tbuckley/cabot-search huggingface dataset:
Quality performance improvement with the implementation of standard chemotherapy forms
Authors: L. Dumasia, E. Harris, A. Drelichman
Journal: Journal of Clinical Oncology (2005)

6097 Background: There is always a need for quality improvement. Our oncology division has a quality improvement committee with a focus on reducing pharmaceutical chemotherapy clarifications. We hypothesize that reduced clarifications may in turn lead to decreased medication errors. In the past, chemotherapy orders were handwritten by the physician on blank order sheets. There was no standard to which the physician could accurately complete and include these necessary variables. For this reason, chemotherapy orders were frequently incomplete and had to be adjusted by the pharmacist after discussing the missing variables with the ordering physician. As a part of our goal, standard chemotherapy forms were initiated at our institution in October of 2000. Methods: The first standard form implemented in October of 2000 was a written order form that constituted a standard of the ideal variables necessary to accurately complete chemotherapy orders. These variables were the diagnosis, regimen, height, weight, BSA, route, frequency, duration and chemotherapy dose and calculation based upon BSA. The updated next form was a similar electronic version of the original and was implemented in April, 2002. Those required variables necessary for completeness were electronically made mandatory for submission. Results: With our data from 2/99–3/00, using the traditional unstandardized blank order sheets, the average completeness was around 45%. After the standard written forms were introduced, from 10/00 to 3/02, the average chemotherapy order completeness rose to of 81%; a difference of a 36% improvement. In April of 2002, a standard electronic chemotherapy order form was then implemented. From 4/02- 12/03, the average order completeness rose to 93%. For four consecutive months, the orders were 100% complete. Conclusion: Our quality performance improvement project does demonstrate that chemotherapy order completeness improves considerably through the standardization of chemotherapy forms. The electronic forms do show an additional improvement over handwritten standard forms. This may decrease medication errors, a topic for ongoing research. The standardization of chemotherapy forms should be a model in the practice of oncology. No significant financial relationships to disclose.
Interpretation of do-not-resuscitate (DNR) orders among oncology health care professionals and the potential for these orders to influence care for medical issues unrelated to resuscitation.
Authors: C. R. Lund, R. Samant
Journal: Journal of Clinical Oncology (2010)

9078 Background: Over 30 years ago, literature documented that DNR orders may result in less aggressive care for medical issues not related to resuscitation. In the interim, efforts designed to improve patient autonomy and communicate goals of care have been developed. In spite of this, we hypothesize that the interpretation of DNR orders is variable and continues to result in less aggressive care in general. Methods: All physicians and nurses involved in the care of oncology inpatients at a tertiary care hospital were invited to participate in a web-based simulation measurement and survey. Subjects were not aware of the study hypothesis. Participants were randomized to a clinical vignette varying only by the patient's code status (DNR or Full Code). Subjects were presented a second vignette involving a DNR patient. Each vignette was followed by a series of questions regarding patient management. Lastly, subjects were presented opinion questions directly assessing their views on the use of DNR orders. Results: Sixty-two of 264 eligible subjects responded (24%). Participants randomized to the DNR vignette were more than twice as likely to agree that aggressive care should not be provided. Nearly two-thirds of participants agreed that an acutely septic patient, with a favorable oncologic prognosis, should not receive cardiopulmonary resuscitation if he has a DNR order. This was in spite of no documented discussion of code status and no ability to re-confirm the DNR order with the patient or next of kin. More physicians than nurses agreed that they treat DNR patients differently for medical issues not related to resuscitation, and that DNR patients are more likely to die compared to Full Code patients, independent of their disease severity. Eleven percent of nurses and physicians agreed that DNR was synonymous with “Comfort Measures.” Conclusions: The interpretation of DNR orders among oncology nurses and physicians is variable and results in less aggressive care in general. The degree of care an oncology inpatient with a DNR order receives will vary with the particular health care professionals involved. No significant financial relationships to disclose.
Use of predictive models (PMs) in colorectal cancer (CRC) for diagnosis of Lynch syndrome (LS): A process measure for quality of care.
Authors: Sarmad Sadeghi, Afsaneh Barzi, Michael W. Kattan, Neal J. Meropol
Journal: Journal of Clinical Oncology (2012)

116 Background: LS diagnosis (Dx) in CRC patients (probands or Pds) and their first degree relatives (FDRs) impacts the management, outcomes and quality of care. Lack of a uniform approach to screening in academic and community centers is an impediment. Recent studies advocate universal immunohistochemistry (IHC) testing for Pds; however, these analyses exclude clinical criteria e.g., Amsterdam (Ams), Bethesda (Beth), and PMs, e.g., MMRpro (Mpro), MMRpredict (Mpre), and PREMM (PRE) due to concerns for reliability. This comprehensive comparison of all LS screening strategies (STs) aims to identify a cost effective process measure that addresses this need. Methods: We performed a cost effectiveness analysis with a societal viewpoint using TreeAge software. 21 STs for Pd and general population (GP) screening in a population of 100,000 were examined assuming a 3% LS prevalence (Prev) in Pd and 0.23% in GP, 5 FDRs per LS (Dx), 50% LS Prev in FDRs, and 90% germline testing (GT) compliance in Pds and GP and 52% in FDRs. Sensitivity, life years gained (LYG), and incremental cost effectiveness ratios (ICERs) were calculated. Results: See table. Conclusions: This study suggests that Mpro is a cost-effective first step in screening for LS in Pds, and its routine use may be considered as a possible process measure for quality of care in CRC patients. Up-front IHC +/- BRAF, GT could be reserved for Pds where history is incomplete. [Table: see text]
Compound Heterozygosity of a W493C Substitution and R704/Premature Stop Codon within the γ-Glutamyl Carboxylase in Combined Vitamin K-Dependent Coagulation Factor Deficiency in a French Family.
Authors: Dhouha Darghouth, Kevin W Hallgren, Odile Issertial, Amine Bazaa, Kathleen L Berkner, Jean-Philippe Rosa, Rémi Favier
Journal: Blood (2009)
Using the experience-based design (EBD) approach to strengthen patients’ impact.
Authors: Lesley Moody, Kate Bak, Simron Singh, Laura Macdougall, Esther Green
Journal: Journal of Clinical Oncology (2014)

69 Background: The Experience Based Design (EBD) approach uses patient and clinician experiences to identify opportunities for improvement in the healthcare system. The EBD approach elicits subjective and personal patient, carer, and staff experiences at crucial points in the care pathway by encouraging them to share their stories. Methods: Cancer Care Ontario (CCO), an agency that oversees cancer services in Ontario, held an EBD workshop with the objectives of capacity building and facilitating healthcare improvements throughout the province. 110 participants (27 teams) from across Ontario attended the workshop to engage participants to take an active role in developing actionable plans to address patient experience issues. An evaluation following two years of EBD was necessary to: (a) determine EBD progress and effectiveness; (b) identify successes/challenges for getting projects off the ground; and (c) identify additional resources required to spread EBD across Ontario. The evaluation consisted of: 1) two province-wide electronic surveys (long survey for those directly involved in EBD projects; short survey for frontline staff) and 2) semi-structured phone interviews with patients/caregivers. Results: Some EBD projects have completed multiple initiatives; others are just beginning. Projects address process improvement (e.g., streamlining patient bookings), resource/tool development (e.g., symptom screening tools) and establishing patient advisory boards and committees. Five (28%) survey respondents said that EBD projects elicited implementation of 6 to 10 changes and 6 (38%) respondents indicated that: (1) respect for patient preferences and (2) communication, information and education were two principles of Person-Centred Care (PCC) that improved the most. Conclusions: Future steps include development of a collaborative website, a symposium to showcase projects, an evaluation of the EBD initiative and peer-reviewed publication.
Identification of polymorphisms in ultraconserved elements (UCEs) associated with clinical outcomes in patients (pts) with stage II/III colorectal cancer (CRC).
Authors: M. Lin, E. Hawk, M. Huang, J. Lin, J. Gu, L. M. Ellis, X. Wu, C. Eng
Journal: Journal of Clinical Oncology (2011)

3529 Background: Recent studies have not demonstrated therapeutic advances in pts with stage II-III CRC indicating the need for novel methodology. UCEs are non-coding sequences with 100% sequence identity among orthologous genomic regions of human and murine species. UCEs harbor critical biologic functions including splicing, epigenetics, and transcriptional coactivation. Our analysis aims to determine whether single nucleotide polymorphisms (SNPs) within UCEs correlate with outcomes in CRC pts receiving adjuvant 5-FU based chemotherapy. Methods: AJCC stage II-III pts (diagnosed < 1 yr) had blood and epidemiological data collected. Forty-eight SNPs within UCEs were genotyped. The validation set comprised pts with a history of recurrence (diagnosed > 1 yr). Association between genotypes, recurrence, and survival was conducted using Cochrane Q, K-M, and log-rank testing. Results: Of 662 pts, 285 of 435 pts [66%: stage II/III(N=115/170)] and 227 pts [stage II/III (N=88/112] comprised the training and validation sets, respectively. Median follow-up was 45.1 months. In stage II pts, increased recurrent risk (IRR) for rs7849 was noted in the training (HR: 2.39; 95%CI: 1.04-5.52), replication (HR: 3.70; 95%CI: 1.42-9.64) and meta-analysis sets (HR: 2.89; 95%CI: 1.54-5.41). IRR was observed in pts with one variant allele of rs2421099 (HR: 2.44; 95%CI: 1.08-5.51), rs16983007 (HR: 2.81; 95% CI: 1.02-7.70), or homozygous variant of rs10211390 (HR: 2.79; 95%CI: 1.16-6.71). In stage III pts, reduced RR occurred with at least one variant allele of rs6124509 (HR: 0.38; 95%CI: 0.16-0.91) and rs11195893 (HR: 0.26; 95%CI: 0.08-0.91); homozygous variant rs10211390 resulted in IRR (HR: 2.70; 95%CI: 1.12-6.50). Multiple risk genotypes had a dose-dependent effect on RR in stage II/III pts (p < 0.01). Conclusions: This is the first reported analysis of SNPs within UCEs in CRC following adjuvant 5-FU based therapy. A total of 5 SNP’s were associated with IRR in stage II/III pts; two SNPs resulted in a reduced RR in stage III pts. Identification of these variations suggests they have a biologic role in recurrence and may contribute prognostically to therapeutic decisions.
Capecitabine plus irinotecan versus 5-FU/FA/irinotecan ± celecoxib in first line treatment of metastatic colorectal cancer (CRC). Long-term results of the prospective multicenter EORTC phase III study 40015
Authors: J. De Grève, C. Koehne, J. Hartmann, I. Lang, P. Vergauwe, K. Becker, D. Braumann, M. Debois, U. Bethe, E. Van Cutsem
Journal: Journal of Clinical Oncology (2006)

3577 Background: Oral fluoropyrimidines in combination with irinotecan may be an alternative to infusional 5-FU/FA+irinotecan. Cox-2 inhibitors may enhance the antineoplastic activity of chemotherapy (CT). Methods: Patients with ECOG PS&lt;2, age&gt;18 and measurable disease were randomised in a 2×2 factorial design to FOLFIRI (Douillard’s regimen) or capecitabine 2×1g/m 2 d1–14 plus irinotecan 250mg/m 2 d1, qd22 (CAPIRI), and to daily celecoxib 2x400mg (C) or placebo (P). 692 patients were planned to compare PFS as primary endpoint. The trial was suspended after 85 pts (44 CAPIRI and 41 FOLFIRI) due to the occurrence of 8 fatal events unrelated to disease progression (Köhne, ASCO 2005, A3525). Results: Baseline characteristics were well balanced. Three pts did not start treatment. Of the pts who started CT, 53% (23/43) in the CAPIRI and 33% (13/39) in the FOLFIRI arms required a dose reduction. Grade ≥3 diarrhoea occurred in 37% (16/43) and 13 % (4/39) on CAPIRI and FOLFIRI, respectively. Median number of CT cycles: 3 (CAPIRI) and 5 (FOLFIRI). Median dose intensity for irinotecan: 83% (CAPIRI) and 85% (FOLFIRI). Response rate (RR): 5/23 (22%) in CAPIRI+C, 10/21 (48%) in CAPIRI+P, 6/19 (32%) in FOLFIRI+C and 10/22 (45%) in FOLFIRI+C. RR for CAPIRI vs FOLFIRI: 15/44 (34%) versus 16/41 (39%), RR for Celecoxib vs Placebo: 11/42 (26%) vs. 20/43 (46 %). Median PFS: 5.9 months (95% CI: 4.4–8.9) with CAPIRI vs 9.6 months (95% CI: 6.9–11.8) with FOLFIRI (HR=1.31, 95%CI: 0.8–2.1), and 6.9 months (95% CI: 5.5–10.4) with C vs 7.8 months (95% CI: 6.0–12.0) with P (HR=1.1, 95%CI: 0.7–1.8). Median OS: 14.8 months (95% CI: 10.7–18.3) with CAPIRI vs 19.9 months (95% CI: 18.9-n.a.) with FOLFIRI (HR=3.2, 95%CI: 1.4–7.3), and 18.3 months (95% CI: 10.2-n.a.) with C versus 19.9 months (95% CI: 16.7-n.a.) with P (HR=1.25, 95%CI: 0.6–2.6). Conclusions: The data suggest that celecoxib might reduce response to CT and this warrants further preclinical investigation. The stratified analysis failed to demonstrate the non-inferiority of CAPIRI as compared to FOLFIRI. Small sample size and confounding safety issues prevent us from drawing definitive conclusions. Results of larger studies would be needed. No significant financial relationships to disclose.
Reduction of toxicity by reversing the order of infusion in docetaxel and cyclophosphamide (TC).
Authors: D. Miura, M. Fujii, T. Iwatani, T. Takano, H. Kawabata
Journal: Journal of Clinical Oncology (2011)

2576 Background: Although TC (docetaxel 75mg/m2 and cyclophosphamide 600mg/m2, q3w) combination is among the most widely used neoadjuvant/adjuvant chemotherapy for primary breast cancer, allergic reactions including rash and edema are occasionally met. This study aimed to determine whether adverse events (AEs) particularly allergic reactions were more common in TC, docetaxel infused prior to cyclophosphamide compared to reverse TC (rTC), cyclophosphamide infused prior to docetaxel. Methods: Retrospective analysis was done at a single institution in consecutive 85 patients treated with TC or rTC for stage 1-3 breast cancer from 2007 to 2010. TC was used in former 2.5 years and rTC in latter 1.5 years. Dexamethasone was administered to prevent allergic reaction in both. Two tailed Fisher Exact test was used to evaluate the significance of proportional differences in AEs between two regimens according to CTCAE ver.4. Results: Among 85 patients, 50 were in TC and 35 in rTC. Baseline characteristics of two groups were not different. Significant decreases in fatigue (11% vs. 72%), edema (11% vs. 48%), neuropathy (14% vs. 66%), and myalgia (6% vs. 48%) were observed in rTC as compared with TC. There were also decreased incidences of grade 3 and 4 edema (0% vs. 2%), neuropathy (3% vs. 10%), myalgia (0% vs. 2%), and rash (6% vs. 10%) in rTC. All 2 cases who did not complete their treatments were in TC due to rash. Hematologic AEs were not different in 2 regimens. Conclusions: Patients receiving cyclophosphamide infused prior to docetaxel were decreased risk for several toxicities as compared with docetaxel infused prior to cyclophosphamide. The immunosuppressive effects of cyclophosphamide may reduce hypersensitivity reactions with docetaxel by reversing order of infusion.
Stability of white blood cell counts following standard radiation approaches for high-risk adenocarcinoma of the prostate: Implications for combination therapy.
Authors: Steven E. Finkelstein, Francisco A. Myslicki, Sharon Salenius, Constantine Mantz, Neal Shore, Eduardo Fernandez, Todd DeVries, Robert Brownell Sims
Journal: Journal of Clinical Oncology (2013)

201 Background: Traditional wisdom has suggested that under some circumstances radiation therapy may be immunosuppressive, thus obviating effective combination approaches with immunotherapy. Our purpose was to test whether standard radiation therapy for high-risk prostate cancer are immune modulating, thereby prohibiting potential combination with cellular based immunotherapies such as sipuleucel-T. Methods: Retrospective analysis of complete blood count with differential (CBC) data was performed on 26 patients with high-risk adenocarcinoma of the prostate undergoing external beam radiation therapy between January 2008 and November 2010. CBC data were collected prior to radiation therapy and at up to 4 time points thereafter, and compared to normal ranges from an outside reference lab (WBC 3,800-10,700/μL; ALC 910-4,280/μL). Results: The median age was 73 (range 62-86), and 16 patients were on concurrent androgen deprivation therapy. Patients received intensity modulated, dose-escalated external beam radiotherapy. Baseline and subsequent median white blood counts (WBC) and absolute lymphocyte counts (ALC) remained within the normal ranges. In the clinically relevant time frame of &lt;3 months following radiation therapy where sipuleucel-T could be considered, the WBC and ALC were 5,350 and 970, respectively. The median WBC and ALC then gradually increased to 5,800 and 1,250, respectively, at 6-12 months post radiation therapy. Conclusions: These data suggest that in the setting of external beam radiation approaches for high-risk adenocarcinoma of the prostate, no significant changes in either WBC or ALC were observed. The hematologic status in these patients remained stable, suggesting that combination radiation / cellular based immunotherapy approaches are feasible. Further analysis is warranted to test the potential of novel immunotherapeutic agents with radiation therapy. [Table: see text]
Mathematical modeling of CA125 kinetics in recurrent ovarian cancer (ROC) patients treated with chemotherapy and predictive value of early modeled kinetic parameters in CALYPSO trial: A GCIG study.
Authors: B. You, O. Colomban, M. Heywood, C. Lee, M. Davy, N. Reed, S. Pignata, R. Fossati, G. Emons, K. L. Rehman, K. D. Steffensen, E. Petru, V. Gebski, A. Burges, N. Tubiana-Matthieu, M. Hansen, P. A. Vasey, U. Denison, P. De Bruyne, A. M. Oza
Journal: Journal of Clinical Oncology (2011)

5065 Background: Although CA125 kinetic profiles may be related with relapse risk in ovarian cancer patients treated with chemotherapy, no reliable kinetic parameters have been reported. Mathematical modeling may help describe CA125 decline dynamically and determine parameters predictive of relapse. Methods: Data from CALYPSO phase III trial data comparing 2 carboplatin-based regimens in ROC patients were analyzed. Based on population kinetic approach (Monolix software), a semi-mechanistic model was used to fit serum log (CA125) concentration-time profiles with following parameters: tumor growth rate constant (BETA); CA 125 tumor production (KIN); tumor decay rate constant (KOUT) and treatment indirect effect (Emax relationships with A and A50) “d[CA125]/dt=(KIN* exp [BETA*t]) * (1 - [A/{A+A50}]) – KOUT * (CA125)” where t is time. The predictive values of KIN; KOUT; BETA and A50 estimated during the first 50 treatment days were tested regarding progression free survival (PFS) against other reported prognostic factors using Cox-models: treatment arm; platinum-free interval (PFI), metastatic site number, largest tumor size, elevated WBC and measurable disease. Results: The CA125 kinetics from 898 patients were analyzed. Individual CA125 profiles were well fit by the model, as validated by a visual predictive check. Two modeled kinetic parameters had strong predictive values using univariate analyses: BETA (HR=1.38, p<10e-5) and KOUT (HR=0.13, p<10e-10). BETA and KOUT were not different between treatment arms. Using multivariate analysis adjusted on treatment arms, 4 independent predictive factors of PFS remained significant: BETA (HR=1.35, p<10e-4); KOUT (HR=0.18, p<10e-8); PFI (p<10e-9) and measurable disease (p<10e-4). Conclusions: Determination of mathematical equations describing CA125 kinetics in ROC patients treated with chemotherapy is feasible. Moreover modeled kinetic parameters estimated early in the first 50 treatment days, assessable in routine, may have promising independent predictive value regarding PFS. Further validation of these results in independent cohorts is warranted.
Functional results after vertebroplasty in metastatic vertebral fractures
Authors: J. C. Barbi-Goncalves, F. Da Cunha, M. Baptistta, D. Grarbarz, M. Tonussi, I. Ribeiro
Journal: Journal of Clinical Oncology (2005)

8049 Background: Percutaneous vertebroplasty may be indicated when a patient with a painful osteoporotic or metastaticvertebral compression fracture remains symptomatic despite of nonoperative management. These vertebral fractures are associated with significant morbidity and mortality. We investigated these outcomes with use of a visual analog scale and Karnovisky quality-of-life instrument. Methods: We performed a prospective study of consecutive patients who underwent percutaneous vertebroplasty. At 24hs, one week, one month, and six months postoperatively, all patients completed a validated quality of life questionnaire and visual analog scale (ranging from 1 to 10) was completed and at each evaluation thereafter. Results: Fifity five consecutive patients (35 women and 20 men) underwent 87 percutaneous vertebroplasty procedures for the treatment of metastatic vertebral compression fractures. The mean age of the patients was 55,34 years. The mean pain rating decreased from 8,2 preoperatively to 0,89 one week after the vertebroplasty (p < 0.001), and it remained substantially improved one month, and six months postoperatively. The Karnovisky quality of life questionnaire were improved at one week postoperatively and remained improved at each evaluation point through six months (p 0.001. Four incident cement leakage occurred in four (4,59%) of the 87 patients, and one patient had a pulmonar embolism and survive and another died within three weeks with heart atack. No deaths or serious adverse events appeared to be related to vertebroplasty. Conclusions: Rapid relief of pain and improvement in the quality of life are observed following percutaneous vertebroplasty in vertebral metastasis patients and these improvements are maintained. Percutaneous vertebroplasty can be performed safely in patients with metastatic vertebral fractures. No significant financial relationships to disclose.
Increase In NK Cell Lysis of Leukemic Blasts Due to Loss of Mismatched HLA Haplotype After Haplo-Identical Stem Cell Transplantation
Authors: Yoshiyuki Takahashi, Itzel Bustos Villalobos, Sayoko Doisaki, Hideki Muramatsu, Akira Shimada, Asahito Hama, Seiji Kojima
Journal: Blood (2010)