bluuebunny/crossref_metadata_2025_split huggingface dataset:
New molecular breast cancer classification with adjuvant therapy in our population
Authors: Richardet E. , Mascheroni B , Magri I , Perelli L , Cortés M 
Published: August 2020

e11624 Background: The molecular classification (Perou) helped to identify new groups of patients with different biological behaviors. A retrospective, descriptive, comparative trial with adjuvant chemotherapy treatment was conducted. Objectives: Analyze the natural history of the subgroups of patients, frequency, site of relapse and Disease-free survival (DFS). Materials and Methods: 200 Medical charts of patients with breast cancer were analyzed from 1997 to 2007, who had received adjuvant treatment without Trastuzumab. The 92, 5 % of Luminal A, 91 % of Luminal B y C, the 75.9 % of Her2 (+) and the 69.2 % of Triple Negative (TN) had received adjuvant therapy with FAC, while 30% of the last two groups were treated with taxanes and anthracyclines. We evaluated the site of the first relapse after adjuvant treatment in relation to the new molecular classification. Log-rank test was used to compare the rates of Disease-free survival (DFS). Results: Frequency: Luminal A (86, 42%) Luminal B y C (65, 33%) Her2 + (33, 17%) TN: (16, 8%) The locoregional relapse in the TN group was 36.4% (P = 0.003), the average of bone relapses were 64.5% on the four groups without statically significance compared to other groups. The CNS had a greater trend in TN groups (16.7%) and Her2+ (13.6%), compared to Luminal Type A-B (0 % y 8.3 %). Disease-free survival (DFS): Luminal A 65.0 ± 5.0 months Luminal B y C 50.3 ± 4.3 months HER2 42.9 ± 5.5 months TN 31.1 ± 7.3 months In the analysis of type A luminal subgroup, a prolonged disease free time was showed when compared with the others subgroups, of major statistical significance Log rank (p = 0.002). Conclusions: Her2 negative and TN tumors have less DFS and a higher locoregional and CNS relapse. No significant financial relationships to disclose.
Characteristics and behavior of HER-2/neu positive tumors in patients under 35 years of age with breast cancer
Authors: Vigo S. A. , Sansano M. , Marmissolle F. , Mainella A. , Lujan L. , Price P. , Antonelli M. , Mohamed F. , Giacomi N. 
Published: August 2020

e11634 Background: Breast cancer (BC) rarely occurs in young women. Presentation, behavior and prognosis of BC in such patients (pts), when compared with older women, are unclear. It is believed that tumor is more aggressive in biologic nature in this group of pts. Objective: to describe Her2/neu status, tumor behavior and prognosis in women aged 35 and under with BC. Methods: We reviewed the records of 45 women aged 35 years or less, with diagnosis of BC between 1999 and 2007. The original Her2 status was analyzed by immunohistochemistry (IHC) with a polyclonal antibody. The results were interpreted using score 0 to 3+. Fluorescence in situ hybridization (FISH) was performed in all samples. Results: Her2/neu overexpression showed up in 8 tumors (17.7%) and all of them were confirmed by FISH. In this group of pts (FISH positive) hormone receptors were positive in 50%. Stage at diagnosis was I 2 pts and II 6 pts. 5 out of the 8 pts with Her2/neu tumors had axillary node involvement (11.1% out of the total of population), and tumor size was more than 2cm at diagnosis. All of them were invasive ductal carcinoma. Postoperative radiotherapy was given to 6pts while all pts with Her2/neu positive tumors received chemotherapy with anthracyclines, taxanes and trastuzumab. Disease free survival of 24 month was achieved in 5pts, 1pt died with bone, lung and liver metastases. 2pts had progressive disease (bone and lung metastases one of them, and local recurrence the other one). Conclusions: In our population of pts, 17.7% were Her 2/neu positive. In this small group of pts lymph node involvement was frequent and tumor size was more than 2cm. Progressive disease with distant metastases in bone, lung and liver was observed. Despite of these negative characteristics 5 out of 8 pts (62.5%) had DFS of 2 years. No significant financial relationships to disclose.
Phase IIb double-blind, randomized, placebo-controlled trials for the efficacy and safety of sorafenib in patients (pts) with metastatic or locally advanced breast cancer (BC): Review of the Trials to Investigate the Effects of Sorafenib in BC (TIES) program
Authors: Baselga J. , Gianni L. , Gradishar W. J. , Hudis C. , Perez E. A. , Piccart-Gebhart M. , Schwartzberg L. S. , Sledge G. , Fleming T. R. 
Published: August 2020

e12000 Sorafenib is a potent multikinase inhibitor approved by the FDA and EMEA for the treatment of advanced renal cell carcinoma and hepatocellular carcinoma. As a single agent, sorafenib has been shown to have activity in pts with BC. Here, we review the TIES program, a compilation of currently ongoing investigator-sponsored phase IIb multinational, randomized, double-blind, placebo-controlled studies that aim to determine the optimal sequencing of pharmacologic agents for the treatment of BC. All studies will combine sorafenib with first- and/or second-line chemotherapy and/or hormonal therapy in pts with HER2-negative metastatic or locally advanced BC, enroll 220 pts, stratify pts by visceral vs nonvisceral disease, allow pts with evaluable and measurable disease, and include pts with treated brain metastases. The primary endpoint of all trials will be progression-free survival. Secondary endpoints will be safety, overall survival, objective response rate, duration of response, and time to progression. Some studies will also assess quality of life, pharmacokinetic sampling, and biomarkers. Additional information on four of the trials is shown below (Table). Patient characteristics and accruals will be reported. [Table: see text] No significant financial relationships to disclose.
Metastatic male breast cancer (mMBC): Prognosis and survival of 35 patients
Authors: Foerster R. , Foerster F. G. , Baaske D. , Schubotz B. , Wulff V. , Rudlowski C. 
Published: August 2020

e12001 Background: Only about 1% of breast cancers occur in men, respectively 400–500 new cases per year in Germany. Clinical studies on breast cancer in men are limited for case studies or retrospective analysis. In the recent years no studies have been published on the clinical course of mMBC. Therefore we here present a retrospective cohort study on this topic. Methods: Clinical and pathological tumor characteristics and the follow-up of male breast cancer patients with metastatic disease diagnosed in the region Chemnitz/Zwickau in the state of Saxony between 1995 and 2007 were documented and statistically evaluated. Results: 35 men (median age 64.7 years) were diagnosed with mMBC; 10 (28.6%) of them with primary metastasis. Median survival time: 37 months. 85.7% (n = 30) had an invasive-ductile carcinoma. Most common localizations of metastasis: bones (n = 19), lungs (n = 19), liver (n = 7). Tumor characteristics at the point of diagnosis: 63.9% (n = 22) T2-T4, 38.7% (n = 12) G3, 48.4% (n = 15) N+, 79.3% (n = 23) ER+, 72.4% (n = 21) PgR+, 12.5% (n = 3) HER-2+, 13.8% (n = 4) triple negatives, and 69.2% (n = 9) AR+. The therapy in the metastatic state was very heterogeneous and consisted of systemic endocrine therapy in 45.5% (n = 10), systemic chemo therapy in 9% (n = 2) or a combination of both in 45.5% (n = 10). In 14 (40%) cases a palliative radio therapy was administered. The initial tumor characteristics like tumor size, nodal state and grading were not of any prognostic relevance on a future development of metastasis. Prognostic unfortunate were a negative hormone receptor state (p < 0.001) and triple negative receptor state (n.s.). Patients with primary metastasis showed a tendency towards worse survival than patients who developed the metastasis during follow up (n.s.). If a systemic therapy was given the prognosis was significantly improved (p < 0.005). Conclusions: Patients suffering from metastatic male breast cancer had a comparatively good prognosis and showed significant benefit from systemic therapy in this study. In patients with negative receptor state and without systemic therapy the prognosis was especially worsened. Our data suggest that an up-to-date adequate systemic therapy is capable of improving survival in men with metastatic breast cancer. No significant financial relationships to disclose.
Patterns of metastatic (met) disease sites in breast cancer (BrCa): Implications for availability of fresh tumor tissue (FTT) for personalized BrCa treatment (Rx) planning (TP) in met disease
Authors: Presant C. A. , Bosserman L. , Howard F. , Emilio B. 
Published: August 2020

e12004 Background: Personalized Rx for patients (PTs) can improve response. Although archival tissue is available in all PTs, FTT testing of molecular, immunohistochemical, and/or chemosensitivity characteristics may be more optimal for TP than tissues obtained before previous Rx and/or new mets, and archival tissue is inadequate for cell culture information. This study was performed to determine the availability of FTT in a multi-site cancer center. Methods: Pts seen over 22 months were evaluated. PT clinical characteristics were evaluated to determine the prevalence of mets by site, and feasibility of biopsy (bx) for FTT by site. A bx algorithm for FTT was developed and quantified. Results: 26,794 successive PTs were evaluated. BrCa was present in 2043 (7.6%). Median age was 61 (range 27 to 98). Mets were present in only 174 (8.5% of BrCa) who had 256 sites involved (1.47 site per PT). 68% of PTs had multiple sites involved. Of PTs with multiple sites, 96 (81%) had 2, 16 (14%) had 3, and 6 (5%) had 4 sites involved. Single site was the pattern in only 9% of liver, 7% of lung, 32% of bone, 0% of adrenal 6% of skin, but 71% of brain mets. The most frequent sites of mets were bone (50%), lung (31%), liver (26%), brain (10%), skin or soft tissue (11%), lymph node (6%), and effusion/ascites (3.4%). In order to theoretically obtain FTT for development of a personalized TP based on an algorithm preferring in order local bx > para/thoracentesis, > non-osseous needle bx > video-assisted tissue bx > osseous bx, 18% of PTs would have had a local bx, 3% para/thoracentesis, 23% liver bx, 19% lung bx, 17% bone bx, and 12% would not have had a bx because of brain-only mets. Conclusions: Most BrCa PTs in oncology practices have only locoregional disease. Most PTs with mets have multiple sites. FTT acquisition would be feasible for 88% of PTs with mets for personalized TP, and in most the bx would be simple and non-invasive. However, tissue culture tests would necessitate a more invasive video-assisted bx in 42% of PTs. Physicians should consider additional bx to personalize TP when appropriate for improving outcomes. [Table: see text]
HER-2 gene amplification in circulating tumor cells (CTCs): Concordance with amplification status in primary breast cancers and metastatic lesions
Authors: Yerushalmi R. , Mishaeli M. , Huntsman D. G. , Gelmon K. A. 
Published: August 2020

e12006 Background: Recent studies have suggested a significant incidence (10%-30%) of discordance in HER-2 expression between metastatic lesions and the primary breast cancer (BC) which can result in inappropriate treatment recommendations. Biopsies of recurrent BC can aid in determining the expression but are often painful, costly, or cause delays in therapy. We initiated a study with the objective to determine and compare the molecular characteristics of the primary tumor, CTCs and metastases to assess whether the assessment of HER-2 gene amplification status in CTCs by FISH analysis could be used to determine treatment. Methods: After consent, patients with metastatic BC were enrolled, peripheral blood was collected (5 cc-10 cc), metastases were biopsied and HER-2 expression was determined. Blood samples were used for the CTC assay. We performed the CTC enrichment assay using a combination of anti CK and anti-EpCAM. The criteria for CTCs were: positive for cytokeratins 8, 18, 19, positive for DAPI and negative for CD45. Slides were scanned for CTCs using the Ariol system. When a CTC was identified the slide was reused for HER-2 FISH staining using the PathVysion HER-2 DNA Probe Kit. Initial attempts of FISH on CTCs took 48 hours to complete; to hasten the process, the second scan for FISH was done only on selected areas and the images for CTCs and FISH analysis were fused to obtain FISH images on a specific CTCs resulting in a 1 hour process. Results: To date 58 samples were collected, 40 of which had CTCs. At present, biopsies are being assessed and compared to the primary lesion in the initial 20 cases. Conclusions: FISH analysis of CTCs is a feasible technique and may be used to assess the specific molecular characteristics of breast cancer. Whether their HER-2 status reflects the metastatic or primary tumor is still unclear but is being determined and may have useful clinical application. No significant financial relationships to disclose.
Circulating tumor cells (CTC), [18F]fluorodeoxyglucose positron emission tomography, and computed tomography (PET/CT) for treatment monitoring in patients with metastatic breast cancer (MBC)
Authors: Tamkus D. , Chandana S. R. , Berger K. , Aung T. 
Published: August 2020

e12007 Background: Use of [18F]-fluorodeoxyglucose PET /CT and/or CTC is being investigated to follow up response to treatment in patients with MBC. It is not clear if these tests can be a surrogate for one another. Methods: We retrospectively analyzed a database of female patients with MBC undergoing chemotherapy or hormonal therapy. Most of these patients received at least 2 lines of therapy. Standard CT scan tumor measurements were used to assess response to therapy. CTC were defined either low (0–5) or high (>5). Maximum standard uptake values (max SUV) on PET scan were defined either low (<3) or high (>3). Correlation between the max SUV and CTC counts was statistically analyzed. Sensitivity, specificity, positive and negative predictive values were calculated from 2 x 2 table. Results: A total of 9 female patients with MBC were identified (mean age of 52 years). The receptor status of these patients includes 67 % positive for ER and 33 % positive for HER-2/neu. Median follow up was 9.8 months. There were 59 time points (> or = 4 weeks apart) when either PET/CT or CTC were performed. The results of PET/CT scans were compared with CTC at 38 events. The sensitivity of CTC to detect metastatic disease shown on PET/CT was 32% and specificity of 100%. The positive and negative predictive values were 100% and 32% respectively. There was a positive correlation between the max SUV and CTC count (p = 0.001). However in three patients, despite of progression of disease per PET/CT, CTC were undetectable at three different time points. Interestingly, two out of these three patients were triple negative. Disease progression was confirmed by biopsy in two of these patients. Conclusions: Our data suggest positive correlation between PET/CT scan and CTC. However, CTC had poor sensitivity and negative predictive value to detect progressive metastatic disease. Normal CTC values have to be interpreted cautiously in patients with MBC. We are now planning to investigate the utility of these tests, prospectively, in a large cohort of MBC patients. No significant financial relationships to disclose.
First-line trastuzumab utilization: Patterns of care and progression in the community setting
Authors: Gruschkus S. K. , Shankleton J. A. , Brammer M. , Forsyth M. , Lalla D. 
Published: August 2020

e12009 Background: This study describes patterns of care and outcomes in metastatic breast cancer (MBC) patients treated with trastuzumab (T) within the US Oncology network. Methods: This retrospective study utilized data from US Oncology's iKnowMed EMR system. HER-2 (+) MBC patients who initiated a first-line regimen containing T between January 1, 2006 and July 31, 2007, were identified. Patients were divided into three treatment cohorts: A) those who discontinued T prior to disease progression; B) those who continued T following discontinuation of chemotherapy prior to progression; and C) those who received T monotherapy. Patients were followed through October 31, 2008, to measure treatment duration and observe progression (as defined as escalation to second-line therapy). The Kaplan Meier method/log-rank test were used to estimate and compare progression free survival (PFS) across cohorts. Results: We identified 139 patients receiving first-line therapy including T. The median age was 58 years and 84 patients were ER and/or PR (+). The top 5 chemotherapy regimens included T plus: paclitaxel (n = 14); docetaxel (n = 14); vinorelbine (n = 14); carboplatin/paclitaxel (n = 12); carboplatin/docetaxel (n = 7 pts). Twenty-one (15%) patients were in cohort A, 55 (40%) were in cohort B, and 63 (45%) were in cohort C. Overall, the median duration of first-line T use was 281 days (mean = 287; range = 1–862). Following the initiation of first-line therapy, a total of 56 (40%) patients progressed (median follow up = 15 months). Following progression, 22 (39%) patients received second-line regimens containing T. The overall median PFS was 17.4 months (mean = 18.6). Patients in cohort A (n = 15) had significantly shorter PFS versus patients in cohort B/C (median 3.9 and 19.6 months, respectively; p < 0.001). Conclusions: In this observational study within the outpatient community setting, persistent first-line T use for MBC was associated with delayed disease progression. Future research should evaluate the causal relationship of this association. In addition, a more comprehensive evaluation should be conducted of therapies prescribed concomitant to T for patients treated with T “monotherapy.” [Table: see text]
Allogeneic stem cell immunotherapy for advanced metastatic breast cancer
Authors: El Cheikh J. , Goncalves A. , Esterni B. , Furst S. , Faucher C. , Chabannon C. , Gravis G. , Extra J. , Viens P. , Blaise D. 
Published: August 2020

e12012 Background: Despite continuous progress, advanced breast cancer (ABC) remains an incurable disease. Immunotherapy using allogeneic stem cell transplantation (ASCT) has been proven successful in malignant hematological diseases. We have investigated ASCT as a possible way of improving tumor control in ABC. Methods: Between 1998 and 2008, 21 ABC pts underwent ASCT after the same reduced intensity conditioning (RIC) based on fludarabine, busulfan and ATG or low dose irradiation from a HLA-identical sibling. Results: Pre-treatment characteristics of pts receiving ASCT were the following: ER or PR +, 79%; HER-2+, 27%; liver metastasis, 48%; adjuvant chemotherapy, 90%; median number of metastatic sites, 2 (1–4); 95% have received anthracyclines and/or taxanes; 71% have received endocrine therapy; 48% received more than 2 lines of cytotoxics; median age at transplant was 39 years (range 22–57). At time of transplant, 48% pts had progressive disease (PD), and 52% pts had a stable disease (SD). All pts engrafted and none died from transplant related mortality. While outcome was uniformly poor for pts with PD (no response and no surviving pt at 2 years), pts with SD achieved a 36% response rate (p = 0.09) and a 55% (CI95%, 28–79%) overall survival (OS) probability at 2 years (p = 0.001). To better assess the impact of ASCT, we looked for control group. During the same period, a total of 93 pts were searched for a HLA match sibling: 41 pts had an identified donor while 52 had no donor (group A). Of those 41 pts with a donor, 21 proceeded to transplant (group C) and 20 did not (group B). Reasons for not proceeding to transplant when a donor was found were: disease progression: 12 pts; patient decision: 6 pts; referring MD decision: 2pts. Progression-free survivals (PFS) were assessed from the first day of the last therapy immediately preceding HLA typing. Median PFS were 7.4 (CI95%, 6.2–12.4), 5.7 (CI95%, 4.6–12.8), and 18.2 (CI95%, 12.9–30.7) months for groups A, B, and C, respectively and were strikingly different between the 3 groups (p = 0.014). OS were not different. Conclusions: ASCT can be safely performed in ABC and may provide an outcome advantage to selected pts deserving further investigations. No significant financial relationships to disclose.
French experience of patient management when receiving oral vinorelbine chemotherapy (NVBO) for metastatic breast cancer: Final results of a prospective observational survey on practices
Authors: Lotz J. , Husseini F. , Finck M. , Rotarski M. , Bastit L. , Riviere A. , Youssef A. , Mouysset J. , Nahon S. , Piolat V. 
Published: August 2020

e12013 Background: An observatory on practices has been implemented in France with the aim of investigating the correlation between patient (pt) profile and the use of an oral chemotherapy (OCT), NVBO. Methods and Materials: Three questionnaires were used: a “Physician” questionnaire (medical practice conditions, role of OCT), a “Patient” questionnaire (pt disease history, prescription selection factors and compliance), and a Patient Preference self-questionnaire (partly based on the EORTC QLQ-BR23). Results: Between February 06 and February 08,355 pts were enrolled in 47 centers. Breast tumours were classified as having limited aggressiveness with or without visceral metastasis (41.2%) or slowly progressing visceral metastasis and DFI>24 months (42.3%) or aggressive disease with visceral metastasis and DFI<12 months (16.5%). Pts had previously received hormonotherapy in 72.4%, iv CT in 78.6% and OCT in 31%. NVBO was prescribed as monotherapy in 53,6% and association in 46,4%, with iv in 35% (66.7% with trastuzumab), with oral in 65% ( 97.2% with capecitabine ). 86.2% of pts preferred OCT for 3 main reasons : more time with their family, social life maintained and treatment at home. Physicians’ major parameters of OCT choice according to score (1 to 4) were : patient-related factors (QOL 3.61), reduced hospital stays (2.99) and problems related to venous administration (2.62). Conclusion: NVBO brings added value in terms of pt convenience allowing improved QOL and reduced hospital stays while keeping optimal compliance to treatment schedule. [Table: see text]
CA 125 in the early detection of metastatic breast cancer
Authors: Ertl I. , Heinemann V. , Laessig D. , Nagel D. , Seidel D. , Stieber P. 
Published: August 2020

e12015 Background: Kinetics of CA 15–3 and CEA have a high specificity in the early detection (= asymptomatic patients) of metastatic breast cancer disease. However, this high specificity is associated with a lack of sensitivity (false-negative results). To decrease the number of false negative (FN) patients, the additional diagnostic potential of CA 125 kinetics was evaluated. Methods: We analysed 1,011 follow-up samples of 95 patients. Forty-seven of these patients showed metastatic recurrence during follow-up. Based on analyses, published previously, a reproducible increase of CA 125, CA 15–3, or CEA ≥100% based on the individual baseline value of each patient was selected as a reliable indicator for metastatic disease. Results: None of the 48 patients with NED had a reproducible increase of either CEA, CA 15–3, or CA125, i.e., all three tumor markers reached a specificity of 100%. At the time of first metastatic disease, the overall sensitivity was 29.8% for CA 125, 44.7% for CA 15–3, and 21.3% for CEA. In 7 patients (14.9%) only CA 125, in 14 patients (29.8%) only CA 15–3 and in 6 patients (12.8%) only CEA increased. In 8 patients (17.0%) more than one marker increased. The sensitivity of the CA 15–3/CEA combination was 59.6% (95%-CI: 45.5%-73.6%). With the additional use of CA 125, the sensitivity could be increased by 14.9% to 74.5% (95%-CI: 62.0–86.9%). The sensitivity of the marker combination was 66.6% for metastases in one site (n = 33) and 100% for metastases in more than one site (n = 14). Conclusions: This retrospective analysis indicates that CA 125 increased the sensitivity of the CA 15–3/CEA combination by 14.9% without loss of specificity. The combined use of CA15–3/CEA/CA125 may therefore be helpful for early detection of metastatic disease. The usefulness of this approach is presently verified in a prospective trial. [Table: see text]