tbuckley/cabot-search huggingface dataset:
Correlates of capecitabine treatment for breast cancer in women insured by medicaid or medicare in North Carolina
Authors: R. T. Anderson, G. Kimmick, F. Camacho, S. Zelt, R. Balkrishnan
Journal: Journal of Clinical Oncology (2008)

6603 Background: Capecitabine is an oral, tumor-activated flouropyrimidine, used as monotherapy or in combination for metastatic breast cancer (MBC). In clinical trials with taxanes, the combination improved overall survival. Here, we describe capecitabine use in a population of breast cancer patients. Methods: Study cases were women with breast cancer in 1998–2002 NC Central Cancer registry actively treated for MBC, enrolled in Medicare and/or Medicaid, with > 12 months survival. Data on use of capecitabine was located in registry and claims files. Logistic regression models of capecitabine treatment were adjusted for age, insurance, race, comorbidity, residence, hospital size, antecedent cancer treatment, and tumor. Results: 18,876 women had a diagnosis of breast cancer: 2,474 patients (mean age 63.3± 13.5; 67.2% white, 80.2% ER/PR+, 60.4% urban residents, and Charlson comorbidity index 3.21±2.7) met the study criterion: 445 (18%) were originally diagnosed as MBC; 1,829 (82%) had recurrent disease; and 831 had active 2nd+ line therapy. Overall, 15% (n=363) had ever received capecitabine, 264 (11%) as 1st line treatment and 134 (16%) as 2nd+ line treatment. Capecitabine was used in 11 (< 1%) of 1,314 patients treated with prior adjuvant hormone or chemotherapy. Capecitabine was significantly less likely used among dual- eligible elderly than Medicare only elderly (65–74 years: OR=0.38, 95% CI =[0.21, 0.69]; 75+ years: OR=0.25, 95% CI =[0.13,0.47]), but more likely used in women with ER/PR+ tumors (OR= 1.48, 95% CI=[1.13,1.93]) and those with MBC identified >12 months after diagnosis of breast cancer, versus MBC at diagnosis (OR= 1.61, 95% CI =[1.19,2.17]). Patients were more likely to have 1st line or 2nd line capecitabine treatment if pretreated with taxane mono or combo adjuvant therapy (OR= 1.58, 95% CI=[1.00, 2.49]; OR=2.53, 95% CI=[1.57,4.07] respectively). Conclusion: Capecitabine therapy for MBC was used in a small proportion of breast cancer patients with NC Medicaid or Medicare Patients with dual-eligibility were less likely to receive capecitabine, potentially due to health care system accessed or residential setting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Roche Bayer, Roche Roche
Racial comparison in young men with prostate cancer at a single institution
Authors: A. Husain, A. Liman, K. Alluri
Journal: Journal of Clinical Oncology (2008)

16138 Background: Prostate cancer is uncommon in men younger than 50 years. Those with familial prostate cancer and African origin are considered ‘high risk’ for developing it at a younger age and African Americans are expected to have aggressive disease. This retrospective study was aimed at studying disease pattern in young men with prostate cancer at our institution. Methods: After IRB approval, charts of patients at UT Cancer Institute and VA Medical Center in Memphis who were diagnosed with prostate cancer at or below age 50, between 1997 and 2006 were reviewed. Data were collected regarding age, PSA, stage at diagnosis, family history of prostate cancer, race, pathology, progression free survival and overall survival. Comparative analysis of PSA, Gleason score and age at diagnosis between black and white patients were done using Wilcox Mann Whitney test; survival functions were estimated for overall survival and PFS using Kaplan Meier method and were compared between black and white patients using log rank test. Results: Median PSA at diagnosis for early stage disease was 6.5, locally advanced disease was 7.25 and metastatic disease was 1372. 13 patients have been followed for over 4 yrs with 5 progressions and 12 patients for less than 4 yrs with 3 progressions. There were 2 deaths at 4 and 36 months after diagnosis. Median PFS and OS for the entire study population have not yet been reached. There was no significant difference in PFS between black and white (P=0.0527) though trend was favoring blacks. Conclusions: While this small sample size precludes major conclusions, it is interesting to note that black and white patients with prostate cancer at age 50 years or under had similar pattern of disease at our institution. A collaborative effort to study a larger sample is needed to challenge the established notions about racial disparities. Black White P value Number 17 10 Median age 48 49 0.60 Family history 3 1 High Gleason score(8&9) 1 4 Median GS 7 7 0.55 Median PSA at diagnosis 7 15 0.19 Advanced stage at diagnosis(T3a to M1) 5 4 PFS (median in months) (NR) (17) 0.0527 OS (median) (NR) (NR) 0.25 *NR = not reached. No significant financial relationships to disclose.
Initial results of a phase II study of oxaliplatin (OX), capecitabine (CAP), bevacizumab (BV), and cetuximab (CET) in the treatment of metastatic colorectal cancer (mCRC)
Authors: J. C. Bendell, H. E. Uronis, M. A. Morse, G. Blobe, M. Aklilu, A. Nixon, D. Niedzweicki, W. Honeycutt, L. Howard, H. Hurwitz
Journal: Journal of Clinical Oncology (2008)

4063 Background: FOLFOX/XELOX + BV are standard 1st line regimens for the treatment of mCRC. Based upon the activity of CET in mCRC, promising data with the XELOX-A regimen, and preclinical and early clinical data suggesting benefit from simultaneous targeting of the VEGF and EGFR pathways, we evaluated the safety and efficacy adding CET to the XELOX-A regimen. Methods: Pts with untreated mCRC received XELOX-AE: OX 130 mg/m2 d1, CAP 850 mg/m2 BID d1–14, BV 7.5 mg/kg d1, and CET 250 mg/m2 d1, 8, and 15 (loading dose CET = 400 mg/m2). Cycles were repeated every 3 weeks. Blood was collected for markers of response and resistance. Results: 29 pts have mature data for toxicity; 24 for efficacy. Median age 56 (range 33–76). Grade 3/4 adverse events which occurred in > 10 % of patients were: diarrhea (7/29 G3) and skin rash (9/29 G3). Other events of interest were: neuropathy (21/29, 2 G3), hypomagnesemia (15/29, 3 G 3) proteinuria (3 G2), HTN (1 G1), hand-foot syndrome (1 G1, 4 G2). 17/29 pts required dose modifications (16 OX, 9 CET, 11 CAP). There were 24 pts evaluable for response, 1 CR, 10 PR, 12 SD, and 1 PD (RR=45.8%; 95% CI: 27.0%-64.6%). Median progression free survival was 10.6 months (95% CI: 7.4–16.2). Median time to progression (TTP) was 14.0 months (95% CI: 7.4–16.2). Conclusions: XELOX-AE is an active regimen in the first line treatment of metastatic colorectal cancer. However, initial RR and PFS data approximate that of treatment with CAP, OX, and BEV alone, with an increase in toxicity, mainly skin rash, hypomagnesemia, and possibly diarrhea. Patient accrual is continuing. Updated data will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bristol-Myers Squibb, Roche Genentech™ BioOncology, Roche, sanofi-aventis Bristol-Myers Squibb, Roche, sanofi-aventis
FDG-PET/CT imaging for staging and definition of tumor volumes in radiation treatment planning in non-small cell lung cancer
Authors: Y. Xu, S. Ma, D. Yu, J. Wang, L. Zhang, X. Di
Journal: Journal of Clinical Oncology (2009)

7574 Background: 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) /computed tomography (CT) has a potential improvement for staging and radiation treatment (RT) planning of various tumor sites. But from a clinical standpoint, the open questions are essentially the following: to what extent does PET/CT change the target volume? Can PET/CT reduce inter-observer variability in target volume delineation? We analyzed the use of FDG-PET/ CT images for staging and evaluated the impact of FDG- PET/CT on the radiotherapy volume delineation compared with CT in patients with non-small cell lung cancer (NSCLC) candidates for radiotherapy. Intraobserver variation in delineating tumor volumes was also observed. Methods: Twenty-three patients with stage I-III NSCLC were enrolled in this pilot study and were treated with fractionated RT based therapy with or without chemotherapy. FDG-PET/CT scans were acquired within 2 weeks prior to RT. PET and CT data sets were sent to the treatment planning system Pinnacle through compact disc. The CT and PET images were subsequently fused by means of a dedicated radiation treatment planning system. Gross Tumor Volume (GTV) was contoured by four radiation oncologists respectively on CT (CT-GTV) and PET/CT images (PET/CT-GTV). The resulting volumes were analyzed and compared. Results: For the first phase, two radiation oncologists outlined together the contours achieving a final consensus. Based on PET/CT, changes in TNM categories occurred in 8/23 cases (35%). Radiation targeting with fused FDG-PET and CT images resulted in alterations in radiation therapy planning in 12/20 patients (60%) by comparison with CT targeting. The most prominent changes in GTV have been observed in cases with atelectasis. For the second phase was four intraobserver variation in delineating tumor volumes. The mean ratio of largest to smallest CT-based GTV was 2.31 (range 1.01–5.96). The addition of the PET data reduced the mean ratio to 1.46 (range 1.12–2.27). Conclusions: PET/CT fusion images could have a potential impact on both tumor staging and treatment planning. Implementing matched PET/CT reduced observer variation in delineating tumor volumes significantly with respect to CT only. [Table: see text]
Pharmacokinetics (PK) of edotecarin (J-107088), a topoisomerase I inhibitor, in patients with metastatic breast cancer (mBC) or glioblastoma multiforme (GBM)
Authors: D. Yin, S. Toler, F. Guo, B. Duncan, A. Sharma
Journal: Journal of Clinical Oncology (2005)

2073 Background: Edotecarin is an indolocarbazole topoisomerase I inhibitor currently under clinical development for cancer treatment. Objectives of the present PK investigations were to fully characterize the PK of edotecarin at the previously defined maximum tolerated dose (MTD, 13 mg/ m2) in patients with mBC or GBM, and to evaluate effects of concomitant use of enzyme-inducing anticonvulsants (EIAC) on edotecarin PK in GBM patients. Methods: Edotecarin was administered via 1-hr IV infusion every 3 weeks at a dose of 11 to 15 mg/m2 in mBC patients and 13 mg/m2 in GBM patients. Serial plasma samples for PK evaluation were collected for up to 96 hrs after edotecarin treatment in 26 mBC patients and 30 GBM patients (13 receiving concurrent EIAC therapy and 17 receiving no EIAC therapy). Plasma concentration-time data from each patient population were analyzed by noncompartmental Methods: Results: Steady-state plasma concentrations were rapidly achieved during the infusion. After stop of the infusion, the concentrations followed a bi-exponential decline with a very steep initial phase and a relatively shallow terminal phase. No apparent difference in PK parameters was observed between mBC and GBM patients. The AUC0-∞ and Cmax were comparable between cycle 1 and cycle 2 in BC patients, indicating little or no accumulation in plasma exposure when edotecarin was dosed every 3 weeks. AUC0-∞ and Cmax were similar between GBM patients treated with or without EIAC therapy. Edotecarin has a plasma clearance (CL) of 45 to 53 L/hr/m2, a volume of distribution (Vss) of 650 to 850 L/m2, and a terminal half-life of approximately 20 to 25 hours. Conclusions: Edotecarin has a moderate plasma CL and a large volume of distribution in cancer patients. The PK is not different in mBC and GBM patients. Consistent with previous data suggesting biliary excretion as the major route of edotecarin elimination, concurrent EIAC therapy in GBM patients has no apparent effect on edotecarin PK. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer
Assortative Mating—A Missing Piece in the Jigsaw of Psychiatric Genetics
Authors: Robert Plomin, Eva Krapohl, Paul F. O’Reilly
Journal: JAMA Psychiatry (2016)

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Abstract 173: The Effectiveness of Continuous Voice Feedback in Telephone CPR to Maintain the Quality of Hands-Only Cardiopulmonary Resuscitation
Authors: Takahiro Hara, Hideharu Tanaka, Hiroyuki Takahashi, Tomoya Kinoshi, Toru Shirakawa, Soh Gotoh, Eiichi Hasegawa
Journal: Circulation (2014)

Background: Also, it is well known that telephone-CPR (T-CPR) is effective to increase the rate of bystander CPR. However few reported suggested that T-CPR’ effective trough neurologically favorable outcome due to lack of adequate feedback. Purpose: The aim is this study is to identify the effective voice feedback during on T-CPR. Method: Twenty layperson without CPR training experience for at least 1 year were enrolled. They performed Hands-only CPR for 4 minutes followed by in 3 ways randomly. The first way is no feedback in the trial (non-FB Group). Second, they receive feedback in each 30 seconds (30sec-FB group). The third, they receive feedback in each 10 seconds (10sec-FB group) with enough interval time(30min) to restoration by fatigue, respectively. The feedback is simply telling by phone laypersons to push harder no matter how their compressions. Paired t-test were applied for statically analysis. Result: The average depth of 4 minutes through is 40.9±8.3mm with non-FB group, 43.8±6.5mm with 30sec-FB group, 47.8±5.9mm with 10sec-FB group, respectively. Statically significance were seen in non-FB groups and 30 sec-FB groups(P&lt;.05) compared with 10sec-FB group. The compression depth decreasing by time in each group, however the decrease rate is higher in non-FB group than 10sec-FB group and 30sec-FB group(P&lt;.05), respectively. Discussion: Chest compression depth in layperson is normally not enough. But the depth increased when they positive voice feedback. However they could keep better compressing for entire 2 minutes. Conclusion: The continuous feedback by phone is necessary to make layperson to perform quality chest compression. Further investigation warrant.
Breast cancer risk prediction using the novel germ-line signatures in epigenome regulatory pathways.
Authors: Christina Adaniel, Justin Rendleman, Julia Anne Smith, Robert J. Klein, Freya Ruth Schnabel, Yongzhao Shao, Kenneth Offit, Tomas Kirchhoff
Journal: Journal of Clinical Oncology (2013)

1500 Background: Epigenetic regulatory pathways are intensely studied for their involvement in breast tumorigenesis, however little is currently known about the genetic variation in epigenome components contributing to the risk and/or prognosis of breast cancer. In this study we have tested how the novel germline genetic signatures identified in epigenetic regulatory genes (ERGs) may potentially contribute to clinical prediction of breast cancer risk. Methods: We have genotyped 711 SNPs tagging 87 ERGs in 1985 breast cancer cases and 1609 controls, using Sequenom i-Plex. The samples were of white European origin with the fraction of Ashkenazi Jewish (AJ) ancestry (n=1642). The association of SNPs with breast cancer risk was assessed using logistic regression, adjusted by age, AJ status and estrogen-receptor (ER) status. The predictive ability of SNP signatures was tested by ROC curves using logistic regression fitting the SNP/clinical covariate models, and the area under the curve (AUC) was used to assess their utility in the classification of breast cancer risk. Results: We have identified the signature of 20 SNPs tagging 13 ERGs, significantly associated with breast cancer risk. The strongest association has been observed for RUNX1 (rs7280097, OR=0.83, CI 95%: 0.71-0.94, p=0.006) and PRDM16 (rs12135987, OR=1.22, CI 95%: 1.06-1.42, p=0.007). The inclusion of predictor variables (age, AJ status, ER status) and 20 associated SNPs in logistic regression ROC curve analysis yielded in best fitting model involving 10 SNPs tagging 8 ERGs with AUC of 0.723, compared to 0.660 with predictor variables alone (p=0.003). Conclusions: We have identified a signature of 20 SNPs in epigenetic regulatory genes (20-SNP-ERG) significantly associated with breast cancer risk. In addition, the incorporation of 10 SNPs from 20-SNP-ERG into risk prediction model increases the ability to classify breast cancer risk in addition to other clinical and demographic covariates. The results suggest the promising clinical potential of 20-SNP-ERG signature in identification of high-risk individuals in the population, and point to possible biological implication of germline patterns in epigenetic enzymes in breast tumorigenesis.
Expressed emotion, depression, and survival in patients diagnosed with hepatobiliary carcinoma
Authors: J. L. Steel, J. Hammond, B. I. Carr, T. C. Gamblin
Journal: Journal of Clinical Oncology (2009)

e20597 Background: The aims of the present study were to (1) investigate the association between expressed emotion, health related quality of life, and depression, and (2) explore the association between expressed emotion and survival in patients diagnosed with hepatobiliary carcinoma. Methods: The study was prospective in design. Ninety-six patients diagnosed with hepatobiliary carcinoma were administered a battery of questionnaires that measured depression, health-related quality of life, and expressed emotion. Medical chart review was used to gather disease specific information. Mann Whitney U and Kruskal Wallis tests were performed to test differences between groups and Cox regression analyses were performed to test predictors of survival. Results: At diagnosis, 54% of the patients reported a CES-D score ≥ 16 (clinical range). Patients who reported CES-D scores in the clinical range were found to have significantly lower overall health related quality of life (Mann Whitney U= 506, p = 0.003) and in particular lower emotional (Mann Whitney U=551, = 0.009) and functional well being (Mann Whitney U=507.5, p = 0.003). Patients who reported CES-D scores in the clinical range also reported a higher frequency of cancer-related symptoms (Mann Whitney U=503.5, p= 0.002) at diagnosis using the FACT-Hepatobiliary module. Patients who reported lower levels of emotional expression were found to have higher levels of depression (Mann Whitney U-6.6, p=0.04) and lower social and family well-being (Mann Whitney U=6.4, p=0.04). Using Cox regression, sociodemographic and disease-specific characteristics, depression, and expressed emotion were entered into a model. Significant predictors of survival included greater number of lesions (p=0.04), larger size of tumor (p=0.02), and lower levels of emotional expression (p=0.03). Conclusions: Preliminary findings suggest that patients with low levels of emotional expression reported higher rates of depression, poorer quality of life, and shorter survival. Interventions should be developed to treat symptoms of depression to improve quality of life. Expression of both positive and negative emotions should be encouraged by health care professionals. No significant financial relationships to disclose.
A phase II study of picoplatin (pico) as second-line therapy for patients (pts) with small cell lung cancer (SCLC) who have resistant or refractory disease or have relapsed within 180 days of completing first-line, platinum (plat)-containing chemotherapy
Authors: D. Bentzion, O. Lipatov, I. Polyakov, R. MacKintosh, J. Eckardt, H. Breitz
Journal: Journal of Clinical Oncology (2007)

7722 Background: Pico is a sterically hindered plat analogue designed to overcome plat resistance with improved safety and efficacy. In &gt;600 pts pico had single-agent activity in lung, prostate, ovarian and other malignancies with rare significant nephro-, oto-, or neurotoxicity (∼2% grade 3 and 0% grade 4). In a previous phase 2 study of single agent pico as 2nd line therapy in SCLC, 4 of 48 pts (8%) had a partial response and 21 (44%) stable disease. Median survival was 27.0 (95% CI = 16–35) wks. This multi-center phase 2 trial was designed to confirm the activity of pico as 2nd line monotherapy for plat-resistant SCLC. Methods: Pts with SCLC who either 1) failed or progressed through 1st line plat-containing chemo (refractory disease), or 2) initially responded to 1st line plat-containing chemo and then relapsed/ progressed within 3 months (resistant disease), or 3) initially responded and then relapsed/progressed between 90 to 180 days (sensitive, relapsed 90 to 180 days), had measurable disease and ECOG PS 0–2 were treated with pico, 150 mg/m 2 iv over1–2 hrs, q 21 days. Tumor response was assessed q 6 wks. Adverse events (AEs) were graded using the NCI CTCAE. Results: 77 pts received pico (45 refractory, 27 resistant, 5 sensitive). The median number of cycles received was 2 (mean = 2.9). The most frequently reported AEs of any severity were thrombocytopenia (39% of pts), anemia (35%), neutropenia (22%), nausea (20%), emesis (14%) and dyspnea (25%). Neutropenic fever occurred in 1 pt; there were no treatment related deaths. One pt had grade 3 neuropathy; there was no grade 3 or 4 ototoxicity or nephrotoxicity. Median overall survival is 28.1 (95% CI = 26–37) wks. Median progression free survival is 9.3 (95% CI = 7–12) wks. Of 63 pts with at least 1 post-treatment assessment of disease status, 33 (52%) had stable disease. Conclusion: Median survival compares favorably with other therapeutic options and toxicity is reduced in pico treated SCLC pts who have failed prior plat-containing first-line chemo or who have progressed within 180 days of first-line chemo. A phase III trial to confirm these results has been initiated. No significant financial relationships to disclose.