tbuckley/cabot-search huggingface dataset:
Impact of the rounding-off function of the computerized physician order entry system on the ordering time of chemotherapeutic regimens.
Authors: Kenji Tsuda, Yuko Nishide Kimura, Yuji Takaba, Kensuke Okubo, Tomotaka Ishii, Tatsuo Itokawa, Takahiro Isshiki, Naoko Takei, Tetsuya Tanimoto, Masahiko Nakagawa, Tsunehiko Komatsu
Journal: Journal of Clinical Oncology (2014)

e17599 Background: EGMAIN-GX (Fujitsu Ltd., Tokyo, Japan) is a popular computerized physician order entry (CPOE) system in Japan. Version 2 was used since 2009, but the newly introduced version 4 has been used since 2012. Notable among the new features is the automatic rounding-off of the calculated dose of anticancer drugs to the nearest whole number. Because studies on ordering times using CPOE are limited, we conducted a study to compare the ordering times with CPOE versions 2 and 4 in a mock clinical practice setting. Methods: Twelve physicians ordered 5 predefined chemotherapeutic regimens for a hypothetical patient: idarubicin and cytarabine (IDR/AraC); fludarabine and busulfan (Flu/BU16); rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP); cyclophosphamide, doxorubicin, vincristine, and dexamethasone (Hyper-CVAD); and rituximab, etoposide, cytarabine, cisplatin, and methylprednisolone (R-ESHAP). Data were entered twice for each regimen, using versions 2 and 4, and 120 regimens were ordered. We calculated the ordering times and compared the median times of the 2 groups using the Wilcoxon signed rank sum test. Results: The Table shows the median ordering times with versions 2 and 4. Overall, EGMAIN-GX version 4 significantly reduced ordering times compared to version 2 (635 seconds vs. 259 seconds, p < 0.01). Time reduction was observed consistently for all regimens except R-CHOP and R-ESHAP. Conclusions: The rounding-off function of CPOE significantly reduced the ordering time for complex chemotherapeutic regimens. Median ordering times for versions 2 and 4. Regimens Ordering time Version 2 (n = 12) Version 4 (n = 12) p IDR/AraC, seconds (range) 122 (57-213) 22 (23-173) <0.01 Flu/BU16, seconds (range) 212 (106-271) 53 (37-260) <0.01 R-CHOP, seconds (range) 45 (22-85) 64 (35-174) 0.02 Hyper-CVAD, seconds (range) 104 (43-213) 38 (30-226) <0.01 R-ESHAP, seconds (range) 103 (35-213) 55 (38-306) 0.06 Total, seconds (range) 635 (284-826) 259 (171-1138) <0.01
Increases in Premature Mortality
Authors: Jennifer Abbasi
Journal: JAMA (2017)

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Association of <i>Wnt</i> pathway activation with prechemotherapy abiraterone acetate resistance in metastatic castration-resistant prostate cancer (mCRPC) by genome-wide analysis of metastases.
Authors: Manish Kohli, Liguo Wang, Scott Dehm, David W. Hillman, Hugues Sicotte, Michael Gormley, Vipul Bhargava, Deborah S. Ricci, Weimin Li, Winston Tan, Brian Addis Costello, Henry C. Pitot, Roxana Stefania Dronca, Thai Huu Ho, Alan Haruo Bryce, Ye Zhenqing, Peter T Vedell, Poulami Barman, Rachel Carlson, Liewei Wang
Journal: Journal of Clinical Oncology (2017)

175 Background: Genome and transcriptome aberrations associated with primary resistance to abiraterone acetate/prednisone (AA/P) in mCRPC are not known. In a prospective trial (NCT#01953640) we assessed whole-exome and RNA-seq based aberrations in metastases of CRPC stage patients (pts) for identifying markers associated with primary resistance to AA/P. Methods: Whole-exome and RNA-seq of biopsies from metastases was performed followed by analyses for association between genomic aberrations &amp; primary resistance. Primary resistance was defined by progression on AA/P after 12-weeks of therapy(non-responders) using PSA, RECIST, bone scan and symptom criteria (per PCWG2). Gene network analysis was performed in genes mutated more frequently in non-responders, and also in genes that were differentially expressed between non-responders and responders and a “risk ratio” (RR) was calculated thereof. Results: Between 6/2013 &amp; 8/2015, 92 pts were enrolled of which 82 had complete whole-exome, RNA-seq and 12-week outcome data available for analysis. Median age was 72.5 yrs (IQR: 68.5-78); median PSA-18 ng/ml (IQR: 8.1- 46.6). At 12-weeks 33/82 had progressed. Using the RR of 2 as threshold, we identified 113 and 292 genes that were more frequently mutated in non-responders &amp; responders respectively. Among the 113 genes, OBSCN, ADAM21, LPHN3, DOCK10 ( P = 0.08, RR= inf) &amp; USP42 ( P = 0.16, RR = 5.71) were the top candidates.Gene network analysis revealed that in non-responders, genes involved in the Wnt/β-catenin pathway were frequently mutated and negative regulators of Wnt pathway ( DKK4, SFRP2 &amp; LRP6) were also frequently deleted. Gene expression analyses revealed the expression levels of Wnt/β-catenin pathway inhibitors were significantly reduced while expression levels of cell cycle regulatory genes were significantly increased in non-responders. Conclusions: In this study we observed Wnt/β-catenin pathway activation to be associated with primary AA/P resistance. This finding offers a potential for the development of predictive biomarkers and modulation of targeted pathways to overcome AA/P resistance. Clinical trial information: NCT# 01953640.
Subgroup analyses of a randomized sequential open-label study (SWITCH) to evaluate efficacy and safety of sorafenib (SO)/sunitinib (SU) versus SU/SO in the treatment of metastatic renal cell cancer (mRCC).
Authors: Peter J. Goebell, Walter Vervenne, Maria De Santis, Ludwig Fischer Von Weikersthal, Christian A. Lerchenmuller, Uwe Zimmermann, Monique M.E.M. Bos, Werner Freier, Silke Schirrmacher-Memmel, Michael D. Staehler, Sascha Pahernik, Maartje Los, Marcus Schenk, Anne Flörcken, Cornelis Van Arkel, Kirsten Hauswald, Martin Indorf, Dana Gottstein, Christian Eichelberg, Maurice Stephan Michel
Journal: Journal of Clinical Oncology (2014)

4567 Background: Results of the sequential randomized phase III SWITCH study comparing SO/SU and SU/SO have been reported previously (ASCO GU 2014, abstract 393) showing no significant difference in the primary endpoint total PFS (T-PFS, Hazard Ratio [HR] 1.01) nor the secondary endpoints overall survival (OS, HR 1.0) and 1st-line PFS (HR 1.19). We here report results of SWITCH study subgroup analyses per endpoints T-PFS, OS, and 1st-line PFS. Methods: Pts with mRCC unsuitable for cytokines without prior systemic therapy, ECOG PS 0/1, MSKCC score low or intermediate, and ≥1 measurable lesion were randomized to receive open-label SO/SU (arm A) or SU/SO (arm B) in standard dosage. Retrospective subgroup analyses according to age, sex, MSKCC score, and ECOG PS were performed to identify any subgroup that profits more from one sequence or the other by comparing both groups using Cox proportional hazard regression model and log-rank testing. Results: A total of 365 pts were enrolled: 182 arm A, 183 arm B.At time of final T-PFS analysis 220 events had occurred (A, n=117 [64%]; B, n=103 [56%]). The Table shows the subgroup analyses comparing group A vs group B including HR and p value of tests for difference. Conclusions: There was no significant difference in T-PFS, OS, and 1st-line PFS in the evaluated subgroups between the two sequential treatments apart from OS per age group in which different results have been found. Both drugs provided overall benefit regardless of sequence and subgroup. However, the analyses were exploratory and hypothesis-generating as they were retrospective and the significance analysis was not corrected for multiple testing. Clinical trial information: NCT00732914. Subgroup T-PFS HR (p value) OS HR (p value) PFS in 1st-line HR (p value) Age < 65 yrs 1.17 (0.37) 1.57 (0.04) 1.25 (0.18) Age ≥ 65 yrs 0.84 (0.40) 0.60 (0.04) 1.10 (0.63) Male 1.04 (0.80) 0.99 (0.94) 1.27 (0.09) Female 0.86 (0.59) 1.08 (0.81) 0.96 (0.86) ECOG PS 0 1.02 (0.91) 1.05 (0.82) 1.33 (0.08) ECOG PS 1 1.04 (0.84) 0.97 (0.90) 1.08 (0.14) MSKCC low 0.98 (0.91) 1.24 (0.48) 1.30 (0.20) MSKCC intermediate 1.01 (0.95) 0.83 (0.34) 1.14 (0.44)
Causes of mortality in patients with plasma cell disorders.
Authors: Ajay K. Nooka, Jonathan L. Kaufman, Amelia A. Langston, Sagar Lonial
Journal: Journal of Clinical Oncology (2014)

e17690 Background: Therapeutic improvement in survival for patients with plasma cell disorders have been demonstrated over the last decade and half, mainly due to the newer therapies. We have performed a retrospective cohort study using the Surveillance, Epidemiology, and End Results (SEER) 18 database to assess the causes of mortality among various patient groups with plasma cell disorders. Methods: ICD-O-3 histology codes 9731/3: solitary plasmacytoma of bone (SPB); 9732/3: multiple myeloma (MM) and 9734/3: extramedullary plasmacytoma (EMP) were used to identify cases with primary malignancy. The causes of mortality were broadly grouped under myeloma, secondary hematological malignancies (SHM), secondary solid malignancies (SSM), non-infectious and infectious causes. Results: 2610 patients (pts) with SPB, 73897 with MM and 1475 with EMP were identified. OS improved for MM and EMP in new millennium compared to patients diagnosed before 2000 (SPB: 73 months (m) vs 73m; P=0.70, MM: 33m vs 25m; P<0.000, EMP: 112m vs. 58m; P<0.000). Among pts that received radiation vs no radiation, median OS for SPB was 84m vs 48m; P<0.000 and EMP was 90m vs 50m; P<0.000. The primary causes of mortality did not differ in patients that received radiation vs none for both SPB and EMP. Causes of death for all plasma cell disorders as % are listed in table. Conclusions: Myeloma as the primary cause of death has declined in the new millennium compared to the previous. In SPB pts, we have not seen a major change in survival, possibly due to absence of major changes in definitive options. Interestingly myeloma as the cause of death declines with progressing age except in patients >75. Cause of death 15-44 45-54 55-64 65-74 75-84 85+ Total SPB Myeloma 60.8 66.2 64.2 60.1 53.2 47.4 58.8 SHM 3.9 1.5 2.6 2.5 2.7 2.1 2.5 SSM 7.8 9.0 9.4 8.8 11.1 9.5 9.6 Non-infectious 19.6 20.3 21.1 27.0 30.0 38.9 26.5 Infectious 7.8 3.0 2.6 1.7 3.0 2.1 2.7 MM Myeloma 80.2 78.3 76.1 71.9 67.0 62.8 71.2 SHM 2.0 1.9 1.7 1.5 1.0 .8 1.4 SSM 2.1 3.3 3.6 3.9 4.0 3.7 3.7 Non-infectious 12.3 14.1 16.6 20.7 25.3 29.7 21.2 Infectious 3.4 2.5 2.1 2.1 2.6 3.1 2.4 EMP Myeloma 50.0 57.0 55.3 51.7 49.5 32.7 51.4 SHM 17.2 5.0 6.1 5.4 2.3 7.7 5.7 SSM 5.2 12.0 14.7 12.4 10.3 7.7 11.6 Non-infectious 13.8 24.0 22.3 25.9 34.1 46.2 27.3 Infectious 13.8 2.0 1.5 4.6 3.7 5.8 4.1
Incidentally discovered pancreatic ductal adenocarcinoma: Is detection of asymptomatic cancer associated with better outcomes than symptomatic cancer?
Authors: Yoshinori Takeda, Akio Saiura, Yoshihiro Mise, Takeaki Ishizawa, Yosuke Inoue, Yu Takahashi, Hiromichi Ito
Journal: Journal of Clinical Oncology (2017)

243 Background: The number of incidentally discovered asymptomatic pancreatic ductal adenocarcinoma (APDAC) has been increasing along with recent wide spread use of imaging studies in general practice. However, the clinical implication in early detection of asymptomatic pancreatic cancer remains yet to be determined. In this study, we reviewed our experience of patients with PDAC in high volume cancer center and compared the characteristics and long-term outcomes between those with APDAC and symptomatic PDAC (SPDAC). Methods: This retrospective study included 569 consecutive patients with PDAC initially treated in our institution from January 2007 to December 2012. Median follow-up period was 29 months for the survivors. Two hundred and fifty patients underwent surgical resection and 319 patients were deemed unresectable. The patient’s demographics, tumor locations, pathologic stages, and treatment type received, and the overall survival (OS) were compared between the patients with APDAC and those with SPDAC. Results: One hundred and sixty-three patients (29%) presented without any subjective symptoms. When compared with SPDAC, APDAC was associated with early stage (stage I, 6% vs. 1%, p&lt;0.01). Among 163 patients with APDAC, 104 patients (64%) underwent surgical resection, while only 146 patients (36%) out of 406 SPDAC underwent resection ( p&lt;0.01). The 5-year OS rate of the patients with APDAC was 18%, comparing with 7% for those with SPDAC ( p&lt;0.01). Among the patients who underwent resection, the presence of symptoms did not affect the chance of incomplete resection (R1, 12% vs. 22% for patients with APDAC and SPDAC, respectively, p=0.06) and the 5-year OS rate (23% vs. 22%, p=0.09). However, the patients with SPDAC required complex operation (concomitant vascular resection and reconstruction 56% vs. 29% for those with APDAC, p&lt;0.01). Conclusions: Asymptomatic PDAC is associated with better long-term outcomes than symptomatic PDAC due to early stage at presentation and higher chance of resectability. Our findings highlight the potential implication of screening program for early detection of PDAC for selected high-risk patient population.
Does liposomal bupivacaine use intraoperatively decrease postoperative narcotic use in radical cystectomy patients?
Authors: Janet Baack Kukreja, Courtney M Chang, Mohamed Seif, Neema Navai, Ashish M. Kamat, Colin P.N. Dinney, Jay Bakul Shah
Journal: Journal of Clinical Oncology (2017)

311 Background: Bupivacaine liposome injectable suspension (LB) can be used to help control postoperative pain. It slowly releases bupivacaine for up to 96 hours after injection. This study sought to determine if the use of LB intraoperatively for radical cystectomy (RC) patients decreases postoperative narcotic use. Methods: A retrospective cohort study was performed. 281 patients underwent RC between November 2013 and May 2016, 203 received LB. LB was administered after fascial closure but before skin closure by performing suprafascial and subfascial injection with 20ml of LB. Patient demographics, BMI, renal function, operative characteristics, and the total postoperative intravenous morphine equivalents were reviewed. Where appropriate chi-squared, Mann-Whitney and t-tests were used for statical analysis. Multivariable analysis and linear regression models were performed. Because enhanced recovery principles were used simultaneously, enhanced recovery status was also used to adjust for predictors of post-operative opioid use. Results: There was no difference in baseline demographics, BMI, renal function or baseline opioid use between the LB and non-LB group. The operative time was longer in those who had LB administered and there were more open RCs performed in the LB group. Total morphine equivalents averaged to 8.0 mgs for the LB group and 50.7 mgs for the non-LB group, p-value &lt;0.001. More patients had epidurals and IV PCA pumps in the non-LB group, (p=0.001 and &lt;0.001, respectively). There were 42 patients whom did not require any IV morphine equivalents in the LB group compared to only 4 in the non-LB group (p=0.002). After adjusting for modality, and operative time, the linear regression model was predictive of less IV morphine equivalents in those with LB, p=0.044. Conclusions: The addition of LB to enhanced recovery principles increases the number of patients with zero narcotic use postoperatively. Irrespective of open or robotic modality and operative time, LB use decreases opioid use after RC.
Phase I and pharmacological study of orally administered indibulin in advanced solid tumors
Authors: R. L. Oostendorp, P. O. Witteveen, B. Schwartz, J. H. Beijnen, E. E. Voest, J. H. Schellens
Journal: Journal of Clinical Oncology (2007)

2565 Background: Indibulin (ZIO-301/D-24851) (N-(pyridin-4-yl)-[1-(4-chlorbenzyl)-indol-3-yl]-glyoxyl-amid) a novel, oral, synthetic, anti-mitotic drug is widely active against human tumor cell lines and xenografts, including multidrug resistant and taxane refractory tumors. Indibulin destabilizes microtubule polymerization; its tubulin binding site is distinct from taxanes and vinca alkaloids. In preclinical studies indibulin lacks neurotoxicity typically associated with other tubulin binding drugs. Methods: Phase I study to evaluate safety, pharmacokinetics (PK), maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advanced solid tumors. Initial dosing was in lactic acid drinking solution, which later was converted to a capsule formulation. Administration was po daily for 14 consecutive days at 21 day intervals at pre-determined dose increases between cohorts. Results: 31 patients (20 M, 11F) with advanced refractory cancers were treated; 14 received 20–80 mg/dose po in lactic acid solution and 17 po capsules 100–600 mg/dose. Median age was 60 y (29–72 y); median number of prior therapies was 4 (1–8); ECOG PS = 2. Median number of cycles was 2 (1–14). Patients continued on study until disease progression or significant toxicity. DLT for solution was nausea and emesis, ascribed to lactic acid. To date, no MTD or DLT observed with oral capsules at 600 mg daily; dose escalation continues using a twice daily schedule. No neurotoxicity has been observed. There was a disproportionate increase of the AUC with dose, with declining AUC corrected for dose starting at the 250 mg dose-level. The terminal half-life at the 600 mg dose was 25.2 ± 2.4 h. Prolonged disease stabilization was seen in 2 adenoid cystic carcinoma patients for 3 and 14 months and in one prostate cancer patient for 5 months. The latter patient went off study after 5 months due to liver function disorder (ALT CTC grade 2 and AST grade 3). Conclusions: Indibulin was well tolerated at doses showing preliminary clinical activity. Target plasma concentrations above the IC 50 have been achieved. Dose escalation twice daily continues. Prolonged disease stabilization was noted in adenoid cystic carcinoma and prostate cancer. [Table: see text]
Neuroprotective Effects of the Glucagon-Like Peptide-1 Analog Exenatide After Out-of-Hospital Cardiac Arrest
Authors: Sebastian Wiberg, Christian Hassager, Henrik Schmidt, Jakob Hartvig Thomsen, Martin Frydland, Matias Greve Lindholm, Dan Eik Høfsten, Thomas Engstrøm, Lars Køber, Jacob Eifer Møller, Jesper Kjaergaard
Journal: Circulation (2016)

Background: In-hospital mortality in comatose patients resuscitated from out-of-hospital cardiac arrest (OHCA) is ≈50%. In OHCA patients, the leading cause of death is neurological injury secondary to ischemia and reperfusion. Glucagon-like peptide-1 analogs are approved for type 2 diabetes mellitus; preclinical and clinical data have suggested their organ-protective effects in patients with ischemia and reperfusion injury. The aim of this trial was to investigate the neuroprotective effects of the glucagon-like peptide-1 analog exenatide in resuscitated OHCA patients. Methods: We randomly assigned 120 consecutive comatose patients resuscitated from OHCA in a double-blind, 2-center trial. They were administered 17.4 μg exenatide (Byetta) or placebo over a 6-hour and 15-minute infusion, in addition to standardized intensive care including targeted temperature management. The coprimary end points were feasibility, defined as initiation of the study drug in &gt;90% patients within 240 minutes of return of spontaneous circulation, and efficacy, defined as the geometric area under the neuron-specific enolase curve from 24 to 72 hours after admission. The main secondary end points included a composite end point of death and poor neurological function, defined as a Cerebral Performance Category score of 3 to 5 assessed at 30 and 180 days. Results: The study drug was initiated within 240 minutes of return of spontaneous circulation in 96% patients. The median blood glucose 8 hours after admission in patients receiving exenatide was lower than that in patients receiving placebo (5.8 [5.2–6.7] mmol/L versus 7.3 [6.2–8.7] mmol/L, P &lt;0.0001). However, there were no significant differences in the area under the neuron-specific enolase curve, or a composite end point of death and poor neurological function between groups. Adverse events were rare with no significant difference between groups. Conclusions: Acute administration of exenatide to comatose patients in the intensive care unit after OHCA is feasible and safe. Exenatide did not reduce neuron-specific enolase levels and did not significantly improve a composite end point of death and poor neurological function after 180 days. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT02442791.
Population-based evaluation of second-line palliative chemotherapy (SCT) versus erlotinib (E) in advanced non-small cell lung cancer (NSCLC) patients (pts).
Authors: Krista Noonan, Cheryl Ho, Sophie Sun, Barbara L. Melosky, Janessa J. Laskin, Nevin Murray
Journal: Journal of Clinical Oncology (2014)

e19080 Background: Several SCT options improve overall survival (OS) in advanced NSCLC. Recent evidence questions efficacy of E in EGFR wild type (WT) pts. Our objective was to evaluate the clinical effectiveness of SCT versus E in a diverse community population. Methods: The British Columbia Cancer Agency (BCCA) provides comprehensive cancer care to a population of 4.5 million. A retrospective analysis of all referred pts with stage 3b/4 NSCLC diagnosed in BC in 2009 who received SCT was performed. Kaplan-meier method with log-rank and Cox-proportional hazards model was used for survival analyses. Results: Of 748 pts seen by medical oncology, 415 (55%) had first-line CT, and 187 (25%) received SCT. Of these 107 (57%) received E, 55 (29%) pemetrexed (P), 11 (6%) docetaxel (D), 8 (4%) vinorelbine (V), 5 (3%) platinum-doublet, 1 an investigational drug. EGFR status was known in 44%. E treated pts were older, with a worse ECOG, and less third-line CT than SCT (P,V,D). PFS was longer in E than SCT at 2.3 mos (CI 1.2-3.4), and 2.1 mos (CI 1.5-2.7), p=0.01. OS was similar in the E and SCT at 8.2 mos (CI 6.9-9.4), and 6.8 mos (CI 3.9-9.7) respectively, p=0.203. Controlling for age and ECOG, the PFS HR was 1.00 (CI 0.44-2.3), p=0.99; and the OS HR was 1.04 (CI 0.41-2.6) for E treated pts. In the subgroup of EGFR WT pts, mPFS and mOS were statistically similar in E and SCT gps (Table). Conclusions: Although a higher proportion of pts who received E were older, poorer ECOG and had less subsequent CT, PFS and OS were similar to SCT pts. The effectiveness of E versus SLC will be evaluated in a larger cohort of pts. E (n=107) SCT (n=74) P value Sex Male 51 44 0.08 Female 56 30 Age, range 67, 44-80 63, 46-76 0.04 ECOG PS 0-2 62 54 0.03 3-4 45 20 Geographical site Rural 19 10 0.37 Urban 88 63 Unknown 0 1 Histology Non-squamous 79 52 0.45 Squamous 16 9 Not otherwise specified 12 13 EGFR WT 18 13 0.96 Mutated 1 1 Unknown 69 60 CT Third-line Fourth-line Fifth-line 36 8 2 45 6 3 <0.0001 0.88 0.41 Number cycles Third-line Fourth-line Fifth-line 3 1.5 2 2 2 1 0.82 0.90 0.50 Entire cohort, mos (95% CI) mPFS mOS 2.3 (1.2-3.4) 8.2 (7.0-9.4) 2.1 (1.4-2.7) 6.8 (4.3-9.3) 0.01 0.20 EGFR WT subgroup mPFS mOS 1.4 (1.9-3.3) 4.7 (3.5-6.9) 2.6 (1.9-3.2) 5.5 (2.8-8.2) 0.86 0.65