Adjuvant Chemotherapy For Breast Cancer Research Articles

Changes in vitamin D and calcium metabolism markers in patients undergoing adjuvant chemotherapy for breast cancer

BackgroundChanges in calcium metabolism and calcium urinary excretion during chemotherapy have not been thoroughly assessed in patients with early breast cancer (EBC), a population who frequently present vitamin D insufficiency. As hypercalciuria is a classical contra-indication to vitamin D (VD) supplementation, this study evaluated changes in VD and calcium metabolism parameters in patients with EBC undergoing adjuvant chemotherapy (CT).MethodsIn patients with EBC who received six cycles of adjuvant CT, VD and calcium parameters were monitored at inclusion, and then every 3 weeks, at each CT cycle initiation. The primary endpoint was the percentage of patients showing hypercalciuria during adjuvant CT (between Day 1, Cycle 1 [D1C1] and Day 1, Cycle 6 [D1C6]).ResultsThe primary endpoint could be evaluated in 82 patients. Most patients (n = 66, 80.5%) had VD insufficiency (< 30 ng/mL) at baseline. Hypercalciuria was detected in 29 patients (35.4%; 95% CI: 25.6–46.5) between D1C1 and D1C6, but was not clinically significant in any of the affected patients. The percentage of hypercalciuria events was not different between patients with sufficient and insufficient baseline VD levels (34.8% vs. 37.5%), and between patients who received or not VD supplementation (37.5% vs. 34.5%,).ConclusionsThis comprehensive study on VD and calcium parameter changes in patients with EBC during adjuvant chemotherapy shows that hypercalciuria is a frequent abnormality in this setting, although asymptomatic. Therefore, it should not be considered as a limitation for high dose VD supplementation in this population.Trial registrationEudraCT:2014-A01454-43. Registered 29 august 2016.

Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer

The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an ancillary analysis of the GIM2 trial evaluating the absolute treatment effect through a composite measure of recurrence risk (CPRS) in patients with hormone receptor-positive HER2-negative eBC. CPRS was estimated through Cox proportional hazards models applied to the different clinicopathological features. The treatment effect was compared to the values of CPRS by using the Sub-population Treatment Effect Pattern Plot (STEPP) process. The Disease-Free Survival (DFS)-oriented STEPP analysis showed distinct patterns of relative treatment effect with respect to CPRS. Overall, 5-year DFS differed across CPRS quartiles ranging from 95.2 to 66.4%. Each CPRS quartile was characterized by a different patients’ composition, especially for age, lymph node involvement, tumor size, estrogen and progesterone receptor expression, and Ki-67. A number needed to treat of 154 and 6 was associated with the lowest and the highest CPRS quartile, respectively. Dose-dense adjuvant chemotherapy showed a consistent benefit in node-positive eBC patients with hormone receptor-positive HER2-negative disease, but its effect varied according to CPRS.

Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer in Sub-Saharan Africa: A Retrospective Analysis of Recurrence and Survival in Women Treated for Breast Cancer at the Korle Bu Teaching Hospital in Ghana.

PURPOSEIt is established that addition of systemic therapy to locoregional treatment for breast cancer improves survival. However, reliable data are lacking about the outcomes of such treatment in women with breast cancer in low middle-income countries. We compared the outcomes of treatment in patients who had received neoadjuvant chemotherapy (NACT) or adjuvant chemotherapy and examined the factors associated with breast cancer recurrence and survival at the National Radiotherapy Oncology and Nuclear Medicine Centre, Korle Bu Teaching Hospital, Ghana.METHODSThis was a retrospective cohort study. The medical charts of women with breast cancer managed at the National Radiotherapy Oncology and Nuclear Medicine Centre from 2005 to 2014 were reviewed. A total of 388 patients with a median follow-up of 48 months were included in the study. Logistic regression was used to estimate the risk of recurrence. Survival was estimated using cox proportional hazards model. All models were adjusted with clinicopathologic variables. A P value of < .05 was considered statistically significant.RESULTSFifty-nine percent received adjuvant chemotherapy. In an adjusted logistic model, no difference was observed in locoregional recurrence between patients receiving NACT compared with those receiving adjuvant chemotherapy (odds ratio = 1.05; 95% CI, 0.44 to 2.47). However, NACT recipients had a higher likelihood of distant recurrence (odds ratio = 1.97; 95% CI, 1.24 to 3.15). In a multivariable analysis, no differences were observed in overall survival between the two chemotherapy groups (hazard ratio = 1.43; 95% CI, 0.91 to 2.26).CONCLUSIONNACT yields similar outcomes compared with adjuvant chemotherapy; however, recipients of NACT with advanced disease may have more distant failures. Early detection in a resource-limited setting is therefore crucial to optimal outcomes, significantly limiting recurrence and improving survival.

Interstitial lung disease associated with adjuvant and neoadjuvant chemotherapy in early breast cancer

BackgroundInterstitial lung disease (ILD) is a rare adverse event in patients receiving adjuvant or neoadjuvant chemotherapy (NAC) for breast cancer. Few studies have reported the frequency of ILD in detail, and only small numbers of cases have been described in the literature.Given these previous findings concerning ILD, we retrospectively examined the clinicopathological characteristics of five cases of ILD who had received epirubicin and cyclophosphamide (EC) and compared their findings with non-ILD cases.MethodsThe present single-center retrospective study included breast cancer patients who underwent adjuvant chemotherapy or NAC at our hospital between January 2014 and January 2021.ResultsThirty-nine patients who had received EC for operable breast cancer were enrolled in this study. ILD developed 5 out of 39 patients (12.8%). The incidence of ILD in patients with non-dose-dense (dd) or dd chemotherapy was statistically significantly different (p = 0.0149). ILD occurred in three patients during dd EC treatment and two during weekly paclitaxel (wPTX) after dd EC. ILD was detected in one patient with high Krebs von den Lungen-6 (KL-6) levels, in two patients with continuous pyrexia, and in two patients from computed tomography imaging, which was taken to estimate the efficacy of chemotherapy, in two patients. Three of the 5 ILD patients underwent bronchoalveolar lavage, and 2 of these patients were diagnosed with Pneumocystis jirovecii pneumonia (PCP). There were no cases of serious ILD that required steroid pulse therapy.ConclusionsDd chemotherapy may be associated with an increased ILD frequency, which may reflect developing PCP. Careful monitoring and a timely diagnosis are useful for detecting early-stage ILD.

A Neoadjuvant Chemotherapy Trial for Early Breast Cancer is Impacted by COVID-19: Addressing Vaccination and Cancer Trials Through Education, Equity, and Outcomes.

While COVID-19 vaccine distribution has addressed vulnerabilities related to age and comorbidities, there is a need to ensure vaccination of patients with cancer receiving experimental and routine treatment, where interruption of treatment by infection is likely to result in inferior outcomes. Among patients with cancer, those undergoing neoadjuvant chemotherapy (NAC) or adjuvant chemotherapy (Adj chemo) for early breast cancer (EBC) are at particularly high risk for inferior outcomes, in part, because optimal timing of chemotherapy is essential for promoting distant disease-free survival. COVID-19 data from the ongoing multicenter I-SPY 2 trial of NAC for EBC provides a window into the magnitude of the problem of treatment interruption, not only for the trial itself but also for routine Adj chemo. In the I-SPY 2 trial, 4.5% of patients had disruption of therapy by COVID-19, prior to wide vaccine availability, suggesting that nationally up to 5,700 patients with EBC were at risk for adverse outcomes from COVID-19 infection in 2020. To address this problem, vaccine education and public engagement are essential to overcome hesitancy, while equity of distribution is needed to address access. To accomplish these goals, healthcare organizations (HCO) need to not only call out disinformation but also engage the public with vaccine education and find common ground for vaccine acceptance, while partnering with state/local governments to improve efficiency of vaccine distribution. These approaches are important to improve trial access and to reduce susceptibility to COVID-19, as the pandemic could continue to impact access to clinical trials and routine cancer treatment.

The Effects of Chemotherapy on Circulating Plasma Carotenoids and Fat-Soluble Vitamins in Breast Cancer Patients

Abstract Objectives Chemotherapy upregulates inflammatory processes as measured by circulating concentrations of pro-inflammatory cytokines and their signaling lipids. Our objective was to observe if breast cancer chemotherapy influenced the circulating concentrations of provitamin A and non-provitamin A carotenoids and fat-soluble vitamins (FSVs) in free-living patients. Methods Serum samples were collected from patients (n = 34) immediately prior to standard adjuvant and neo-adjuvant chemotherapy for breast cancer, and 4 months following chemotherapy commencement. Patient multivitamin and non-steroidal anti-inflammatory (NSAID) drug use was noted at both visits. Lipophilic extracts of serum were analyzed using ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) to quantify α- and β-carotene, lycopene, lutein, zeaxanthin, β-cryptoxanthin, retinol, α-tocopherol and phylloquinone. Linear mixed models were developed to assess the relationship between the main factors (i.e., chemotherapy, multivitamin, and NSAID use), and their interaction effects, on serum carotenoid and fat-soluble vitamin concentrations. Random effects included a fixed intercept for each subject. Results Chemotherapy was significantly associated with reduced serum concentrations of α-carotene (P = 0.053) and retinol (P = 0.042), with a trend observed for reduced β-carotene (P = 0.076) and phylloquinone (P = 0.082). There was no main effect of multivitamin or NSAID use on any analytes investigated. An interaction effect was observed for chemotherapy * multivitamin use, with increased concentrations of serum retinol (P = 0.004) and lycopene (P = 0.004), and a trend observed for zeaxanthin (P = 0.087) for those who took multivitamins. Chemotherapy * NSAID use was also significantly associated with a trend in increased serum lutein (P = 0.061) for those who consumed NSAIDS. Conclusions Our results suggest randomized, controlled trials of multivitamin use and/or provitamin A carotenoid-rich food consumption merit further investigation in patients undergoing chemotherapy treatment. Funding Sources This research was supported by The Ohio State University Stefanie Spielman Breast Cancer Center Kroger Fund, Pelotonia, NIH R01CA189947, NIH Award Number Grant P30 CA016058, OSU, and OSUCCC.

De-escalation of adjuvant chemotherapy for HER2 negative breast cancer

De-escalation of adjuvant chemotherapy for HER2 negative breast cancer

PD-L1 expression and TOP3A mutation as prognostic factors for adjuvant chemotherapy in triple negative breast cancer.

541 Background: Triple negative breast cancer (TNBC) is a highly aggressive subtype of breast cancer that is markedly heterogeneous and lacks specific targets. The aim of this study is to explore potential predictors and therapeutic targets based on clinical and genetic characteristics. Methods: 138 patients with triple-negative breast cancer after surgical treatment were 1:1 randomly assigned to the paclitaxel combined with carboplatin (TCb) group or the epirubicin combined with cyclophosphamide sequential paclitaxel (EC-T) adjuvant chemotherapy group. PD-L1 was retrospectively analyzed by surgically resected specimens, and 733 cancer-related genes were detected by NGS. Pathway enrichment analysis was performed using DAVID for functional enrichment genetic alterations. Cox regression models and Kaplan-Meier were used to evaluate disease-free survival (DFS). Results: In this study, there was no significant difference in DFS between the TCb and EC-T groups. 31 (22.5%) of 138 TNBC patients were positive for PD-L1 expression, including 15 (10.9%) patients positive for PD-L1 in tumor cells (TCs) and 29 (21.0%) patients positive for PD-L1 in tumor-infiltrating immune cells (TICs). Patients with positive PD-L1 expression, either in TCs or TICs, achieved better DFS [HR=0.13 (95% CI: 0.02-0.93), p=0.016], the difference was also shown in the EC-T group [HR=0 (95% CI: 0- inf), p=0.037], but not in the TCb group [HR=0 (95% CI: 0.04-2.1), p=0.189]. In addition, we identified 7 patients with mutations in DNA topoisomerase IIIα(TOP3A), a homologous recombination (HR)-related gene, and patients with mutations in this gene had worse DFS than those without mutations [HR=4]. However, there was no statistically significant association between BRCA mutation and response to either therapeutic regimens. Conclusions: In this TNBC patient population, immunohistochemistry (IHC) and NGS analyses identified potential prognostic markers. PD-L1 positive and TOP3A mutation were significantly associated with early triple-negative breast cancer prognosis.

Efficacy of epirubicin plus cyclophosphamide followed by taxanes versus carboplatin plus taxanes as adjuvant chemotherapy in triple-negative breast cancer: 8.1 years median follow-up on a randomized clinical trial.

529 Background: Four cycles of adjuvant taxanes (paclitaxel or docetaxel) after four cycles of adjuvant doxorubicin plus cyclophosphamide (ECT) are considered a standard adjuvant treatment and improves survival outcomes of triple negative breast cancer (TNBC). The purpose of this analysis was to further assess whether adjuvant carboplatin plus taxanes (TP) was non-inferior to or superior to standard ECT chemotherapy in prolonging the survival time. Methods: This randomized, open-label, multicenter clinical trial conducted at three hospital in China from June, 2009 and October, 2015. Eligible early triple-negative breast cancer (TNBC) patients were randomized (1:1) to receive ECT (four cycles of epirubicin 90 mg/m2 + cyclophosphamide 600 mg/m2 followed by four cycles of docetaxel 75 mg/m2 or paclitaxel 175 mg/m2 every 3 weeks, ECT arm, n = 154) or receive TP (six cycles of docetaxel 75 mg/m2 or paclitaxel 175 mg/m2 + carboplatin AUC 5 every 3 weeks; TP arm, n = 154), which was then followed by surgery. Results: Three hundred and eight patients were recruited in this trial and final date of follow-up was January 20, 2021. Baseline characteristics were balanced between ECT arm and TP arm. Median follow-up was 97.6 months. Median disease free survival (DFS) was not reached; 8-year DFS rate was 78.35% with ECT arm and 81.73% with TP arm (hazard ratio [HR] = 0.84; 95% confidence interval [CI] = 0.50 - 1.40; P = 0.496). Median overall survival (OS) was also not reached; 8-year OS rate was 87.15% with ECT arm and 89.14% with TP arm (HR = 0.87; 95% CI = 0.44 - 1.70; P = 0.676). For TNBC patients with DFS &gt; 4 year, TP arm had a longer DFS than ECT ( P = 0.01), and had a tendency with better OS ( P = 0.4). In this subgroup analysis of SPARC &gt; 50%, TP arm had a longer DFS than ECT ( P &lt; 0.05), and also had a tendency with better OS ( P = 0.06). In subgroup analysis of PD-1 (-) and intravascular invasion (+), TP arm had a better DFS ( P = 0.02) and OS ( P = 0.03) than ECT arm. DFS or OS had no significant differences in ECT and TP arm with BRCA mutation or BRCA wild ( all P values &gt; 0.05). Conclusions: TP chemotherapy showed significant non-inferiority for PFS and OS versus ECT in the first-line adjuvant treatment of early TNBC. For some particular subgroup of TNBC, TP may be a more effective chemotherapy than ECT. TP may be considered an effective alternative to early TNBC. Clinical trial information: NCT01150513.

Impact of timing of adjuvant chemotherapy for early breast cancer: the Royal Marsden Hospital experience

The optimal time to deliver adjuvant chemotherapy has not been defined. A retrospective study of consecutive patients receiving adjuvant anthracycline and/or taxane 1993-2010. Primary endpoint included 5-year disease-free survival (DFS) in patients commencing chemotherapy <31 versus ≥31 days after surgery. Secondary endpoints included 5-year overall survival (OS) and sub-group analysis by receptor status. We identified 2003 eligible patients: 1102 commenced chemotherapy <31 days and 901 ≥31 days after surgery. After a median follow-up of 115 months, there was no difference in 5-year DFS rate with chemotherapy <31 compared to ≥31 days after surgery in the overall population (81 versus 82% hazard ratio (HR) 1.15, 95% confidence interval (95% CI) 0.92-1.43, p = 0.230). The 5-year OS rate was similar in patients who received chemotherapy <31 or ≥31 days after surgery (90 versus 91%, (HR 1.21, 95% CI 0.89-1.64, p = 0.228). For 250 patients with triple-negative breast cancer OS was significantly worse in patients who received chemotherapy ≥31 versus <31 days (HR = 2.18, 95% CI 1.11-4.30, p = 0.02). Although adjuvant chemotherapy ≥31 days after surgery did not affect DFS or OS in the whole study population, in TN patients, chemotherapy ≥31 days after surgery significantly reduced 5-year OS; therefore, delays beyond 30 days in this sub-group should be avoided.

The use of genomic assays reduces rates of chemotherapy: a single-institution experience.

The National Institute for Clinical Excellence recommends the use of tumour profiling tests to guide adjuvant chemotherapy in breast cancer. The Oncotype DX™ score (Genomic Health) has superseded more traditional tools such as PREDICT in appropriate patients (ER + ve, HER2-ve, lymph node negative and with a Nottingham Prognostic Index [NPI] ≥ 3.4). The aim of this study was to see whether the introduction of Oncotype DX within our institution resulted in an overall reduction in rates of chemotherapy. Data was collected retrospectively using the Somerset Cancer Register, Pathology department databases and the institution's own online medical records system. Two groups were compared: (1) pre-oncotype (Jan 2012-Dec 2014) and (2) post-oncotype (Jan 2016-July 2018). During the pre-oncotype period, 28/82 (34%) patients who would have been eligible for testing (patients who were ER + ve, HER2-ve, and a NPI ≥ 3.4) received chemotherapy compared to 34/135 (25%) who were sent for oncotype during the second study period (p = 0.157). For grade 3 cancers, and those aged under 50, the results were more marked: grade 3 pre-oncotype 23/43 (53%), post-oncotype 29/76 (38%) (p = 0.101), aged under 50 pre-oncotype 8/15 (53%), post-oncotype 10/31 (32%) (p = 0.197). Within our institution, overall rates of chemotherapy have reduced since the introduction of Oncotype DX with the results more marked in subgroups of traditional indicators of tumour aggression. As genomic assays provide a more accurate prediction of the benefit of chemotherapy, its overall reduction has potential cost saving implications as well as reducing risk in patients who will derive little benefit.

Anthracycline-free or short-term regimen as adjuvant chemotherapy for operable breast cancer: A phase III randomized non-inferiority trial

BackgroundDe-escalating anthracycline is gaining popularity for breast cancer patients. We aim to evaluate the non-inferiority of an anthracycline-free or short-term regimen to the standard anthracycline-based regimen for operable patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer. MethodsIt is a prospective, open-label, phase 3, randomized non-inferiority trial from June 1, 2010 to June 1, 2017. Follow-up had been kept until July 2019. This trial was conducted at Fudan University Shanghai Cancer Center. Patients with pT1–3N+ or pT2–3N0 but high-risk (grade II/III, lymphovascular invasion, ≤35 years of age or hormone-receptor negative) HER2-negative operable breast cancer were eligible and stratified by age, pathological tumour stage, pathological node status and hormone-receptor status. Patients were randomized to 6 cycles of docetaxel and cyclophosphamide (TC, n = 524), 3 cycles of cyclophosphamide/epirubicin/fluorouracil followed by 3 cycles of docetaxel (CEF-T, n = 523) or epirubicin and cyclophosphamide for 4 cycles followed by paclitaxel for 12 weeks (EC-P, n = 524) as the intention-to-treat population. Of these patients, 94% completed allocated therapy. Difference in disease-free survival (DFS) compared to EC-P. The prespecified non-inferiority margin was 4.5%, corresponding to the hazard ratio (HR) of 1.44 (one-sided α = 0.05), with an assumed 5-year DFS of 89% for EC-P. FindingsIncluded in the intention-to-treat population were 1571 patients (median [IQR] age, 50 [45–57] years; 92% estrogen receptor [ER]-positive; 59% pN+). Through a median follow-up of 5.5 years, HR for TC versus EC-P was 1.05 (5-year DFS: 85.0% vs. 85.9%; 90% confidence interval [CI]: 0.79–1.39, non-inferior P = 0.048) and for CEF-T versus EC-P, 0.99 (5-year DFS: 85.1% vs. 85.9%; 90% CI: 0.75–1.30, non-inferior P = 0.045). Grade 3 or 4 adverse events for TC included rash (3.9%) and peripheral neuropathy (2.8%) and for CEF-T and EC-P diarrhea and nausea/vomiting were predominant. Results of per-protocol analyses were similar. InterpretationBoth TC and CEF-T are non-inferior adjuvant regimen to EC-P mainly in patients with ER+HER2- breast cancer. TC is a safe regimen that avoids anthracycline-related side effects. FundingThis work was supported by grants from the National Natural Science Foundation of China (Grants 81672600, 81722032, 82072916, and 91959207), the 2018 Shanghai Youth Excellent Academic Leader, the Fudan ZHUOSHI Project, the Municipal Project for Developing Emerging and Frontier Technology in Shanghai Hospitals (grant SHDC12010116), the Cooperation Project of Conquering Major Diseases in the Shanghai Municipality Health System (grant 2013ZYJB0302), the Innovation Team of the Ministry of Education (grant IRT1223), and the Shanghai Key Laboratory of Breast Cancer (grant 12DZ2260100) and the National Cancer Institute (grant P30 CA16058).

61P Estimating the cost of adjuvant chemotherapy in ER+/HER2- early breast cancer and distant recurrence of breast cancer in the UK

Multigene assays (MGAs) can reduce over and under-treatment with adjuvant chemotherapy in oestrogen receptor positive (ER+), human epidermal growth factor 2 negative (HER2-) early breast cancer. The cost of treatment of early breast cancer and distant recurrence of breast cancer are important parameters in the economic evaluation of MGAs. The recent approval of new treatments in the UK, such as CDK4/6 inhibitors, is likely to increase the cost of management of breast cancer. This study aimed to estimate the cost of adjuvant chemotherapy in early breast cancer and the cost of treating distant recurrence in the UK using expert opinion and published sources.

COVID‑19 in a patient receiving adjuvant breast cancer chemotherapy with granulocyte olony‑stimulating factor (G‑CSF) support: A case report

Patients receiving chemotherapy are at high risk for severe infections and complications such as acute respiratory syndrome. The most commonly used adjuvant chemotherapy protocols (docetaxel-cyclophosphamide every 3 weeks or the dose-dense regimen, doxorubicin-cyclophosphamide every 2 weeks followed by paclitaxel) incorporate granulocyte-colony stimulating factor (G-CSF). G-CSF is routinely administered to prevent chemotherapy-associated neutropenia but often results in significant neutrophilia. The present case describes a patient with breast cancer who was successfully treated for severe COVID-19 respiratory syndrome while under adjuvant chemotherapy (docetaxel-cyclophosphamide) treatment and long-term G-CSF support. In addition, the potential effect of G-CSF on the respiratory deterioration of the patient given its cardinal role in innate inflammation and, accordingly, the cytokine storm associated with COVID-19 was described. The case described in the present study indicated how solutions to the immunity challenges faced when treating a patient with chemotherapy may be the source of a larger problem within the coronavirus COVID-19 pandemic.

The effect of comorbidity on primary care use during breast cancer chemotherapy: a population-based retrospective cohort study using CanIMPACT data.

Background:Patients with breast cancer visit their primary care physicians (PCPs) more often during chemotherapy than before diagnosis, but the reasons are unclear. We assessed the association between physical comorbidities and mental health history (MHH) and the change in PCP use during adjuvant breast cancer chemotherapy.Methods:We conducted a population-based, retrospective cohort study using data from the Canadian Team to Improve Community-Based Cancer Care along the Continuum (CanIMPACT) project. Participants were women 18 years of age and older, who had received a diagnosis of stage I–III breast cancer in Ontario between 2007 and 2011 and had received surgery and adjuvant chemotherapy. We used difference-in-difference analysis using negative binomial modelling to quantify the differences in the 6-month rate of PCP visits at baseline (the 24-month period between 6 and 30 months before diagnosis) and during treatment (the 6 months from start of chemotherapy) between physical comorbidity and MHH groups.Results:Among 12 781 participants, the 6-month PCP visit rate increased during chemotherapy (mean 2.3 visits at baseline, 3.4 visits during chemotherapy). Patients with higher physical comorbidity levels or MHH visited their PCPs 4.2 or 1.7 more times, respectively, over 6 months compared to those with low physical comorbidity or no MHH at baseline and 2.5 or 1.1 more times, respectively, over 6 months during treatment. During treatment, the adjusted 6-month rate of PCP visits more than doubled in the group with the fewest physical comorbidities or no MHH compared with baseline (rate ratio 2.52, 95% confidence interval [CI] 2.43–2.61). This increase was lower in those with MHH (rate ratio 1.81, 95% CI 1.68–1.96) and in the highest physical comorbidity group (rate ratio 1.16, 95% CI 1.07–1.28).Interpretation:Patients with breast cancer who have more physical comorbidities and MHH have a higher frequency of PCP visits during adjuvant chemotherapy but lower absolute and relative increases in visits compared with baseline. Therefore, PCPs can expect to see their patients with fewer physical comorbidities and no MHH more often during chemotherapy. Primary care physicians can plan for their patients with high physical comorbidity levels and MHH to continue having frequent appointments while they undergo chemotherapy, and they can expect their patients with low physical comorbidity levels and no MHH to increase the frequency of their visits during chemotherapy, and should be prepared to provide breast cancer–related care to these patients.

An updated review of epidemiology, risk factors, and management of male breast cancer.

Unlike female breast cancer, male breast cancer (MBC) is rare and not very well understood. Prospective data in the management of MBC are lacking and majority of treatment strategies are adopted from the established guidelines for breast cancer in women. The understanding of biology, clinical presentation, genetics, and management of MBC is evolving but there still remains a large knowledge gap due to the rarity of this disease. Older age, high estradiol levels, klinefelter syndrome, radiation exposure, gynecomastia, family history of breast cancer, BRCA2 and BRCA1 mutation are some of the known risk factors for MBC. Routine screening mammography is not recommended for asymptomatic men. Diagnostic mammogram with or without ultrasound should be considered if there is a suspicion for breast mass. Majority of men with early-stage breast cancer undergo mastectomy whereas breast conserving surgery(BCS) with sentinel lymph node biopsy (SLNB) remains an alternative option in selected cases. Since the majority of MBC are hormone receptor positive (HR+), adjuvant hormonal therapy is required. Tamoxifen for a total of 5 to 10years is the mainstay adjuvant hormonal therapy. The role of neoadjuvant and adjuvant chemotherapy for early-stage breast cancer is uncertain and not commonly used. The role of gene recurrence scores like oncotype Dx and mammaprint is evolving and can be used as an aid for adjuvant chemotherapy. Majority of metastatic MBC are treated with hormonal therapy with either tamoxifen, gonadotropin-releasing hormone agonist (GnRH) with aromatase inhibitors (AI), or fulvestrant. Chemotherapy is reserved for patients with visceral crisis or rapidly growing tumors.

P038 - Scenarios of cost-savings associated with Oncotype DX® test-guided decisions for adjuvant chemotherapy in early breast cancer in Germany

P038 - Scenarios of cost-savings associated with Oncotype DX® test-guided decisions for adjuvant chemotherapy in early breast cancer in Germany

Adjuvant chemotherapy and survival outcome in node-negative breast cancer with a 21-gene recurrence score of 26-30.

Aim: To investigate thebenefit of chemotherapy among early-stage breast cancer patients with 21-gene recurrence scoresof 26-30. Methods: We identified 3754 patients in the Surveillance, Epidemiology, and End Results database. Results: 57.6% of the patientsreceived adjuvant chemotherapy. Patients with higher tumor grade, larger tumorsand younger age were more likely to receive chemotherapy. The receipt of chemotherapy was independently associated with better breast cancer-specific survival than in patientswithout chemotherapy before (p = 0.016) and after (p = 0.043) propensity score matching. The sensitivity analyses showed that survival gain was pronounced in patients with poorly differentiated orundifferentiated disease. Conclusions: Adjuvant chemotherapy improves the outcome for early-stage breast cancer with 21-gene recurrence score of 26-30, especially for patients with high-grade tumors.

Improving early breast cancer treatment: the role of granulocyte colony-stimulating factor

Breast cancer is still the leading cause of death in patients with malignant tumors. Among women with breast cancer, standard combination chemotherapy with anthracyclines and taxanes reduces mortality from this disease by about one third compared to patients not receiving chemotherapy and is the standard for neoadjuvant or adjuvant chemotherapy of breast cancer. Understanding the patterns of tumor growth has made it possible to improve the current paradigms of the treatment of early forms of breast cancer and to use dose-dense chemotherapy regimens to achieve better treatment results. Nowadays, chemotherapy in a dose-dense regimen for breast cancer is the preferred option in all world and Russian clinical guidelines. However, the use of such chemotherapy regimens significantly increases the incidence of side effects, primarily febrile neutropenia. The appearance of more effective methods of supportive care, particularly short-acting and long-acting granulocyte colony-stimulating factor, in clinical practice has made it possible to use dose-dense chemotherapy regimens to increase the effectiveness of the treatment.

Abstract PD12-01: Evaluation of sleep problems and their association with febrile neutropenia, leucopenia and infections in women receiving adjuvant chemotherapy for breast cancer in the Canadian Cancer Trials Group MA.21 trial

Abstract BackgroundInsomnia is a frequent complaint in patients with cancer. Sleep problems can affect immune functioning in healthy individuals. Our aim was to evaluate the association between sleep disturbance and the risk of febrile neutropenia, leukopenia and infections in patients treated with chemotherapy in an adjuvant setting for breast cancer.MethodologyThis is a retrospective study using the Canadian Cancer Trial Group data collected for the MA.21 trial, in which three adjuvant chemotherapy regimens (CEF, EC-T dose dense or AC-T) were compared in 2104 patients with node positive or high-risk node negative breast cancer. A total of 1731 patients had completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and 1727 patients had completed the Breast Cancer Chemotherapy Questionnaire (BCQ) quality of life questionnaires, which both include a question about sleep difficulties. The primary definition for patients with insomnia was a score of three (quite a bit) or greater at Question 11 (Have you had trouble sleeping? with answers ranging from one (not at all) to four (very much)) on the EORTC QLQ-C30 questionnaire. We compared patients classified as having “clinical insomnia” based on their response to this question with patients considered “good sleepers”. The primary endpoint was the risk of febrile neutropenia. Secondary endpoints were the risks of grade one or more leukopenia, neutropenia and infection. ResultsFebrile neutropenia was more frequent in patients with sleep problems compared with those without, with 16.3% and 12.2% of patients having at least one episode in each group respectively (p value = 0.01 in the univariate analysis (table 1)). However, after adjustment for potential confounders in the multi-variate analysis, it was not statistically significant with an odds ratio of 1.07, a 95% confidence interval of 0.76-1.50 and a p value of 0.71. Similarly, no statistically significant difference in the risk of leukopenia could be demonstrated in the multi-variate analysis for patients with sleep problems with an odds ratio of 0.92 a 95% confidence interval of 0.69-1.24 and a p value of 0.59. No significant association could be found between sleep problems and neutropenia and infections. In an unplanned exploratory analysis, chemotherapy dose reductions were significantly more frequent in patients with sleep problems with 30.6% in this group compared to 21.8% in good sleepers, with a p value &amp;lt;0.0001. ConclusionWhile our univariate analysis suggested an increased risk of febrile neutropenia and leucopenia in patients with sleep problems, after adjustment for confounders, we could not show a statistically significant association in women undergoing adjuvant chemotherapy for high-risk locoregional breast cancer. Table 1: Univariate analysis of primary and secondary outcomes in patients with sleep problems and good sleepersCharacteristicsSleep problem= yesSleep problem = noFebrile neutropeniaNo781 (83.7%)701 (87.8%)Yes152 (16.3%)97 (12.2%)P-value0.01White blood cell count (WBC)Grade 0157 (16.8%)141 (17.7%)Grade 1135 (14.5%)138 (17.3%)Grade 2184 (19.7%)186 (23.3%)Grade 3214 (22.9%)173 (21.7%)Grade 4243 (26.1%)160 (20.1%)P-value0.02NeutropeniaGrade 0778 (83.4%)700 (87.7%)Grade 10 (0%)1 (0.1%)Grade 22 (0.2%)0 (0%)Grade 3152 (16.3%)96 (12.0%)Grade 41 (0.1%)1 (0.1%)P-value0.014InfectionGrade 0619 (66.4%)564 (70.7%)Grade 168 (7.3%)62 (7.8%)Grade 2158 (16.9%)110 (13.8%)Grade 387 (9.3%)61 (7.6%)Grade 41 (0.1%)1 (0.1%)P-value0.24Chemotherapy delayNo1 (0.1%)12 (1.5%)Yes932 (99.9%)786 (98.5%)P-value0.0008Chemotherapy dose reductionNo648 (69.4%)624 (78.2%)Yes285 (30.6%)174 (21.8%)P-value&amp;lt; 0.0001 Citation Format: Audreylie Lemelin, Josée Savard, Michelle Chen, Margot Burnell, Mark N Levine, Lois Shepherd, Bingshu E Chen, Julie Lemieux. Evaluation of sleep problems and their association with febrile neutropenia, leucopenia and infections in women receiving adjuvant chemotherapy for breast cancer in the Canadian Cancer Trials Group MA.21 trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD12-01.