%)	0,03*
No	210 (85%)	32 (86.4%)	5 (13.5%)	0,03*
Hair permanent
Yes	8 (3%)	7 (88%)	1 (13%)	0,44*
No	239 (97%)	169 (71%)	70 (29%)	0,44*

*p-value: Fischer’s exact test.

Table 5. The hair loss degree according to the patient characteristics.

Variables	Hair loss ≤ 50% N. of Patients (%)	Hair loss > 50% N. of Patients (%)	p-Value
BMI
Overweight	61 (80.3%)	15 (19.7%)	0,003*
Healthy weight	82 (64.1%)	46 (35.9%)
Underweight	5 (50.0%)	5 (50.0%)
Obese	29 (87.9)	4 (12.1)
Smokers
Yes	22 (84.6%)	4 (15.4%)	0,114*
No	137 (69.2%)	61 (30.8%)	0,114*
Age
Under 50	94 (69.6%)	41 (30.4%)	0,480*
Over 50	83 (74.1%)	29 (25.9%)	0,480*
Menopausal status
Premenopausal	91 (67.4%)	44 (32.6%)	0,117*
Postmenopausal	83 (76.9%)	25 (23.1%)	0,117*

*p-value: Fischer’s exact test.

Univariate and multivariate logistic regression analysis of hair loss degree according to the patient and treatment characteristics were reported in Table 6. The multivariate analysis identified the type of chemotherapy regimen, BMI and high hair thickness as independent factors for hair loss.

Table 6. Univariate and multivariate analysis

Variable	Univariate		Multivariate
Variable	OR (95% CI)	p-Value	OR (95% CI)	p-Value
Anthracycline based chemotherapy
No	Ref.	0.002	Ref.
Yes	25.1743 (3.387-187.096)	0.002	21.447 (2.845-161.676)	0.003*
Hair thickness
Medium	Ref.		Ref.
Fine -Medium	0,918 (0.402-2.096)	0.838	1.031 (0.419-2.535)	0.946
Thick - Medium	2.490 (1.218-5.091)	0.012	2.577 (1.185-5.601)	0.017*
Hair straightening
No	Ref.		Ref.
Yes	0.428 (0.157-1.165)	0.097	0.391 (0.132-1.162)	0.091
Hair permanent
No	Ref.
Yes	0.385 (0.0463-3.202)	0.377
BMI
Healthy Weight	Ref.		Ref.
Overweight-Healthy weight	0.438 (0.2242-0.857)	0,016	0.549 (0.247-1.219)	0.141
Under-weight-Healty-weight	1.783 (0.4902-6.483)	0,380	3.519 (0.724-17.099)	0.119
Obese-Healthy-weight	0.246 (0.0814-0.743)	0,013	0.250 (0.067-0.926)	0.038*

*p-value < 0.05

4.3 Adverse Events

Sixty-nine percent of all evaluable patients had almost one adverse event, 13% of them early interrupted the use SC system, the majority within the first cycles. The most frequent cause was incoming alopecia in 15 patients (47%). Fear of scalp metastases was the reason of early discontinuation in one patient. Five patients early discontinued due to coldness and two patients due to cervical pain and headache respectively.

Table 7 show the frequencies of the adverse events associated with the SC device reported by patients. Coldness was the most frequently adverse event registered in 152 out of 247 (62%) patients, severe in 43%. The second most common adverse event was headache (129/247), mostly mild in gravity (24%).

Table 7. Frequencies of SC adverse events and their gravity according to the patient’s description.

Adverse Events	No (%)	Yes (%)	Mild (%)	Moderate (%)	Severe (%)
Headache	118 (47.8%)	129 (52.2%)	66 (51.2%)	39 (30.2%)	24 (18.6%)
Scalp Pain	138 (55.9%)	109 (44.1%)	54 (49.1%)	37 (33.6%)	19 (17.3%)
Neck Pain	147 (59.5%)	100 (40.5%)	49 (49.5%)	35 (35.4%)	15 (15.2%)
Coldness	94 (38.1%)	153 (61.9%)	54 (35.8%)	36 (23.8%)	61 (40.4%)
Heavy Head	110 (44.5%)	137 (55.5%)	51 (37.2%)	64 (46.7%)	22 (16.1%)

4.4 Follow-up

Median follow-up was 35 months (range 12-62) for 248 evaluable patients; fifteen (6%) patients had a relapse of breast cancer. The site of relapse was known in ten patients: one local, six in the liver, two in the brain and one in the bone. At the end of the data cut-off, 11 died for breast cancer relapse (4.4%). No scalp metastasis was reported among the study participants.

Chemotherapy-induced alopecia is one of the most stressful adverse event for breast cancer patients. Our prospective observational analysis confirmed the possibility of avoiding CIA with the use of the scalp cooling system (DigniCap®) in the majority of early breast cancer patients. These data, collected in our center in a larger number of patients, confirmed our previously reported results [13]: overall hair preservation rate was observed in 72% of patients, also in those who received an anthracycline-based chemotherapy regimen (78% of the total population) and only 34.5% of them experienced hair loss > 50%. In line with the literature, we found a statistically significant difference in the efficacy of the scalp cooling system according to the use of anthracyclines (p < 0.001). Moreover, all 46 of patients treated with a weekly paclitaxel-based chemotherapy had a success rate of 100%, with the majority of them (42 out of 46) with hair loss G0 according to the Dean’s scale of alopecia. These results are consistent with two other prospective studies both evaluating the efficacy of the use of the DigniCap® scalp cooling system in preventing CIA in early breast cancer patients. Giarratano et al, showed an overall success rate of 60% which was higher in non-anthracycline (71%) than in anthracycline-based regimens (54%, p<0.001) [15]. Carbognin et al, reported hair preservation in 88% of patients in taxane-based (docetaxel or paclitaxel) chemotherapy group compared to 60.2% in anthracycline and taxane-based chemotherapy group (p < 0.001) with also a 100% success rate in the paclitaxel alone group [16]. In our study the multivariate analysis identified the chemotherapy regimen as an independent risk factor for hair loss, remarking that chemotherapy with anthracycline increased the risk of alopecia when compared to non-anthracycline chemotherapy regimens also with the use of scalp cooling system.

Another prospective study conducted in 2021 evaluated 163 early breast cancer patients eligible for adjuvant therapy. This study confirmed that with the use of the DigniCap® scalp cooling system, hair preservation was successful in 57% of patients in the overall series, reaching 81% of success in the patient subgroup treated with a paclitaxel and trastuzumab regimen. Side effects (feeling cold, headache, head heaviness, scalp and cervical pain) were mild to moderate and did not correlate with the rate of hair loss [17].

Several studies have found that some patients' characteristics as nicotine abuse, premenopausal status or some hair’s features like hair density, hair structure and thickness were associated with scalp cooling system outcomes. [16-18]. In our analysis we confirmed the relationship between hair thickness and scalp cooling system efficacy, but we also reported a relationship with hair straightening and hair permanent. Moreover, we found a statistically significance relation between high BMI and hair loss of less than 50%, which was never found before. These data were confirmed by the multivariate analysis. Many reasons can be hypothesized to explain this data. Overweight or obese women with breast cancer often received a reduced dose of cytotoxic drugs, based on ideal body weight [19]. Another reason for this association might be related to the lower relative dose intensity (RDI) of anthracycline and taxane-based chemotherapy due to excess adiposity [20]. Both these possible explanations might explain a lower rate or intensity of CIA, especially if associated with the use of scalp hypothermia, but these associations should be further investigated.

In our study, 13% of patients discontinued the use of the device early, mainly for adverse events. This data is in line with results reported in literature where a percentage of discontinuation ranging from 10% to 13% was reported.

With a median follow-up of 35 months, only 6% of patients had a relapse of the disease, no one had skin scalp metastases and only two progressed in the central nervous system. One of the most frequent worries of the patients and concerns of physicians about SC system is the hypothetical increased risk of cutaneous scalp relapse due to the lower concentration of the chemotherapy in their vessels. In 2017, a systematic review and meta-analysis of longitudinal studies was undertaken to evaluate the effect of scalp cooling versus no scalp cooling on the risk of scalp metastasis in breast cancer patients treated with chemotherapy. The study showed a very low incidence rate of scalp metastasis in the scalp cooling group versus the no scalp cooling group (0.61% versus 0.41%, P=0.43) suggesting that the use of scalp hypothermia to prevent CIA did not increase the incidence of scalp metastases [21]. Few data are available on the risk of central nervous system metastases and in our series only two patients, both with HER-2 positive disease, experienced CNS metastasis as first recurrence .

In conclusion, our data confirmed prospectively the scalp cooling efficacy in a large number of patients enrolled in a single oncological center; efficacy and tolerability of the scalp cooling system are in line with that found in the literature with an overall success rate of 72% and of 100% for patients undergoing a weekly paclitaxel chemotherapy regimen, thus confirming the results of our previous analysis in a larger number of patients without new or long term toxicity or particular concerns with a longer follow-up. However, some limitations need to be highlighted. The present study was observational and didn't collect data about global patients personal experience, quality of life, the contemporary use of an headgear, dermatological analysis of the hair status by a specialist at baseline and at the end of the treatment.

Despite these considerations, the use of the scalp cooling device like DigniCap® is an important equipment to offer to early breast cancer patients to improve compliance to treatments, outcome and quality of life.

CIA

Chemotherapy-induced alopecia

Breast cancer

EC/AC

Epirubicin/Adriamiycin and cyclophosphamide

WHO

World Health Organization

Hormone Receptors

HER2

Human Epidermal Growth Factor Receptor 2

TXL

Paclitaxel

CTLA-4

T-lymphocyte-associated protein-4

PD-1

Programmed cell Death protein-1

PD-L1

Programmed Death-Ligand-1

HFs

Scalp hair follicles

Scalp Cooling

FDA

Food and Drug Administration

Chemotherapy

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Competing Interests

The authors have no relevant financial or non-financial interests to disclose.

Author Contributions

All authors contributed to the study's conception and design. Material preparation and data collection were performed by Dario Loparco, Annamaria Quaranta, Paola Schiavone, Chiara Caliolo, Mariangela Pasqualoni and Mariangela Rendini. The first draft of the manuscript was written by Mariangela Pasqualoni and Laura Orlando. All authors read and approved the final manuscript.

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

«Breast C (2022) –2024» Facts & Figs. s.d
Loibl S, André F, Bachelot T, Barrios CH, Bergh J, Burstein HJ, Cardoso LMJ et al (2023) «Early Breast Cancer: ESMO Clinical Practice Guideline for Diagnosis, Treatment and Follow-Up†». Annals of Oncology, dicembre. S0923753423051049. https://doi.org/10.1016/j.annonc.2023.11.016
Curigliano G, Burstein HJ, Gnant M, Loibl S, Cameron D, Regan MM, Denkert C et al (2023) «Understanding Breast Cancer Complexity to Improve Patient Outcomes: The St Gallen International Consensus Conference for the Primary Therapy of Individuals with Early Breast Cancer 2023». Annals of Oncology, settembre. S0923753423008359. https://doi.org/10.1016/j.annonc.2023.08.017
; Chemotherapy induced alopecia management clinical experienze, McGarvey EL, Baum LD, Pinkerton RC, Rogers LM (2017) and practical advice. Psychological sequelae and alopecia among women with cancer. Cancer Pract 2001; 9: 283–89
Liu D, Wu J, Lin C, Ding S, Lu S, Fang Y, Huang J et al (2022) 30 giugno. «The Comparative Safety of Epirubicin and Cyclophosphamide versus Docetaxel and Cyclophosphamide in Lymph Node-Negative, HR-Positive, HER2-Negative Breast Cancer (ELEGANT): A Randomized Trial». Cancers 14, fasc. 13 : 3221. https://doi.org/10.3390/cancers14133221
Loparco D, Caloro M, Orlando L, Lutrino ES, Schiavone P, Caliolo C, Quaranta A et al (2017) ottobre. «Alopecia/Hair Loss in All Patients Treated with Trastuzumab and Paclitaxel: Myth or Reality?» Annals of Oncology 28 : vi42. https://doi.org/10.1093/annonc/mdx424.063
Belum VR, Marulanda K, Ensslin C, Gorcey L, Parikh T, Wu S, Busam KJ, Gerber PA, Lacouture ME (2015) Alopecia in patients treated with molecularly targeted anticancer therapies. Ann Oncol 26(12):2496–2502. 10.1093/annonc/mdv390Epub 2015 Sep 19. PMID: 26387145; PMCID: PMC4658542
Trüeb RM (2009) «Chemotherapy-Induced Alopecia». Seminars in Cutaneous Medicine and Surgery 28, fasc. 1marzo : 11–14. https://doi.org/10.1016/j.sder.2008.12.001
Inhibition of Shh Signaling through MAPK Activation Controls Chemotherapy-Induced Alopecia
Rossi A, Fortuna MC, Caro G, Pranteda G, Garelli V (2017) Umberto Pompili, e Marta Carlesimo. «Chemotherapy-induced Alopecia Management: Clinical Experience and Practical Advice». Journal of Cosmetic Dermatology 16, fasc. 4dicembre : 537–41. https://doi.org/10.1111/jocd.12308
Rubio-Gonzalez B, Juhász M (2018) Jamie Fortman, e Natasha Atanaskova Mesinkovska. «Pathogenesis and Treatment Options for Chemotherapy‐induced Alopecia: A Systematic Review». International Journal of Dermatology 57, fasc. 12dicembre : 1417–24. https://doi.org/10.1111/ijd.13906
Shin H, Jo SJ, Kim DH, Kwon O, marzo, e Seung-Kwon Myung (2015). «Efficacy of Interventions for Prevention of Chemotherapy‐induced Alopecia: A Systematic Review and Meta‐analysis». International Journal of Cancer 136, fasc. 5 https://doi.org/10.1002/ijc.29115
Orlando L, Loparco D, Fedele P, Schiavone P, Quaranta A, Caliolo C, Cinefra M et al (2019) ottobre. «Final Results of a Prospective Study of Scalp Cooling in Preventing Chemotherapy-Induced Alopecia». Future Oncology 15, fasc. 29 : 3337–44. https://doi.org/10.2217/fon-2019-0066
Dean JC, Salmon SE, Griffith KS (1979) Prevention of doxorubicin-induced hair loss with scalp hypothermia. N Engl J Med 301:1427
Giarratano T, Frezzini S, Zanocco M, Giorgi CA, Mioranza E, Miglietta F, Griguolo G et al (2020) luglio. «Use of Scalp Cooling Device to Prevent Alopecia for Early Breast Cancer Patients Receiving Chemotherapy: A Prospective Study». The Breast Journal 26, fasc. 7 : 1296–1301. https://doi.org/10.1111/tbj.13711
Carbognin L, Accetta C, Giorgio DD, Fuso P, Muratore M, Tiberi G, Pavese F et al «Prospective Study Investigating the Efficacy and Safety of a Scalp Cooling Device for the Prevention of Alopecia in Women Undergoing (Neo)Adjuvant Chemotherapy for Breast Cancer». Current Oncology 29, fasc. 10 (30 settembre 2022): 7218–28. https://doi.org/10.3390/curroncol29100569
Pedersini R, Fornaro C, Mauro Pdi, Bianchi S, Vassalli L, Amoroso V, Gelmi M et al (2021) giugno. «Efficacy of the DigniCap System in Preventing Chemotherapy-induced Alopecia in Breast Cancer Patients Is Not Related to Patient Characteristics or Side Effects of the Device». International Journal of Nursing Practice 27, fasc. 3 : e12888. https://doi.org/10.1111/ijn.12888
Schaffrin-Nabe D, Schmitz I, Josten-Nabe A, von Hehn U, Voigtmann R (2015) The Influence of Various Parameters on the Success of Sensor-Controlled Scalp Cooling in Preventing Chemotherapy-Induced Alopecia. Oncol Res Treat 38(10):489–495. 10.1159/000440636Epub 2015 Sep 27. PMID: 26451590
Griggs JJ, Melony ES, Sorbero H Lyman. «Undertreatment of Obese Women Receiving Breast Cancer Chemotherapy». Archives of Internal Medicine 165, fasc. 11 (13 giugno 2005): 1267. https://doi.org/10.1001/archinte.165.11.1267
Cespedes Feliciano EM, Wendy Y, Chen V, Lee KB, Albers CM, Prado S, Alexeeff J, Xiao, Shlomit S Shachar, e Bette J. Caan. «Body Composition, Adherence to Anthracycline and Taxane-Based Chemotherapy, and Survival After Nonmetastatic Breast Cancer». JAMA Oncology 6, fasc. 2 (1 febbraio 2020): 264. https://doi.org/10.1001/jamaoncol.2019.4668
Rugo HS, Susan A, Melin eJ, Voigt (2017) «Scalp Cooling with Adjuvant/Neoadjuvant Chemotherapy for Breast Cancer and the Risk of Scalp Metastases: Systematic Review and Meta-Analysis». Breast Cancer Research and Treatment 163, fasc. 2giugno : 199–205. https://doi.org/10.1007/s10549-017-4185-9

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Scalp Cooling in Preventing Chemotherapy-Induced Alopecia for Early Breast Cancer Patients: Long-Term Outcomes of Real- Life Data

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Abstract

Purpose

Methods

Results

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INTRODUCTION

MATERIALS AND METHODS

2.1 Study Design and Participants

2.2. Procedures

2.3 Objectives

2.3 Statistical Analysis

RESULTS

4.3 Adverse Events

4.4 Follow-up

DISCUSSION

Abbreviations

Declarations

References

Additional Declarations

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