tbuckley/cabot-search huggingface dataset:
Serum peptide profiling (SPP) by mass spectrometry (MS) to identify post-menopausal women with metastatic breast cancer
Authors: K. L. Smith, J. Villanueva, G. D’Andrea, M. E. Moynahan, N. Sklarin, L. Norton, C. Hudis, P. Tempst, M. Robson
Journal: Journal of Clinical Oncology (2005)

9540 Background: Previous studies evaluating the use of SPP by MS to identify candidate breast cancer biomarkers have been compromised by small sample sizes, heterogeneous populations and variable sample collection and analytic techniques. To address these limitations, we performed a pilot study utilizing standardized sample collection and analysis techniques in a clinically homogeneous population to assess the ability of SPP by MS to differentiate women with metastatic breast cancer from women without metastatic disease. Methods: 149 post-menopausal women (61 Stage IV, 88 Stage I/II NED for ≥3 years) receiving hormonal therapy were studied. Samples were collected and handled in a uniform manner. Serum peptide profiles were derived by MALDI-TOF MS. Mass lists of all identified peaks and those that potentially differentiated the two groups were compiled for each sample after manual external calibration and imported into GeneSpring software. Candidate peaks were evaluated using ANOVA with correction for multiple comparisons. Support Vector Machine Linear Kernel Class Prediction (SVMLKCP) was used to assess the ability of the identified peaks to predict disease status. Results: A total of 578 peaks were identified. From these, 29 were identified as candidates potentially separating the two groups. After statistical analysis, only one candidate was significantly different between the two groups (p<0.05). In a model using all 29 candidate peaks, SVMLKCP correctly predicted disease status for 34 of 61 Stage IV patients and 54 of 88 NED patients (sensitivity 56%, specificity 61%). Conclusions: In a study designed to control for potentially confounding clinical and analytic variables, SPP was suboptimal for the identification of patients with metastatic disease. No significant financial relationships to disclose.
Disparity in early mortality among racial groups with multiple myeloma in the United States: A National Cancer Data Base study of 108,352 patients.
Authors: Wilson I. Gonsalves, Adam C Bartley, Ronald S. Go
Journal: Journal of Clinical Oncology (2016)

311 Background: Previous population-based studies have shown variations in disease incidence and overall survival (OS) among multiple myeloma (MM) patients (pts) from different ethnic and racial backgrounds. However, the impact of race and ethnicity on early mortality (EM) or death in the first year after the diagnosis of MM is less well known. Methods: Pts with MM diagnosed from 2000-2011 were identified in the NCDB. We obtained data associated with socio-demographics, type and location of care facility, as well as the use of autologous stem cell transplant (ASCT) as an initial treatment option. Two cohorts were created based on the use of ASCT: 1) The group who received an upfront ASCT and 2) Pts who were 75 years or older who are unlikely to have ever received an ASCT. The rate of early mortality (EM) was estimated using the 1-year OS and assessed for all pts based on racial/ethnic background and the use of ASCT in their therapy. Results: There were a total of 108,352 pts who were included in this analysis. The median age of this cohort was 65 years (Range: 20 – 90). Of these 58,223 (54%) were male. The racial distributions of these cohorts were as follows: 78,589 (73%) White non-Hispanic (WNH), 21,292 (20%) Black non-Hispanic (BNH), 1,943 (2%) Asian Pacific-Islander (API), 293 (&lt; 1%) Native-American (NA) and 6,235 (5%) Hispanics-any race (HIS). The estimated 1-yr OS (95% CI) was 71% (71 – 72) for WNH, 74% (73 – 74) for BNH, 77% (75 – 79) for API, 73% (68 – 78) for NA and 75% (74 – 76) for HIS. Amongst patients who received an upfront ASCT, the estimated 1-yr OS (95% CI) was 97% (97 – 98) for WNH (Reference), 98% (97 – 98) for BNH (P = 0.99), 99% (99 – 100) for API (P = 0.96) and 98% (97 – 99) for HIS (P = 0.99). Whereas amongst pts who likely never received an ASCT (75 years or older), the estimated 1-yr OS (95% CI) was 55% (54 – 56) WNH (Reference), 57% (56 – 59) for BNH (P = 0.03), 62% (58 – 67) for API (P = 0.02), 55% (43 – 72) for NA (P = 0.99) and 55% (52 – 58) for HIS (P = 0.99). Conclusions: In general, WNHs have a worse 1-yr OS compared to BNH and API. However, this disparity appears significant only among pts unlikely to get an ASCT. Further studies are required to identify explanations for such disparate outcomes based on race and use of ASCT.
Factors associated with receipt of radiation therapy for rectal cancer.
Authors: Daniel A. Sussman, Laura A. McClure, Monique N. Hernandez, Stacey L. Tannenbaum, Judith M. Bonner, D. Diane Zheng, David J. Lee
Journal: Journal of Clinical Oncology (2015)

747 Background: Appropriate treatment for rectal cancer is vital to increasing the likelihood of survival. Disparities in receipt of appropriate radiation treatment have been observed with respect to race/ethnicity and socioeconomic status. We used enriched cancer registry data to identify alternative factors associated with receipt of appropriate radiation therapy for rectal cancer. Methods: Data were obtained from the Florida Cancer Data System and were enriched with detailed treatment information collected from a Centers for Disease Control and Prevention Comparative Effectiveness Research study. Using multivariable regression, we evaluated factors associated with receipt of radiation therapy among rectal cancer cases summary stage II/III. Our sample (n=403) included cases diagnosed in Florida in 2011 who were 18 years and older. Cases clinically staged as 0/1/4 were excluded. Though patients over age 80 years (n=67) and those with stage IIA disease (n=185) may not routinely be prescribed radiation, these cases were included in order to maximize the sample size. Results: Our sample was an average of 64 years-old, more often male (59%), NH White (56%), diagnosed with stage III disease (54%), insured (92%), had received surgical intervention (87%), chemotherapy (68%), or radiation (57%), were in the highest SES quartile (56%), and had one or more comorbid condition (57%). Older age (OR=0.96; 95%CI=0.94-0.97), the presence of more than one comorbidity (0.61; 0.39-0.96), and receipt of surgical intervention (0.44; 0.22-0.90) were predictors of not receiving radiation. Conclusions: Contrary to our hypothesis, socio-demographic factors such as race/ethnicity, insurance status, and socioeconomic status, did not influence the receipt of radiation. Further research is needed, however, to understand why age, comorbidity, and surgery present a barrier to radiation, particularly given that radiotherapy is a well-tolerated modality.
Evidence to support a decline in prostate cancer-specific mortality
Authors: S. L. Galper, M.-H. Chen, W. J. Catalona, K. A. Roehl, J. P. Richie, A. V. D’Amico
Journal: Journal of Clinical Oncology (2005)

4550 Purpose: Prostate-specific antigen doubling time (PSA-DT) < 3 months has been suggested as a surrogate endpoint for prostate cancer-specific mortality (PCSM). We evaluated whether stage migration during the PSA era has translated into longer PSA-DTs in men who experience PSA failure. Methods: Between July 1988 and July 2002, 3719 men with clinically localized prostate cancer treated with radical prostatectomy (RP) comprised the study cohort. A chi square metric was used to compare the distribution of clinical factors at presentation and postoperatively, 5-year actual PSA failure rates, and PSA-DTs for patients treated during two equally divided eras: the early PSA era, 7/88–7/95, and the late PSA era, 8/95–7/02. Patients in the early PSA era whose PSA failure time exceeded the maximum from the later PSA era were excluded to ensure there was no significant difference in the minimum, median and maximum PSA failure times between the two eras. Results: As compared with patients presenting in the early PSA era, patients presenting in the more recent PSA era were of younger age (p<0.0001), with earlier stage (p<0.0001), and lower grade disease (p = 0.03). Similarly, patients had lower grade (p<0.0001), stage (p<0.0001), positive margin (p<0.0001) and lymph node rates (p = 0.0004) at RP. 5-year actual PSA failure rates declined from 14.3% in the early PSA era to 2.5% in the later PSA era (p<0.0001). There was a 37% reduction in the proportion of patients with a PSA-DT < 3 months, corresponding to a decrease in absolute magnitude from 9.1% to 5.7% between the two eras. Significant reductions also were noted for the proportion of PSA-DTs 3–5.99 months and 6–11.99 months; whereas PSA DTs ≥ 12 months increased as shown in the Table. Conclusions: During the recent PSA era, postoperative PSA failure has significantly decreased and PSA-DTs have lengthened suggesting that PCSM will continue to decline. No significant financial relationships to disclose.
Efficacy of combined androgen blockade with zoledronic acid treatment in prostate cancer with bone metastasis: The Zoledronic Acid/Androgen Blockade Trial on Prostate Cancer (Zabton-PC) study.
Authors: Satoru Ueno, Atsushi Mizokami, Takashi Fukagai, Naohiro Fujimoto, Hitoshi Ohoka, Yukihiro Kondo, Gaku Arai, Hisamitsu Ide, Mikio Namiki
Journal: Journal of Clinical Oncology (2014)

207 Background: Zoledronic acid (ZA) reduces the onset risk of skeletal-related events (SRE) caused by bone metastasis in prostate cancer (PCa) patients and improves the QOL. Therefore ZA has become a standard supportive therapy for PCa with bone metastasis. However, it remains unclear when the physicians should start ZA treatment. In the present study, we investigated whether combination of ZA could delay PSA relapse of PCa and prevent SREs. Methods: The patients were randomly classified in two groups (combined androgen blockade (CAB) alone group and CAB + ZA treatment group). In the CAB + ZA group, 4 mg ZA was intravenously administered every 4 weeks with the start of treatment. The first end point was a period to PSA relapse, and the secondary end point was SREs rate. Results: Untreated 60 PCa patients with bone metastasis were enrolled by 2011 from 2006. Thirty one patients were treated with CAB alone and 29 patients were treated with CAB + ZA. There were no significant differences in the baseline characteristics in the both groups, and the mean observation period was 27.4 months and 32.1 months, respectively. Although there was no significant difference in progression free survival (PFS) (p=0.073), tendency that CAB + ZA shows better PFS than CAB alone group was observed (time to 50% PFS was extended 11.6 months than CAB alone group). Moreover, the sub analysis using the patients with more than Gleason score 7, CAB +ZA group showed significantly longer PFS than the CAB group (p=0.021). And statistically significant difference was recognized in SRE rate between the two groups (p=0.019), ZA tended to delay the occurrence of SRE in PCa patients. Conclusions: This result indicates that the use of ZA at the beginning of hormonal therapy have not only a preventive effect on the occurrence of SREs but also a relapse-delaying effect, especially in the patients with high Gleason score and severe bone metastasis. Though careful observation is essential, since the long-term use of ZA may increase the incidence of adverse effects, CAB-ZA treatment may be recommended for the treatment of PCa patients with bone metastasis.
Texas Cancer Plan: 19-year report card
Authors: D. Vugrin
Journal: Journal of Clinical Oncology (2005)

6108 Background: In the 1980s, the Texas State Health Department projected that between 1986 and 2000 the number of new cancer cases in Texas would increase by more than 85%. In 1986 the Legislature responded by creating the Texas Cancer Council (TCC) to implement and administer the statewide cancer reduction program. Funding came from tax dollars. Existing state, private and voluntary organizations served as the building blocks to implement the programs through competitive grants. The objective of this study is to evaluate results of the cancer plan on state cancer burden. Methods: TCC databases, funded projects and publications were researched and analyzed. Incidence and mortality data were obtained from the Texas Cancer Registry. Results: Between 1986 and 2004, TCC funded 570 cancer project years focusing on public and professional education, screening, resource development and data collection. It produced original and 3 updates of the Comprehensive Cancer and 4 Specific Cancer Targeted Action Plans. Major targets were un- and underinsured, minorities and rural population (groups traditionally bypassed by preventive care) in all regions of the state. Age-adjusted cancer mortality between 1992–2001 showed greater all cancer reduction in men (M) then women (W) 12% and 8% respectively and it varied by race. Lung, prostate and colon cancer (Ca) mortality was reduced in men 18, 25 and 18 percent, respectively. In women reduction was seen in colon and breast Ca mortality (13% and 15%), but lung Ca mortality increased. Both, in men and women rectal cancer mortality increased. Data for other cancers were analyzed Conclusion: This seems to be an effective model for coordinated and cooperative public, private and volunteer organizations efforts toward reducing the cancer burden. No significant financial relationships to disclose.
Do case rates affect physicians' clinical practice in radiation oncology?
Authors: Bryan A. Loy, Clive Shkedy, Mark A. Tankersley, Brian Altonen, Julie Royalty
Journal: Journal of Clinical Oncology (2014)

59 Background: Radiation oncology practices and health plans typically engage in fee for service (FFS) contractual relationships, which employ utilization management techniques to manage treatment accordance with recognized guidelines. FFS contracts often result in unpredictable revenue streams for practices and burdensome administrative processes for both practices and payers. Moreover, there are limited mechanisms in FFS arrangements for practices and payers to systematically measure quality. Radiation oncologists and health plans share the common goal of systematically improving quality of patient care while reducing administrative burden. Methods: In 2012, Humana collaborated with a large national radiation therapy provider to implement ‘bundled’ case rate reimbursement instead of FFS. The case rate model was developed with HealthHelp, a radiation oncology quality vendor, and the payments were developed in the context of the appropriate modality for each cancer type. Changes in practice patterns were measured in the Medicare population by average fraction ratios across breast cancer, bone metastases, and prostate cancer. Fraction ratios compare delivered fractions to standards established by the National Comprehensive Cancer Care Network guidelines. A ratio of 1.0 means that the delivered amount met the recommended guideline. Ratios nearer to one (over or under) demonstrate appropriate therapy. Ratios were compared for 2011 vs. 2013 using T-tests. Results: Conversion from a FFS to case rate reimbursement did not coincide with a change in fraction ratios for breast cancer treatment. Fraction ratios for both bone metastases and prostate cancer moved towards the target ratio of 1.0 after the move to case rate reimbursement. Conclusions: After the implementation of case rate reimbursement, fraction ratios improved for bone metastases and prostate cancer, while breast cancer fraction ratios did not change. Future work will evaluate additional markers of quality and practice efficiency measurements. [Table: see text]
Evolving techniques for negative pressure wound therapy and the value of grass roots comparative effectiveness research.
Authors: Robert Lohman, Vijayvel Jayaprakash, Amir Dorafshar, Lawrence Gottlieb, Mieczyslawa Franczyk
Journal: Journal of Clinical Oncology (2013)

160 Background: There is debate over the value of comparative effectiveness research to address national health problems, but less attention has focused on its value to solve smaller questions. We present an example of local, clinician initiated, and unfunded comparative effectiveness research to address problems related to negative pressure wound therapy (NPWT) at our hospital. NPWT was popularized as the VAC (Vacuum Assisted Closure, Kinetic Concepts, Inc., San Antonio, TX) system and became standard treatment for many inpatient wounds. Between 2000 and 2006, VAC was the only form of NPWT at our hospital. When it became apparent that VAC therapy was costly, and painful, clinicians tried an alternative method using wall suction and gauze (GSUC). In 2007 and 2008 a randomized prospective trial showed the techniques were equally effective while GSUC was less painful and less costly. After the trial, we tracked the frequency of VAC and GSUC use, as well as the cost of NPWT. Methods: From 2000 to 2011, 3,184 inpatients required NPWT; demographics, the method of treatment, and associated costs were recorded prospectively. Data from 2000 – 2006, when only VAC was available, was compared to data from 2009 – 2011, when both VAC and GSUC were available. Results: Between 2000 and 2006, all patients (N=1,746) were treated using the standard VAC. After 2008, fewer patients were treated using the VAC compared to GSUC: 21 (2%) vs 907 (98%), p=0.001. Between 2000 and 2006, the daily cost of therapy with VAC was $97.09/patient (SD=2.54). After 2008, the daily cost of therapy with VAC was $101.34/patient (SD=0.80) compared to $4.22/patient (SD=0.80) for GSUC, p=0.001. The average yearly direct cost of NPWT was $217,500 from 2000 – 2006 and then fell to fell to $14,690 per year for the period of 2009 – 2011, p=0.001. Conclusions: The tools of comparative effectiveness research can be scaled down to assess problems facing single institution. When encouraged to take ownership of the research process, clinicians will also take ownership of the results. In this case, a standard method of wound care was abandoned less than a year after an in-house trial showed it was more painful, more expensive, but not more effective than a homegrown method.
Postoperative CA19-9 and Glasgow prognostic score to predict early recurrence and poor prognosis in pancreatic cancer patients undergoing adjuvant chemotherapy after surgery.
Authors: Yusuke Katayama, Soichiro Morinaga, Ippei Murata, Masahiro Asari, Koji Numata, Sho Sawazaki, Teni Godai, Akio Higuchi, Manabu Shiozawa, Yasushi Rino, Munetaka Masuda, Makoto Akaike
Journal: Journal of Clinical Oncology (2014)

198 Background: Despite proven benefit of adjuvant chemotherapy in pancreatic cancer patients, earlyrecurrenceoccursinaconsiderablerate. Therefore, outcomeprediction in these patients remains a challenge. The aim of this study was to determine whether Glasgow Prognostic Score (GPS) and CA19-9 could predict early recurrence in patients undergoing adjuvant chemotherapy after surgery. Methods: 67 pancreatic ductal adenocarcinoma (PDAC) patients underwent curative resection and received adjuvant chemotherapy with gemcitabine after surgery at Kanagawa Cancer Center between 2007 and 2012.The GPS, CA19-9(measured prior to adjuvant therapy) and other clinicopathological factors were retrospectively reviewed. The GPS was calculated from CRP and albumin as follows: patients with both an elevated CRP level (&gt;0.5mg/dl) and hypoalbuminemia (&lt;3.5g/dl) were allocated a score of 2, patients with only one of these biochemical abnormalities were allocated a score of 1, and patients with neither of these abnormalities were allocated a score of 0. Patients were divided to high and low CA19-9 group with cutoff points of 180 U/ml, on the basis of several RCT trials. Univariate and multivariate analyses were performed to identify clinicopathological variables associated with early recurrence (within 6 months after surgery), disease free survival (DFS), and overall survival (OS). Results: Postoperative elevated GPS and CA19-9 were independent risk factors for early recurrence. Positive/negative predictive value (PPV/NPV) were 0.86/0.54 in GPS and 0.84/0.69 in CA19-9 respectively, and in combination use, the PPV/NPV increased to 0.88/0.82. Additionally, the elevated GPS and CA19-9 were independently associated with worse DFS (GPS GHR1.95, 95%CI 1.03-3.69, p=0.042)(CA19-9 GHR5.03, 95%CI 2.05-12.3, p&lt;0.001)and OS (GPS; HR5.29, 95%CI 2.14-13.1, p&lt;0.01, CA19-9 GHR4.79, 95%CI 1.99-11.5, p&lt;0.001). Conclusions: Our results show the potential utility of GPS and CA19-9 as a predictor of early recurrence and prognostic factor in pancreatic cancer.
A multicenter random assignment phase II study of irinotecan and flavopiridol versus irinotecan alone for patients with p53 wild-type gastric adenocarcinoma (NCI 8060).
Authors: Yelena Yuriy Janjigian, Laura H. Tang, Stephen Shibata, David Paul Kelsen, Michal Segal, Catherine Cheng, Gary K. Schwartz, L. Austin Doyle, Manish A. Shah
Journal: Journal of Clinical Oncology (2012)

e14586 Background: Preclinical studies demonstrate that tumors wild-type for p53 (p53wt) are refractory to irinotecan relative to non-functional or mutant p53, and that sequential therapy with flavopiridol, a cyclin dependent kinase inhibitor that inhibits homologous recombination and DNA repair, and irinotecan overcomes p53 mediated drug resistance in vivo. This phase II study is designed to assess cell cycle mediated drug resistance in p53wt gastric cancer, and test the hypothesis that administration of flavopiridol following irinotecan can overcome resistance to irinotecan. Methods: Pts with advanced p53wt (≤ 20% nuclear IHC staining using D07 antibody) gastric adenocarcinoma and disease progression on non-irinotecan chemotherapy regimen were randomized in 2:1 fashion to irinotecan 100 mg/m 2 followed 7 h later by flavopiridol 60 mg/m 2 administered over 1h or irinotecan 100 mg/m 2 administered weekly on a 2 week on/1 week off schedule. Response assessment is performed every 2 cycles and the primary endpoint is 3-month progression free survival (PFS). Pre- and post-treatment biopsies were obtained for molecular assessments of p53 mediated drug resistance. Results: To date 30 of 55 patients screened were p53wt (54%), 19 pts were randomized to receive irinotecan + flavopiridol (n=13) and irinotecan (n=6). Median characteristics of 19 evaluable patients: age 61 (44 to 76), KPS 80% (70 to100), 13 male, 1 prior regimen (1 to 2). The common treatment emergent toxicities were anemia (Grade 2/3 21%), neutropenia (grade 2/3 31%, grade 4 .05%), nausea (grade 2/3 21%) and fatigue (grade 2/3 37%). With irinotecan + flavopiridol 1/13 (8%) confirmed partial response was seen and 5 month disease stabilization in 3/13 (23%) patients. No responses were seen with single agent irinotecan. The median PFS was similar, 1.6 mos irinotecan + flavopiridol vs 1.3 mos in irinotecan group (p=0.21). Conclusions: 54% of gastric cancers are p53wt. Correlative tissue analysis including p53 sequencing, p21, Rad51 is ongoing. Due to lack of activity with irinotecan alone, an amendment to a single arm irinotecan + flavopiridol study is planned.