tbuckley/cabot-search huggingface dataset:
Impact of marital status on prostate cancer-specific mortality and overall mortality after radical prostatectomy.
Authors: Kenneth Gerard Nepple, Adam Stuart Kibel, Gurdarshan S Sandhu, Dorina Kallogjeri, Seth A. Strope, Robert L. Grubb, Kathleen Y. Wolin, Siobhan Sutcliffe
Journal: Journal of Clinical Oncology (2012)

73 Background: Analysis from population-based cancer registry data has suggested that being married is associated with improved survival in men with prostate cancer. However, a limitation of such analysis is the inability to control for PSA or medical comorbidity which may differ by marital status. We investigated the association between marital status and both prostate cancer specific mortality (PCSM) and overall mortality (OM) in men treated with radical prostatectomy. Methods: The study population included 3596 men treated with radical prostatectomy at a single institution between 1994 and 2004 and followed for a median of 72 months. Disease specific factors (PSA, clinical stage, and biopsy Gleason grade), comorbidity (validated ACE-27 comorbidity index), ethnicity, age, and marital status at time of treatment were retrieved from an institutional cancer registry. Differences between marital status groups were evaluated by Chi square or ANOVA. Multivariable Cox proportional hazard regression models were used to estimate the hazard ratio (HR) of PCSM and OM by marital status. Results: 86.9% of men were married, 5.3% divorced, 2.4% widowed, and 5.5% never married. Marital status was associated with differences in PSA (p&lt;0.01), comorbidity (p=0.04), and age (p&lt;0.01). Married men had the lowest mean PSA at diagnosis and never married men were younger and the most likely to have no known medical comorbidity. A total of 386(11%) men were dead at the end of follow up, but only 55 of them died of prostate cancer. In multivariable analyses (Table), never married men had a significantly increased risk of PCSM and OM compared to married men, whereas no additional risk was observed for divorced or widowed men. Conclusions: Never married men had an increased risk of PCSM and OM. Factors associated with social isolation or unhealthy behaviors may have a detrimental effect on survival after prostatectomy. [Table: see text]
A combination of fecal tests for the detection of colon cancer: A new strategy for appropriate prioritization of referrals to colonscopy—A prospective Italian study.
Authors: A. Ardizzoia, F. Parente, B. Marino, A. Ilardo, F. Perna, I. Saracino, A. Zullo, C. Hassan, P. Fracasso, R. A. Moretti, M. Cremaschini, D. Vaira, G. Ucci
Journal: Journal of Clinical Oncology (2011)

1580 Background: Mass screening programs for colorectal cancer are based on fecal occult blood test (FOBT). To improve its low sensitivity other fecal tests such as tumor M2-PK or fecal calprotectin have been studied with conflicting results. Methods: We tested an innovative combination of fecal tests (immunochemical FOBT, tumor M2-PK and calprotectin) as markers for patients who should undergo colonoscopy for the clinical suspicion of colorectal cancer (CRC). I-FOBT, fecal tumor M2-PK and fecal calprotectin were measured in a stool sample, in patients aged 50-80 years candidate to colonoscopy for abdominal symptoms. I-FOBT (OC sensor), tumor M2-PK (ScheBo) and fecal calprotectin (Bühlmann) were assayed using commercial kits. Results: A total of 280 patient’s stool single samples were analyzed for the 3 fecal markers. 46 patients had CRC and 85 patients had one or more advanced adenoma/s at colonoscopy/histology. CRCs were associated with a highly significant increase (p < 0.001) in fecal tumor M2-PK (median 27.1 KU/L). The overall sensitivity for CRC alone was 0.63 for i-FOBT, 0.76 for fecal calprotectin and 0.87 for tumor M2-PK. The corresponding values for CRCs + advanced adenomas (133 patients) were 0.35, 0.67 and 0.63, respectively. The combination of i-FOBT and fecal calprotectin increased sensitivity in the detection of CRC to 0.79, whereas the combination of i-FOBT and tumor M2-PK increased sensitivity to 0.93. Moreover, the negative predictive value of fecal calprotectin assay combined with tumor M2-PK determination in i-FOBT positive patients was 0.96 for the exclusion of CRC alone. Conclusions: A combination of multiple fecal markers such as tumor M2-PK, fecal calprotectin and i-FOBT seems to constitute an appropriately sensitive tool for pre-selecting those patients who require prompt colonoscopy to confirm a suspected CRC. Further studies are warranted in order to evaluate the usefulness of this panel of tests in the context of CRC screening, especially in older age groups.
Castration resistance and risk of bone metastases among men with nonmetastatic prostate cancer on androgen-deprivation therapy: A population-based cohort study from the Henry Ford Health System (HFHS) in Detroit, Michigan.
Authors: Jennifer Beebe-Dimmer, Karynsa Cetin, Cecilia Yee, Scott Stryker, Lois Lamerato, Kendra L. Schwartz, Vahakn B. Shahinian
Journal: Journal of Clinical Oncology (2013)

163 Background: Androgen deprivation therapy (ADT) is the cornerstone treatment of metastatic prostate cancer (PC), but is frequently used in the non-metastatic (M0) setting. After a variable period of hormone sensitivity, most patients develop castration-resistant prostate cancer (CRPC). These men are at increased risk of developing bone metastases (BM), particularly in those with higher serum PSA and shorter PSA doubling time (DT). The epidemiology and natural history of M0 CRPC has not been well studied in a population-based setting. Methods: Using HFHS patient records, a retrospective cohort study was conducted among 723 men diagnosed with M0 PC between 1996 and 2005 (with follow-up [f/u] for outcomes through 12/31/2008), who received ADT, including 613 men with serial PSA measurements for CRPC determination. CRPC was defined as 2 consecutive PSA rises, with “high-risk” defined as PSA ≥ 8 ng/mL or PSA DT ≤ 10 months (mos) after the development of CRPC. The risk of subsequent BM was estimated for the overall cohort and for the CRPC and non-CRPC subsets. Results: The median age among patients in the study was 73 years, 48% were African American, and median f/u time after ADT initiation was 58 mos. 15% (n=93) met criteria for CRPC during f/u (with a median of 23 mos between ADT initiation and establishment of CRPC), with the majority considered being at high risk (n=81). Among the entire cohort, 74 men (10%) developed BM during f/u. The rate of BM was 4 times higher among CRPC patients compared to non-CRPC patients (p&lt;0.001), with a median of 6 mos between CRPC and subsequent BM. No racial difference was observed with either the incidence of CRPC or BM. Conclusions: The HFHS resource allowed for investigation of disease progression in a racially diverse population. A substantial proportion of M0 PC patients on ADT will eventually develop CRPC and once castration-resistant, risk of BM is high.
Eribulin mesylate (halichondrin B analog E7389) in platinum-sensitive ovarian cancer: A phase II study, CTEP #7431.
Authors: M. L. Hensley, S. J. Kravetz, X. Jia, W. P. Tew, L. Pereira, P. Sabbatini, C. Whalen, C. Aghajanian, C. Zarwan, S. T. Berlin
Journal: Journal of Clinical Oncology (2011)

5090 Background: Eribulin mesylate is a novel tubulin inhibitor which suppresses microtubule growth without affecting depolymerization, sequestering tubulin into non-functional aggregates. In NIH:OVCAR-3 human epithelial ovarian cancer xenograft models, eribulin increased survival and reduced size and number of metastases, with activity superior to paclitaxel. We sought to determine the frequency of objective response to treatment with eribulin in women with platinum-sensitive recurrent ovarian cancer. Methods: Patients with recurrent, platinum-sensitive (progression-free interval from last platinum > 6 months) epithelial ovarian, fallopian tube, or primary peritoneal cancer who had measurable disease, ≤ 2 prior cytotoxic regimens, ECOG performance status 0-1, and adequate organ function were eligible. Treatment: eribulin 1.4 mg/m2 over 15 minutes by vein days 1 and 8, every 21 days. Response assessed by computed tomography every other cycle. Results: 37 patients enrolled, median age 60 (range 45-77), median platinum-free interval 10 months (range 6.5-45). All 37 patients were evaluable for response, with partial response (PR) achieved in 7 (19%), and stable disease in 20 (54%). Rustin criteria CA125 response was observed in 11/31 (35%) of patients with CA125-evaluable disease. Median progression-free survival was 4.1 months (95% confidence interval, 2.8-5.8 months). Grade 3 or 4, at least possibly treatment-related, adverse events for platinum-sensitive patients included: neutropenia 54%, leucopenia 3%, lymphopenia 5.4%, pain 8%, generalized muscle weakness 5.4%, elevated liver enzymes 5.4%, thrombosis 2.7%, hyperglycemia 2.7%, hyponatremia 2.7%, hypophosphatemia 2.7%, hypomagnesemia 2.7%, diarrhea 2.7%, and ataxia 2.7%. Conclusions: Eribulin achieved objective response in 19% of platinum-sensitive epithelial ovarian cancer patients. Median progression free survival was 4.1 months.
Use of Patient-Reported Outcomes (PROs) to Assess Prognosis, Toxicity, and Response: The Bortezomib Experience in Relapsed and Refractory Multiple Myeloma (MM).
Authors: Dominique Dubois, Dhawan Ravinder, Helgi van de Velde, Dixie Esseltine, Sanjay Gupta, Muriel Viala, Christine de la Loge
Journal: Blood (2004)
Analysis of phase I pharmacokinetic studies with targeted molecules based on gender and age
Authors: S. Di Segni, I. Sperduti, A. Cinquina, M. Contestabile, B. Nuvoli, D. Giannarelli, F. Cognetti, A. J. Gelibter
Journal: Journal of Clinical Oncology (2009)

2521 Background: Pharmacokinetic parameters are usually not sufficiently correlated with patient characteristics, such as age, gender, or excretory organ function, and with outcome measures. Female sex has been shown to be a risk factor for clinically relevant adverse drug reactions and acting as a predictive/prognostic factor. Methods: We analyzed Phase I/II oncology trials of solid tumors with targeted agents enrolling Male and Female population (age&gt;18yrs), reporting pharmacokinetic analysis, published between 2000 and 2007. We excluded trials involving Radiation therapy alone, Hematological malignancies, and trials of Gender related pathology (ovarian, prostate and breast cancer). Standard descriptive statistics was used. Results: 160 phase I and II trials involving 48 targeted agents has been selected. 44%, 37% and 19% of the population enrolled for PK analysis is respectively male, female or unknown gender. 65% of the trials have male preponderance. Authors did not specified number of male and female if only a group of patients enrolled in the trial was submitted to pharmacokinetic analysis. 95% of the trials enrolled patients &gt; 65years, while 16% of the trials enrolled patients &gt;80years. But only 3% of studies specified individual patient age and less than 6% of papers showed the number of male and female for each dose level, while about 10% of studies considered ethnicity as a characteristic. Conclusions: What emerged from our analysis is the irregularity and the lack of important informations when reported for publication. Knowing the impact of important prognostic/predictive factor of such clinical parameter (age, gender) we believe that more informations should be reported in the trials in order to evaluate if Toxicity and Efficacy could be gender or age related. Definitive data will be presented at the meeting. No significant financial relationships to disclose.
Oxaliplatin (OXA)/5-fluorouracil (5FU)/folinic acid (FA) in patients (pts) with advanced colorectal cancer (ACRC): Report of an Algerian trial
Authors: M. Oukkal, H. Mahfouf, B. Larbaoui, L. Djellali, N. Smail, B. Benhabyles, M. Rebaine, A. Makhloufi, N. Benouniche, K. Bouzid
Journal: Journal of Clinical Oncology (2005)

3734 Background: While it is a major health problem in western countries, Algeria has a relatively low incidence of colorectal cancer with 14,3/100’000 (men) and 13,8/100’000 (women) [INSP 2001]. The majority of patients are diagnosed with metastatic disease. 5FU has been the only agent for years but the combination OXA/5FU/FA has shown higher activity than 5FU/FA in ACRC. The objective of this study was to evaluate the efficacy & safety of the FOLFOX combination in Algerian ACRC patients. Methods: Inclusion criteria were histologically proven colorectal carcinoma, no prior chemotherapy (adjuvant chemotherapy allowed if more than 6 month before), no CNS metastases, no peripheral neuropathy ≥ grade 2, no other serious concomitant illness, ECOG PS <2, adequate renal and liver function, good bone marrow reserve and informed consent. Treatment regimen: OXA 85 mg/m2 2h infusion D1, FA 200 mg/m2 2h infusion D1–2, 5FU 400 mg/m2 bolus D1–2 and 5FU 600 mg/m2 22h continuous infusion D1–2 (D1=D14). Results: From 11/2000 to 12/2001, 45 pts (M/F = 27/18; Colon/Rectum = 20/25) were enrolled in the study. Median age 55 years old (22–75), with 11 locally advanced and 34 metastatic diseases. A total 334 cycles were administered, median = 5 (1–17). All pts were evaluable for toxicity and survival, 37 for response. There were 3 (8,1%) complete responses (CR), 12 (32,4%) partial responses (PR), 13 (35,1%) stable disease and 9 (24,3%) progressive disease. The overall response rate (ORR =CR+PR) is 40,5%. Grade 3/4 toxicities (CTC/NCI) evaluated over the 334 cycles were anemia 0,9%, neutropenia 2,7%, thrombocytopenia 0,9%, vomiting 1,2%, diarrhea 3%, stomatitis 0,3%, alopecia 1,2% and allergy 0,3%. No severe neuropathy was reported. Neuropathy grade 1 was observed in 41,1% and grade 2 in 11,5% of pts. The median Progression Free Survival was 7 month and Overall Survival 12 months (95% CI 8–16). Conclusions: These results confirm that the FOLFOX 4 regimen is an active and well tolerated therapy for pts with ACRC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi-Synthealbo
An international collaborative design of clinical nursing practice guidelines for patients with cholangiocarcinoma.
Authors: Susan Acquisto, Renuka V. Iyer, Karen M Driskill, Natasha Pinheiro, Jacqueline Weatherly, Kaitlyn R Musto, Heidi Lowitzer, Lynne McCallum, Lorraine Drapek
Journal: Journal of Clinical Oncology (2015)

65 Background: Cholangiocarcinoma (CC) accounts for approximately 3% of all gastrointestinal cancers and have a poor incident to mortality rate. The incidence in the United States (US) is 2,000-3,000 cases annually, with this rate steadily increasing during the last twenty years; this trend is not solely observed in US but also seen in Europe, Australia and Japan. The highest incidence is seen in Southeast Asia due to parasitic infection. CC presents many challenges to healthcare professionals due to the anatomic nature of CC (Lowe et al, 2015). The worldwide increase in incidence of CC is indication for the essential development of nursing practice guidelines underpinned by expert evidence and knowledge and regarding the key aspects of care. Methods: A collaboration of nursing professionals representing major cancer research institutions from around the country and the United Kingdom worked together to identify key aspects of care, the aim being to develop Clinical Nursing Practice Guidelines. The process included an exhaustive literature review using Pubmed, Uptodate, Medline, and CINAHL databases; submission of respective institutional practices; group consensus on guideline content, evidence-based scoring assignment and approval by the Cholangiocarcinoma Medical Advisory Board. Results: The guidelines developed include the care of the patient: (1) with external biliary drains and internal bile duct stents, (2) with intractable nausea and vomiting resulting from disease process, (3) with fatigue resulting from disease process, (4) undergoing chemotherapy, (5) undergoing photon radiation, (6) undergoing radiation on a clinical trial, and (7) preparing for liver transplantation. The purpose of the guidelines are to advance the scientific knowledge of the symptoms experienced, quality of life of patients with CCA, establish standards in patient care, and improve quality of care and satisfaction for patients diagnosed with CC. Conclusions: Creation of evidence-based guidelines will provide a springboard for expanded competent knowledge and a model to test for improvement in the care and quality of life of the patient with CC.
Influence of expression of estrogen (ERS-1) and progesterone (PGR) receptors on metastatic spread and outcome in non-small cell lung cancer (NSCLC).
Authors: W. M. Brueckl, C. Eschbach, G. H. Wiest, J. H. Ficker, S. Zirlik, R. Hake, S. Eidt, A. Hartmann, R. M. Wirtz
Journal: Journal of Clinical Oncology (2011)

7585 Background: Estrogen receptor (ERS-1) is the prototype predictive marker in breast cancer (BC). ERS-1 positive BC has a better prognosis, strong tropism to metastasize into the bones and responds to endocrine treatment. The prognostic value of hormone receptor expression in non-small cell lung cancer (NSCLC) until now is less established. Methods: DNA and mRNA were isolated from formalin-fixed, paraffin embedded primary tumor tissue specimen from 78 metastatic NSCLC patients. The cohort was split into finding cohort (n=34) and validation cohort (n=44) by clinical site. Real time RT-PCR has been performed from ESR1, PGR and SNAI2. A Two-Gene-Ratio using the inversely related transcription factors ESR1 and SNAI2 was generated. mRNA expression of the candidate gene was correlated to site of metastatic lesion. In addition, Affymetrix microarray data from 138 non-metastatic NSCLC patients undergoing curative surgery were retrieved from public data bases (Lee et al. Clin Cancer Research 2008). Prognostic value of ESR1, PGR and SNAI2 mRNA expression were analyzed by unsupervised Cluster analysis, partitioning tests and Kaplan Meier estimates of recurrence free survival. Results: Within the FFPE validation cohort the ESR1/SNAI2 ratio was positively associated with bone metastasis (r=0.29) and negatively associated with liver and brain metastasis (r=0.32 and r=0.26, respectively). Additionally, there was a trend toward better survival in the ESR-1 expressing cohorts. Cluster analysis in the non-metastatic microarray cohort identified a hormone receptor positive subtype of superior recurrence free survival. Both hormone receptors, ESR1 and PGR, significantly predicted good outcome in 138 female and male NSCLC patients (log rank p=0.003 and p=0.002, respectively). Conclusions: Resembling BC, hormone receptors are prognostic factors indicating metastatic tropism to the bones and comparably outcome in early stage NSCLC. These results indicate, that NSCLC patients as well may be stratified according to their hormonal status to receive endocrine and bone preserving treatment options. These findings warrant prospectively stratified endocrine trials.
Efficacy and safety of ultrasound-guided central venous access in oncological and haematological patients: Results of a monocenter series of 519 consecutive patients
Authors: A. Lazzaro, D. Vallisa, R. Bertè, C. F. Moroni, A. Arcari, C. Rodinò, L. Bidin, M. Palladino, F. Artioli, L. Cavanna
Journal: Journal of Clinical Oncology (2005)

8152 Background: The management of the cancer patients frequently relies on the ability to deliver a variety of intravenous agents over a prolonged period. A central venous catheter (CVC) currently represents the most frequently adopted intravenous line for patients undergoing infusional chemotherapy and/or high-dose chemotherapy with concomitant blood stem cell transplantation and parenteral nutrition. The aim of this study was to explore the feasibility and safety of CVC insertion under ultrasound (US) control. US offers the advantage of real-time, multiplanar imaging as well as Doppler analysis, which makes it very practical and improves safety by allowing the operator to identify major vessels. Methods: The patient is placed in Trendelenburg’s position. After sterilization, local anaesthesia is applied and a 7.5 MHz puncturing US probe is placed in the right supraclavicular site and a 16 gauge needle is advanced into the last portion of internal jugular vein nearly innominate vein under US-control; after insertion of the guidewire the catheter (Secalon Seldy, Becton Dickinson) is advanced into the superior vena cava until insertion to right atrium. At the end of the procedure an upright chest X-ray is carried out to confirm CVC position and to rule out a pneumothorax. Results: From June 2001 to June 2004 this procedure has been performed 600 times in 519 consecutive patients: 350 with solid tumors and 169 with hematological malignancies. Some patients underwent CVC insertion more then one time along their clinical course (complete remission, relapse, stem cell collection and transplantation, parenteral nutrition). The procedure was successful in 595/600 times (99.1%), mean time of CVC permanence was 151 days (range 7–701 days). Four cases of deep vein thrombosis were detected successfully treated with low molecular weight heparin. Infections episodes were 1.7/1000 days of use, successfully treated with antibiotics. No increase of infections was registered in the transplantation setting. No pneumothorax occurred. Conclusions: This procedure is safe, cheap with high accuracy and success rate, and above all US-guidance avoids pneumothorax. No significant financial relationships to disclose.
Epidemiologic and survival characteristics of breast cancer (BC) among the U.S. Asian Indian and Pakistani women compared with other U.S. population groups: A SEER database study.
Authors: Shahzad Raza, Akm Mosharraf Hossain, Rubayat Rahman, Carl Freter, Jame Abraham
Journal: Journal of Clinical Oncology (2013)

19 Background: The Asian Indian/Pakistani population living in the U.S. (USAIP) is a rapidly growing minority group with persistent cancer disparities. According to SEER (Surveillance, Epidemiology, and End-Result) database, BC is the most frequently diagnosed cancer in USAIP women.The customizing therapeutic and preventive approaches are important to improve health quality across different population therefore, we conducted the largest epidemiological and survival disparities of BC in USAIP women. Methods: SEER has been collecting and reporting data on USAIP as a separate ethnic group since 1988. Using 18 SEER registries from 1988-2009 and SEER*Stat 7.0.9, we performed frequency and survival sessions (Kaplan-Meier adjusted for age) on USAIP women with BC and compared with non-Hispanic White (NHW), Hispanics (H),and African American women (AA) with BC. Cox proportional hazards regression analysis was performed to estimate relative risks (RR) on BC mortality after adjusting confounders using SAS v 9.3. Results: A total of 2,750 BC cases reported in USAIP women in SEER database, accounting (38%) of all cancers compare to NHW (30%), H (31%) and AA (32%). The median age at diagnosis in USAIP is significantly less (54 y, p &lt; 0.001) than other ethnicities. Significantly more USAIP (14%, p &lt; 0.001) were diagnosed at age &lt; 40y vs NHW (5%), H (7%) and AA(10%). Compare to NHW, USAIP were more likely to have stages III or IV (22% vs. 18%, p &lt; 0.01); ER/PR+ (84% vs. 75%, p &lt; 0.001); poorly differentiated histology (47% vs. 35%, p &lt; 0.001). 5 yr overall survival is better in USAIP (97%, p &lt;0.01) vs NHW (87%), H (83%) and AA (75%). RR of death from BC in US AIP was higher with age (&gt; 71y), stage III or IV, high grades, ER/PR negative, divorced/widowed, and diagnosis year (1988-1994). Conclusions:This study identifies unique biological features and disparities of BC in US AIP women compared with other US populations. The difference in survival is intriguing, and could be due to differences in tumor biology, access to care, and other epigenetic factors.This study has potential implications for screening and therapeutic recommendations for BC in the US AIP population.