Abstract P5-10-02: Decreased rates of chemotherapy-induced alopecia in patients receiving chemotherapy (including anthracyclines) with use of scalp-cooling devices
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Abstract BACKGROUND: Chemotherapy-induced alopecia (CIA) is a frequent complication that is mostly reversible, however permanent alopecia has been associated with some curative adjuvant regimens. CIA can be decreased through the use of scalp-cooling devices (SCDs) averting the negative psychosocial impact from the change in appearance, however there is little data on the worth of SCDs, especially in anthracycline-based adjuvant regimens. METHODS: We conducted a retrospective study of 87 women and 3 men with either breast (n=74), ovarian, endometrial or gastric malignancies receiving adjuvant or neoadjuvant chemotherapy at a single infusion center located within a community hospital. We included data for all patients who completed chemotherapy between June 2016 and May 2018, and received SCDs with at least one cycle. All patients were given a list of rules (see below) that would allow the caps to be comfortable, and fit properly. Objective hair-loss (using Common Terminology Criteria for Adverse Events scale, v4.03) was assessed by the same nurse twice - prior to their first session of chemotherapy, and again after the final one. If patients did not continue with SCDs for all chemotherapy cycles, their alopecia grade was assessed at the time of discontinuation. The patients were divided into four groups for analysis based on the chemotherapy regimen: (a) taxane-based, (b) anthracyclines only, (c) combination of anthracyclines & taxane, and those that (d) received neither anthracyclines or taxanes. The taxane-based group included patients who received any of the following: Abraxane, paclitaxel, Abraxane-Herceptin, taxol/carboplatin, TC, TCH, TCHP, TH or THP. All patients used the Dignicap™ Cold-Cap, and each patient had a designated capper for each chemotherapy session. A capper is a caregiver specifically trained to facilitate the appropriate fitting and use of a scalp-cooling device during chemotherapy. RESULTS: Among the 90 patients (Table 1), 29 received anthracyclines (86% in combination with taxanes). Of these, 18 (62%) had alopecia grade 1 after completing treatment. Out of the 36 taxane-based patients to be both compliant and received SCD with all chemotherapy cycles, 33 (92%) had grade 1 alopecia. In the cohort of 7 patients who received neither anthracyclines or taxanes, none had an alopecia grade of 2. Overall compliance was 89%. CONCULSION: At our community-based infusion center, SCDs reduced rates of CIA with all regimens of chemotherapy, including those receiving anthracycline-based chemotherapy (32% of total patients). The low rate of alopecia is most likely facilitated by educating the patients on hair-care in between cycles and the use of a capper for each patient. Compliance with our rules can improve efficacy of cold-caps and can be beneficial in preventing alopecia. Cold Cap Patient RulesHair washed weekly with sulfate-free shampooDry shampoo allowedNo cutting/color-processing of hairPowder color products allowedNo blow dryersComb hair daily with wide tooth combs onlyElectric warming blankets during chemotherapy Table 1: Summary of resultsChemotherapy Regime (n=90)Grade 1 alopecia, n (%)Grade 2 alopecia, n (%)Taxane (54)43 (80)11 (20)Combination of anthracyclines & taxanes (25)15 (60)10 (40)Anthracycline only (4)3 (75)1 (25)Neither anthracycline or taxane (7)7(100)0 (0) Citation Format: Angad Deengar, Linda Vahdat, Maxim Dulgher. Decreased rates of chemotherapy-induced alopecia in patients receiving chemotherapy (including anthracyclines) with use of scalp-cooling devices [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-10-02.Keywords:
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Regimen
Carboplatin
Chemotherapy regimen
Discontinuation
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e12045 Background: 3rd generation adjuvant chemotherapy regimens for breast cancer include FEC every three weeks (Q3W) x 3 cycles and Docetaxel (D) Q3W or weekly paclitaxel (P1W) x 9 weeks (FEC-D/P1W) and AC Q3W x 4 followed by P1W x 12 weeks or D x 4 cycles (AC-P1W). These regimens were developed independently and have not been directly compared. Real world effect of weekly paclitaxel schedule is unknown. Methods: Women with stage 1-3 breast cancer who received 3rd generation adjuvant chemotherapy (with 1 year of adjuvant trastuzumab if HER2+) between 2010-2015 inclusive were identified in the New Zealand Breast Cancer Database. Taxane regimens Q3W D and P1W were grouped for analysis. We compared 5 year overall survival (OS) between shorter FEC-D/P1W (total 6 cycles) and longer AC-P1W or Docetaxel Q3W x 4 cycles (total 8 cycles). Patients who received other taxane schedules or non-standard duration of chemotherapy were excluded. Results: 772 women received the FEC-D/P1W regimen and 488 were treated with AC-P1W. The FEC-D/P1W had more grade II/III disease (96.4% v 93.8%), BMI ≥30 (44.7% v 34.5%), HER2 positive (37.8% v 23.6%) and higher chemotherapy completion rate (95.1% v 83.8%). The AC-P1W cohort had higher nodal positive cases (97.1% v 80.6%). Univariate analysis showed no statistical significance for age, BMI, ethnicity, histological subtype and surgery type but tumour grade, stage and hormone status were significant. We constructed a cohort (n = 926) matched for these factors. After median follow up 27 months, 5yr OS for case matched cohort is 87.4% for FEC-D/P1W v 86.4% for AC-D/P1W (p = 0.825) with HR 0.96 (95%CI 0.67-1.38) in favour of FEC-D/P1W. Conclusions: These results suggest one can de-escalate chemotherapy by using a 6 cycle anthracycline/taxane regimen offering an opportunity to reduce the burden of chemotherapy without compromising survival.
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背景：Neoadjuvant 化疗为潜在的预兆的因素的评估提供一个优秀模型。这研究的目的是在与 neoadjuvant taxane 和 anthracycline 化疗对待的乳癌病人评估不同生物因素的预兆的价值。方法：与 neoadjuvant taxanes 和 anthracycline 的 4 个周期对待的 135 个病人在这回顾的研究被包括。用预告的处理活体检视材料，免疫组织化学的研究为雌激素受体被执行(嗯) ，孕酮受体(PgR ) ， HER-2， Ki-67 和 p53 蛋白质表示。在生物标记和临床、病理学的完全的反应(pCR ) 之中的协会被分析。结果：全面临床的反应是 86% ，包括 33% 临床的完全的反应(cCR ) 和 53% 临床的部分反应。pCR 只是 17% 。在 univariate 分析，仅仅在表示上的 HER-2 到 neoadjuvant 化疗(P=0.018 ) 的 cCR 是预兆的。在另外的生物因素和 cCR 之间的重要协会都没被发现。缺席嗯， PgR 表示并且 pCR 在 HER-2 的表示上是预兆的(P=0.002， 0.001， 0.01，分别地) 。Ki-67 和 p53 没能与 pCR 显示出一个协会。在里面多变量分析，在在预言 cCR (P=0.021 ) 作为一个独立变量仍然是的 HER-2 的表示上。然而，否定嗯是在预言 pCR (P=0.001 ) 维持了统计意义的唯一的参数。结论：病人与在 HER-2 和否定神经质的受体的表示上，地位是更可能的与相反的特征比那些对 neoadjuvant taxane 和 anthracycline 化疗作出回应。这些因素能为这政体用作预兆的标记。
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Neoadjuvant Therapy
Univariate analysis
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客观 Anthracycline 和 taxane 是在先进乳癌的联合化疗的标准代理人。然而，这些代理人什么时候基于化疗，是失败，抢救政体的选择仍然具有问题。Gemcitabine，在两肺癌症的一个活跃代理人和胰癌症，被表明在胸 caner 有效。但是有相对在 anthracycline 或 taxane 抵抗的乳癌的 gemcitabine 的更少的数据。因此我们雇员探索 gemcitabine 的功效和安全的这研究在这张人口基于联合政体。从 2002 年 5 月的方法到 2006 年 3 月，对优先的 anthracycline 和 taxane 抵抗的有先进变形乳癌的可测量的损害的 28 个病人基于化疗被注册。病人们与 gemcitabine 被对待基于的联合化疗与一 3 的中部的周期(范围 2 6 ) 。结果全面反应率是 28.6%(8/28 ) ，与 1 CR (完成反应 3.5%) 并且 7 PR (部分反应 25%) 。当疾病在 12 patiens (42.8%) 进行了时，稳定的疾病在 8 个病人(28.6%) 被看见。前进的中部的时间是 4.5 m (范围， 2 23 m ) 。主要毒性包括了骨髓消沉，脱发，粘膜炎和外部 neurotoxicity。等级 3 ～ 4 临床的不利效果在 8 种情况(30%) 中是在 5 种情况(17.9%) 和血小板减少中的白细胞减少。结论 Gemcitabine 基于联合政体在 anthracycline 和 taxane 抵抗的先进乳癌是可行的。临床的反应和 TTP 与有限毒性模式是可接受的。
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Objective To explore the relationship between HER-2 expression and the efficacy of different breast cancer adjuvant chemotherapy for screening of effective chemotherapy.Methods 308 cases ofⅠ-Ⅲ breast cancer patients were adjuvant chemotherapyed with three kinds of programs of anthracycline and(or) taxane,HER-2 expression was detected by immunohistochemistry SP samples,the median follow-up 45.00(13.2 ~ 94.1) months,and analysis the relationship among chemotherapy and pathological features(HER-2 status,hormone receptor status,pathological stage) and the survival rate.Results Overall recurrence rate 22.07%(68/308),the average time to progression 27.58 months.In HER-2 positive patients,disease-free survival in anthracycline chemotherapy groupis DFS(135/191),in taxane group chemotherapyis DFS(15/16),and the difference was significant(x2= 3.938,P0.05);the difference between DFS(35/39) in Anthracycline-taxane combination group and that in anthracycline chemotherapy group was significant(x2 = 6.104,P 0.05).In hormone receptor-positive patients,the difference between DFS(116/165) in anthracycline-chemotherapy group and DFS(19/20) in taxol chemotherapy was significant(x2=5.517,P0.05).In the axillary lymph node-positive patients,the difference of the disease-free survival between DFS(73/113) in anthracycline chemotherapy group and DFS17/19 in taxane chemotherapy was significant(x2=4.638,P0.05);the difference between DFS(36/41) in anthracycline-taxane combination group and that in anthracycline was significant(x2 =7.831,P 0.01).Conclusion Breast cancer patients of HER-2 positive were more sensitive to taxane chemotherapy drug,The efficacy of taxane on the hormone receptor-positive patients is better than that of anthracycline,and the efficacy of taxane and anthracycline on the hormone receptor-negative patients was not significantly different.The efficacy of anthracycline-taxane combined and taxane on lymph node-positive is better than that in anthracycline,and the efficacy of anthracycline and taxane and the combined drugs on lymph node-negative is rather.
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Abstract Background: Anthracycline and taxane-containing chemotherapy regimens reduce the rate of breast cancer recurrence by about one third compared to no chemotherapy. However, concerns about the increased risks of cardiac toxicity and leukaemia with anthracyclines have resulted in wider use of taxane chemotherapy schedules without anthracycline, in particular docetaxel-cyclophosphamide (DC). The benefits and risks of this approach have been assessed in several randomised trials but with conflicting results. Methods: We did an individual patient-level meta-analysis of data on 16,500 participants from 13 randomised controlled trials starting before 2010. Four compared 6 courses of DC with and without concurrent anthracycline (Anth), six compared sequential Anth then taxane (3 or 4 courses of Anth then 3 or 4 D, or vice versa) versus 6 courses of DC (resulting in a higher cumulative dose of taxane in the DC group), and 3 compared sequential Anth + D versus other taxane schedules. Primary outcomes were time to invasive breast cancer recurrence (distant, loco-regional, or new contralateral breast primary) and breast cancer mortality (by log-rank subtraction). Log-rank analyses were used to assess the first-event-rate ratio (RR) and confidence intervals. Pre-specified subgroup investigations included site of recurrence, age, ER/PR status, nodal status, tumor diameter, grade and HER2 status. Results: Overall, patients treated with an anthracycline and taxane combination averaged 18% lower rates of breast cancer recurrence (RR 0.82, 95%CI 0.75-0.90; p<0.0001) than those receiving a taxane schedule without anthracycline, equating to an absolute reduction of 3.1% (95%CI 1.4-4.8) in 10-year recurrence. The 10-year risk of death from breast cancer was reduced by 1.8% (RR 0.85, 95%CI 0.75-0.95; p=0.006) with no increase in deaths without recurrence. The proportional reduction in recurrence was greatest in trials of concurrent Anth + DC versus DC (RR 0.66, 95%CI 0.55-0.79; p<0.0001), where the only difference between arms was the addition of anthracycline (cumulative dose of doxorubicin≈300mg/m2). By contrast, in trials of sequential Anth + D versus the higher cumulative taxane dose DC regimen there was no significant benefit from Anth (cumulative dose of epirubicin≈300mg/m2): RR 0.93, 95%CI 0.80-1.07; p>0.1. In sub-group analyses of all trials, the benefit of anthracycline and taxane chemotherapy persisted throughout years 0-1, 2-4 and 5-9 with little data beyond year 10. There was a similar and highly significant proportional reduction in recurrence in ER-positive and in ER-negative disease and the RRs for recurrence did not differ significantly by any other pre-specified group including age, nodal status, tumor diameter, grade and HER2 status. There were no significant increases in deaths from cardiovascular disease or leukaemia, though longer follow-up is needed to fully assess risks. Conclusion: The addition of anthracycline to taxane chemotherapy, compared to taxane alone reduced the risk of breast cancer recurrence by 18% with larger proportional reductions in trials of DC ± concurrent Anth, in which the taxane dose was the same in both groups and the cumulative anthracycline dose was higher. Citation Format: Jeremy Braybrooke, Rosie Bradley, Richard Gray, Robert Hills, Zulian Liu, Hongchao Pan, Richard Peto, Joanne Blum, Xiaosong Chen, Bent Ejlertsen, Wolfgang Janni, Ulrike Nitz, Dennis Slamon, Masakazu Toi, Toru Watanabe, Sandra Swain, Jonas Bergh, on behalf of the Early Breast Cancer Trialists Collaborative Group. Taxane with anthracycline versus taxane without anthracycline: An individual patient-level meta-analysis of 16,500 women with early-stage breast cancer in 13 randomised trials [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr GS2-06.
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Introduction: Chemotherapy is the only systemic treatment option for triple-negative breast cancer (TNBC) patients, and is often used in combination with anthracycline and taxane. However, it was reported that many TNBCs show BRCA dysfunction, and are sensitive to DNA-damaging agents, but tend to be resistant to mitotic poisons, such as taxanes. Case Series: Triple-negative breast cancer patients who underwent neoadjuvant chemotherapy with anthracycline followed by taxane were analyzed. Clinical responses to taxane were evaluated by the percentage of shrinkage in tumor size after anthracycline treatment. BRCAness was analyzed by mutiplex ligation-dependent probe amplification (MLPA) in core-needle biopsy specimens of 7 patients with progressive disease or stable disease after taxane treatment. BRCAness scores of the 7 patients were between 0.779 and 1.000 (0.939 ± 0.084), and all were categorized as having BRCAness. Conclusion: Patients resistant to taxane were categorized as having BRCAness by MLPA. Mutiplex ligation-dependent probe amplification may hence be a promising method to identify TNBC patients with taxane resistance.
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Eribulin mesylate has efficacy in patients who have received ≥2 prior chemotherapies for metastatic breast cancer (MBC) including an anthracycline and taxane. Phase 2 trials showed clinical activity and acceptable tolerability of first-line eribulin (HER2- MBC; Study 206) and eribulin plus trastuzumab (HER2+ MBC; Study 208). Prespecified analyses evaluated efficacy by prior anthracycline and/or taxane use. Patients received eribulin mesylate (1.4 mg/m(2) IV; Days 1 and 8) and, in Study 208, trastuzumab (8 mg/kg IV/Cycle 1, then 6 mg/kg; Day 1) in 21-day cycles. Endpoints included objective response rate (ORR), progression-free survival (PFS), and tolerability. In Study 206 (N = 56), 48 % of patients had received prior anthracycline, 46 % prior taxane, 36 % prior anthracycline and taxane, and 41 % were chemotherapy-naïve. In Study 208 (N = 52), these percentages were 21, 44, 17, and 52 %, respectively. In Study 206, ORR and median PFS were similar for anthracycline-pretreated (25.9 %, 5.8 months), taxane-pretreated (26.9 %, 5.8 months), anthracycline- and taxane-pretreated (25.0 %, 6.7 months), and anthracycline/taxane-naïve patients (30.4 %, 7.6 months). In Study 208, ORR/median PFS were 63.6 %/6.7 months among anthracycline-pretreated patients, 56.5 %/6.8 months among taxane-pretreated patients, 55.6 %/5.9 months among anthracycline- and taxane-pretreated patients, and 81.5 %/13.1 months among anthracycline/taxane-naïve patients. Tolerability was generally similar among subgroups. In these studies, first-line eribulin in HER2- MBC and eribulin/trastuzumab in HER2+ MBC was effective with acceptable tolerability, regardless of prior anthracycline/taxane treatment. Prior chemotherapy was associated with lower ORR and shorter PFS with eribulin/trastuzumab in HER2+ MBC but not with eribulin in HER2- MBC.
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Tolerability
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It's widely accepted that adjuvant chemotherapy and endocrine treatment significantly improved DDFS and OS in breast cancer . Nowaday, The chemotherapeutic drugs of anthracycline and taxane are used widely in breast cancer. It was proved that taxane alone can get more benefit than anthracycline alone in breast cancer. The combining chemotherapy of anthracycline and taxane can improve clinical outcomes because of their different anticancer mechanism, but how to use them perfectly is a hot topic. Another interesting avenue of investigation regarding adjuvant therapy relates to the utilization of prognostic and predictive biomarkers to quantify risk for recurrence and to identify populations of patients who benefit more or less from treatment in adjuvant chemotherapy of early-Stage breast cancer .
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Adjuvant Chemotherapy
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