Dean Scale Research Articles

Retrospective cohort study of CDK4/6-inhibitor-induced alopecia in patients with breast cancer.

e13083 Background: The synergistic effects of novel combined cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) and endocrine therapy has increased their utilization for treatment of metastatic breast cancer. When compared to endocrine monotherapy, CDK4/6i may increase the risk of alopecia by nearly two-fold (Eiger D, et al. PMID: 32167397; Chan D, et al. J Clin Oncol.). The prevalence of this adverse effect underscores the importance of characterizing CDK4/6i-induced alopecia (CDKIA) and investigating therapeutic options. Methods: A retrospective cohort of 28 female patients with breast cancer and endocrine-induced alopecia (EIA) or CDKIA. Onset of alopecia was measured by time (months) between initiation of anticancer therapy and dermatology referral. Therapeutic response to minoxidil (LDOM or topical [5%] solution or foam) was assessed by both Dean Scale and qualitative clinical improvement by comparison of pre-treatment and post-treatment clinical images by 2 board certified academic dermatologists (ST and BD). Results: Androgenetic alopecia was the most common hair loss distribution (n=27, 96.4%), with CDKIA patients having preferential vertex involvement (n=7 [70.0%] CDKIA vs. n=4 [36.4%] EIA; p=0.04). Patients on CDK4/6i had shorter times to dermatology referral (mean time [months]: 44.6±37.1 for EIA vs. 9.4±13.7 CDKIA; p=0.003). After 16-24 weeks of minoxidil, moderate to significant improvement of alopecia occurred in 80% of CDKIA patients versus 94.4% of EIA patients. Despite similar baseline alopecia grade severity, significant improvement was only observed in EIA patients (mean pretreatment Dean Score – post-treatment Dean Score: -0.44; p=0.0002). Conclusions: Compared to EIA, the onset of CDKIA happened more rapidly and was more resistant to minoxidil. The preferential vertex involvement observed among patients with CDKIA may suggest combination therapy with topical or oral minoxidil and topical anti-androgens may lead to more favorable outcomes. Prompt dermatology referral should be considered for patients treated with CDK4/6i + ET. [Table: see text]

Comparable effectiveness of 45- and 20-min post-infusion scalp cooling time in preventing paclitaxel-induced alopecia — a randomized controlled trial

PurposeScalp cooling can prevent chemotherapy-induced alopecia (CIA). Previously, the post-infusion cooling time (PICT) could be successfully reduced in docetaxel-treated patients from 90 to 45 and 20 min. Therefore, it seems plausible that the PICT can be shortened for paclitaxel-treated patients as well.MethodsPatients treated with weekly paclitaxel were included in this multi-centre trial and randomly assigned to a PICT of 45 or 20 min. The results were compared to a standard PICT of 90 min, derived from prospective collected data from the Dutch Scalp Cooling Registry. The primary endpoint was the percentage of patients who decide to not wear a wig or head covering. Secondary endpoints were the degree of CIA assessed with the Dean scale for assessment of hair loss; alopecia graded according to NCI CTC toxicity version 4.03 (CTCAE4.03); tolerance of scalp cooling and perceived distress of CIA.ResultsNinety-one patients were enrolled in this study; 74 patients were evaluable for hair loss. Hair preservation was successful in 27 patients (75%) with a PICT of 45 min and in 31 patients (82%) with a PICT of 20 min. There was no difference in success rate with the standard PICT of 90 min (85%, p = 0.29). Similar success rates were seen when using the Dean scale and CTCAE assessment, with no differences between groups (p = 0.12 and p = 0.38).ConclusionsA 20 min PICT is as effective as 45 and 90 min to prevent weekly paclitaxel-induced alopecia and should be the new standard of care.Trial registerClinicalTrials.gov Identifier: NCT03266185.

Prevention of Chemotherapy-induced Alopecia: Experience of a Cancer Center in Romania

"Background: Chemotherapy still represents the backbone of systemic treatment for many solid tumors. Alopecia remains one of its most distressing side effects. Scalp cooling is an effective strategy to reduce the risk of alopecia induced by chemotherapy, therefore this study aimed to assess the efficiency of DigniCap scalp-cooling system in our center. Material&Methods: 113 patients diagnosed with solid tumors, who underwent chemotherapy using the DigniCap scalp-cooling system in our center between January 2018 - December 2020, were included in the study. Alopecia was evaluated by the physician according to Dean’s scale at baseline and after the last cycle of chemotherapy. The primary endpoint was to evaluate scalp-cooling efficiency defined by a Dean's scale score of 0–2 (hair loss ≤50%). Results: 78 (72.3%) out of the 113 patients who used scalp cooling presented hair loss of 50% or less, the majority were females (91.2%) and had a diagnosis of breast cancer (49.6%) or gynecological cancer (27.4%). The mean number of chemotherapy cycles using DigniCap was 4.82 cycles. Hair loss greater than 50% of the scalp surface was observed in 27.7% of patients, the highest grade of alopecia being observed for anthracycline-based chemotherapy. No serious adverse events were reported. Conclusion: The results of this study support the evidence existing so far in the literature. Among patients who underwent chemotherapy for various cancer types, the DigniCap System significantly prevented hair loss and we consider that it should be integrated in the supportive care of patients."

Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer?

Despite U.S. Food and Drug Administration approval to reduce alopecia, data on efficacy of scalp cooling in Black patients with cancer are limited by lack of minority representation in prior clinical trials. Scalp cooling devices may have less efficacy in Black patients; additional studies are required to explore the possible causes for this, including hair texture and cap design. The Paxman scalp cooling (SC) device is U.S. Food and Drug Administration (FDA)-approved for prevention of chemotherapy-induced alopecia. Studies report 50%-80% success rates and high patient satisfaction, yet there have been no studies of SC in Black patients. We conducted a phase II feasibility study of Paxman SC with a planned enrollment of 30 Black patients receiving chemotherapy for stage I-III breast cancer. Black patients who planned to receive at least four cycles of chemotherapy with non-anthracycline (NAC) or anthracycline (AC) regimens were eligible. Alopecia was assessed by trained oncology providers using the modified Dean scale (MDS) prior to each chemotherapy session. Distress related to alopecia was measured by the Chemotherapy Alopecia Distress Scale (CADS). Fifteen patients enrolled in the intervention before the study was closed early because of lack of efficacy. Median MDS and CADS increased after SC, suggesting increased hair loss (p < .001) and alopecia distress (p = .04). Only one participant was successful in preventing significant hair loss; the majority stopped SC before chemotherapy completion because of grade 3 alopecia (>50% hair loss). SC may not be efficacious in preventing alopecia in Black women. Differences in hair thickness, hair volume, and limitations of cooling cap design are possible contributing factors.

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.

The DigniCap System is an effective scalp cooling device for the prevention of chemotherapy-induced alopecia in early breast cancer patients. This prospective study was designed to confirm the efficacy and tolerability of the device, to explore potential factors associated with its efficacy and to collect data on patient perceptions and satisfaction. Between January 2016 and June 2018, 163 early breast cancer patients eligible for adjuvant chemotherapy were enrolled. Hair loss was assessed using the Dean scale, where a score of 0-2 (hair loss ≤50%) was defined as successful. Hair preservation was successful in 57% of patients in the overall series. The proportion was even higher (81%) 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. Lifestyle, anthropometric factors and hair characteristics failed to be associated with device efficacy. The DigniCap System was well tolerated and found to be effective in preventing alopecia in early breast cancer patients. Our study failed to identify factors other than type of chemotherapy regimen associated with hair preservation.

Scalp cooling to prevent chemotherapy induced alopecia (CIA) in black patients: Differences in efficacy?

12101 Background: The Paxman scalp cooling device has been used for over 20 years to prevent CIA, obtaining FDA clearance in the U.S. in 2017. Prior studies reported 50-80% success and high patient satisfaction yet included few or no black patients. In the U.S. this may reflect disparities in access due to cost, awareness, or availability. We opened a prospective observational study combining patient-reported outcomes with clinical assessments of alopecia and planned to deliver scalp cooling to 30 black patients receiving chemotherapy for breast cancer. Methods: Patients who self-identified racially as black, had a new diagnosis of stage I-III breast cancer, and planned to receive chemotherapy with taxane-containing regimens were eligible. Anthracycline (AC) and non-anthracycline (NAC) chemotherapy agents were included; costs for the intervention were covered by Paxman and internal philanthropic funding. Patients who declined scalp cooling were approached for enrollment as controls. Primary endpoints were grade of alopecia as measured by providers and patient self-report using Modified Dean Scale and Visual Analog Scale (VAS) respectively. Hair preservation was defined as &lt;50% hair loss (&lt;grade 2) by Dean and score &lt; 50 on VAS. Secondary endpoints were alopecia by NCI grading scale and psychosocial from CADS and EORTC QLQ BR45 questionnaires. Results: 15 out of 30 planned participants enrolled by February 2020 with interim analysis and hold in accrual due to lack of efficacy. Four patients remain on treatment. Of 11 scalp cooling patients who completed chemotherapy, 0 prevented significant alopecia. Nine discontinued use of scalp cooling before completion (1 due to scheduling, 8 due to &gt;grade 3 alopecia). The 2 patients who used scalp cooling for the duration had &gt;grade 3 alopecia before the last cycle of treatment. Conclusions: Scalp cooling is an important supportive therapy that can reduce chance of alopecia, a bothersome side effect for patients. Our experience indicates decreased efficacy in black patients with both AC and NAC regimens. This is an important negative result to explore. Discussions with the Paxman team and providers with expertise in alopecia are underway to explore contributing factors such as hair thickness, prior hair treatments, and cap design. [Table: see text]

Use of scalp cooling device to prevent alopecia for early breast cancer patients receiving chemotherapy: A prospective study.

Chemotherapy-induced alopecia (CIA) affects the majority of patients receiving chemotherapy (CT) for early breast cancer. It is a highly distressing side effect of CT, with psychological and social impact. Primary aim of the present analysis was to assess the efficacy of scalp cooling with DigniCap® in preventing CIA. Success rate was defined as patients' self-reported hair loss <50% according to Dean scale. In this analysis, we reported success rate at 3weeks after the first CT course and at 3weeks after the last CT course. Secondary endpoints included self-reported tolerability and patients' judgment on scalp cooling performance. Consecutive early breast cancer patients admitted to Istituto Oncologico Veneto who were recommended to receive neoadjuvant or adjuvant CT, were eligible to undergo scalp cooling during the CT administration within this study. 135 patients were included: 74% received adjuvant CT and 26% neoadjuvant CT (P<.001). The type of CT was: docetaxel-cyclophosphamide (26%), paclitaxel (23%), epirubicin-cyclophosphamide followed by paclitaxel (32%), and paclitaxel followed by epirubicincyclophosphamide (19%). The rate of success in preventing alopecia was 77% (104/135) at 3weeks from the start of CT and 60% (81/135) at 3weeks from the end of treatment. Higher success rates were reported in non-anthracycline (71%) compared to anthracycline-containing CT regimens (54%; P<0.001). Premature discontinuation of scalp cooling was reported in 29/135 patients (21.5%), including withdrawal for alopecia (16/29), for low scalp cooling tolerability (8/29) or both (5/29). Scalp cooling was generally well tolerated. These results overall suggest that the use of scalp cooling is effective in preventing alopecia in the majority of early breast cancer patients receiving neoadjuvant or adjuvant CT, especially for patients undergoing a taxane-based non-anthracycline regimen.

Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines

BackgroundChemotherapy-induced alopecia (CIA) is a distressing side effect of cancer therapy. The trial aimed to assess feasibility and effectiveness of scalp-cooling system DigniCap® to prevent CIA in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT).MethodsHair loss (HL) was evaluated by patient self-assessment and by the physician according to the Dean’s scale at baseline and after each cycle of CT. The primary efficacy endpoint was the patient self-assessment HL score evaluated at least 3 weeks after completing CT. A Dean's scale score of 0–2 (i.e. HL ≤50%) was considered a success.ResultsFrom July 2014 to November 2016, 139 consecutive breast cancer patients were enrolled and received at least one treatment with scalp cooling. Fifty-six out of 131 evaluated patients successfully prevented HL (43%, 95% CI: 34–51%). Twenty-four patients (32%) discontinued the scalp cooling because of alopecia or scalp-cooling related AE, three patients had missing information on CIA, and 48 patients (64%) had a HL greater than 50% after CT. No serious AEs were reported.ConclusionsDigniCap® System resulted as a promising medical device to be safely integrated in supportive care of early breast cancer patients. Longer follow-up is needed to assess long-term safety and feasibility.Clinical trial registration numberNCT03712696.

Abstract P1-11-03: Impact of scalp cooling device (SCD) in preventing alopecia in women undergoing chemotherapy for breast cancer

Abstract Background. Alopecia (A) is a common and emotionally traumatic adverse effect for breast cancer (BC) patients (pts) undergoing chemotherapy (CT). Food and Drug Administration (FDA) cleared the DigniCap® SCD, for patients with breast cancer in 2015. This device was designed to reduce hair loss during chemotherapy. However, the impact of SCD in pts undergoing anthracycline and taxane-based sequential regimen is not entirely established. Thus, the aim of this analysis was to prospectively explore the role of SCD in a cohort of pts including also this regimen. Methods. From February 2016 to June 2018 patients with early/locally advanced breast cancer treated with neoadjuvant/adjuvant CT including anthracycline, taxane or both in sequential regimen were enrolled. The estimate of hair-loss was evaluated by photographs of the head using the Dean scale during and one month after the end of chemotherapy. Alopecia was graduated according to Dean scale: G0 = no A; G1 &amp;lt; 25% A; G2 = 25–50% A; G3 = 50–75% A; G4 &amp;gt; 75%. A score of 0-2 (≤ 50% hair loss) was defined as treatment success. Tolerability was defined as the percentage of patients who completed all chemotherapy cycles using the SCD. All patients received the Patient Symptoms Survey (self-reported). A database for individual data and information was appropriately fulfilled. Descriptive statistics was adopted. Results. Overall 121 pts were enrolled; 118 pts were evaluable for efficacy of Dignicap® SCD. Median age was 44 years (range: 24-74 years). CT regimens included docetaxel/cyclophosphamide (37 pts), epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2 iv) three weekly followed by 12 courses of paclitaxel (80 mg/m2 iv weekly) (84 pts). Alopecia all grade was showed in 52.5% (n=62): G1 in 35 pts (29.6%)and G2 in 23 pts (19.5%). No hair loss in 42 pts (35.6 %). Treatment success was seen in 103 pts (87.3%). Toxicity included grade 1/2 headache in 56 pts (47.4%), cervical discomfort in 36 pts (30.5%), pain of skin in one pts (8.5%). Discontinuation of SCD was seen in 28 pts (23.7%) primarily for headache G3 (4 pts – 3.4%), hair loss G3 in 15 pts (12.7%), discomfort in 8 pts (6.8%), use of head cover in one pt (0.8%). Conclusions. This prospective observational study suggests that SCD is effective in preventing A in a relevant number of patients (87.3%), undergoing also anthracyclines followed by taxanes regimen in sequential schedule. Citation Format: Paris I, Accetta C, Carbognin L, Di Giorgio D, Magno S, Terribile D, Franceschini G, Sanchez M, Ferrandina G, Pasciuto T, Fulvi A, Scambia G, Masetti R. Impact of scalp cooling device (SCD) in preventing alopecia in women undergoing chemotherapy for breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-03.

Abstract P1-17-04: Long-term safety follow-up of patients with early stage breast cancer treated with scalp cooling on the Dignitana scalp cooling trial

Abstract Background Scalp cooling has demonstrated efficacy in preventing hair loss in women with early stage breast cancer receiving neo/adjuvant chemotherapy. Data from 2 prospective trials (Rugo et al, and Nangia et al, JAMA 2017) led to FDA clearance of 2 automated scalp-cooling devices to prevent chemotherapy induced alopecia (CIA). Although scalp metastases from breast cancer are rare, historical concerns about scalp cooling included a theoretical increase in risk of recurrence in scalp due to reduced delivery of chemotherapy to the scalp. Methods We conducted a multicenter prospective trial evaluating the efficacy and safety of the DigniCap in women with stage I-II breast cancer receiving neo/adjuvant chemotherapy excluding sequential or combination anthracycline/taxanes with concurrent matched controls. The primary endpoint was unblinded patient self-assessment of 5 photographs using the Dean scale to estimate hair loss 4 weeks following the last dose of chemotherapy, with success defined as a Dean score of 0-2 (≤ 50% hair loss); additional endpoints included quality of life (QOL) and both short and long-term safety. Results 106 patients using the scalp cooling device and 16 concurrent controls were enrolled. As previously reported, the use of scalp cooling was associated with less alopecia and improvement in several measures of QOL (Rugo et al, JAMA 2017). 91 patients have follow-up (FU) out to 3 years; 73 with estrogen receptor (ER) positive and 18 with ER negative disease. 5 DigniCap patients have developed recurrent breast cancer in breast (n=1), liver (n=1), bone, liver and breast (n=1), bone, liver, lung, and nodes (1), and bone, breast, GI tract and bladder (n=1). Of 12 control patients with available FU, 1 developed metastases to liver. 2 patients have died of metastatic disease, one in the DigniCap arm and one in the control arm. No new safety signals have been detected. Conclusion Scalp cooling using the DigniCap system in patients with early stage breast cancer receiving taxane based neo/adjuvant chemotherapy is safe and effective. No scalp metastases have been reported 3 years following completion of study treatment. 4 year FU data will be presented. The study was funded by The Lazlo Tauber Family Foundation (UCSF), the Anne Moore Breast Cancer Research Fund (Weil Cornell), and the Friedman Family Foundation (Mount Sinai Beth Israel), as well as partially by Dignitana. Citation Format: Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, D'Agostino, Jr. RB, Deluca A, Cigler T. Long-term safety follow-up of patients with early stage breast cancer treated with scalp cooling on the Dignitana scalp cooling trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-17-04.

COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer.

Chemotherapy-induced alopecia (CIA) is a distressing side effect for women with breast cancer undergoing chemotherapy. Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Randomized trials until recently and at the time this trial was designed have been lacking. Patients undergoing (neo)adjuvant chemotherapy for early breast cancer (EBC) were randomized to scalp cooling (CAP) or observation (NoCAP). All patients received 18-24weeks of anthracycline- and/or taxane-based chemotherapy. The primary endpoint was patient-reported rate of alopecia according to a modified version of the Dean Scale. Hair preservation was defined as hair loss ≤ grade 2 (≤ 50%). Secondary endpoints were rate of alopecia determined by medical staff, rate of wig/scarf use, tolerability as well as quality of life (QoL). Seventy-nine patients were randomized. Hair preservation was observed in 39.3% of patients in the CAP arm versus 0% in the NoCAP arm (p < 0.001). Wig/scarf use was significantly less frequent in the CAP group (40.7% vs 95.5% outside home before cycle 3, p < 0.001). The drop-out rate was 31.7% and 34.2% in the CAP and NoCAP arm, respectively. Main reasons for drop-out were hair loss, adverse events (CAP), and randomization into control arm. We observed no differences in efficacy between anthracycline-based and non-anthracycline-based regimens. QoL did not differ between the study arms. This trial adds to the evidence that scalp cooling effectively prevents CIA in a meaningful number of patients. This option should be made available for patients undergoing (neo)adjuvant chemotherapy for EBC.

RELATIONSHIP BETWEEN FLUORIDE CONTENTS IN GROUNDWATER AND PREVALENCE OF FLUOROSIS IN TAY SON DISTRICT, BINH DINH PROVINCE, VIETNAM

The communities within Binh Dinh province in the Central Vietnam are reliant on groundwater as their primary supply of domestic and potable water. Meanwhile, it is seriously contaminated with fluoride that causing fluorosis problem for people. This study aims to investigate the link between severity of dental fluorosis rate in a population and fluoride concentration in drinking water in Tay Son area. A total of 50 well-water samples were collected and 220 people were surveyed by questionnaire from 50 households at 3 villages: Tay Phu, Binh Tuong, Tay Giang of Tay Son district, Binh Dinh province, Vietnam. The quantitative assessment of severity of dental fluorosis was done by calculating the Community Fluorosis Index (CFI) using Dean’s classification. Result of this study showed that fluoride concentration in well-water varied from 0.31 mg/L to 7.69 mg/L (mean 2.66 mg/L, SD: 2.18 mg/L) with 70 % of well-water samples above the maximum permissible limit of 1.5 mg/L of World Health Organization (WHO) drinking water standard. 100 % people surveyed was suffered from dental fluorosis and Dean scale of dental fluorosis ranged from level 2 to level 5. CFI varied from 3.45 to 4.13 above limit value (0.6). The community seriously suffered from dental fluorosis. The fluoride concentrations and Dean Index have high correlation (r = 0.580, p &lt; 0.0001). Based upon results of this study, it is recommended that the government should supply drinking water with appropriate fluoride content for this community.

COOLHAIR: A prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing neoadjuvant chemotherapy for early breast cancer.

525 Background: Chemotherapy induced alopecia (CIA) is a distressing side effect for women with breast cancer (BC) undergoing chemotherapy (CT). Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Observational studies show a positive effect of scalp cooling to reduce hair loss, but randomized trials until recently have been lacking. Methods: In our monocentric prospective randomized trial patients with early BC undergoing (neo)adjuvant CT were 1:1 randomized to either scalp cooling (CAP) or not (noCAP). All patients received 18 to 24 weeks of anthracycline (A) and/or taxane (T)-based CT. The DigniCap System was used for scalp cooling. The primary endpoint was patient reported rate of alopecia according to the Dean Scale (Grade 0: no hair loss, grade 1: &gt; 0 - 25%; grade 2: &gt; 25 - 50%; grade 3: &gt; 50 - 75%; grade 4: &gt; 75%). Hair preservation was defined as hair loss £ grade 2. Secondary endpoints were rate of alopecia determined by nursing staff and an independent and blinded evaluator, rate of wig/scarf use as well as quality of life. Results: From August 2014 until January 2016 seventy-nine patients were included (41 CAP and 38 noCAP). The drop-out rate was 32% in the CAP arm and 34% in the noCAP arm. Main reasons for drop out were hair loss, adverse events (CAP) and randomization into control arm. At the time of this analysis all patients had completed CT. Hair preservation was observed in 39% of patients in the CAP arm versus 0% in the No CAP arm (p &lt; 0.001). There was a strong concordance between patients and staff evaluation (weighted Cohen's Kappa = 0.92). Wig/scarf use was significantly less frequent in the CAP group (36% vs 92% at home, p &lt; 0.001; 64% vs 91% outside, p &lt; 0.001). We did not observe any differences in hair preservation between A-based and non A-based regimens. Conclusions: Our prospective randomized trial shows that scalp cooling is effective in preventing CIA in a relevant number of patients. This option should be made available for patients undergoing T+/-A-based (neo)adjuvant chemotherapy for EBC.

Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

Chemotherapy-induced alopecia is a common and distressing adverse effect. In previous studies of scalp cooling to prevent chemotherapy-induced alopecia, conclusions have been limited. To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life. A prospective cohort study conducted at 5 US medical centers of women with stage I or II breast cancer receiving adjuvant or neoadjuvant chemotherapy regimens excluding sequential or combination anthracycline and taxane (106 patients in the scalp cooling group and 16 in the control group; 14 matched by both age and chemotherapy regimen). The study was conducted between August 2013 and October 2014 with ongoing annual follow-up for 5 years. Use of a scalp cooling system. Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward. Self-estimated hair loss using the Dean scale was assessed 4 weeks after the last dose of chemotherapy by unblinded patient review of 5 photographs. A Dean scale score of 0 to 2 (≤50% hair loss) was defined as treatment success. A positive association between scalp cooling and reduced risk of hair loss would be demonstrated if 50% or more of patients in the scalp cooling group achieved treatment success, with the lower bound of the 95% CI greater than 40% of the success proportion. Quality of life was assessed at baseline, at the start of the last chemotherapy cycle, and 1 month later. Median follow-up was 29.5 months. Among the 122 patients in the study, the mean age was 53 years (range, 28-77 years); 77.0% were white, 9.0% were black, and 10.7% were Asian; and the mean duration of chemotherapy was 2.3 months (median, 2.1 months). No participants in the scalp cooling group received anthracyclines. Hair loss of 50% or less (Dean score of 0-2) was seen in 67 of 101 patients (66.3%; 95% CI, 56.2%-75.4%) evaluable for alopecia in the scalp cooling group vs 0 of 16 patients (0%) in the control group (P < .001). Three of 5 quality-of-life measures were significantly better 1 month after the end of chemotherapy in the scalp cooling group. Of patients who underwent scalp cooling, 27.3% (95% CI, 18.0%-36.6%) reported feeling less physically attractive compared with 56.3% (95% CI, 31.9%-80.6%) of patients in the control group (P = .02). Of the 106 patients in the scalp cooling group, 4 (3.8%) experienced the adverse event of mild headache and 3 (2.8%) discontinued scalp cooling due to feeling cold. Among women undergoing non-anthracycline-based adjuvant chemotherapy for early-stage breast cancer, the use of scalp cooling vs no scalp cooling was associated with less hair loss at 4 weeks after the last dose of chemotherapy. Further research is needed to assess outcomes after patients receive anthracycline regimens, longer-term measures of alopecia, and adverse effects. clinicaltrials.gov Identifier: NCT01831024.

Abstract P2-12-11: Use of the DigniCap™ System to Prevent Hair Loss in Women Receiving Chemotherapy (CTX) for Stage I Breast Cancer (BC)

Abstract Background: Alopecia is a non-life threatening complication of adjuvant CTX for early stage BC. CTX induced hair loss affects quality of life and potentially impacts decisions regarding the risks and benefits of treatment. Scalp cooling (SC), used internationally by thousands of patients (pts) including a growing number in the U.S., is thought to prevent hair loss through decreased follicular metabolic rate and vasoconstriction resulting in reduced delivery and cellular uptake of drugs. The DigniCap™ System is a self-contained SC system with circulating coolant. We sought to evaluate feasibility and efficacy of the DigniCap™ System in pts with stage I BC. Methods: We performed an initial prospective feasibility study before a planned pivotal trial. The primary endpoint was feasibility, defined as &amp;lt;50% of pts discontinuing cap use due to cap-associated toxicity. Secondary endpoints included prevention of hair loss (HL) assessed by an independent panel (IP) consisting of a hairdresser, patient advocate, and dermatologist using photographs taken from 5 angles and blinded to pt and CTX cycle using the 5 point Dean's scale for HL: grade 0 (no HL), 1 (&amp;lt; 25% HL), 2 (25–50% HL), 3 (50–75% HL), and 4 (&amp;gt;75% HL). Pts assessed their own HL using the Dean's scale, and pt-assessed quality of life, time to and quality of hair re-growth, and impact of HL on treatment decisions were also evaluated. Successful prevention of alopecia was defined as &amp;lt; grade 2 HL by the Dean's scale. Eligibility included stage I disease and excluded use of anthracycline-taxane combination or sequential CTX. Results: 20 pts were enrolled. CTX regimens included: docetaxel and cyclophosphamide (TC) × 4–6 cycles (n = 16), weekly paclitaxel and trastuzumab × 12 (n = 2), and docetaxel, carboplatin, and trastuzumab (TCH) × 6 (n = 2). 19 of 20 pts (95%) completed all CTX using the DigniCap™ System. By IP assessment, 15 pts (75%) had a maximum of ≤ grade 2 HL; 2 pts (10%) and 3 pts (15%) had a maximum grade 3 or 4 HL respectively. By pt assessment, 11 pts (55%) reported ≤ grade 2 HL. 68% and 32% of pts reported grade 1 or 2 toxicity, respectively, including head/scalp pain, feeling chilled, and rash. 85% of pts reported that SC made decisions about CTX easier. At a median follow-up of 15.4 months, no scalp metastases have been observed. Conclusions: Use of the DigniCap™ System is feasible, effective in preventing CTX-induced alopecia in the majority of users, and safe with short-term follow-up in pts with stage I BC. Additional studies should help to define potential causes for cap failure. This is the first prospective US trial to evaluate the effect of SC using an expert IP and blinded photographs to assess extent of alopecia. A larger trial is planned to confirm these results in pts with stage I/II disease. Support for this trial was provided by the Tauber Foundation (UCSF), the Madonia and Cooper Funds (WFBH), and Dignitana. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-12-11.

Abstract P2-12-12: Efficacy and safety of scalp cooling (SC) treatment for alopecia prevention in women receiving chemotherapy (CTX) for breast cancer (BC).

Abstract Background: CTX induced hair loss (HL) is one of the most distressing side effects of BC treatment. Compared to women without CTX induced alopecia, those with alopecia have reported poorer body image, lower self-esteem and worse quality of life. In some cases, CTX induced HL may affect choice of therapy. Given the emotional impact of HL, the potential benefit of preventing CTX induced alopecia is great. We conducted a registry study tracking safety and efficacy in BC patients (pts) treated at our center who independently elected to use Penguin Cold Cap Therapy (PCCT). Methods: Pts who chose to use PCCT during CTX for early stage (ES) or advanced (M) disease signed informed consent to participate in the registry. HL was rated by practitioner assessment using the 5 point Dean's scale for HL: grade 0 (no HL), 1 (&amp;lt; 25% HL), 2 (25–50% HL), 3 (50–75% HL), and 4 (&amp;gt;75% HL), and by pt assessment using a visual analogue scale (VAS) from 0–100 where 0 = no HL and 100 = 100% HL. Assessments were every 2–3 weeks at the start of each CTX cycle, and once in follow-up 1–6 months after completing CTX. Additional data collected included pt reported adverse events and pt satisfaction with the success, ease of use, and tolerability of PCCT. Results: 31 pts (29 with ES and 2 with M disease) have registered. 25 have completed CTX and 20/25 are off study. 6 pts currently on CTX and 2 pts who stopped PCCT after cycle1 due to toxicity of CTX rather than issues with PCCT were excluded from the safety and efficacy analyses due to incomplete data. 2 additional pts were excluded from efficacy analysis due to beginning PCCT after the start of CTX, leaving 21 pts evaluable for efficacy and 23 pts for toxicity. CTX regimens included: docetaxel and cyclophosphamide (TC), docetaxel, carboplatin and trastuzumab (TCH), sequential doxorubicin and cyclophosphamide and paclitaxel, (AC/T), weekly nab-paclitaxel (nab). PCCT toxicities were all &amp;lt; grade 2 and included: 15 pts (71%) with headaches and 5 (22%) with dandruff during PCCT. All pts experienced head pain, and 20 pts (95%) had scalp pain and felt chilled during the PCCT. Table 1 depicts clinician and patient reported efficacy. Of the 20 pts assessed following completion of CTX and PCCT, 12 (60%) “highly recommend” PCCT, and 8 (40%) “recommend to some degree”. No ESBC pts have worn a wig at any point. Conclusions: SC treatment (PCCT) is a viable but variably effective method of preventing HL for ESBC pts receiving CTX. The success of SC in hair preservation was dependent on the type and length of CTX regimen. Other patient factors impacting HL may exist. Short term toxicity is minimal. Given the emotional impact of CTX induced HL, ongoing study of PCCT and other SC devices, comparing different CTX regimens, is worthwhile. Ongoing studies at our center will include independently graded photographs to eliminate reporting bias by the clinician. Support for this trial was provided by the Tauber Foundation. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-12-12.