bluuebunny/crossref_metadata_2025_split huggingface dataset:
Menstrual status and lung cancer in female patients from the Spanish WORLD07 database.
Authors: Cantos Blanca , Majem Margarita , Garrido López Pilar , Vinolas Nuria , Isla Dolores , Garcia-Campelo M. Rosario , Catot Silvia , Lianes Pilar , Artal Angel , Bover Isabel , Terrasa Josefa , Blasco Ana , Rolfo Christian Diego , De Castro Javier , Gonzalez-Larriba Jose-Luis , Lazaro Quintela Martin , Izquierdo Angel , Vazquez Estévez Sergio , Figueroa Salvador , Felip Enriqueta ,   ICAPEM Association
Published: March 2020

e12012 Background: There is very little information about the menstrual status in women presenting with lung cancer. In other tumors, the menstrual status constitutes an independent prognostic factor. We proposed to investigate whether this status has any influence in clinical aspects, diagnosis or survival. Methods: WORLD07 is a Spanish prospective, multicenter, epidemiologic female-specific lung cancer database sponsored by ICAPEM, a professional association committed to WLC research. Results: Between October/2007 and October/2011, 1371 p newly diagnosed WLC were included in an e-database from 32 Spanish centers. Patient (p) characteristics were: median age 71.1 years (y)(range 22-91); median age of menarche 13y.; motherhood 91.2% (median 2.3 children, median age at first child 26.4y); oral contraceptive use 11.9%; postmenopausal 86% (median age of menopause 49y. No statistically significant differences were found with respect to menstrual status, clinical characteristics, histological type, nor in the TNM at diagnosis. Median overall survival in pre-menopause (preM) was 24.2 months (m) and 27.5 m in post-menopause (postM). Overall 1 year survival in both groups was similar, 70% IC95% (61.5-79.1%) in preM vs 72.4% IC 95% (69.15-75.7%) in postM, and at 2 years, was 50% in both. Conclusions: According to our e-database, the menstrual status does not have any significant influence in the presentation, histologic type or survival in women with lung cancer.
Distribution of malignant neoplasms in the eastern Rajasthan region of India.
Authors: Bang Bhavesh Amarnath , Sharma Raj Govind , Kapoor Rahul 
Published: March 2020

e12014 Background: Cancer is not a notifiable disease in India. Cancer data in India is derived mainly from Population & Hospital based cancer registries which pursue active data collection. Rajasthan, which is the largest state of India, has no established Cancer registry. Therefore, cancer data from this region is limited. This study was done to put the Cancer data from Eastern Rajasthan region in proper perspective Methods: A retrospective analysis of histopathology records of 5 years was done by studying the proportion & site wise distribution of malignancy cases which were reported at major hospitals & pathology centers in the region. Approximately 200,000 histopathology & cytology reports were analyzed & 34,486 new cancer cases were identified. Cases were classified according to the WHO International Classification of Disease (ICD) coding. Results: Of the 34,486 new cases of cancer that were recorded in five years, 58.58% were (20202) males and 41.42% (14284) females, with the male to female ratio being 1.41:1. Organ wise, Lung (13.25%), Larynx (5.35%), Oropharynx (5.09%), Brain (4.84%), Tongue (4.62%) and Prostate (4 %) were the most common sites involved in males, whereas Breast (25.6%), Cervix (10.26%), Ovary (5.4%), Brain (3.68%), Esophagus (3.4%), Lung (3.01%) & Gall Bladder (2.35%) were common sites of malignancy in females. System wise distribution of cancers revealed that Head & Neck (24.93%), Pulmonary (13.25%), Gastrointestinal (12.01%), Hematological (10.6%) & Genitourinary tract (10.5%) were the most common systems involved in males, where as, in females, Breast cancer was the most common (25.6%) followed by Genitourinary tract (20.27%), Gastrointestinal cancers (11.2%) and Head and Neck cancers (8.11%). Conclusions: A high frequency of tobacco related cancers i.e. Lung cancer and Head & Neck cancer in males, and screening detectable cancers (Breast & Cervix) in females was observed. Frequency of Lung cancer in females was noted to be high in comparison to previous studies from the region. An unusually high frequency of Gall Bladder Cancers especially among the female population in this region is also a cause of concern.
Clinical characteristics of triple-negative breast cancer in the African American population: A retrospective cohort analysis.
Authors: Modi Tejas , Shaaban Hamid , Modi Yashpal , Guron Gunwant K. 
Published: March 2020

e12025 Background: Triple-negative breast cancer (TNBC) is defined by a lack of expression of estrogen receptor (ER), progesterone receptor (PR), and HER2/neu. It is a very heterogeneous group of which a subset is clinically associated with an aggressive behavior and poor prognosis. They typically have a high relapse rate despite standard therapy. This study aimed to characterize the clinicopathologic findings and outcomes of these patients in an urban, predominantly African American (AA) population. Methods: Patients diagnosed with TNBC at the Regional Cancer Center at St Michael’s Medical Center in Newark, NJ between 2000 and 2008 were identified from the tumor registry databases. The clinical data was reviewed as a retrospective cohort for demographic information, clinical stage at presentation, recurrence rates and outcomes. Results: 42 pts were identified (median age 56) of which 28 (67%) were AA, 7 (16.7%) Hispanic (H) and 7 (16.7%) Caucasian. 22 patients (52.4%) presented with advanced disease (Stage 3, 4) and 18 of these patients were AA. At mean follow-up of 28 months, 12 (28.5%) pts had progressive disease with pulmonary metastases most common followed by brain metastases. The AA group displayed a trend towards shorter time to progression (TTP) (AA: 10.7 months vs. others: 14.7 months) and the younger patients less than 50 had a shorter TTP (12.3 months vs. 14.1 months). Tumor size was described > than 2 cm in 60%, < than 2 cm in 40%. Lymph nodes were positive in 43% and negative in 57%. Nuclear grade was 1 in 7%, 2 in 8.5% and 3 in 84.5%, respectively. A total of 8 (19%) patients died during the follow-up period. Conclusions: In the cohort we studied, we observed a trend that patients with TNBC in our urban city cancer center were more likely to be AA. These patients were more likely to present with advanced disease. AA and younger patients (less than 50) were more likely to have a more aggressive disease. Whether this could be attributed to non-compliance with mammogram screenings and healthcare disparities in the underserved AA inner city population is not clear but more research is needed to identify germline markers associated with TNBC which could potentiate effective therapies for women with TNBC.
Implementation of a population-based breast screening program for high-risk women in Ontario: The Ontario Breast Screening Program (OBSP) High-Risk Program.
Authors: Eisen Andrea , Carroll June , Chiarelli Anna M. , Heale Esti , Horgan Meaghan , Meschino Wendy , Rabeneck Linda , Shumak Rene , Warner Ellen 
Published: March 2020

e12034 Background: Genetic testing for mutations in BRCA1 and BRCA2 has been clinically available in Ontario since 2000. It is estimated that over 15000 individuals have been tested. Evidence from clinical trials have consistently shown that women at high risk of breast cancer such as BRCA1/2 mutation carriers benefit from breast cancer screening that includes both magnetic resonance imaging (MRI) of the breast and mammography, yet access to MRI in Ontario was variable. In 2011, Cancer Care Ontario established an expert panel to develop a protocol for expanding the Ontario Breast Screening Program, initially created for average risk women 50-74, to include MRI and mammography for eligible high risk women. Methods: The panel’s tasks included: 1. determining the criteria for high risk, 2. estimating the prevalence of high risk women, 3. selecting a model to estimate cancer risk, 4. developing a referral and assessment pathway for potentially eligible subjects to receive genetic counseling/risk assessment and screening if eligible, 5. developing educational resources, training plan and communication strategy for relevant stakeholders including primary care providers, oncologists, geneticists and genetic counselors, 6. developing indicators to permit program evaluation, 7. providing guidance for post-implementation issues such as subject eligibility and interpretation of genetic test results. Results: The program was initiated July, 2011 at 19 sites. Women aged 30-69 with and without a history of breast cancer are eligible if they 1. are BRCA1/2 mutation carriers or untested first degree relatives of carriers, 2. have a lifetime risk of breast cancer >=25% based on family history, or 3. received prior radiation therapy to the chest. It is estimated that 34000 high risk women in the target age group live in Ontario. Conclusions: A population based organized screening program for high risk women that includes genetic risk assessment has been implemented in Ontario. To our knowledge, this is the first organized screening program for women at high risk of breast cancer.
Combination therapy for glioblastoma multiforme with primitive neuroectodermal tumor components: Case series.
Authors: Lee Adrian Pak Siu , Brewer Janice , Back Michael , Wheeler Helen 
Published: March 2020

e12507 Background: Glioblastoma multiforme (GBM) with sharply demarcated hypercellular nodules of primitive neuroectodermal tumor (PNET) are a rare variant of GBM and present with both diagnostic and management dilemmas. Controversy as to whether these mixed lesions originate from differential clonal expansion stem cells or the PNET element arise from the pre-existing astrocytic component has not been resolved. In a recent series of 53 patients (Perry et al. Brain Pathology. 2009;19:81-90), the median survival for this cohort managed with standard GBM therapy was only 9.1 months. Authors suggested addition of platinum-based chemotherapy appeared to improve survival. Methods: We report 3 cases of GBM and PNET that were treated at our institution with combination adjuvant therapy that included carboplatin. Patients were aged 17, 33 and 42. All patients had gross total resection followed by 60gy radiation. Concurrent chemotherapy included Temozolomide 60mg/m2 daily in combination with carboplatin AUC 1.5 weekly. After a 4 week break, 3 cycles of consolidation Ifosfamide 1600mg d1-3, Carboplatin AUC 5 d1 and Etopside 100mg/m2 d1-3 with G-CSF support every 3 weeks were administered and this was followed up by adjuvant Temozlomide at 150-200mg/m2 d1-5 for 6-36 months. Results: 2 patients remain disease free at 36 and 56 months after diagnosis. 1 patient relapsed with a new lesion in the other hemisphere which on biopsy contained GBM alone with no PNET elements. She succumbed to progression of disease 32 months after diagnosis. There was no grade 3-4 toxicity but low blood counts lead to some treatment delays. Conclusions: Overall this protocol was well tolerated and appears to improve survival compared to the literature. Further studies are warranted but will be limited by the rare occurrence of this disease.
Does the use of complementary and alternative medicine (CAM) influence survival in glioblastoma multiforme?
Authors: Ambady Prakash , Morrison Tara 
Published: March 2020

e12509 Background: Glioblastoma multiforme (GBM) is a devastating CNS tumor with an incidence of around 14,000 per year in the USA. Patients often independently adopt complementary and alternative medicines (CAM) in addition to the recommended surgery and chemoradiation due to the poor prognosis of the disease despite maximal therapy. We try to document the most frequently used supplement therapies and identify differences in side effect profiles, and survival rates (PFS and OS) between groups of patients taking standard therapy versus standard therapy with CAM Methods: This is a retrospective single institution study. We reviewed charts of 25 GBM patients seen in Neuro-Oncology Clinic at Fox Chase Cancer Center between September 2010 and September 2011. All patients received standard chemoradiation. Information regarding the age, sex, use of CAM, performance status at diagnosis, side effect profile, PFS and OS was obtained. Results: 9/25 (36%) patients reported using CAM. The most frequently used supplement was the homeopathic medication Ruta-6 followed by curcumin, hydroxychloroquine, melatonin and green tea extract. The mean PFS were 14 vs 17 months in the CAM vs non-CAM groups. OS rates were 17 vs 20.5 months in the CAM vs non-CAM groups. There were no statistically significant differences between the groups. In addition, no differences in side effects were noted. Conclusions: Most neuro-oncologists are eventually confronted with questions about CAM in the treatment of GBM.Considering the limited therapeutic options available for GBM and the multiple options that CAM offers, this retrospective study provides insight into the most frequently used supplements and compares the benefits and their side effect profiles. Information regarding the use of CAM was based on voluntary disclosure at the time of documentation. Information about genetic markers was not always available. Larger prospective studies are required to elucidate any meaningful clinical differences between the groups.
Early-phase trials compared to first- and second-line FDA-approved treatments in patients with advanced gallbladder cancer and cholangiocarcinoma.
Authors: Subbiah Ishwaria Mohan , Tsimberidou Apostolia Maria , Naing Aung , Subbiah Vivek , Kaseb Ahmed Omar , Fu Siqing , Hong David S. , Piha-Paul Sarina Anne , Wheler Jennifer J. , Janku Filip , Hess Kenneth R. , Falchook Gerald Steven , Kurzrock Razelle 
Published: March 2020

e13020 Background: Patients with advanced cholangiocarcinoma (CC) and gallbladder carcinoma (GC) have few effective therapeutic options. We compared prognostic factors and clinical outcomes of CC/GC pts treated on phase I trials with that of their first-, second-line and last Food and Drug Administration (FDA)-approved therapy given in setting of metastatic disease. Methods: We retrospectively reviewed electronic medical records of patients with GC and CC evaluated in the phase I program clinic from November 2004 to March 2011. Results: Of the 72 patients with CC or GC, 32 (44%) were not enrolled on a trial mainly due to clinical deterioration (n=25). Of 40 treated patients (GC=6; CC=34; median age 60 years; median prior systemic therapies = 3), 8 (20%) had stable disease (SD) > 6 months; 3 (8%) achieved a partial response (PR); SD > 6 months/PR was observed mainly on protocols with hepatic arterial infusion drug administration and/or angiogenic inhibitors, anti-her2/neu agents or a novel MAPK/ERK kinase (MEK) inhibitor. Median progression-free survival (PFS) on phase I trials was 2.0 months (95% CI 1.7, 2.8) versus 3.0 months (95% CI 2.4, 5.0; p=0.95), 3.0 months (95% CI 2.3, 4.6; p=0.98), and 3.0 months (95% CI 2.4, 3.9; p=0.79) for their first-, second-, and last systemic therapy with FDA-approved agents given in the metastatic setting, respectively. In univariate analysis, factors associated with a shorter Phase I PFS were > 3 metastatic sites, elevated ALT (>56 IU/L), serum creatinine (>1.6mg/dL), and CA19-9 (>35U/mL). Conclusions: In heavily pretreated patients, PFS in the clinical trials setting remained poor but did not differ significantly from that of their first-line, second-line, and last prior therapy with FDA-approved agents. Response rate (SD >6 months/PR) of 28% was seen in trials with locoregional treatment or inhibitors of angiogenesis, her2/neu or MEK.
Pharmacokinetic and pharmacodynamic analysis of fluorouracil in nasopharyngeal cancer patients.
Authors: Zhao Liping , Liu Wanli , Zhao Chong , Guo Xiang , Huang Yan , Xu Fei , Hu Zhihuang , Wang Zhiqiang , Zhao Hongyun , Zhang Li 
Published: March 2020

e13021 Background: Pharmacokinetic (PK) variability of 5-FU has been demonstrated for +30 years and a significant link between 5-FU exposure and therapeutic response has been identified. A maximum tolerated exposure (MTE) using area under curve (AUC) has been characterized for various regimens and therapeutic drug management (TDM) has been used to achieve effective dosing in several tumor types. The regimen most used to treat nasopharyngeal cancer (NPC) is cisplatin and 5-FU. The objective of this study was to characterize the PK variability of 5-FU in this population and examine the relationship between AUC and toxicity. The 5-FU MTE in this Chinese population will be compared with the MTE identified for HNC European patients. Methods: Fifty-three treatment naïve Chinese NPC patients were administered cisplatin (80mg/m2, day 1) and 5-FU (4g/m2, 120 h continuous infusion) and had blood samples collected at steady state after the first 18h of 5-FU infusion. Plasma was analyzed by a 5-FU immunoassay and AUC calculated from the steady state concentrations. We examined the relationship between 5-FU AUC and 5-FU-related toxicities (mucositis and myelosuppression). Results: The patient AUC values varied widely, ranging from 20 to 103 mg · h/L. 34% of the patients were within the target range of 25-35 mg· h/L , 15% were below and 51% were above the range. Toxicity was recorded for 53 patients. Severe mucositis in 17 and myelosuppression in 1 of 27 patients occurred with 5-FU exposure above the target range, versus no severe toxicity in any of the 27 patients within or below the target range (p=0.000). ROC analysis for 5-FU AUC and severe mucositis identified a cut-point of 37 mg· h/L (p<0.001). Conclusions: Results of this study demonstrate wide PK-variability of 5-FU exposure and a significant relationship between severe toxicity and AUC in Chinese NPC patients. The study confirms that the MTE in this population is similar to a European HNC population treated with cisplatin/5-FU. TDM using the target range of 25-35 mg· h/L may have benefit in lowering toxicity in NPC patients.
Physicians’ ability to correctly identify values important to cancer patients enrolled in phase I clinical trials.
Authors: Pentz Rebecca D. , Liu Yuan , Wall Louise , Daugherty Christopher , Green Michael J , Hlubocky Fay J. , Peterson Susan K. , Sun Charlotte C. , Dixon Margie , Harvey R Donald , Owonikoko Taofeek Kunle , Khuri Fadlo Raja 
Published: March 2020

e13026 Background: ASCO recommends that physicians assess treatment preferences of patients with advanced cancer. To facilitate this process, we developed a tool to assess patients’ treatment-related values, since no standardized tool exists. This study evaluated the need for the tool by testing concordance between patient and physician identification of values important to the patient. Methods: Forty patients enrolled in phase I trials chose the 4 most important values from a list of 16 pretested values. The treating physicians also selected the values they thought their patient would choose based on their independent assessment of the patient. Concordance and discordance between the patient and physician choices were calculated. Subsequently, 18 physicians were given the tool to use during a phase I consent conversation. Satisfaction was tabulated. Results: Physicians (PHY) were unsuccessful in choosing the values selected by patients (P) 56% of the time. The highest concordance was observed for (1) fighting my cancer as much as possible (68%P, 80%PHY); (2) having access to the best cancer treatment (65%P, 58%PHY). The highest discordance was observed for (1) Feeling as good as possible every day given my condition (60%P; 18%PHY p=0.002); (2) Taking part in a research study if it is my only option (8%P; 55%PHY p=0.0001); (3) Having access to new treatments even if they are not yet proven and are a part of research (18%P; 55%PHY p=0.0008). Physicians agreed that the values tool has great utility, influences treatment recommendations and should be used with all patients (4.5/5). Physicians were neutral about whether the tool would save time (3.5/5). Patients were neutral on tool utility (3.8/5). Conclusions: Physicians’ ability to identify their patients’ most important values is poor (44% concordance). This is low compared to levels reported in other concordance studies for treatment choices (53-56%) and for what makes life worth living (57%). While physicians thought patients would value participation in research, patients more frequently identified quality of life as an important value. The tool was considered useful for portraying patients’ values by the majority of physicians, but not by most patients.
Use of inflammation-based scores to optimize the selection of patients with advanced cancer considered for early-phase clinical trials.
Authors: Pinato David James , Stavraka Chara , O'Cathail Sean Micheal , Seckl Michael , Blagden Sarah Patricia 
Published: March 2020

e13033 Background: The presence of adequate organ function, favorable performance status (PS) and exhaustion of standard treatments are the main factors guiding accrual onto Phase I trials. As inflammation is inherent to the pathogenesis and prognosis of cancer we investigated the prognostic and predictive performance of inflammation based indices including the neutrophil (NLR) and platelet to lymphocyte ratio (PLR). Methods: Unselected referrals to the Phase I unit (2007-2011) were considered. Demographic, treatment, staging data and routine blood tests were collected. Patients were defined as high risk if NLR>5 or PLR>300 respectively. Changes in the NLR (ΔNLR) were recalculated at disease reassessment. Kaplan Meier and log rank test were used to assess Progression Free (PFS) and Overall Survival (OS) with each variable. Significant factors were further tested in a multivariate Cox model. C-index was used to calculate the discriminative ability of each score and ROC curves to predict 90 days survival (90DS). Results: We included 126 patients with median age 63 years (range: 22-80); median OS 4.4 months (0.2-39), 36% male; 92% with metastases, 23% PS>1. On univariate analysis LDH>450, PS, NLR≥5, hypoalbuminaemia, NLR normalization (ΔNLR) (p<0.001), >2 previous treatment lines (p=0.01) predicted for OS. After multivariate analysis low albumin, high LDH and ΔNLR remained independent predictors (p<0.05). Shorter PFS was predicted by elevated LDH and ΔNLR (p<0.05). PS and NLR ranked as most accurate predictors of both 90DS with area under the ROC curve values of 0.66 (0.55-0.77) and 0.64 (0.54-0.75) and OS with c-index scores of 0.69 (0.56-0.82) and 0.60 (0.50-0.70). When combined to PS, the NLR improved its accuracy to 0.72 (0.59-0.83). NLR≥5 at screening was associated with advanced PS, low albumin (p<0.002), LDH>450 and >2 metastatic sites (p<0.05). Conclusions: The NLR can improve the selection of patients considered for experimental therapies, with its normalization following treatment predicting for a survival benefit of 7 months in our series.