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Abstract P6-11-14: Safety and effectiveness of sensor-controlled scalp cooling to prevent alopecia in primary breast cancer patients receiving neoadjuvant or adjuvant epirubicin, taxanes, or both
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Abstract
Background: Chemotherapy (Ctx)-induced alopecia (CIA), produces a deep psychological distress in many women involved. Sensor-controlled scalp cooling (SCSC) is now approved by the FDA due to both its effectiveness and safety to prevent CIA demonstrated in two randomized trials in patients (pts) with primary breast cancer (PBC). However, SCSC is still infrequently used in many countries due to physicians´ concerns regarding both its safety and feasibility, in particular regarding anthracycline-based Ctx [Nangia et al., 2017]. This retrospective analysis was initiated to obtain more detailed information on the effectiveness and safety of SCSC using the Paxman system (Paxman, Huddersfield, UK) in PBC pts exposed to CIA-inducing neoadjuvant (NACT) or adjuvant Ctx (ACT) based on epirubicin (E), taxanes (T), or both (ET) in the clinical routine. Methods: 79 pts who underwent SCSC alongside with Ctx for PBC from 2014-2017 were identified from our database: NACT, 41 (51.9%); ACT, 38 (48.1%); dose-dense (dd) Ctx, 56 (70.9%); non-dd Ctx 23 (29.1%); premenopausal, 44 (55.7%); postmenopausal, 35 (44.3%). The following Ctx regimens were used: E, 1 (1.3%); T, 23 (29.1%); ET, 55 (69.6%). Pts were subjected to SCSC during each Ctx cycle. CIA was quantified according to the Dean score (DS) determined 3 wks after the last Ctx cycle. Data were analyzed regarding feasibility indicated by the SCSC completion rate, quality of hair preservation (success: DS 0-2, failure: DS 3-4), reasons of SCSC discontinuation, and safety. Moreover, the following parameters were investigated in regard to the success of SCSC: menopausal status (pre- vs postpenopausal), NACT vs ACT, dd Ctx vs non-dd Ctx, E- or ET-based Ctx vs T-based Ctx. Results: 55 pts (69.6%) completed SCSC, with 36 (45.6%) experiencing complete hair preservation (DS 0), and 19 (22.8%) showing partial success (DS 1-2). 24 pts (30.4%) discontinued SCSC, with CIA being the main reason in 18 pts (22.8%). Headache or earache was reported in 2 pts (1.3%) each, and local discomfort in another 4 pts (5.1%). Side effects were all not severe and resolved quickly after cessation of SCSC. SCSC was equally effective in most analyzed subgroups. The relative risk (RR) to experience CIA was 1.11 (CI: 0.82-1.54) for post- vs premenopausal pts, 1.11 (CI: 0.83-1.53) for ACT vs NACT, and 0.99 (CI: 0.72-1.43) for dd Ctx vs non-dd Ctx. Pts receiving E or ET had a significantly higher RR for SCSC failure: 1.39 (CI: 1.04-1.81, p=0.035). However, the success rate in this group was still 62.5%, thus clearly indicating a clinically meaningful benefit. Conclusions: In our study, SCSC was feasible, safe and effective in order to prevent CIA in pts with PBC. All therapeutic subgroups benefited from SCSC. Although patients on E or ET are at higher risk for CIA, the success rate in this subgroup indicates that SCSC can be reasonably offered to patients subjected to NACT or ACT with epirubicin-containing regimens.
Citation Format: Kurbacher CM, Kurbacher AT, Herz S, Kolberg G, Kettelhoit N, Schweitzer C, Kurbacher JA, Eichler C. Safety and effectiveness of sensor-controlled scalp cooling to prevent alopecia in primary breast cancer patients receiving neoadjuvant or adjuvant epirubicin, taxanes, or both [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-14.
American Association for Cancer Research (AACR)
Title: Abstract P6-11-14: Safety and effectiveness of sensor-controlled scalp cooling to prevent alopecia in primary breast cancer patients receiving neoadjuvant or adjuvant epirubicin, taxanes, or both
Description:
Abstract
Background: Chemotherapy (Ctx)-induced alopecia (CIA), produces a deep psychological distress in many women involved.
Sensor-controlled scalp cooling (SCSC) is now approved by the FDA due to both its effectiveness and safety to prevent CIA demonstrated in two randomized trials in patients (pts) with primary breast cancer (PBC).
However, SCSC is still infrequently used in many countries due to physicians´ concerns regarding both its safety and feasibility, in particular regarding anthracycline-based Ctx [Nangia et al.
, 2017].
This retrospective analysis was initiated to obtain more detailed information on the effectiveness and safety of SCSC using the Paxman system (Paxman, Huddersfield, UK) in PBC pts exposed to CIA-inducing neoadjuvant (NACT) or adjuvant Ctx (ACT) based on epirubicin (E), taxanes (T), or both (ET) in the clinical routine.
Methods: 79 pts who underwent SCSC alongside with Ctx for PBC from 2014-2017 were identified from our database: NACT, 41 (51.
9%); ACT, 38 (48.
1%); dose-dense (dd) Ctx, 56 (70.
9%); non-dd Ctx 23 (29.
1%); premenopausal, 44 (55.
7%); postmenopausal, 35 (44.
3%).
The following Ctx regimens were used: E, 1 (1.
3%); T, 23 (29.
1%); ET, 55 (69.
6%).
Pts were subjected to SCSC during each Ctx cycle.
CIA was quantified according to the Dean score (DS) determined 3 wks after the last Ctx cycle.
Data were analyzed regarding feasibility indicated by the SCSC completion rate, quality of hair preservation (success: DS 0-2, failure: DS 3-4), reasons of SCSC discontinuation, and safety.
Moreover, the following parameters were investigated in regard to the success of SCSC: menopausal status (pre- vs postpenopausal), NACT vs ACT, dd Ctx vs non-dd Ctx, E- or ET-based Ctx vs T-based Ctx.
Results: 55 pts (69.
6%) completed SCSC, with 36 (45.
6%) experiencing complete hair preservation (DS 0), and 19 (22.
8%) showing partial success (DS 1-2).
24 pts (30.
4%) discontinued SCSC, with CIA being the main reason in 18 pts (22.
8%).
Headache or earache was reported in 2 pts (1.
3%) each, and local discomfort in another 4 pts (5.
1%).
Side effects were all not severe and resolved quickly after cessation of SCSC.
SCSC was equally effective in most analyzed subgroups.
The relative risk (RR) to experience CIA was 1.
11 (CI: 0.
82-1.
54) for post- vs premenopausal pts, 1.
11 (CI: 0.
83-1.
53) for ACT vs NACT, and 0.
99 (CI: 0.
72-1.
43) for dd Ctx vs non-dd Ctx.
Pts receiving E or ET had a significantly higher RR for SCSC failure: 1.
39 (CI: 1.
04-1.
81, p=0.
035).
However, the success rate in this group was still 62.
5%, thus clearly indicating a clinically meaningful benefit.
Conclusions: In our study, SCSC was feasible, safe and effective in order to prevent CIA in pts with PBC.
All therapeutic subgroups benefited from SCSC.
Although patients on E or ET are at higher risk for CIA, the success rate in this subgroup indicates that SCSC can be reasonably offered to patients subjected to NACT or ACT with epirubicin-containing regimens.
Citation Format: Kurbacher CM, Kurbacher AT, Herz S, Kolberg G, Kettelhoit N, Schweitzer C, Kurbacher JA, Eichler C.
Safety and effectiveness of sensor-controlled scalp cooling to prevent alopecia in primary breast cancer patients receiving neoadjuvant or adjuvant epirubicin, taxanes, or both [abstract].
In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX.
Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-14.
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