Recurrence In Women Research Articles

Levonorgestrel intrauterine system for endometrial protection in women with breast cancer on adjuvant tamoxifen.

Levonorgestrel intrauterine system for endometrial protection in women with breast cancer on adjuvant tamoxifen.

Quantification of Recurrence Risk Based on Number of Adverse Prognostic Factors in Women with Early Stage Uterine Endometrioid Carcinoma

We sought to quantify the risk of recurrence in women with International Federation of Gynecology and Obstetrics (FIGO) stage I endometrial carcinoma, solely of endometrioid based on the number of adverse prognostic factors We identified 1133 women at our institution who underwent a hysterectomy and did not receive any adjuvant therapy between 1/1990 and 12/2019. Cox proportional hazards model was used to identify independent predictors of recurrence. Prognostic groups were created based on the number of independent predictors of recurrence (0, 1 or 2 or 3 risk factors). Median follow-up was 84 months. Independent prognostic factors of recurrence included age ≥ 60, grade 2/3 and the presence of lymphovascular space invasion (LVSI). Due to small number in groups with 2 or 3 risk factors, these were combined into one group (group 2). Isolated vaginal cuff recurrence was the most common site of recurrence in the study groups (81%, 58% and 70% for groups 0, 1 and 2, respectively). Five-year recurrence rates were 4%, 15%, and 43% for groups 0, 1, and 2 (p<0.001), respectively. Five-year disease-specific survival were 99%, 96% and 85% and 5-year overall survival were 94%, 85% and 63% (p<0.001), respectively. On the basis of 3 well-known prognostic factors, individualized recurrence rate can be predicted in women with stage I endometrial carcinoma. This simplified predictive tool may be helpful in estimating individualized risk of recurrence and guide counseling with regard to adjuvant treatment.

Does the presence of nodal micrometastases or isolated tumor cells increase the risk of recurrent endometrioid adenocarcinoma? A case control study

Objective: The purpose of this case control study was to explore whether the presence of micrometastases (MMs) or isolated tumor cells (ITCs) is associated with an increased the risk for recurrence in women with fully staged, stage I–II endometrioid endometrial cancer.

Menopausal replacement therapy following the treatment of gynaecological malignancies including the breast

Gynaecological malignancies have been known to be prevalent among the postmenopausal category of women, although a considerable fraction is being increasingly diagnosed in the premenopausal age group as well. Owing to the improvement in survival rates among women who are being diagnosed with gynaecological malignancies in recent times, the need to improve the quality of life among these women has become imperative. Standard treatment regimens for gynaecological malignancies include surge1y, chemotherapy and radiotherapy and these are known to cause a prolonged oestrogen deficiency which inevitably leads to menopause in younger women. Therefore, it is essential to formulate an appropriate strategy to overcome this concern. This article focuses on the benefits of MRT in women following menopause after having been subjected to standard therapeutic methods for gynaecological malignancies. It also scrutinizes whether the benefits outweigh the risk of recurrence in women suffering from ovarian, endometrial, cervical, vaginal and vulval malignancies. In addition, this article also focuses on the use of MRT before (the at-risk population), and after breast cancer. Estrogen alone MRT is considered safe carrying no or similar· risks among the population. Among those whose symptoms are refractory, MRT can be considered, but it should only be prescribed following a careful discussion between the patient and a breast specialist.

Impact of antibiotic treatment during platinum chemotherapy on survival and recurrence in women with advanced epithelial ovarian cancer

Objective(s)To determine whether antibiotic treatment (ABX) during platinum chemotherapy (PC) for epithelial ovarian cancer (EOC) impacts progression-free survival (PFS) and overall survival (OS). Study designRetrospective single institution cohort study in women with newly diagnosed stage III/IV EOC (n = 424) who underwent cytoreductive surgery (CRS) and PC from 2009 to 2015. ABX for >48 h, including ABX against gram-positive (anti-G + ABX) bacteria were recorded. The impact of ABX on PFS and OS was assessed using univariate and multivariable Cox regression models. ResultsOf 424 eligible women, 34.7% (n = 147) received ABX, with 11.3% (n = 48) treated with anti-G + ABX. ABX decreased PFS (17.4 vs. 23.1 months, HR 1.50, 95% CI 1.20–1.88, p < 0.001) and OS (45.6 vs. 62.4 months, HR 1.63, 95% CI 1.27–2.08, p < 0.001) compared to no ABX. Similarly, anti-G + ABX worsened PFS (16.5 vs. 23.1 months; HR 1.85, 95% CI 1.33–2.55) and OS (35.0 vs. 62.4 months; HR 2.12, 95% CI 1.50–3.0, p < 0.001). On multivariable analysis, all ABX and anti-G + ABX significantly worsened PFS (HR 1.31, 95% CI 1.04–1.65, p = 0.02), (HR 1.50, 95% CI 1.07–2.10, p = 0.02) and OS (HR 1.52, 95% CI 1.18–1.96, p = 0.001), (HR 1.83, 95% CI 1.27–2.62, p = 0.001) respectively. Increased Clavien Dindo score was associated with worsened PFS (1–2 – HR 1.52, 95% CI 1.14–2.03, p = 0.004; 3–4 – HR 1.86, 95% CI 1.27–2.72, p = 0.001) but not OS (1/2 – HR 1.35, 95% CI 0.97–1.88, p = 0.08; 3/4 – HR 1.53, 95% CI 1.00–2.34, p = 0.05); residual disease (p < 0.05) and neoadjuvant chemotherapy (p < 0.001) were associated with worse PFS and OS. Conclusion(s)In this retrospective cohort study of women with advanced EOC undergoing PC, ABX treatment was associated with decreased PFS and OS. Mechanistic studies are needed to investigate the negative impact of ABX upon PC response in EOC.

Expansile Endocervical Crypt Involvement by CIN2 - 3 as a Risk Factor for High Grade Cytology Recurrence After Cold Coagulation Cervical Treatment.

Introduction To determine whether expansile endocervical crypt involvement (ECI) on pretreatment cervical punch biopsies is a risk factor for high grade cytology recurrence in women following cold coagulation for cervical intraepithelial neoplasia (CIN). Materials and Methods This was a secondary analysis on the results of an observational study of women who had a single cold coagulation cervical treatment between 2001 – 2011 and who were followed up for cytology recurrence. Women with a previous cervical treatment were excluded. Results 559 women were identified with a mean age of 28.7 ± 6.2 years. Expansile and non-expansile ECI were identified in 5.4 and 4.3% of women, respectively. The proportion of women with high grade cytology recurrence was 10% for those with expansile ECI and 2.3% for those without. Multivariate analysis showed that women with expansile ECI when compared to those without, had a four-fold greater risk for high grade cytology recurrence (HR = 4.22; 95% CI: 1.10 – 16.29, p = 0.036). There was no significant association found between non-expansile ECI and overall or high grade cytology recurrence. The increased biopsy depth and the CIN3 grade of pretreatment cervical punch biopsies were significantly associated with greater odds for the detection of expansile ECI. We calculated that the optimal-cut off of pretreatment cervical punch biopsy depth for the detection of expansile ECI was 4 mm (sensitivity: 73.3%; specificity: 55.1%). Conclusions Expansile ECI is a risk factor that increases the likelihood of high grade cytology recurrence following cold coagulation. Deeper pretreatment cervical punch biopsies need to be taken so as not to miss expansile ECI prior to ablative treatment.

A prospective multicenter international single-arm observational study on the oncological safety of the sentinel lymph node algorithm in stage I intermediate-risk endometrial cancer (SELECT, SEntinel Lymph node Endometrial Cancer Trial)

BackgroundIn the primary treatment of apparent uterine-confined endometrial carcinoma, pelvic ± para-aortic lymphadenectomy has been considered the standard of care. Although some retrospective data suggest that the sentinel lymph node...

Postoperative hormonal treatment for prevention of endometrioma recurrence after ovarian cystectomy: a systematic review and network meta-analysis.

BackgroundThe efficacy of hormonal regimens for the prevention of endometrioma recurrence in women who have undergone conservative surgery is still controversial.ObjectiveTo compare the efficacy of different hormonal regimens in this context and to rank them.Search strategyMEDLINE and Scopus databases were searched through January 2020.Selection criteriaRandomised controlled trials (RCTs) or cohorts, comparing the effect of any pair of interventions (i.e. cyclic oral contraceptives [OC], continuous OC, gonadotropin‐releasing hormone agonist [GnRHa], dienogest [DNG], levonorgestrel‐releasing intrauterine system [LNG‐IUS] and expectant management) on endometrioma recurrence were selected.Data collection and analysisData were independently extracted by two reviewers. Relative treatment effects were estimated using network meta‐analysis (NMA) and ranked in descending order.Main resultsSix RCTs (675 patients) and 16 cohorts (3089 patients) were included. NMA of the RCTs involving expectant management, cyclic OC, continuous OC, GnRHa and GnRHa + LNG‐IUS, showed that all hormonal regimens had a nonsignificant lower risk of endometrioma recurrence compared with expectant management. NMA of the cohorts involving expectant, cyclic OC, continuous OC, GnRHa, DNG, LNG‐IUS, GnRHa + OC, and GnRHa + LNG‐IUS indicated that LNG‐IUS, DNG, continuous OC, GnRHa + OC and cyclic OC had a significantly lower risk of endometrioma recurrence than expectant management. LNG‐IUS was ranked highest, followed by DNG and GnRHa + LNG‐IUS. Long‐term use of hormonal treatment either OC or progestin had a significantly lower risk of endometrioma recurrence than expectant treatment.ConclusionIn the NMA of RCTs, there was no evidence supporting hormonal treatment for postoperative prevention of endometrioma recurrence. This was at odds with the cohort evidence, which found the protective effect of OC and progestin regimens, especially long‐term treatment. Large‐scale RCTs of these agents are still required.Tweetable abstractHormonal regimens given as long‐term treatment tend to reduce risk of endometrioma recurrence after conservative surgery.

"It's just an issue and you deal with it… you just deal with it, you move on and you do it together.": Men's experiences of bacterial vaginosis and the acceptability of male partner treatment.

Bacterial vaginosis (BV) is a common vaginal infection among women of reproductive age. Increasing evidence suggests BV may be sexually transmitted indicating a potential role for the treatment of sexual partners. If partner treatment reduces BV recurrence in women, real-world success will depend on sexual partners' willingness to accept it. However, a lack of data exists on the acceptability of partner treatment among sexual partners, and no data exists on male partners' experience of BV specifically. The aim of this study was to explore male partners' views and experience of BV and their attitudes toward associated partner treatment. A social constructionist approach informed the framework of this study. Semi structured interviews were conducted with eleven men who participated in a BV partner treatment trial. Interviews were transcribed verbatim and analysed thematically. In the absence of symptoms in themselves, BV had little impact on men beyond their concerns for their partner's health and self-esteem. Acceptance of treatment was largely a demonstration of care and support. While all participants had accepted treatment, men surmised the primary reasons other men may reject treatment as being: if they felt BV had "nothing to do with them", which was related to not wanting to be viewed as having a 'problem' and exacerbated by norms of masculinity and STI-related stigma; lack of a diagnostic test to indicate if a male "had BV"; and a casual or less established relationship. Men's attitudes to BV and partner treatment were primarily influenced by the nature of their relationships. The ambiguous aetiology of BV appears to attenuate STI related stigma and questions of infidelity.

The Effect of Prognostic Factors on Long-Term Protection in Breast Cancer.

ObjectıvesAxillary lymph node involvement is considered to be one of the most important factors in the staging and survival of breast cancer. Recurrences in women with a negative axillary condition detected as a result of long patient follow-up have revealed the importance of other prognostic factors and many studies have begun. The aim of this study is to evaluate breast cancer patients and to investigate other factors affecting breast cancer.Materials and methodsPatients with breast cancer who were operated in our clinic between January 2005 and June 2007 were included in the study. Demographic characteristics, tumor size, lymph node involvement, grade, histological type, the status of estrogen and progesterone receptors (ER and PR), type of surgery performed, and cerb-B2 receptor status were recorded retrospectively.ResultsThe mortality rate of the ER (+) PR (+) group was significantly lower than that of the ER (-) PR (-) group (p<0.05). There was no statistically significant difference between the ER (+) PR (+) cases and the mortality rates of any positive cases (p>0.05). There was a statistically significant difference between survival rates according to cerb-B2 status (p<0.01); cerb-B2 was positive in all patients who died. In cerb-B2 positive cases, there was a statistically significant difference between survival rates according to the tumor stages (p <0.05).ConclusionAs a result; preoperative and postoperative staging of all breast cancer patients who applied to surgery clinics should be performed. Prognostic factors should be determined and patients should be directed to post-surgical treatment according to this information. Axillary lymph involvement, number, tumor size, estrogen receptor, progesterone receptor, and cerb-B2 status are safe markers that can be used to determine prognosis in our series.

4553 An investigation into the use of curcumin, a topical herbal agent, for the treatment of cervical intraepithelial neoplasia

4553 An investigation into the use of curcumin, a topical herbal agent, for the treatment of cervical intraepithelial neoplasia

Breast cancer recurrence rate in patients treated for early breast cancer.

e12508 Background: Recurrence rates for early breast cancer vary in different studies from 7% to 18%. Recurrent breast cancer is associated with poorer outcome and higher mortality rates. The recurrence rate in the Kenyan population remains unknown despite high prevalence of known risk factors. Methods: Single institution retrospective study of all women (18 -75 years) treated for early breast cancer at a single center private tertiary unit from 2009 to 2017. Results: 239 patient records were reviewed. The mean age at diagnosis was 51 (SD13.1). 98% of women presented with a palpable breast lesion. The molecular sub-type’s prevalence was: ER/PR+ (76%), triple negative (12.1%), HER2+ (2.9%). The overall recurrence rate was 7.2%, 66% recurrences were loco-regional, while 27% were metastatic disease, with 61% of the recurrences being detected initially on clinical/ self-breast examination. 77% of the recurrences were in women with ER/PR+ molecular sub-types. Recurrences in women with DCIS (2/27) were invasive breast cancers. There were no identified risk factors on uni-variate and multivariate regression analysis which conferred a risk of breast cancer recurrence. Discussion: The mean age at diagnosis in this group is younger than the western average (65 - 75 years). Majority of the women presented with symptoms – a presentation that differs from that of countries with a national breast cancer screening program. The molecular distribution of breast cancers is comparable to western populations. Conclusions: Recurrence rate for early breast cancer in this series is 7.2%, which is comparable with documented western data, with majority of the recurrences being detected initially on clinical/self-breast examination.

Wait-time for hysterectomy and survival of women with early-stage cervical cancer: A clinical implication during the coronavirus pandemic

ObjectiveA global pandemic caused by a novel coronavirus (Covid-19) has created unique challenges to providing timely care for cancer patients. In early-stage cervical cancer, postponing hysterectomy for 6–8 weeks is suggested as a possible option in the Covid-19 burdened hospitals. Yet, literature examining the impact of surgery wait-time on survival in early-stage cervical cancer remains scarce. This study examined the association between surgery wait-time of 8 weeks and oncologic outcome in women with early-stage cervical cancer. MethodsThis is a single institution retrospective observational study at a tertiary referral medical center examining women who underwent primary hysterectomy or trachelectomy for clinical stage IA-IIA invasive cervical cancer between 2000 and 2017 (N = 217). Wait-time from the diagnosis of invasive cervical cancer via biopsy to definitive surgery was categorized as: short wait-time (<8 weeks; n = 110) versus long wait-time (≥8 weeks; n = 107). Propensity score inverse probability of treatment weighting was used to balance the measured demographics between the two groups, and disease-free survival (DFS) and overall survival (OS) were assessed. A systematic literature review with meta-analysis was additionally performed. ResultsIn a weighted model (median follow-up, 4.6 years), women in the long wait-time group had DFS (4.5-year rates, 91.2% versus 90.7%, hazard ratio [HR] 1.11, 95% confidence interval [CI] 0.47–2.59, P = 0.818) and OS (95.0% versus 97.4%, HR 1.47, 95%CI 0.50–4.31, P = 0.487) similar to those in the short wait-time group. Three studies were examined for meta-analysis, and a pooled HR for surgery wait-time of ≥8 weeks on DFS was 0.96 (95%CI 0.59–1.55). ConclusionOur study suggests that wait-time of 8 weeks for hysterectomy may not be associated with short-term disease recurrence in women with early-stage cervical cancer.

S206. ARIPIPRAZOLE LONG-ACTING INJECTABLE IN SCHIZOPHRENIA DURING PREGNANCY: A CASE REPORT

BackgroundLong-acting injectable (LAI) antipsychotics provide some advantages in treatment compliance of psychotic disorders. However, information about their effects during pregnancy is still very limited. We expose a clinical case of aripiprazole LAI use in a pregnant woman diagnosed of schizophrenia.MethodsA non-systematic review using Pubmed was conducted using the following terms: schizophrenia, pregnancy, aripiprazole and aripiprazole LAI. A clinical record review was performed for the clinical case report.ResultsWe report the case of a 30-year-old woman diagnosed of schizophrenia. She required several hospital admissions in the past because of the mental disorder and the lack of treatment adherence, what was the consequence of having no insight of illness and her pregnancy desires.She was initially treated with risperidone, suffering from some adverse effects like prolactine elevation and amenorrhea. In the last hospital admission, she started treatment with aripiprazol 20mg, having a good tolerability and being finally changed into aripiprazole LAI 400mg/28days. No incidences were reported and stability was achieved.After five months, she became pregnant and started being followed up in the Perinatal Mental Health Unit that belongs to the same hospital. The severity of the mental disorder and her stability at that moment made psychiatrists; obstetricians and patient decide to keep the antipsychotic treatment with subsequent appointments. The goal was to supervise psychopathology and blood tests during pregnancy.Prolactine was in physiologic levels and there were no obstetric complications. She finally delivered at 41 gestational weeks to a 3465g baby girl (Apgar 1’: 9 Apgar 5’: 10). No neonatal complications were reported. The Stafford interview was also administered in order to explore her social, obstetric and psychological background as well as possible psychiatric complications due to pregnancy and puerperium. No psychiatric complications were reported. Postpartum Bounding Questionnaire was also administered. No bounding disorder was detected.DiscussionPregnancy and postpartum are periods that carry a high risk of illness onset or recurrence in women with severe mental disorders, such as schizophrenia. Having a good control of the symptoms may prevent from risks to both patient and child, due to the important influence that exists on the development of the baby and the mother-infant relationship.

Long-term Recurrence of Endometriosis in Women with Subfertility Caused by Endometriosis: A Comparison of the Efficacy of Surgery and Assisted Reproductive Technology as Fertilization Treatment Approaches

Background: The evolution of fertility treatment methods such as laparoscopic surgery and assisted reproductive technology (ART) leads to an increased chance for conception in women with endometriosis. However, it is still not clear which treatment is more likely to result in endometriosis recurrence. Objectives: The current study aimed at assessing the recurrence rate of endometriosis and its main determinants following fertility treatment with surgery or ART. Methods: The current historical cohort study was conducted on 51 consecutive women with endometriosis undergoing fertilization procedures, including laparoscopic surgery (n = 42) and ART (n = 9) in Tehran from 2006 to 2016. All patients with complete hospital records were enrolled in the study. The patients in the two groups were followed up for five years for endometriosis recurrence. Results: Within the follow-up time, the rate of endometriosis recurrence in patients of the surgery and ART groups was 28.6% and 44.4%, respectively, indicating no significant difference between the groups (P = 0.436). In this regard, the 1-, 2-, and 3-year recurrence-free survival rate in the ART group was 87.5%, 50.0%, and 50.0%, and in the surgery group was 96.9%, 90.6%, and 70.5%, respectively. Using the Cox proportional hazard modeling adjusted for baseline variables, the method of fertilization (ART or surgery) could not affect the rate of long-term recurrence of endometriosis (odds ratio = 1.428, 95% confidence interval: 0.177 - 9.900, P = 0.784). Conclusions: The method of fertilization treatment-e g, surgery, and ART- may not affect the rate of endometriosis recurrence in women with subfertility caused by endometriosis.

Risk Factors for Disease Recurrence in Women With Phyllodes Tumors of the Breast in Southern Colombia: A Nine-Year Cohort Study.

IntroductionPhyllodes tumors (PTs) are uncommon fibroepithelial breast tumors that occur in middle-aged women, and they tend to vary in biologic behavior. Surgical management is the standard therapy for the condition, but factors associated with recurrence remain unclear. The aim of this study was to evaluate clinical and surgical characteristics related to PT recurrences.MethodsThis retrospective cohort study included patients in southern Colombia who were diagnosed with PT and managed at a level I teaching and referral hospital over a nine-year period. Factors associated with recurrence were determined by Cox regression analysis.ResultsThis study included 61 patients; their median age was 46 years [interquartile range (IQR): 39-55 years]. Pathologically, 37 tumors (60.7%) were classified as low-grade. The median tumor size was 7 cm (IQR: 4-11.5 cm). Thirty-nine (63.9%) patients underwent quadrantectomy. Nine patients (14.8%) experienced tumor recurrence, with the median time to recurrence being one year (IQR: 0.5-2 years). Distant metastasis was observed in four patients (6.6%) at a median of nine months (IQR: 0.4-2.5 years). Univariate analyses showed that patients with high-grade tumors [hazard ratio (HR): 2.90, p = 0.148] and those who underwent mastectomy (HR: 2.90, p = 0.460) were at higher risk of recurrence.ConclusionPT recurrence may be associated with biological features, the extent of local excision, tumor size, and negative margins. However, multicenter data are needed to confirm these findings.

Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial

BackgroundBreast cancer-related lymphedema (BCRL) and its associated symptoms harm the quality of life (QoL) of cancer survivors and can stimulate fear of cancer recurrence (FCR). Self-management education for lymphedema has been introduced as an effective method in controlling FCR. This study investigates the effect of lymphedema group-based education compared to the social network-based and control group on QoL and FCR in breast cancer patients.MethodsThis three-arm clinical trial studied 105 patients with breast cancer-related lymphedema referred to Seyed_Khandan rehabilitation center. Sampling was done by random allocation method in blocks of 3 with 35 subjects in each group. All subjects received routine lymphedema treatments. The group-based education (GE) and social network-based education (SNE) groups received self-management education in the clinic and Telegram™ messenger channel, respectively. Impairment in QoL and mean score of FCR were assessed before, immediately after, and three months after the intervention by using the Persian version of Lymphedema Life Impact Scale (LLIS) and Fear of Progression Questionnaire-Short Form (FoPQ-SF), respectively. Mixed-model ANOVA was applied for statistical analysis.ResultsThere was a significant time effect on total LLIS (P = 0.007), psychosocial (P = 0.038) and functional (P = 0.024) subscale changes in three groups of study. Interaction between the main effect of group and time on psychosocial subscale changes was statistically significant (P = 0.017). The multicomparison results illustrated that the main effect of time, the main effect of group, and interaction of them on the mean score of FCR were P = 0.084, P = 0.380, and P = 0.568, respectively.ConclusionDespite no significant reduction in the FCR score, results showed the improvement of most QoL aspects after three months of intervention. Although the social network-based education method was effective, the group-based education method was more beneficial. Applying these educational methods in lymphedema treatment protocols needs cost-effectiveness studies.Trial registrationThis study was registered at the Iranian Registry of Clinical Trials (IRCT2017052834176N1).

Abstract P5-12-06: Non-adherence to endocrine therapy is associated with a significant increased risk of local recurrence in women ≥65 years with stage T1N0 breast cancer treated with adjuvant endocrine therapy alone after breast-conserving surgery

Abstract Purpose: Clinical guidelines recommend that for women ≥65 years with stage T1N0 breast cancer (BC) treated with breast-conserving surgery (BCS) that breast RT may be omitted and treatment with ET alone is acceptable. However, population-based studies report that up to two-thirds of women with T1N0 BC do not complete 5 years of ET. The effect of non-adherence to ET on recurrence risks in women treated with ET alone is unclear. We established a contemporary population-based cohort of women aged ≥65 years with stage T1N0, hormone receptor positive, breast cancer treated with single modality adjuvant ET or RT alone. We examined the effect of non-adherence in those treated with ET alone and compared the outcomes (ipsilateral LR, any breast event and any invasive in-breast event) of women who were non-adherent to those who were adherent to ET or those treated with RT alone. Methods: A population-based cohort of women diagnosed with T1N0 BC from 2010-2016, aged ≥65 years at diagnosis, treated with BCS and single modality adjuvant therapy with RT alone or ET alone was identified from the Ontario Cancer Registry. ER-/PR-, ER unknown/PR unknown, HER2+ cases and those without sentinel node biopsy or axillary dissection were excluded. Treatment and outcomes were ascertained using deterministic linkages of administrative databases. Receipt of adjuvant ET was identified using dispensing records from the Ontario Drug Benefit Claims database. Adherence percentage at any specific time was calculated by dividing the number of days dispensed (up to that time) by the number of days since diagnosis. This was updated every 3 months for each woman receiving ET. Adherence to ET was captured as a 3-level time-varying covariate (RT only, &amp;lt;80% ET adherence, ≥80% ET adherence). Patients were censored at the time of recurrence. Differences in recurrence risks were compared by Chi-square test. Multivariable Cox regression adjusted for age was used to evaluate risks of ipsilateral LR, any in-breast event (ipsilateral or contralateral, DCIS or invasive) and any first invasive in-breast recurrence. Results: The cohort includes 1551 women; 1054 women treated with BCS + adjuvant RT alone and 497 treated with BCS + adjuvant ET alone. The median follow-up time was 5 years. Almost half (45.7%) of cases prescribed ET alone were &amp;lt;80% adherent. For those who were followed for 5 years, 35% of follow-up time was spent non-adherent to ET. The 5-year risk of LR was 5.8% in patients treated with ET alone who spent &amp;lt;80% of time adherent to ET, 0.4% in patients treated with ET alone who were &amp;gt;80% adherent and 0.9% in those treated with RT alone (p&amp;lt;.001). The 5-year risk of any in-breast event was 6.6% in women &amp;lt;80% adherent, 0.7% in those adherent to ET and 3.2% in those treated with RT alone (p=.001). Women treated with ET alone who were &amp;lt;80% adherent during their follow-up time had a 5-fold increased risk of LR (HR=4.93, 95%CI: 2.13, 11.42, p=0.0002), a 1.6 fold increased risk of any breast event (HR=1.65, 95% CI: 0.89, 3.07, p=0.11) and a 1.6 fold increased risk (HR=1.68, 95% CI: 0.87, 3.25, p=0.13) of any invasive in-breast event compared to those treated with either RT alone or compared to those who were &amp;gt;80% adherent to ET. There was no significant difference in outcomes between those treated with ET who were &amp;gt;80% adherent during their follow-up time and those treated with RT alone. Conclusions: Almost half of women older than 65 years with stage T1N0 breast cancer treated with breast-conserving surgery and adjuvant ET alone are &amp;lt;80% adherent to ET. Non-adherence to ET is associated with higher risks of local recurrence compared to those treated with adjuvant RT alone. Adjuvant approaches incorporating RT may be preferable to ET alone. Citation Format: Mira Goldberg, Rinku Sutradhar, Lawrence Paszat, Timothy Whelan, Sumei Gu, Cindy Fong, Eileen Rakovitch. Non-adherence to endocrine therapy is associated with a significant increased risk of local recurrence in women ≥65 years with stage T1N0 breast cancer treated with adjuvant endocrine therapy alone after breast-conserving surgery [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 P5-12-06.

Abstract P5-07-07: A generalizable relationship between mortality and time-to-death among breast cancer patients can be explained by tumor dormancy

Abstract Background: Women with ER-positive breast cancer may recur as late as twenty years post diagnosis. The reason for this delayed recurrence is unknown. We studied survival patterns, including time-to-death in 123,705 women with stage I to III invasive breast cancer, enrolled in the SEER database. We sought to determine if time from diagnosis to death could be explained by variation in tumor dormancy. Methods: We divided the cohort into ten classes based on their 20-year risks of death from breast cancer. Probability of death at 20 years was estimated for each patient using year of diagnosis, patient characteristics (age, race, household income), tumor characteristics (grade, tumor size, nodal status, stage, ER and PR-status) and treatment (radiotherapy, chemotherapy). The 20-year mortality for women in the highest risk decile (decile 10) was 69% versus 5% for women in the lowest decile (decile 1). We define a variable α which represents the annual rate of reactivation from tumor dormancy. Using the highest risk decile as a reference distribution, we determined what α value gives the best fit for the time-to-death distribution of each decile. As a complementary analysis we performed quantile regression to determine independent predictors of time-to-death among women who died from breast cancer. Results: The duration of tumor dormancy was much longer, on average, for ER-positive breast cancers than for ER-negative breast cancers. Time at peak mortality rate monotonically decreased by decile, ranging from 19 years post-diagnosis in the lowest risk decile to two years post-diagnosis in the highest risk decile (Table 1). The difference in the time-to-death distributions by decile could be explained by the variable α which represents the annual rate of reactivation from tumor dormancy. In the regression analysis, ER-positive breast cancers had a median time-to-death 3.67 years longer than ER-negative breast cancers (Table 2). However, this effect was attenuated by risk factors correlated with ER status (adjusted difference 1.76 years). Notable independent predictors of time-to-death include ethnicity, tumor size, grade, nodal status and PR-status. Conclusion: Reactivation from tumor dormancy appears to occur at random wherein the rate of tumor activation is correlated with probability of death from breast cancer. This model may explain the very long time to cancer recurrence in women with ER-positive node-negative breast cancers. The clinical course of women with low-risk breast cancer is inherently unpredictable. Table 1: Factors related to breast cancer mortality and time-to-death by decile.Risk DecileNumber of patients (N)Annual death rate (per 100 person-years)20-year actuarial mortality (%)Peak mortality time (years)Median time-to-death (years)10th percentile time-to-death (years)90th percentile time-to-death (years)Optimal α (reactivations per person-year)112,3700.255.3%19.012.24.018.70.10212,3710.438.6%19.511.04.318.40.16312,3700.6011.3%9.510.33.517.60.20412,3710.7413.2%5.58.93.016.70.32512,3700.9016.0%3.58.62.617.40.32612,3711.1720.0%4.08.12.616.90.35712,3711.5124.8%3.07.62.316.70.41812,3702.1231.7%3.06.41.915.90.74912,3713.2242.5%2.55.61.714.81.291012,3706.6463.0%2.03.81.112.3InF (Ref.) Table 2: Predictors of time-to-death in breast cancer patients.PredictorValueUnadjustedAdjustedMedian time-to-death (years)Difference* (years)Difference (years)**POverall/ Reference5.6713.05***&amp;lt;.0001Year of diagnosis19905.42Reference19915.670.250.170.360919925.670.250.220.289919935.580.170.350.059919946.000.580.530.0054Age at diagnosis&amp;lt;505.58Reference50-595.920.330.070.580760-696.170.58-0.060.655170-805.25-0.33-1.18&amp;lt;.0001EthnicityWhite5.75ReferenceBlack4.33-1.42-0.320.009East Asian6.670.920.930.0058Southeast Asian6.080.330.090.8208Other/Unknown6.170.420.420.4176Tumor size (cm)&amp;lt;1cm8.33Reference1-2cm7.33-1.00-0.650.07922-3cm5.58-2.75-1.42&amp;lt;.00013-5cm4.75-3.58-1.76&amp;lt;.00015+cm3.83-4.50-2.16&amp;lt;.0001Tumor gradeI11.17ReferenceII7.58-3.58-2.82&amp;lt;.0001III4.25-6.92-4.78&amp;lt;.0001IV3.92-7.25-5.18&amp;lt;.0001Unknown6.25-4.92-3.57&amp;lt;.0001Nodal statusN06.83ReferenceN15.67-1.17-0.69&amp;lt;.0001N25.00-1.83-1.08&amp;lt;.0001N33.83-3.00-2.03&amp;lt;.0001Unknown2.42-4.42-2.32&amp;lt;.0001ER statusPositive7.17ReferenceNegative3.50-3.67-1.76&amp;lt;.0001PR statusPositive7.25ReferenceNegative3.83-3.42-1.7&amp;lt;.0001Unknown5.08-2.17-1.35&amp;lt;.0001RadiotherapyNo5.42ReferenceYes6.080.670.260.0214Unknown5.08-0.33-0.470.1043ChemotherapyNo/Unknown6.58ReferenceYes5.17-1.42-0.310.0091*Difference in median time-to-death relative to reference value.**Independent difference in median time-to-death after adjusting for all covariates in table.***Median time-to-death of the reference group. Citation Format: Vasily Giannakeas, Steven A Narod. A generalizable relationship between mortality and time-to-death among breast cancer patients can be explained by tumor dormancy [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 P5-07-07.

Abstract P3-08-10: Characterization of oncotype DX recurrence score and chemotherapy utilization patterns in young women (≤40) with early stage ER+/HER-, lymph node negative breast cancer

Abstract Background: Meta-analyses have demonstrated that young women ≤40 (YW) derive the most benefit from chemotherapy (EBCTCG, Lancet. 1998). Oncotype DX was designed to determine the benefit of chemotherapy in women with ER+/HER2-, node-negative (LN-) breast cancer based on recurrence score (RS). TAILORx reported clinically meaningful benefits in freedom-from-distant recurrence in women &amp;lt;50 with the addition of chemotherapy to endocrine therapy when RS was 16-25. Recent TAILORx analyses suggest that women &amp;lt;40 with an intermediate (int) RS do not derive chemotherapy benefit, though YW comprised &amp;lt;4% of the trial population [1]. Defining the optimal adjuvant treatment strategy for this population of YW remains a clinical challenge. We sought to determine national patterns of RS utilization in association with receipt of chemotherapy and to characterize the association of RS with tumor characteristics and demographics among YW with early stage ER+, LN- breast cancer. Methods: Using the National Cancer Data Base (NCDB), we identified individuals age &amp;lt;75, diagnosed 2010-2015 with stage I-II, ER+/HER2-, LN- breast cancer with known RS. Cohorts were defined as low (0-10), int (11-25), and high (&amp;gt;25) RS. Age categories were classified as ≤40, 41-50, and &amp;gt;50. Chi-square tests or Fisher’s exact tests were used to compare categorical variables. Logistic regression was used to estimate the association of RS score and age group with adjuvant chemotherapy use, after adjustment for known covariates. Kaplan-Meier curves were used to visualize unadjusted overall survival (OS), and Cox proportional hazards models were used to estimate adjusted OS. Results: 120,051 women were identified, of whom 4,781 were ≤40 years, 24,846 were 41-50, and 90,424 were &amp;gt;50. By age group, 20% of YW had a high RS compared to 12% of women age 41-50 and 15% of women &amp;gt;50 (p&amp;lt;0.001). Among YW, black women were more likely than white women to have a high RS; 29% vs. 19% (p&amp;lt;0.001). RS was strongly associated with receipt of chemotherapy in YW (86% of high RS vs. 33% of int RS vs. 7% of low RS, p&amp;lt;0.001). Chemotherapy was omitted in 55% of YW with RS 16-25. YW in multivariate analysis with a low or int RS were more likely than women 41-50 or &amp;gt;50 to receive chemotherapy (p&amp;lt;0.001). Receipt of chemotherapy for YW with an int RS was associated with younger chronologic age (p&amp;lt;0.001), ductal histology (p=0.02), high grade (p&amp;lt;0.001), and higher pathologic T-stage (p&amp;lt;0.001). Among YW, the unadjusted 5-year OS (95% CI) was as follows: low RS= 100% (0.99-1), int RS= 100% (1-1), high RS= 93% (0.90-0.96). Chemotherapy did not influence 5 year OS in YW with an int RS. In univariate analysis, a high RS was associated with a worse 5-year OS in YW (log-rank p&amp;lt;0.001). After adjustment for race and chemotherapy receipt, high vs. low RS was associated with an increased risk of death (HR=5.86, 95% CI 1.19-28.82, p=0.03) in YW. Conclusions: High RS is more common in YW (≤40) than those age 41-50 or &amp;gt;50, and is associated with worse OS. YW with an int or low RS are more likely to receive chemotherapy despite unclear benefit. Chemotherapy was omitted in over half of YW with RS of 16-25, highlighting the uncertainty in clinical practice which will remain until further studies inform optimal systemic treatment specific to YW. 1. Sparano, J.A., et al., Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer. New England Journal of Medicine, 2019. 380(25): p. 2395-2405. Citation Format: Sarah Sammons, Yi Ren, Jeremy Force, Oluwadamilola M. Fayanju, Laura H. Rosenberger, Jennifer K. Plichta, Gretchen Kimmick, Kelly Westbrook, Susan Dent, Carey Anders, Samantha M. Thomas, Terry Hyslop, E. S. Hwang, P. K. Marcom, Rachel A. Greenup. Characterization of oncotype DX recurrence score and chemotherapy utilization patterns in young women (≤40) with early stage ER+/HER-, lymph node negative breast cancer [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 P3-08-10.