tbuckley/cabot-search huggingface dataset:
Impact of CPOE on workflow and direct patient care time in an inpatient hematology/oncology service.
Authors: D. A. Hanauer, K. Zheng, S. W. Choi, R. Beasley, J. Schumacher, M. Duck, D. W. Blayney
Journal: Journal of Clinical Oncology (2010)

6142 Background: Few data exist on the impact of computerized prescriber order entry (CPOE) on the workflow of inpatient leukemia and lymphoma care, yet concerns exist that CPOE use could cause increased work and changes in standard workflow for clinicians. Methods: We conducted a direct observation time and motion study pre- and postimplementation of a commercial CPOE system on an inpatient hematology/oncology (H/O) service at a large, regional medical center. We studied the work patterns of physician assistants (PAs) who consistently worked under the supervision of faculty physicians and entered all orders except chemotherapy. Data were recorded on a tablet computer with a data entry tool containing 63 individual activity categories that were further grouped into 12 analysis categories. Observations were made at −1, +3, and +8 months post-implementation, totaling 228 hours. Data were normalized to account for varying census levels. Results: Mean patient census was 11.3 per day at -1 months, 9.2 at +3 months and 6.4 at +8 months postimplementation. Overall percent time spent on order-related activities was unchanged, with 10.2% at -1, 10.6% at +3, and 11.4% at +8 months. Percent time spent on direct patient care activities was also unchanged: 50.7% at -1, 49.8% at +3, and 47.8% at +8 months. We also analyzed the data for differences in consecutive sequential patterns. The most common 3-sequence pattern (talking/rounding –> walking/moving –> talking/rounding) was identical in all 3 observation periods, suggesting that CPOE did not drastically change the flow of the work for the H/O service. The total number of alphanumeric pages received by the PAs, used as a proxy for order clarifications, was 119 at -1, 25 at +3, and 17 at +8 months. Conclusions: Our results suggest that CPOE use in a busy H/O inpatient service has minimal impact on time and workflow for trained PAs at 3 and 8 months after CPOE implementation, and reduced the number of pages needed for order clarification. More research is needed to determine if using CPOE for hematology patients may result in a change in the quality of patient care or safety. No significant financial relationships to disclose.
Is there a role for neoadjuvant chemotherapy in the management of non-carcinoid epithelial neoplasms of the appendix?
Authors: M. H. Katz, P. F. Mansfield, C. Eng, R. A. Wolff, P. Diaz, C. Ng, L. Lambert
Journal: Journal of Clinical Oncology (2007)

15115 Background: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS and HIPEC) are considered the standard of care for patients with pseudomyxoma peritonei (PMP) and carcinomatosis of appendiceal origin. The role of neoadjuvant chemotherapy (CTX) in the management of these patients is unknown. Methods: Retrospective analysis of all patients evaluated for the treatment of appendiceal epithelial neoplasms at a tertiary center between 1992 and August 2006. All diagnoses were confirmed pathologically and classified by a single group of pathologists. Patients with carcinoid tumors or metastases to the appendix were excluded. Tumor histology, stage, peritoneal-based disease, and the potential for complete cytoreduction dictated treatment. Results: 250 consecutive patients were evaluated, 140 of whom had low grade disease. 114 underwent CRS and HIPEC. Median follow-up was 24 mos from referral. Average time to referral was 13 mos after diagnosis (range 0–243); 85% had undergone prior surgical therapy (median 1.3 operations, range 1–4); 22% had previous CTX consisting of many different regimens. 5- and 10-year survival for patients with low grade tumors treated with CRS and HIPEC alone (n=80) were 84% and 68%, respectively. 21 patients with low grade tumors had CTX prior to CRS and HIPEC. There was no effect on overall survival (p = 0.61). 5-and 10-year survival of 39 patients with low grade histology who did not receive CRS and HIPEC was 55% and 30%, respectively (p = 0.009). 83 patients with intermediate and high-grade disease who received CTX but not CRS and HIPEC had a 5- year survival of 27%. 5-year survival for patients with intermediate or high grade disease who underwent CRS and HIPEC (n=13) was 67%. Conclusions: Patients with peritoneal-based disease from non-carcinoid epithelial neoplasms of the appendix who undergo CRS and HIPEC have a more favorable survival. Currently there is no survival advantage to the use of CTX before CRS and HIPEC for low grade appendiceal neoplasms. The role of neoadjuvant CTX and biologic agents for patients with high grade neoplasms needs to be determined. Early referral to a peritoneal malignancy center will help standardized treatment for these patients. No significant financial relationships to disclose.
Former drug firm president is charged with masterminding kickback scheme for physicians
Authors: Owen Dyer
Journal: BMJ (2015)

Less than a month after a US Justice Department memo urged prosecutors to target individual executives in corporate wrongdoing cases,1 the former president of the drug company Warner Chilcott has been arrested and charged, accused of masterminding a kickback scheme that funded lavish entertainments for physicians who agreed to prescribe the company’s products.

Carl Reichel, 57, of New Jersey, pleaded not guilty in a Massachusetts district court to a charge under the federal Anti-Kickback Statute, which prohibits the offer or acceptance of inducements to refer treatment paid by federal health programs. Also charged were a regional sales director and two district managers, who pleaded guilty, and one physician accused of accepting kickbacks, the Massachusetts gynecologist Rita Luthra, 64, who entered a not guilty plea.

At the same time the company itself pleaded guilty to felony healthcare fraud and paid $22.9m (£15m; €21m) in criminal fines and $102m to settle a civil suit making similar allegations that was brought by two former sales employees but later joined by the federal government.

The case will send shockwaves through the industry, …
Phase I study of intravenous (IV) milataxel in adult patients with advanced malignant tumors
Authors: E. Bourbouloux, M. Campone, J. B. Vermorken, M. Martin, C. Sessa, A. Perotti
Journal: Journal of Clinical Oncology (2006)

2037 Background: M (TL139, MAC-321) is a novel taxane with activity in human xenograft models against tumors resistant to paclitaxel. The maximum tolerated dose (MTD) when given IV every 3 weeks was 35 mg/m 2 . The current study was designed to determine if the dose intensity of M could be increased by a weekly IV schedule. Methods: The primary objective of the study was to determine the maximum tolerated dose (MTD), the dose limiting toxicity (DLT) and the recommended dose (RD) for phase II. Secondary objectives were pharmacokinetic (PK)/pharmacodynamic (PD) parameters of M given IV weekly and a preliminary estimate of efficacy in an expanded cohort at the RD. Key pt eligibility criteria included in adult pts with refractory malignant tumors, ECOG PS &lt;3 and adequate hematologic, hepatic and renal function. Patients were not allowed concurrent strong inhibitors of cytochrome p450 3A4. Dose escalation was based on Fibonacci method. At the RD, additional pts with tumors that typically respond to taxane treatment were added. PK data were obtained on day 1 and 15. Results: A total of 32 pts were treated, 15 (6 females, 9 males) in the dose escalation part and 17 (15 females, 2 males) in the MTD confirmation part. The median number of doses was 11 (range 1–18). In the dose escalation phase, 3, 4, and 3 pts were treated at 8, 12, and 16 mg/m 2 IV weekly without DLT. At 20 mg/m 2 , 2 of 5 pts developed DLT (1 pt - myalgia and neuropathy, 1 pt grade 4 neutropenia &gt; 5 days in duration). The RD was 16 mg/m 2 weekly. 17 more pts were treated at the RD. The most frequent grade 3 or 4 adverse events were asthenia (19%), nausea (9%), parethesia (9%) and neuropathy (9%). Of the 10 pts with breast cancer who were evaluable for response, one had a PR. Another breast cancer pt with a PR was a protocol violation and was not evaluable. In 20 pts at the MTD, the Tmax was 4 hr, the Cmax was 51.97 ng/mL, AUC 2711 ng*hr/mL, and the Vss was 1496 L/m 2 . Conclusions: Milataxel had an RD of 16 mg/m 2 IV per week. Objective responses were observed in pts with metastatic breast cancer. No significant financial relationships to disclose.
Disease relapse in patients with stage I nonseminomatous germ cell tumor of the testis on active surveillance.
Authors: P I Thompson, J Nixon, V J Harvey
Journal: Journal of Clinical Oncology (1988)

Thirty-six patients with apparent stage I nonseminomatous germ cell tumor (NSGCT) of the testis were treated by inguinal orchidectomy and intensive follow-up only. Assessment included measurement of serum alpha fetoprotein (alpha FP) and beta human chorionic gonadotropin (beta HCG) (tumor markers) and chest x-ray monthly for 1 year, then twice monthly for 1 year, with computed tomographic (CT) scans of abdomen and chest repeated three times monthly for the first year and six times monthly for the second year. Median follow-up was 36 months (range, 14 to 92 months). Relapse occurred in 12 patients (33.3%) at a median of 7 months (range, 2 to 28 months). Elevated markers were of limited importance in relapse detection, confirming the need for close clinical and radiological follow-up. Of nine histological factors examined in the primary tumor only the presence of lymphatic invasion was associated with a significantly higher relapse rate. All patients were treated at relapse with cisplatin-based chemotherapy. Four underwent surgery in addition, two before and two after chemotherapy. Eleven were rendered disease-free, but four had a second relapse. One patient has died, one is alive with disease, and ten are disease-free. Chemotherapy failed to cure six patients who had relapsed but bulk of disease was not a factor. Despite the good overall result reported here, optimal postorchidectomy management of apparent stage I disease remains to be defined.
Neoadjuvant chemotherapy followed by extrapleural pneumonectomy (EPP) for malignant pleural mesothelioma (MPM): An Italian experience with cisplatin-based regimens
Authors: A. Marino, C. Pinto, V. Mutri, D. Galetta, M. Di Bisceglie, A. Bini, D. Dell’amore, R. Sacco, A. L. Gentile, A. A. Martoni
Journal: Journal of Clinical Oncology (2006)

17022 Background: We have evaluated the feasibility and the impact on survival of two different preoperative chemotherapy regimens in potentially resectable MPM. Methods: Eligibility criteria were: histologically confirmed MPM, stage T1–3 N0–2 M0, adequate organ function, KPS ≥80. A first group of pts (group A) received cisplatin 75 mg/m 2 d1 and gemcitabine 1200 mg/m 2 d1,8, every 3 weeks for 4 courses, followed by EPP and by 6 courses of adjuvant chemotherapy with mitoxantrone 10 mg/m 2 d1, methotrexate 35 mg/m 2 d1 and mitomycin 7 mg/m 2 d1, every 3 weeks with mitomycin in alternate cycles. A second group of pts (group B) received cisplatin 75 mg/m 2 d1 plus pemetrexed 500 mg/m 2 d1 with full vitamin supplementation for 4 cycles. In each group, only pts with metastatic lymph nodes and/or positive resection margins underwent radiotherapy after EPP. Results: Twenty-five pts were enrolled from February 2000 to August 2005 (8 in group A and 17 in group B). Pt characteristics were: 21 (84%) males and 4 (16%) females, asbestos exposure in 16 (64%) pts, median age 64 years (range, 51–72), median KPS 100 (80–100), histological subtype: 19 (76%) epithelial, 2 (8%) sarcomatous, 3 (12%) mixed, 1 (4%) unknown; IMIG stage: 6 (24%) I, 14 (56%) II, 5 (20%) III. Clinical response to neoadjuvant chemotherapy consisted of 4 (16%) CR, 2 (8%) PR, 11 (44%) SD, 5 (20%) PD; 3 (12%) pts were not evaluable. The overall response rate (CR + PR) was 24% (95% CI: 9.4 - 45.1). Toxicity was mild in each group. Fourteen (56%) pts have undergone EPP, 5 (20%) pleurectomy and 6 (24%) pts were inoperable. Three postoperative complications and two postoperative deaths (one for controlateral pneumonia and one for ARDS) occurred after EPP. The 1-year survival rate was 60%. Long-term survivors (≥18 months) included 5 pts who had undergone EPP (18, 26, 54, 57 and 63 months) and 2 pts who had undergone pleurectomy (22 and 32 months). Conclusions: These preliminary data, albeit in a small series, suggest that preoperative chemotherapy followed by EPP is a feasible approach to be investigated in larger trials in pts with MPM. No significant financial relationships to disclose.
Immunohistochemical analysis of stress-induced phosphoprotein-1 (STIP1) in ovarian cancer tissues with low serum levels of CA125.
Authors: T. Wang, A. Chao, S. Hsueh, C. Lai
Journal: Journal of Clinical Oncology (2010)

e15530 Background: Through a systemic search for biomarkers of human ovarian cancer by comparing proteomes between tumor interstitial fluid (TIF) and normal interstitial fluid (NIF), we have identified stress-induced phosphoprotein 1 (STIP1) to be a candidate tumor marker. Enzyme-linked immunosorbent assay (ELISA) experiments revealed serum levels of STIP1 were significantly (p < 0.00001) higher in ovarian cancer patients (mean = 134.1 ng/mL, n = 36) than in healthy controls (mean 26.9 ng/mL, n = 36). Methods: In this study, we retrospectively analyzed primary cancer tissues in thirty patients with ovarian cancer, in whom serum levels before surgery were less than 35 U/mL, with mean ± SEM being 20.4 ± 1.4 U/mL. The cell types of these 30 cancers included 2 serous adenocarcinoma, 6 clear cell adenocarcinoma, 14 mucinous adenocarcinoma, 7 endometrioid adenocarcinoma, and 1 poorly differential adenocarcinoma. The overall immunohistochemical intensity score in this study was defined as % cell population multiplied by staining score from 0 to 3 (0 = negative, 1 = weak, 2 = moderate, 3 = strong), ranging from 0 to 300 (100% multiplied by 3). Results: The overall immunohistochemical intensity of STIP1 (88.5 ± 12.5, mean ± SEM) was significantly (p < 0.000001, n = 30) higher than that of CA125 (13.6 ± 5.3). Conclusions: Although we did not have archival serum specimens of these patients to do STIP1 measurements, these results suggest that STIP1 may be useful in detecting human ovarian cancer in patients with low CA125 serum levels. No significant financial relationships to disclose.
Repair of the Femoral Nerve After Intra-Abdominal Severance
Authors: Alan Wentworth
Journal: JAMA (1961)

INJURY to the femoral nerve proximal to the inguinal ligament is not common. Repair of abdominal severance of this important structure is apparently rare. One of us (F. B. C.)1reported two such cases in 1956. An additional case was recorded by Chiasserini2a year later. A review of the few published cases and the histories of 3 additional patients observed recently suggests that these remedial lesions may be of some general interest.  The femoral (or anterior crural) nerve, arising as it does from the anterior divisions of the 2nd, 3rd, and 4th lumbar nerves, is a mixed nerve that courses lateral to the iliac vessels from its origin deep to the psoas muscle mass. It remains a single trunk for a short distance over the iliacus muscle to pass behind the inguinal ligament lateral to the femoral artery. Muscular branches supply the iliacus, psoas, pectineus, sartorius,
Potential role of NK cells in tumor growth and metastasis of breast cancer cells in NOD/SCID/γcnull (NOG) mice: Implication of immune therapy
Authors: Dewan Zahidunnabi, Hiroshi Terunuma, Kenji Obha, Masahiro Takada, Yuetsu Tanaka, Masakazu Toi, Naoki Yamamoto
Journal: Cancer Research (2005)

Proc Amer Assoc Cancer Res, Volume 46, 2005

4683 

NK cells play a central role in host defense against tumor and virus-infected cells. We investigated the ability of breast cancer cell lines to induce tumor and metastasis in novel NOD-SCID/γcnull (NOG) mice. Breast cancer cell lines (MDA-231, MCF-7 and T-47) were inoculated subcutaneously in the post-auricular region of NOG mice. MDA-231 cells produced a progressively growing large visible tumor in all mice within 2 to 3 weeks while MCF-7 cells did so within 7 to 8 weeks after inoculation, but T-47 cell line did not induce tumor. Estrogen induced rapid growth of MCF-7 cells in NOG mice, but no organ metastasis was found. MDA-231 cells were able to produce tumor at inoculated site in NOD/SCID mice with common γ-chain while completely failed to metastasize into various organs. Immunosupression of NOD/SCID by treatment with an anti-murine antibody TM-β1, which transiently abrogates natural killer cell activity in vivo, resulted in successful engraftment of tumor growth and metastasis in comparison with non-treated NOD/SCID mice. In contrast, NOG mice without common γ-chain inoculated with MDA-231 cells were most efficient in the formation of a large tumor and metastasis within 3 weeks. Adoptive transfer of activated human NK cells inhibited tumor growth and metastasis in NOG mice. Our results suggest that NK cells play an important role in primary growth and metastasis of breast cancer cells in SCID mice. This new xenotransplant model is relevant and can be recommended for use in clarifying the mechanism of growth of cancer cells as well as for developing new therapeutic strategies against cancer.
A randomized phase I/II trial of hyperfractionated radiation therapy with total doses of 60.0 Gy to 79.2 Gy: possible survival benefit with greater than or equal to 69.6 Gy in favorable patients with Radiation Therapy Oncology Group stage III non-small-cell lung carcinoma: report of Radiation Therapy Oncology Group 83-11.
Authors: J D Cox, N Azarnia, R W Byhardt, K H Shin, B Emami, T F Pajak
Journal: Journal of Clinical Oncology (1990)

A phase Ilate/II trial of hyperfractionated (HFX) radiation therapy for non-small-cell carcinoma of the lung (NSCCL) was conducted by the Radiation Therapy Oncology Group (RTOG) between 1983 and 1987. Fractions of 1.2 Gy were administered twice daily with greater than or equal to 4 hours between fractions. Patients were randomized to receive minimum total doses of 60.0, 64.8, and 69.6 Gy. After acceptable risks of acute and late effects were found, 74.4 Gy and 79.2 Gy arms were added, and the lowest total dose arms were closed. No significant differences in the risks of acute or late effects in normal tissues were found among the 848 patients analyzed in the five arms; risks of severe or life-threatening pneumonitis were 2.6% for 60.0 to 64.8 Gy, 5.7% for 69.6 to 74.4 Gy, and 8.1% for 79.2 Gy. Among 350 patients who had the same criteria as Cancer and Leukemia Group B (CALGB) protocol 84-33 (American Joint Committee on Cancer Staging [AJCCS], 1984, stage III; Karnofsky performance status [KPS] 70 to 100; less than 6% weight loss), there was a dose response for survival: survival with 69.6 Gy (median, 13.0 months; 2 years, 29%) was significantly (P = .02) better than the lower total doses. There were no differences in survival among the three highest total-dose arms. Comparisons with results in similar patients treated with 60 Gy in 30 fractions of 2.0 Gy 5 days per week for 6 weeks suggest benefit from HFX radiation therapy with 69.6 Gy. Improvement in survival with HFX radiation therapy at 69.6 Gy total dose without increase in normal tissue effects, justifies phase III comparison with standard fractionation alone and combined with systemic chemotherapy in this common presentation of NSCCL.
Boron neutron capture therapy in patients with recurrent head and neck cancers who have no other treatment options.
Authors: Itsuro Kato, Yusei Fujita, Masatoshi Ohmae, Yoshinori Sakurai, Minoru Suzuki, Shin-ichiro Masunaga, Isao Murata, Tetsuro Sumi, Mitsuhiro Nakazawa, Koji Ono
Journal: Journal of Clinical Oncology (2014)

6046 Background: Boron neutron capture therapy (BNCT) is a targeted type of radiotherapy that has a number of significant advantages over conventional external beam photon irradiation, especially in that radiation can be selectively delivered to tumor cells. We had, first in the world, treated with BNCT for a patient with recurrent head and neck Cancers (HNC) in 2001. Methods: From December, 2001 to February, 2013, we have treated a total of 35 patients with recurrent HNC by means of 52 applications of BNCT. Histopathologically, there were 24 patients with squamous cell carcinomas (SCC), 7 with salivary gland carcinomas and 4 with sarcomas. All of them had received standard therapy and subsequently developed recurrent disease for which there were no other treatment options. All of the patients received intravenously either a combination of two boron containing drugs, sodium borocaptate (BSH, 5g) and boronophenylalanine (BPA, 250mg/kg) or BPA (500mg/kg) alone. In this report we will summarize the clinical results and outcomes of 35 patients with HNC who had received BNCT at either the Kyoto University Research Reactor Institute (KURI) or the Japan Atomic Energy Agency (JAEA) nuclear reactor. Results: All of the patients had advanced disease and 17 of 35 (49%) had regional lymph node metastases and 10 out of 35 (29%) had distant metastases at the time of treatment. (1) Boron concentration ratios of tumor/normal tissue (T/N ratio), as determined by 18FBPA-PET imaging were 1.8-7.0 for SCC, 2.5-4.0 for sarcomas and 2.5-3.7 for parotid tumors. (1) Regression rates were CR: 18 patients (51%), PR: 13 (37%), PD: 3 (9%), and not evaluated (NE):1patient. The overall patient response rate was 88%. (2) The Mean Survival Time was 24.2 months and the 4 year and 7-year OS rates were 42% and 36% , respectively. (3) Survival times following BNCT ranged from 1 to 95months. (4) BNCT improved QOL, PS and survival times. (5) The primary adverse events were brain necrosis, osteomyelitis and transient mucositis and alopecia. Conclusions: Our results indicate that we could make sure that safety and effectiveness of BNCT and BNCT represents a new and promising treatment modality in patients for whom there are no other treatment options.
Left Atrial LGE and Arrhythmia Recurrence Following Pulmonary Vein Isolation for Paroxysmal and Persistent AF
Authors: Irfan M. Khurram, Mohammadali Habibi, Esra Gucuk Ipek, Jonathan Chrispin, Eunice Yang, Kotaro Fukumoto, Jane Dewire, David D. Spragg, Joseph E. Marine, Ronald D. Berger, Hiroshi Ashikaga, Jack Rickard, Yiyi Zhang, Vadim Zipunnikov, Stefan L. Zimmerman, Hugh Calkins, Saman Nazarian
Journal: JACC. Cardiovascular imaging (2016)