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WOS:000518031100008 PMID: 31970972 Background: The synthesis of CDK4/6 inhibitors with endocrine treatment in two series of treatment has been widely accepted as the standard for patients with estrogen receptor-positive metastatic breast cancer. In spite of this, the activity of CDK4/6 inhibitors in patients with metastatic breast cancer who have progressed despite receiving multiple lines of treatment is not well understood. Aims: To report the activity and safety of a CDK4/6 inhibitor (palbociclib) in patients in whom at least three lines of treatment for ER+ metastatic breast cancer had failed. Study Design: Multicenter retrospective observational cohort study. Methods: In this retrospective observational cohort study, we included 43 patients who received palbociclib after at least three lines of systemic treatment for ER+/HER2- metastatic breast cancer. Results: The median progression-free survival in our population was 7 months (25th-75th percentile, 4-10), and the median overall survival was 11 months (25th-75th percentile, 6-19). Although there were some adverse events, palbociclib was generally well tolerated, so dose reduction was needed for only six patients (14%). Conclusion: The efficacy of palbociclib among heavily treated hormone receptor-positive/HER2- patients with advanced breast cancer was acceptable in terms of clinical benefit, and it was generally well tolerated among this population.

Background: MONALEESA-7 is a Phase III study (NCT02278120) and the only dedicated trial of endocrine therapy (ET) ± a cyclin-dependent kinase 4/6 inhibitor in premenopausal patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). The study demonstrated that the addition of ribociclib (RIB) to a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen (TAM) + goserelin (GOS) significantly extended both progression-free survival (PFS; hazard ratio, 0.55; Tripathy D et al. Lancet Oncol. 2018) and overall survival (OS; hazard ratio, 0.71; Im S-A et al. N Engl J Med. 2019). Health-related quality of life (HRQOL) and work productivity are other important aspects of clinical benefit, especially in the premenopausal population. We present analyses of QOL and work productivity from MONALEESA-7. Methods: Premenopausal or perimenopausal patients with HR+/HER2− ABC were treated with RIB or placebo (PBO) + GOS with either an NSAI (letrozole or anastrozole) or TAM. A secondary endpoint was evaluation of patient-reported outcomes (PROs) for HRQOL using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire core 30 (QLQ-C30). Assessments included global health status as well as social, emotional, and physical functioning. Description of Work Productivity and Activity Impairment (WPAI) was an exploratory endpoint and was measured using the WPAI Questionnaire: General Health (WPAI:GH; V2.0). Results: Time to deterioration (TTD) ≥ 10% in EORTC QLQ-C30 global health status was prolonged with RIB vs PBO (median, 35.8 vs 23.3 months; hazard ratio, 0.665 [95% CI, 0.517-0.855]). TTD ≥ 10% in emotional functioning was also prolonged with RIB vs PBO (hazard ratio, 0.636 [95% CI, 0.488-0.828]), as was TTD ≥ 10% in social functioning (hazard ratio, 0.813 [95% CI, 0.610-1.084]) and TTD ≥ 10% in physical functioning (hazard ratio, 0.715 [95% CI, 0.526-0.972]). Compliance rates with the WPAI:GH were > 99% at baseline and > 98% at the end of treatment. Neither arm had an increase from baseline to the end of treatment in mean percentage of work missed due to overall health. Change in percent activity impairment due to overall health was comparable between treatment arms, as were change in percent impairment while working due to overall health and percent overall work impairment due to overall health. The trends observed with RIB vs PBO in the EORTC QLQ-C30 and WPAI:GH in the overall population were generally similar in the NSAI cohort. Conclusions: WPAI and global health are important considerations in the premenopausal patient population. Analysis of PROs demonstrated that TTD ≥ 10% in global health status and emotional functioning were prolonged with RIB vs PBO. Social and physical functioning were maintained in both treatment arms. Results in various WPAI domains demonstrated that productivity was also maintained in both groups. These QOL and WPAI results, in addition to the significantly longer PFS and OS results with RIB vs PBO, indicate a substantial clinical benefit with RIB treatment in premenopausal patients with HR+/HER2− ABC. Citation Format: Nadia Harbeck, Sara Hurvitz, Aditya Bardia, Fabio Franke, K. Gonvind Babu, Paul Wheatley-Price, Young-Hyuck Im, Kadri Altundag, Antonia Ridolfi, David Chandiwana, Brad Lanoue, Lakshmi Menon, Debu Tripathy. Patient-reported outcomes, including work productivity, from the MONALEESA-7 trial of ribociclib plus endocrine therapy in patients with HR+/HER2− advanced 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 P1-19-06.

BACKGROUND The aim of this study was to investigate the association between A, B, O, Rhesus (Rh)-positive and Rh-negative blood groups and breast cancer in a nationwide cohort of 3,944 patients in Turkey. MATERIAL AND METHODS A retrospective study included 3,944 patients diagnosed with breast cancer between 2004 and 2015 and with known blood type. Clinical and demographic patient data included age, sex, body mass index (BMI), menopausal status. The breast tumor type, size, grade, TNM stage, and the presence of lymph node and distant metastases were noted. Histopathology of the breast tumors had included routine detection of human epidermal growth factor receptor 2 (HER2) and estrogen receptor (ER) levels. RESULTS The 3,944 patients with breast cancer were blood group, type A, B, O, and Rh-positive or Rh-negative; the median age was 47.9 years (range, 18.2-89.6 years); 99.5% (3923/3,844) were women, and 0.5% (21/3944) were men. Patients with blood type 0 had a significantly smaller tumor size compared with patients with blood types A or B. There were no significant differences between blood groups and patient age, BMI, menopausal status, tumor histology, ER status, HER2 status, lymph node and distant metastasis. However, there was a significant difference in the prevalence of lobular breast cancer, levels of ER-positive tumor cells, and prevalence of cases with tumor metastases in Rh-positive patients compared with Rh-negative patients. CONCLUSIONS The findings of this retrospective study showed that the type, grade, stage, and hormonal status of breast cancer showed no significant associations with ABO blood grouping.

Background: Endocan, known as endothelial cell specific molecule (ESM), is a novel endothelial dysfunction marker. The aim of this study is to examine the plasma endocan level and its prognostic significance in newly diagnosed breast cancer patients. Methods: A total of 84 patients were enrolled the study. Plasma endocan level was measured by specific enzyme-linked immunosorbent assay (ELİSA) kit. Ethical approval and informed consent were attained. Results: At the time of diagnosis, 33 patients had stage 4 disease. The median plasma endocan level was 619.9 (min 259.9–2813.2) ng/L and its level was significantly higher in metastatic breast cancer group compared to non–metastatic breast cancer group. According to molecular sub-type of breast cancer, there is not statistical difference in plasma endocan level, but its level was higher in patients with Her-2 amplified and triple negative breast cancer (TNBC). Median follow-up time is 11 (1-30) months. Event free survival (EFS) was 15 months in patients with plasma endocan level lower than 620, while it was 4 months in patients with serum endocan level greater than 620 (p = 0.016). There was no difference between groups in terms of hypertension, age, Lymphovascular invasion (LVI), extra capsular extension (ECE), body mass index (BMI) and White blood cells (WBC), platelet count and plasma endocan level. Conclusion: Plasma endocan levels higher than non metastatic breast cancer. Patients with high plasma endocan levels are short EFS. Further studies would be useful to assess endocan level as a prognostic factor in breast cancer. Keywords: Endothelial cell specific molecule, Breast cancer, Prognosis

Background:Body mass index (BMI) is defined as a poor prognostic factor in patients with breast cancer(BC). However, there are controversial results regarding the various effects of BMI on BC, hence the exactpathophysiology of the relation between obesity and BC is still under debate, and remains unclear. Thispaper aims to investigate the association between BMI at presentation and BC subtypes defined accordingto the immunohistochemical classification in both premenopausal and postmenopausal patients with BC.Patients and methods:This study is a retrospective and explorative analysis of the 3767 female BC pa-tients from a single center. All patients' BMI at the time of initial diagnosis and tumor demographics wererecorded. BMI was stratified into 3 groups as normal-weighted (BMI

BACKGROUND AND OBJECTIVES: We sought to evaluate the impact of chemotherapy sequence on survival by comparing node-positive ILC patients who received neoadjuvant (NACT) and adjuvant (ACT) chemotherapy. METHODS: cT1–4c, cN1–3 ILC patients in the National Cancer Data Base (2004–2013) who underwent surgery and chemotherapy were divided into NACT and ACT cohorts. Kaplan-Meier curves and Cox proportional hazards modeling were used to estimate unadjusted and adjusted overall survival (OS), respectively. RESULTS: 5,551 (35.6%) of 15,573 ILC patients treated with chemotherapy received NACT. NACT patients had similar rates of pT3/4 disease (26.6% vs 26.2%), nodal involvement (median 3 vs 4), and number of lymph nodes examined (median 13 vs 14) but higher rates of mastectomy (81.8% vs 74.5%, p

Purpose The accuracy of predictive and prognostic biomarker assessment in breast cancer is paramount since these guide therapy decisions. The aim was to investigate the concordance of biomarkers and immunohistochemical (IHC)-based surrogate tumor subtypes between core needle biopsies (CNB) and consecutive paired breast cancer surgical resections. Methods This retrospective study comprised two cohorts of patients with primary breast cancer diagnosed between 2016 and 2017: one treated with primary surgery (n = 526) and one with neoadjuvant chemotherapy (NAC) (n = 216). The agreement between preoperative CNB and paired tumor specimens regarding the assessment of biomarkers and surrogate tumor subtypes was evaluated in both cohorts. Results In the primary surgery cohort, the concordance rates and kappa values for estrogen receptor (ER), progesterone receptor (PR) and Ki67 were 98.6% (κ = 0.917), 89.3% (κ = 0.725) and 78.8% (κ = 0.529), respectively. Importantly, human epidermal growth factor receptor 2 (HER2) IHC assessment showed only moderate agreement (κ = 0.462). HER2 status combining IHC and in situ hybridization was discordant in 3.6% of cases, potentially impacting on indications for HER2-targeted therapy. The concordance rate for IHC-based surrogate tumor subtypes was only 73.2–78.3%. Generally lower concordance rates for ER, PR and HER2 were observed in the NAC cohort. Here, HER2 status was discordant in 7.4%. Conclusions The agreement of HER2 and Ki67 between CNB and paired surgical specimen in primary breast cancer is insufficient. Limited agreement of surrogate tumor subtypes indicates a significant clinical value of biomarker re-testing on surgical specimens.

The aims of this study were to explore advanced breast cancer patients’ knowledge of treatment intent and expectation of illness course and to evaluate their relationship with optimism, hope, and quality of life (QoL). Patients with advanced breast cancer (n = 55) who were treated in the ambulatory clinic of the University of Hacettepe were included in the study. They completed Life Orientation Scale, The Hope Scale, and the European Organization for Research and Treatment of Cancer Quality of Life questionnaires. The data regarding the knowledge of illness progression and the perceptions of therapy intent were assessed using self-administered open-ended questionnaires that were answered by the patients. The data revealed that 58.2 % of the patients had an inaccurate perception of treatment intent, believing the aim of treatment was cure, whereas only 38.2 % of the patients had a realistic expectation that their disease may remain stable or may progress over a year. In addition, the awareness of disease progression and perception of goals of treatment was significantly related to hope and optimism scores but not to QoL. A large proportion of patients diagnosed with advanced breast cancer believed that their treatment was “curative”, and they would improve within a year. Findings of our study suggest that patients with inaccurate perception of treatment intent and unrealistic expectation of prognosis have higher hope and optimism scores than those who do not, but there were no significant differences in terms of global health status.

Background BOLERO-2 phase III trial established the efficacy of everolimus (EVE) plus exemestane (EXE) for the treatment of postmenopausal patients with hormone receptor (HR)-positive, HER2-negative, advanced breast cancer (aBC). However, in this study only a minority ( Methods EVEREXES is an open-label phase IIIb, single arm, multi-center trial, which from March 2013 to October 2014 enrolled 232 post-menopausal, HR-positive and HER2-negative, aBC patients previously treated with aromatase inhibitors, across 13 countries in Asia Pacific, Middle East, North and South Africa, with a significant majority of patients being of Asian ethnicity (196, 84.5%). Its primary objective was to investigate the safety and tolerability profile of EVE+EXE. Secondary objectives were the evaluation of efficacy (assessed by PFS, ORR, and CBR based on RECIST 1.1 criteria) and change in ECOG performance status. Results At data cut off of 31st of January 2015, at a median follow up of 11.7 months, median PFS for the ITT population was 9.5 months [9.2-11.6 months], based on local assessment, with the observation of 1 (0.4%) CR and 35 (15.4%) PR. Regarding safety and tolerability, a majority (81.1%) of grade (G) 1/2 adverse events (AEs) was reported. In particular, the following pattern was observed in terms of % of patients who developed G1/G2/G3 mTOR-inhibition induced AEs: stomatitis (36.1, 13.7, 10.6), rash (21.6/6.2/0), fatigue (10.6, 4.4, 2.2), hyperglycemia (6.2, 11.5, 7.0), weight decrease (7.5, 7, 0.9), pneumonitis (5.7, 7, 0.9). No Grade 4 AEs related to EVE+EXE treatment were observed, with exception of one case of non infectious pneumonitis (0.4%). Median dose intensity of everolimus was 9.2 mg/day. Conclusions Efficacy and safety results from EVEREXES trial further confirm the role of EVE+EXE for the treatment of HR+/Her2- advanced BC patients in Eastern countries. Results were consistent with data previously reported in BOLERO-2 trial. Citation Format: Im Y-H, Uslu R, Lee KS, Nagarkar R, Sohn J, Sevinc A, Altundag K, Chang Y-C, Abdel-Razeq H, Im S-A, Jeong J, Park HY, Arpornwirat W, Bastick P, Le TH, Ocak Arikan O, Xue HL, Canatar A, Valenti R, Kim S-B. Clinical effectiveness of everolimus and exemestane in advanced breast cancer patients from Asia and Africa: First efficacy and updated safety results from the phase IIIb EVEREXES study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-13-09.

Introduction: The relation between Behçet's disease (BD) and breast cancer (BC) is unclear. Our purpose is to investigate whether BD has an important effect on BC or vice versa. Patients and Methods: A total of 12 female BC patients with a diagnosis of BD were identified from a cohort including 5050 BC patients. The demographic data of the selected patients including previous chemotherapy (CT), radiotherapy (RT), hormonal therapy (HT), drugs used for BD, history of thrombotic events, and overall survival were examined. Results: The rate of BD in the entire cohort was found to be 0.25% (12/4800), and all had early BC at the time of BC diagnosis, with a median age of 47 years (range: 38–51). All patients underwent curative surgery for BC. In the adjuvant setting, CT, RT, and HT were administered in 11 (91%), 10 (83.4%), and 9 (75%) patients, respectively. All patients received acetylsalicylic acid and colchicine for BD. No serious adverse event associated with BC and/or BD was observed. Clinical symptoms in 11 patients with BD were observed to be improved following the BC treatment. Only one patient developed disease progression and then expired. Conclusion: Unlike the natural behavior of BD, which is well-defined to have an increased risk of thrombosis, BC patients with BD in this study did not have any adverse event. However, due to small sample size, it is difficult to drive any definite conclusion regarding the relation between these two pathologies.

Purpose Recurrence risk management of patients with small (≤ 2 cm), node-negative, human epidermal growth factor receptor 2 (HER2)-positive breast cancer remains challenging. We studied the effects of adjuvant chemotherapy and/or trastuzumab and survival outcomes among these patients, using data from the population-based Japanese National Clinical Database (NCD). Methods We identified a cohort of 2736 breast cancer patients with HER2+ pT1N0 disease: 489 pT1a, 642 pT1b, and 1623 pT1c. The median observation period was 76 months, and the 5-year follow-up rate was 48.2%. The number of events was 212 for disease-free survival (DFS), 40 for breast cancer-specific survival, and 84 for overall survival (OS). Results There were 24.5% of pT1a, 51.9% of pT1b, and 63.3% of pT1c patients who were treated systemically after surgery. OS in pT1b (logrank test; p = 0.03) and DFS in pT1c (logrank test; p

To compare the experience of four UK Centres in the use of intradermal microbubbles and contrast enhanced ultrasound (CEUS) to pre-operatively identify and biopsy sentinel lymph nodes (SLN) in patients with breast cancer.In all centres, breast cancer patients had a microbubble/CEUS SLN core biopsy prior to axillary surgery and patients in Centres 1 and 2 had a normal greyscale axillary ultrasound. Data were collected between 2010 and 2016; 1361 from Centre 1 (prospective, sequential), 376 from Centre 2 (retrospective, sequential), 121 from Centre 3 (retrospective, selected) and 48 from Centre 4 (prospective, selected).SLN were successfully core biopsied in 80% (Centre 1), 79.6% (Centre 2), 77.5% (Centre 3) and 88% (Centre 4). The sensitivities to identify all SLN metastases were 46.9% [95% confidence intervals (CI) (39.4-55.1)], 52.5% [95% CI (39.1-65.7)], 46.4% [95% CI (27.5-66.1)] and 45.5% [95% CI (16.7-76.6)], respectively. The specificities were 99.7% [95% CI (I98.9-100)], 98.1% [95% CI (94.5-99.6)], 100% [95% CI (93.2-100%)] and 96.3% [95% CI (81-99.9)], respectively.The negative predictive values were 87.0% [95% CI (84.3-89.3)], 84.5% [95% CI (78.4-89.5)], 86.9% [95% CI (82.4-90.3)] and 86.2% [95% CI (78.4-91.5)], respectively. At Centres 1 and 2, 12/730 (1.6%) and 7/181 (4%), respectively, of patients with a benign microbubble/CEUS SLN core biopsy had two or more lymph node (LN) macrometastases found at the end of primary surgical treatment.The identification and biopsy of SLN using CEUS is a reproducible technique. Advances in knowledge: In the era of axillary conservation, microbubble/CEUS SLN core biopsy has the potential to succeed surgical staging of the axilla.

Denosumab is fully human monoclonal antibody that specifically binds and inactivates receptor activator of NF-kB ligand (RANKL), an important ligand that regulates bone remodeling. In this review, we aimed to show the clinical data about denosumab treatment and discuss its advantages for the management of patients with solid tumors and bone metastasis.Denosumab showed positive results in clinical studies of solid tumors with bone metastasis. PubMed database and ASCO Symposium Meeting abstracts were searched until August 2015 by using the terms 'denosumab', 'RANKL inhibitor' and 'bone metastasis'. The last search was on 21 August 2015. All resulting studies were retrieved and were also checked for related publications. Clinical trials in this review fulfilled the following criterion: inclusion of sufficient data to allow estimation of the efficacy and safety of denosumab.The effects of denosumab on skeletal-related events (SREs) were investigated in three large randomized trials: one in patients with breast cancer, one in patients with prostate cancer, and one in patients with multiple myeloma or solid tumors other than breast or prostate cancer. In the breast cancer and prostate cancer studies denosumab was non-inferior and also superior to zoledronic acid in terms of the primary outcome time to first on-study SRE. In the third study denosumab was non-inferior to zoledronic acid but was not superior to zoledronic acid in solid tumors excluding breast and prostate cancer with bone metastases. In the three studies median overall survival and disease progression rates were similar between zoledronic acid and denosumab. Denosumab has also been studied in bone loss associated with hormonal therapy in both breast and prostate cancer. Adjuvant denosumab significantly reduced the risk of clinical fracture risk by 50% in breast cancer patients and by 62% in non-metastatic prostate cancer patients treated with adjuvant aromatase inhibitors or androgen deprivation therapy. In addition, biochemical markers of bone turnover and fractures were significantly reduced in patients under denosumab treatment.The promising outcomes in the initial trials with denosumab have shown clinical activity and a favorable safety profile in patients with solid tumors and bone metastasis. Denosumab significantly reduced treatment-related osteoporosis associated with breast and prostate cancer and was superior to zoledronic acid in prevention or delaying of SRE.

BACKGROUND The addition of CAP to maintenance BEV demonstrated statistically significant and clinically relevant improvements in progression-free survival (PFS [primary endpoint]; HR 0.38 [95% CI 0.27–0.55]; log-rank p METHODS Pts with HER2-negative measurable mBC, ECOG PS RESULTS Adherence with questionnaire completion was 65–85% for all assessment timepoints during the first year of maintenance therapy. MMRM analysis of the global health status/QoL subscale showed no difference between the treatment arms in change from randomization (least squares mean estimate 0.40 [95% CI –6.07 to 6.87]). Similar results were observed for other subscales, including the diarrhea symptom subscale. No. of pts (%)BEV (N=94)BEV–CAP (N=91)Week 9aN=51N=59Improved15 (29.4)17 (28.8)Stable26 (51.0)34 (57.6)Week 18aN=29N=57Improved11 (37.9)12 (21.1)Stable12 (41.4)30 (52.6)Week 27aN=23N=43Improved7 (30.4)16 (37.2)Stable12 (52.2)20 (46.5)Week 36aN=15N=35Improved4 (26.7)14 (40.0)Stable9 (60.0)17 (48.6)aNo. of patients with completed questionnaires at both randomization and the respective week. Only weeks with ≥10 pts in both arms shown. CONCLUSIONS The IMELDA sample size was smaller than planned but protocol adherence with PRO completion was relatively high. Prespecified change from randomization and exploratory post hoc MMRM analyses of PROs suggest that the clinically meaningful PFS and OS benefit from adding CAP to BEV is achieved while maintaining QoL, with no difference between BEV and BEV–CAP treatments. Responder analyses over time showed improved or stable global health status/QoL scores in the majority of pts at each timepoint in both treatment arms. Citation Format: Dinesh Doval, Saverio Cinieri, Hakan Bozcuk, Jean-Yves Pierga, Kadri Altundag, Xiaojia Wang, Sudeep Gupta, Guillermo Lopez Vivanco, Vineet Gupta, Ewa Chmielowska, Jose Bines, Philippe Montcuquet, Alfred Namour, Emilio Alba, Giorgio Mustacchi, Paulo Cortes, Sabine de Ducla, Ulrich Freudensprung, Lesley Fallowfield, Joseph Gligorov. Exploratory post hoc analyses of patient-reported outcomes (PROs) in the IMELDA randomized phase III trial: Maintenance bevacizumab (BEV) ± capecitabine (CAP) after initial first-line BEV plus docetaxel (DOC) for HER2-negative metastatic breast can [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-12-16.

Introduction: Obesity is an independent risk factor for the development of breast cancer and has been associated with poor breast cancer outcomes. But, this association usually depend on hormone-receptor positivity and ovarian activity. Obesity was confirmed as an adverse prognostic factor in patients treated with aromatase inhibitors, but the adverse effects in patients treated with tamoxifen was not known exactly. Thus, we aimed to examine the efficacy of adjuvant tamoxifen in hormone receptor-positive premenopausal breast cancer patients according to the body mass index (BMI). Material-Methods: Newly diagnosed hormone receptor-positive breast cancer patients who were premenopausal and non-metastatic were enrolled to the study. Patients with BMI ranging between 18.5 and 24.9 kg/m2 as normal weight patients (Arm A, n = 408), and patients with a BMI ranging ≥ 25 kg/m2 were overweight and obese patients (Arm B, n = 418). Results: The median follow-up time for this analysis was 36 (6-327) months. The median age was 39.5 (22-57) and 43 (20-56) in Arm A and Arm B, respectively (P Conclusion: Our study showed that BMI have no worse effect on recurrence risk in patients treated with tamoxifen in hormone-receptor positive premenopausal breast cancer. Poor survival outcome was observed in overweight and obese patients can be due to dose limitations of chemotherapeutic agents and higher rate of comorbid diseases. Citation Format: Kadri Altundag, Mehmet AN Sendur, Sercan Aksoy, Taner Babacan, Yavuz Ozisik. Efficacy of adjuvant tamoxifen in hormone receptor-positive premenopausal breast cancer patients according to the body mass index [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-12-16.

BACKGROUND The open-label randomized phase III IMELDA trial demonstrated that adding CAP to maintenance BEV until disease progression (PD) after initial BEV–docetaxel (DOC) provides statistically significant and clinically meaningful improvements in both progression-free survival (PFS [primary endpoint]; hazard ratio [HR] 0.38 [95% CI 0.27–0.55]; log-rank p METHODS Patients (pts) with HER2-negative measurable mBC, ECOG PS RESULTS Between Jun 2009 and Mar 2011, 284 pts were enrolled and treated. Of these, 99 were not eligible for randomization (most commonly due to PD [41%] or AEs/toxicity [31%]) and 185 (65%) were randomized. At the time of the primary PFS analysis, representing study closure, median follow-up (from randomization) was 31.6 months. Median OS from randomization was 23.7 months in the BEV arm and 39.0 months in the BEV–CAP arm (events in 36% of pts). The HR for OS in the two randomized arms showed consistency between subgroups, favoring the BEV–CAP arm in all subgroups analyzed. SubgroupNo. of events/No. of pts (%)Unstratified HR (95% CI)1-y OS rate (%) BEVBEV–CAP BEVBEV–CAPAll53/94 (56)33/91 (36)0.43 (0.26-0.69)a72901.5×ULNb3/5 (60)3/6 (50)1.01 (0.20-5.00)6044aStratified analysis. bStratification factor. CONCLUSIONS. Combining maintenance BEV with CAP until PD after initial BEV–DOC for mBC provides a statistically significant and clinically meaningful improvement in OS (secondary endpoint), seen consistently irrespective of baseline characteristics. Citation Format: Joseph Gligorov, Jose Bines, Emilio Alba, Giorgio Mustacchi, Saverio Cinieri, Vineet Gupta, Jean-Yves Pierga, Hakan Bozcuk, Rabab Gaafar, Sudeep Gupta, Guillermo Lopez Vivanco, Xiaojia Wang, Romulo Costa, Kadri Altundag, Ewa Chmielowska, Sabine de Ducla, Ulrich Freudensprung, Paulo Cortes, Dinesh Doval. Overall survival (OS) in the IMELDA randomized phase III trial of maintenance bevacizumab (BEV) with or without capecitabine (CAP) for HER2-negative metastatic breast cancer (mBC) [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-17-01.

Background: The standard treatment of local advanced nasopharyngeal cancer is chemoradiotherapy. There is a lack of data concerning induction therapy. In this study we retrospectively examined patients treated with induction therapy and chemoradiotherapy. Materials and Methods: Locally advanced nasopharyngeal cancer patients treated between 1996 and 2013 in our clinic were included in the study. Three different induction regimens were administered to our patients in different time periods. The regimen dosages were: CF regimen, cisplatin 50mg/m 2 1-2 days, fluorouracil 500mg/m 2 1-5 days; DC, docetaxel 75mg/m 2 1 day, cisplatin 75mg/m 2 1 day; and DCF, docetaxel 75mg/m 2 1 day, cisplatin 75mg/m 2 1 day, 5-Fu 750mg/m 2 1-5 days. Most of the patients were stage III (36.4%) and stage IV (51.7%). Results: Median follow-up time was 50 months (2-201 months). Three-year progression-free survival (PFS) was 79.3%, and 5-year PFS 72.4% in all patients. Three-year overall survival (OS) was 87.4% and 5-year OS 76% in all patients. In terms of induction therapies, 3-year OS was 96.5% in the DCF group, 86.6% in the DC group and 76.3% in the CF group (p=0.03). Conclusions: There was no significant differences in response rate and PFS between the three regimens. OS in the DCF group was significantly higher than in the other groups. However, this study was retrospective and limited toxicity data were available; the findings therefore need to be interpreted with care.