bluuebunny/crossref_metadata_2025_split huggingface dataset:
Nine-weeks of adjuvant trastuzumab in HER2-positive breast cancer: A single center experience.
Authors: Kizilarslanoglu Cemal , Petekkaya Ibrahim , Babacan Taner , Altundag Kadri 
Published: March 2020

e11080 Background: Trastuzumab is an effective adjuvant targeted therapy in patients with HER-2 positive breast cancer. However, effect of this therapy on survival is not well described in literature. In this study, we aimed to show characteristics of patients treated with nine week trastuzumab therapy for breast cancer and survival analysis. Methods: We analyzed the data of 2.218 breast cancer patients treated and followed up in our medical oncology department. There were 165 patients treated with 9 weeks of adjuvant trastuzumab therapy in this cohort. Patients’ characteristics, prognostic factors, and survival data were analyzed by using SPSS 18.0 version. Results: The mean age of the patients at the time of diagnosis of breast cancer was 47.3 ± 10.0 years. Sixty two (37.6%) patients were postmenopausal, eighty two patients (49.7%) were premenopausal and twenty patients (12.1%) were peri-menopausal. Invasive ductal carcinoma was the most common pathological type and was observed in 87.9% of the patients. ER and PR was positive in 49.1% of the patients and 54.5 % of the patients, respectively. Percentage of stage of the patients was 10.9 in stage I, 21.1 in stage IIA, 17.6 in stage IIB, 21.2 in stage IIIA, 0.6 in stage IIIB, 23.6 in stage IIIC. Mean follow up time of the patients was 30.9 ± 13.4 months. Numbers of the patients with progression were eighteen (10.9%). Eight (4.8%) patients died due to disease progression. Two-year survival rate was 98.3%. Disease free, progression free and overall survival times could not be obtained due to inadequate number of events. Conclusions: The superiority of nine weeks of adjuvant trastuzumab therapy to standard one year regimen of adjuvant trastuzumab is not well described in literature. The studies comparing 9-weeks and one year of adjuvant trastuzumab use with large numbers of patients are needed to show which regimen is superior.
Randomized pilot study of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy.
Authors: Basen-Engquist Karen , Murray James L. , Baum George , Gutierrez-Barrera Angelica M. , Arun Banu 
Published: March 2020

e11090 Background: Weight gain is a common problem after breast cancer diagnosis and treatment, particularly for women who receive chemotherapy. The weight gain has negative effects on quality of life, increases risk for chronic disease, and may increase risk of breast cancer recurrence. This pilot study tested a behavioral weight gain prevention intervention on weight, IGF-I, and IGFBP-3. Methods: Thirty-nine breast cancer patients receiving neoadjuvant chemotherapy were randomized to the weight gain prevention intervention or usual care. The intervention focused on exercise (resistance training, aerobic) and eating a low energy dense diet. Participants received 20 sessions during chemotherapy (14 in person and 6 by telephone) and 9 sessions after surgery (3 in person, 6 by telephone). They completed weight and other assessments at baseline (t0), mid-chemotherapy (T1), post-chemotherapy (t2), post surgical recovery (T3), after the post-surgical intervention (T4) and long term follow-up 6-9 months post surgery (T5). Serum was collected at T0, T2, T3, and T5 and analyzed for IGF-I and IGFBP-3. Results: Controlling for baseline weight, the intervention group weighed less than the control group at T1-T4, a result which approached significance (p=.08) in the intent to treat analysis. There was also a significant obesity x treatment group interaction, indicating that the intervention was most effective for patients who were obese at baseline (p=0.03). The groups did not differ in weight at the post-intervention follow-up (p=0.839). There was no significant difference between the groups in IGF-I or IGFBP-3. Conclusions: A diet and exercise intervention delivered during and after chemotherapy can promote weight loss in breast cancer patients, but the results may not be sustained after the intervention ends. [caption]Participants’ weights in kilograms, adjusted for baseline weight (least squares means).[caption] [Table: see text]
NFATc1 protein expression and its relationship with clinical characteristics in breast cancer.
Authors: Kang Xinmei , Wang Shuhuai , Song Ying 
Published: March 2020

e11095 Background: The nuclear factors of activated T cells (NFATs) have been previously studied in the immune system as transcription factors during the activation of T lymphocyte. In the recent years, emerging evidences have showed that they may play an important role in the development and progression of human cancer. In this study we investigate NFATc1 protein expression and its relationship with clinical characteristics in breast cancer. Methods: NFATc1 protein expression was determined by immunohistochemical analysis in 86 surgically resected breast cancer samples between Jul 2004 and Jun 2006. The relationship between NFATc1 expression and clinical characteristics of breast cancer was analyzed by multivariate logistic regression and survival analyses. Results: NFATc1 protein was significantly overexpressed in breast cancer tumor cells compared with the matched normal tissues. High expression of NFATc1 proteins was associated with high tumor grade, lymph nodes involved and shorter disease free survival (P<0.05), but there was no correlation between NFATc1 protein expression and tumor size, hormone receptor status or overall survival (P>0.05). Conclusions: This study suggested that high NFATc1 expression was present in breast cancer and it might be involved in the process of cancer development and related to poor prognosis of breast cancer.
Safety and efficacy of eribulin in patients with advanced breast cancer treated outside of a clinical trial: A single institution experience.
Authors: Kessler Luisa , Bergh Jonas , Foukakis Theodoros 
Published: March 2020

e11510 Background: Eribulin is a non-taxane, microtubule dynamics inhibitor that was approved for the treatment of patients with metastatic breast cancer (MBC) in Europe in March 2011. Experience with routine use of eribulin is limited. Methods: All patients receiving eribulin at the Oncology Department, Karolinska University Hospital outside of a clinical trial are treated according to the approved indication and dosology. For the purpose of an internal quality control, treated patients are registered in a database. All patients registered at the time point of the analysis were evaluated for safety and efficacy. Treatment toxicity including fatigue, neurotoxicity and infection was graded according to CTCAE v4.0. Efficacy was investigated using the routinely performed radiological assessments. Results: To date, twenty patients have received a total of 104 cycles of eribulin. All patients were heavily pretreated with a median of 3 (range 1-6) previous chemotherapy lines for MBC. The median age of the patients was 54 years (range 35-74). Fourteen patients are alive and 12 are still undergoing treatment with eribulin. No hypersensitivity reactions and no toxic deaths were seen. Fatigue was observed in 45% of the patients (grade 3 20%), while 20% experienced neurotoxicity and 35% were treated for an infection (grade 3 20%). None of the patients experienced grade 3 neurotoxicity. Interestingly, 3 cases of Herpes zoster reactivation were observed. Fifteen of the patients have been radiologically assessed at the time point of the analysis. Six of those patients had partial response (PR), one patient had complete response (CR) and one patient had stable disease (SD). Seven patients had progressive disease (PD). Conclusions: Eribulin administered outside of a clinical trial in patients with advanced breast cancer was safe and well tolerated. Although the majority of the patients were heavily pretreated, objective response was seen in nearly half of the cases.
Clinical and pathological characteristics of triple-negative breast cancer patients: A single-center experience.
Authors: Akdeniz Aydan , Yalcin Selim , Rahatli Samed , Kucukoztas Nadire , Yagmurdur Mahmut Can , Dizdar Omer , Altundag Ozden , Ozyilkan Ozgur 
Published: March 2020

e11515 Background: Triple negative breast cancer in which estrogen, progesterone receptors and c-erbB2 overexpression are negative, seems to have different clinical course and recurrence pattern. Methods: We evaluated retrospectively clinical demographic and pathological characteristics of triple negative breast cancers and investigated the association of these characteristics with OS and PFS. Results: 59 early stage patients with triple negative breast cancer patients followed in Baskent University Hospital between 1997-2009 were enrolled into the study. The median age of patients was 49. Median follow-up duration was 27 months (0.27-132 months). Two patients died during the follow-up. Invasive ductal carcinoma pathology was reported in 38 patients, invasive lobular in 3 patients, medullary in 5 patients.Almost half of the patients had LVI. 79% of patients had a T2 disease. 30% of patients’ tumor histological grade was III. Cancer history in the family was present in 95% of patients. Almost half of the patients had stage II disease. Adjuvant chemotherapy was given to 43 patients. Relapses were observed in 15 patients.The most common metastatic site was lung. Patients having high grade tumor, >3 (+) lymph nodes, younger age have higher chance of relapse during follow-up. Conclusions: In accordance with the literature, our triple negative breast cancer patients showed more aggressive characteristics. Although median follow-up is short, one-fourth of the patients having recurrence support natue of the triple negative breast cancer patients. In our study, triple negative patients had younger age at diagnosis, high grade tumors and more tendency to metastasize to visceral organs.
Weekly docetaxel in patients with metastatic breast cancer: A Bangladeshi perspective.
Authors: Hoque Ehteshamul , Karim Shanaz , Ahmed Rakib Uddin 
Published: March 2020

e11533 Background: Docetaxel has demonstrated high antitumor activity in first and second line treatment of metastatic breast cancer. Usually it is administrated three weekly at a dose of 75mg/ m2. We evaluated the efficacy and toxicity of Docetaxel in metastatic breast cancer in weekly bases. This study analyzed the efficacy and toxicity of docetaxel given weekly. Methods: Thirty eight patients with metastatic breast cancer received docetaxel, 35 mg/m2 weekly for six weeks, followed by two weeks interval. Additional cycles (three weeks' treatment, two weeks' rest) were given until disease progression or death. All patients had received prior chemotherapy. Of them 32 patients previously received anthracycline-containing regimens and 5 patients had received taxane based regimens. Results: Out of thirty eight patients thirty seven were evaluable. There was one complete response (3%), 11 patient has partial responses (30%), 17 patients with stable disease (46%) and six with disease progression (16%). Overall response rate was 78%. Median progression-free survival was 9.2 months. Three patients showed grade 3 neutropenia. 14 showed grade 3 alopecia, and various grade 1–2 non-haematological toxicities were observed. Treatment was delayed in two patients due to haemalotoxicity and stopped in one patient due to painful nail toxicity. Conclusions: Docetaxel is effective in three weekly regimens. In our study we found weekly docetaxel is as effective as the previous regimen. The efficacy of weekly docetaxel (35 mg/m2) can be an effective schedule for metastatic breast cancer who has received chemotherapy previously. The toxicity in this regimen is very low and manageable.
AVALUZ study: First line with bevacizumab in combination with paclitaxel (P) and gemcitabine (G) in patients with HER2-negative or recurrent mBC: OS analysis.
Authors: Salvador Javier , Ciruelos Eva M. , Codes Manuel , Jaen Ana , Gil Miquel , Galan Antonio , Murias Adolfo , Jara-Sanchez Carlos , De la Haba- Rodriguez Juan , Baena Jose Manuel , Villanueva Silva Maria Jose , Bayo Juan L. , Blancas Isabel , Gonzalez Encarnacion , Perez Diego , Mel Jose Ramón , Manso Luis 
Published: March 2020

e11535 Background: The combination of bevacizumab (B) with taxanes, capecitabine or anthracyclines has shown increased PFS in pts with mBC. The combination with G and P has been evaluated and has demonstrated high response rate and good toxicity profile. The aim of this study is to evaluate the efficacy and toxicity profile of the combination of B with G and P, providing the final result of PFS, update of OS and the toxicity experienced in all pts treated. Methods: A phase II multicenter, national, open-label study in pts diagnosed of recurrent or metastatic HER-2 negative BC, treated with first line B 10 mg/kg, P 150 mg/m2 and G 2000 mg/m2 day 1 and 15 c/28 d until progression disease, unacceptable toxicity or medical decision. This abstract evaluates efficacy by PFS as primary endpoint and as secondary endpoints: OS, response rate and toxicity profile (NCI CTC v3.0 criteria). Results: From January 2009 to December 2009, 82 evaluable pts were recruited in 23 sites. The characteristic of the all of pts included (90) are: median age 51.5 (26-81), ER + 68%, PR + 59%, triple negative pts 19%, previous chemotherapy (neoadj or adj) 64.4% and > 3 metastatic sites 21% of patients (19). The median cycles administered per pts was 7 (1-28) and the relative median dose intensity was 0.93 for B, 0.89 for P and 0.91 for G. Of the 76 pts with response assessment, the overall response rate obtained was 72% with a clinical benefit of 89.5% (80.3-95.34%). Of the 82 pts with a median follow up of 20.21m (0.23- 30.07), median PFS (50% events) for these pts was 11.51 m (9.01-17.6), the median duration of first response (MDR) was 12.4 m (7.6-15.2) and the median OS (42% events) was 27.4 m (21.9- NA). The one year OS % was 84.15 (74.27 – 90.47). Toxicity was generally manageable. Related AEs have been reported in 69/82 pts which were mostly mild or moderate. Safety analysis revealed 24 SAEs in 21 pts Conclusions: Bevacizumab in combination with paclitaxel and gemcitabine showed significant OS compared with the published data with paclitaxel and gemcitabine and high clinical benefit with manageable safety profile.
Patterns of docetaxel application in breast cancer patients from China: Experience in 42 cancer centers.
Authors: Xu Binghe ,   China TAX BC Group
Published: March 2020

e11537 Background: Docetaxel is considered as a fundamental drug in the treatment of breast cancer. It has been extensively incorporated into the neoadjuvant, adjuvant and metastatic treatment. The aim of this study was to investigate how breast cancer patients are treated with docetaxel in China. Methods: A retrospective review of chemotherapy with docetaxel performed from 2009 to 2011 was carried out in China. Study included all patients diagnosed with invasive breast cancer and treated with docetaxel-containing regimens in forty-two cancer centers from 12 provinces in China. Regimens were compared in different subgroups based on stage, subtype, and lymph node (LN) status. Patterns of chemotherapy were also compared to published guidelines. Results: Among 2188 breast cancer patients treated with docetaxel, 1881 (86.0%) were in adjuvant or/and neoadjuvant setting (including 91 in both settings). The mean age was 48.7 (range, 14-82). Compared with 288 patients using docetaxel as single agent therapy, more patients (86.8%) used docetaxel-containing combination regimens. The mean cycle administered and dose for every cycle was 4.8 and 73.0 mg/m2, respectively. Dose reduction and delay occurred in 409 (19.7%) patients mainly due to non-medical factors (10.9%) and hematologic toxicity (5.9%). TAC, TA, TC, TX, and AC-T regimens were given in 34.8%, 19.7%, 17.4%, 5.3%, and 2.2% of patients respectively. TAC was used more frequently in triple-negative breast cancer (TNBC) than other patients (43.0% vs. 32.7%, P=0.004). In the (neo)adjuvant setting, TAC regimen was used more frequently in LN-positive patients than LN-negative group (44.2% vs. 30.0%, P<0.001). Of 1682 patients in adjuvant setting, 729 (43.3%) were treated with triplet (TAC or AC-T). In 290 patients receiving neoadjuvant chemotherapy, only 94 (32.4%) used TAC and none used AC-T (P=0.013). Conclusions: Docetaxel was widely used in the treatment of breast cancer in China, especially in the (neo)adjuvant setting. TAC regimen was the most frequent option, especially in patients with TNBC or LN-positive BC. Although AC-T was also recommended in adjuvant setting by most guidelines, it was less commonly used compared to TAC regimen in China.
Effect of clinical and biological factors on pathologic complete response (pCR) after neoadjuvant chemotherapy for patients (pts) with early-stage breast cancer (BC).
Authors: Kouchner Pierre , Spano Jean-Philippe , Guillot Eugenie , Touboul Emmanuel , Renouvel Florence , Lauratet Betty , Genestie Catherine , Campion Loic , Khayat David , Classe jean Marc , Lefranc Jean-Pierre 
Published: March 2020

e11551 Background: To evaluate predictive factors that impact pathologic complete response (pCR) after neoadjuvant chemotherapy (NC) for BC pts. The identification of such factors may improve pt selection for neoadjuvant therapy to maximize the likelihood of breast conservation surgery (BCS) Methods: A total of 279 pts treated with NC (anthracyclines and/or taxanes based chemotherapy) for BC were analyzed. Pathologic response was evaluated using Sataloff classification. Student’s test and Fisher’s test were used for statistical analysis; OS and DFS rates were estimated by Kaplan-Meier analysis and log rank test for outcome. Results: According to the TNM classification, 87.4% of pts had T2 /T3 tumors, and 45.9% of pts had a lymph node involvement before NC. HER-2 over expression was found in 23.5 % and 18.6 % of pts had triple negative tumors. Forty three (43%) of pts achieved a clinical complete response. BCS was performed in 44.8%. pCR was 26.4% in the breast primary tumor and 32.8% in the axillary nodes. Univariate analysis showed that the following variables at diagnosis were correlated with a pCR: T2 vs T3/T4 (P<0.001), ductal invasive carcinoma (P=0.001), high grade (p<0.007), high mitotic index (P<0.001), estrogen receptor (ER) negative tumors (p=0.001), progesterone receptor negative tumors (p=0.001), chemotherapy with taxanes (p=0.0026), trastuzumab therapy (p<0.001) and the number of chemotherapy cycles (p=0.002). In multivariate analysis, ER negative, high mitotic index and HER-2 overexpression were significantly associated with a pCR (P<0.01). Lymph node pCR was a significant prognostic factor with 5 year RFS and DFS (respectively p<0.001 and p=0.016). At a median follow-up of 53.4 months, OS and DFS at 5 years were 86.1% and 24.2% respectively. Conclusions: Our data support the hypothesis that ER negative, high mitotic index and HER2 overexpression significantly predicted pCR in pts receiving neoadjuvant therapy for early BC. These results may suggest using such factors before deciding neoadjuvant chemotherapy in order to increase eligibility for BCS.
Identification of novel variant of EML4-ALK fusion gene in NSCLC: Potential benefits of the RT-PCR method.
Authors: Maus Martin Karl Herbert , Stephens Craig , Zeger Gary , Grimminger Peter Philipp , Huang Eric ,   R&D Departement at Response Genetics Inc.
Published: March 2020

e12007 Background: The discovery of the transforming fusion gene of the anaplastic lymphoma kinase (ALK) with the echinoderm microtubule-associated protein like 4 (EML4) as an oncogene in 2007 has led to its validation as a clinical target in NSCLC patients in a short period of time. The inhibition of the anaplastic lymphoma receptor tyrosine kinase has demonstrated to prolong progression-free survival compared to the standard of care chemotherapy in patients with advanced NSCLC that are ALK positive. However, the clinical implications of the 15 different variants of the EML4-ALK transforming gene described so far are currently not defined. Here we present a novel variant of the EML4-ALK fusion gene which we named variant 3c. Methods: RNA extracted from formalin fixed paraffin embedded (FFPE) specimens from patients with advanced and metastatic NSCLC was amplified, using primers and probes designed to detect specific EML4-ALK fusion gene fragments. Gel electrophoresis showed a different band for the new variant 3c compared to the known bands of positive cell lines for variant 3a and 3b. These findings were further investigated by dye-terminator Sequencing and FISH. Results: The novel variant, detected in two NSCLC specimens, is longer than v3a and shorter than v3b, representing an 18 base pair insertion of intron 19 of ALK between exon 6 of EML4 and exon 20 of ALK. All of the two samples showed exactly the same sequencing result. One of the samples was negative for FISH break apart testing and the other one showed a positive result, defined by ≥ 15% split nuclei as indicative of an ALK rearrangement. Conclusions: Compared to FISH technology, RT-PCR enables the detection of different isoforms of the EML4-ALK transforming gene, which can be validated by sequencing. Only one out of two samples that were positive for the new variant by RT-PCR could be confirmed by FISH. The clinical significance of the different variants, notably to resistance and response to ALK-Inhibitors and the concordance and sensitivity of FISH and RT-PCR should be subject to further investigations.
Implementation of a community-based cervical cancer screening program using visual inspection with acetic acid and Lugol’s iodine in Kutch District, India.
Authors: Grover Surbhi , Ju Melody , Lin Lilie L. , Krishnan Shobha 
Published: March 2020

e12009 Background: Visual inspection with acetic acid and Lugol’s iodine (VIA/VILI) is increasingly reframed as a bridge modality through which low resource countries can provide cervical cancer screening while waiting for the more effective HPV DNA tests to become affordable. Often the screening programs are organized by government bodies that lack the trust of the local communities and hence such programs suffer from poor participation. Here we aim to describe a locally-sustained VIA/VILI screening program in rural Kutch district in India directed by Kutch Mahlia Vikas Sangathan (KMVS), a local NGO committed to women empowerment. Methods: All capacity-building measures (funding, training, materials, and healthcare workers) were rooted in the local community. Heath workers were sent to Tata Memorial Cancer Center in Mumbai for training. NGO members held information sessions prior the screening camps educating women about the significance of screening. A three-visit screening model using VIA/VILI was implemented. At first visit, all women were consented and screened. VIA/VILI positive women returned for a second visit for biospy. Biopsy positive women then returned for a third visit to arrange for treatment. All the screening camps were conducted in community buildings such as schools with the collaboration of the village leaders. Results: Screening camps were set up in 17 villages in 2010-2011, screening a total of 832 married women upto the age of 50. There were 0 cervical intraepithelial neoplasia (CIN) positive lesions or invasive cancers found. None of the women were lost to follow-up. Conclusions: It is feasible to develop a community level screening program and to provide cancer prevention needs from within a community. Future directions include further evaluation of downstream protocols after VIA/VILI tests, increasing health worker diagnostic and treatment capacity, and determining positive recruitment factors in women attending screening camps. The KMVS screening program has been well-received and has been approached by several other NGO’s and training centers seeking to build similar community-based cervical cancer screening programs.