tbuckley/cabot-search huggingface dataset:
Increasing clinical trial enrollment with the use of incentives in a community oncology practice.
Authors: Elizabeth M Blanchard, Ann-Marie Soucy, Therese M. Mulvey
Journal: Journal of Clinical Oncology (2014)

205 Background: Clinical trials represent a critical component of progress in cancer care, however, enrollment of patients onto adult cancer clinical trials remains disturbingly low at 3-5 percent of patients. In an effort to increase enrollment onto open trials at our center as well as to meet our ACOS requirements, our community cancer center instituted an incentive program to compensate the time medical oncology providers spend enrolling patients onto trials. Methods: In October of 2013 (the beginning of fiscal year 2014), an incentive was given to medical oncologists in our practice if they met an enrollment target of 1% of patients onto trials open at our center. Comparison of enrollment was performed between fiscal year 2014, when the incentive existed, and corresponding months of fiscal year 2013. Results: Enrollment at our center from October 2012-May 2013 was 9 patients with an average of 1.125 per month. For the corresponding period of October 2013-May 2014, when the incentive existed, enrollment was 48 patients, with an average of 6 patients per month. This far exceeded the 1% threshold required to achieve the incentive and has not abated despite the completion of the metric. In addition, enrollment has been similar to unfunded investigator initiated trials and pharmaceutical trials. Cooperative group trials remain limited by lack of funding. All physicians in the group have qualified for the incentive. Conclusions: Incentive programs designed to compensate the time involved with enrolling patients onto clinical trials was very effective in this busy community oncology practice.
Hormonal Maintenance Therapy for Women With Low-Grade Serous Cancer of the Ovary or Peritoneum
Authors: David M. Gershenson, Diane C. Bodurka, Robert L. Coleman, Karen H. Lu, Anais Malpica, Charlotte C. Sun
Journal: Journal of Clinical Oncology (2017)

Purpose The purpose of this study was to examine outcomes associated with hormonal maintenance therapy (HMT) compared with routine observation (OBS) after primary cytoreductive surgery and platinum-based chemotherapy in women with stage II to IV low-grade serous carcinoma of the ovary or peritoneum. Patients and Methods Eligibility criteria for patients from our database were: treatment with primary surgery followed by platinum-based chemotherapy, stage II to IV disease, at least 2 years of follow-up for patients who had not experienced recurrence, and adequate clinical information. The two groups were compared for progression-free survival (PFS) and overall survival, and a multivariable Cox regression analysis was performed. Subset analyses for patients who were disease free or had persistent disease were also performed. Results Between 1981 and 2013, 203 eligible patients-133 who underwent OBS and 70 who received HMT-were seen at our institution. Median PFS for patients who underwent OBS was 26.4 months, compared with 64.9 months for those who received HMT ( P < .001). No statistically significant difference in overall survival was observed between the two groups (102.7 v 115.7 months, respectively). For subgroups of women who were disease free or had persistent disease, median PFS was superior for those who received HMT (81.1 v 30.0 months; P < .001 and 38.1 v 15.2 months; P < .001, respectively). Women who received HMT had a significantly lower risk of disease progression compared with those who underwent OBS (hazard ratio, 0.44; 95% CI, 0.31 to 0.64; P < .001). Conclusion Women with stage II to IV low-grade serous carcinoma who received HMT after primary treatment had significantly longer PFS compared with women who underwent OBS. These findings warrant further investigation using a prospective trial design.
Synergism between 17-AAG and Imatinib in Imatinib-Resistant CML Cells: Inhibition of P-Glycoprotein by 17-AAG as a New Mechanism of Increasing Imatinib Activity.
Authors: Aleksandar Radujkovic, Moritz Schad, Julian Topaly, Stephanie Laufs, Anna Jauch, Beate Schultheis, Junia V. Melo, Anthony D. Ho, Stefan Fruehauf, W. Jens Zeller
Journal: Blood (2004)
Comparison of ultrasound with ultrasound-guided fine-needle aspiration biopsy and core needle biopsy for initial axillary staging of breast cancer patients.
Authors: Hye Shin Ahn, Sun Mi Kim, Mijung Jang, Bo La Yun
Journal: Journal of Clinical Oncology (2013)

96 Background: The sensitivity and specificity of FNAB and CNB performed in suspicious axillary LNs have ranged from 56% to 86% and from 91% to 100%, because FNAB and CNB are operator- and institution-dependent procedures. In addition, previous studies concerning the diagnostic accuracy of these procedures have reported results from only FNAB or CNB. So, the purpose of this study was to determine the diagnostic accuracy of axillary US and compare that of US-guided FNAB with CNB for axillary staging in the same breast cancer population. Methods: Of 220 breast cancer patients who underwent preoperative or prechemotherapy axillary US for axillary staging, 52 patients who underwent US-guided FNAB and CNB of cortical thickening and/or compressed hilum of lymph nodes on US were prospectively enrolled. US and FNAB/CNB findings were compared with final pathology from sentinel lymph node biopsy or axillary lymph node dissection. Results: Forty-eight patients met the final study criteria; we excluded 4 who had received primary systemic chemotherapy and showed negative FNAB/CNB results with negative final post-operative pathology. Positive predictive value (PPV) of axillary US was 54%. The sensitivity and specificity of FNAB were 73% and 100%, and those of CNB were 77% and 100%. Results did not significantly differ between US-guided CNB and FNAB. The complication rates of FNAB and CNB were 4%, and FNAB and CNB cost $180 and $350, respectively. Conclusions: Both US-guided CNB and FNAB were useful for axillary staging in breast cancer patients with high sensitivity. However, FNAB is recommended based on the advantages of low cost and minimal invasiveness.
Stereotactic body radiation therapy for pancreatic cancer: Assessing motion with and without abdominal compression.
Authors: Priscilla K. Stumpf, Bernard Jones, Supriya K. Jain, Arya Amini, Dale A. Thornton, Wayne Dzingle, Tracey E. Schefter
Journal: Journal of Clinical Oncology (2016)

234 Background: Stereotactic body radiation therapy (SBRT) is an emerging treatment option for locally advanced pancreatic cancer. This ablative therapy requires highly accurate delivery due to nearby organs at risk. To minimize tumor motion, our institution applies abdominal compression during computed tomography (CT) simulation. The purpose of this study is to evaluate the effect of compression in the context of pancreatic SBRT. Methods: In the last 6 months, 32 patients who completed SBRT to the pancreas at our institution were selected for analysis. In each patient, two 4DCT images were acquired, one with and one without abdominal compression. Abdominal compression was achieved with an indexed compression belt with a customized degree of inflation. Each patient had fiducial markers implanted in or near the pancreatic tumor prior to simulation. These fiducials were contoured on both planning CT scans for each gated phase. Motion was assessed by fiducial position changes throughout each gated phase. Results: In the anterior to posterior, transverse, and superior to inferior dimension, compression decreased motion in 19 of 32 cases (59%), 21 of 32 cases (66%), and 28 of 32 cases (88%) respectively. In the anterior to posterior (AP) dimension compression decreased motion by a mean of 0.43mm ± 1.7mm with a range of -2.1-6.5mm (p = 0.16). The mean decrease in motion with compression in the transverse dimension was 0.93mm ± 1.9mm with a range of -1.6-8.6mm (p = 0.01). In the superior to inferior dimension, compression decreased motion by a mean of 2.72mm ± 2.8mm with a range of -1.2-11.5mm (p &lt; 0.001). Displacement of tissue due to compression led to increased patient AP separation at the level of T12 by a mean of 9.1±5.8mm (p &lt; 0.001). Conclusions: Abdominal compression significantly reduced tumor motion in the superior to inferior and transverse directions for patients undergoing SBRT to the pancreas. This decrease in motion allows for significant reductions in the size of the volume necessary to treat the tumor. Given our findings, we would recommend using abdominal compression over free-breathing for pancreatic SBRT.
ERCC1 polymorphisms in patients with advanced bladder cancer treated with platinum-based chemotherapy.
Authors: A. Bamias, N. Nikitas, A. Karadimou, D. Gika, V. Karavasilis, E. C. Briasoulis, M. Chrisofos, S. Murray, D. G. Pectasides, M. A. Dimopoulos
Journal: Journal of Clinical Oncology (2010)

e15066 Background: Platinum-based combination chemotherapy represents the standard treatment for advanced urothelial cancer. Determination of prognosis is based on clinical characteristics: ECOG PS and sites of metastases. ERCC1 is involved in the repair of DNA adducts formed by platinum analogues. Recent data suggest that tissue expression of ERCC1 may have prognostic significance. We studied the prognostic relevance of ERCC1 polymorphisms in the blood from patients with advanced bladder cancer treated with platinum-based chemotherapy. Methods: Patients with inoperable (cT4b, N2, N3) or metastatic bladder cancer were included. Treatment consisted of cisplatin-based chemotherapy (n=65) in the context of a randomized trial of HECOG (HD MVAC vs. HD Cem/Cis) or carboplatin/gemcitabine (n=12) for unfit-for-cisplatin patients. DNA was extracted from blood and was amplified using nested PCR and SNPs C19007T and C8092A were studied. The findings were expressed as C/C (normal), C/T and C/A (heterozygous SNP) and T/T and A/A (homozygous SNP). Results: Seventy patients have been included in this analysis. Median PFS was 11 months (95% CI: 8-14) and median OS 15 months (95% CI: 7-22). SNP C17009T: C/C 18 (26%), C/T 34 (48%), T/T 18 (26%); SNP C8092A: C/C 20 (28%), C/A 44 (63%), A/A 6 (9%). Female patients had higher C19007T T/T and lower C/C expression (60% vs. 20% and 10% vs. 28%, p=0.026). Heterozygous C8092A polymorphism was associated with higher frequency of locoregional relapse (95% vs. 77%, p=0.048) and higher frequency of Hb > 10mg/dL (98% vs. 81%, p=0.046). There was no association of SNPs with objective responses. The presence of distant metastases was associated with significantly lower PFS and OS (13 vs. 8 months, p=0.047 and 20 vs. 12 months, p=0.043). Neither SNP17009 nor SNP8092A was associated with a significant difference in PFS or OS. Conclusions: ERCC1 SNPs are present in the majority of patients with advanced baldder cancer. C8092A SNP is associated with prognostically important clinical characteristics but in this cohort of patients treated with platinum-based chemotherapy did not show any predictive or prognostic significance. No significant financial relationships to disclose.
Combination of liposomal doxorubicine plus gemcitabine in heavily pretreated metastatic breast cancer patients: A single center experience.
Authors: Juan Pablo Fusco, Patricia Martin Romano, Eduardo Castanon Alvarez, Lucia Ceniceros, Jairo Legaspi, Jaime Espinós, Ignacio Gil-Bazo, Oscar Fernández-Hidalgo, Jose M. Aramendia, Marta Santisteban
Journal: Journal of Clinical Oncology (2015)

e12015 Background: The combination of Pegylated Liposomal Doxorubicin (PDL) plus Gemcitabine (GEM) has been previously investigated in the treatment of recurrent metastatic breast cancer (RMBC) patients. PLD is a new formulation of doxorubicin with a prolonged circulation time and a better tissue distribution. GEM is a nucleoside analogue with non-overlapping toxicity as compared to PLD. The aim of our study was to assess the efficacy, toxicity and long-term outcome. Methods: Patients (pts) with RMBC were retrospectively analyzed. Chemotherapy consisted of PDL 30mg/m2 day 1 and GEM 800mg/m2 day 1 and 8, on a three-week schedule. Cardiac function was evaluated before initiation. Radiological response was graded according to RECIST criteria v1.1. Toxicity was scored according to NCI-CTC v4.0. The regimen was administered until progression or severe toxicity. Results: From January 2001 to January 2014, 131 pts [(median age 59 (range 28-84); ECOG 0 (36%); 1 (56%); 2 (8%)] were included. Immunohistopathogical patterns were classified as follows: Luminal (82%), pure Her-2 (5%) and Triple negative (13%). Pts had previously received a median of 2 previous treatment schedules including anthracyclines (82%), platins, taxanes, capecitabine, hormonal and anti-Her2 regimens. Median sites of metastatic involvement was 2 (range 1-7); the most common places affected were liver (44%) and lung (39%). Median number of cycles delivered was 5 (1-36). Six complete and 35 partial responses were found, along with 42 pts and 34 pts presenting stable and progressive disease, respectively. Response rate was 35%. Grade 3-4 toxicity was hand-foot syndrome (13%), asthenia (3%), vomiting (2%), mucositis (6%), allergic reactions (3%), anemia (7%) and neutropenia (25%). Grade II cardiac toxicity was detected in 4 pts (3%). Median cumulative PDL dose was 135mg/m2. At a median follow-up of 101 months, median PFS was 8 months along with median OS of 22. The rates of 1 and 2-year OS, were 68 and 46%, respectively. Conclusions: Combination of PLD plus GEM is feasible, safe and achieves a remarkable long-term outcome, with an acceptable toxicity profile in previously treated RMBC patients.
Clinical process analysis.
Authors: Courtney Barnes, Beverly Hayes, Gina Aranzamendez, Laurie Kaufman
Journal: Journal of Clinical Oncology (2012)

157 Background: MD Anderson has been working with Harvard on a pilot project for Time Driven Activity Based Costing: a component is Clinical Process Analysis, which brings value on its own. It provides a visualization that “speaks” to those delivering the service. This brings great awareness of frontline reality for staff and leaders alike and the many “ah-ha” moments creates a urgency for improvement. As Berwick shared in his keynote speech at IHI 2011, "the quality movement will rise or fall on its success in reducing the cost of health care.” In order to make the right changes, who best to reduce the cost, than those delivering the service? According to Don Berwick and Dr. Brent James, the burden of changing the face of healthcare lies with us. Methods: When frequencies, probabilities and salaries are incorporated into processes of patient care, the cost of direct labor can be determined and opportunities for improvement visualized. Based on lessons learned, tools (data driven road maps, blueprints) and successful strategies (standardized process flow maps templates) have been developed to efficiently and effectively disseminate Clinical Process Analysis throughout clinical areas. Results: Data analysis and front-line reality are synchronized. Allows a “broader” view of the patient’s journey outside of one’s own discipline. Builds bridge between financial and clinical worlds by engaging clinicians through a patient-centered care perspective rather than a perspective of budget, variance and financial cost reduction. Identifies opportunities for improvement. Provides opportunities to build “psychological safety” in order for frontline staff to share with clinical area leadership the process realities of patient care. Based on feedback from physicians, managers, staff and financial experts, the process flow charts are useful to track patient flow, resource utilization, customer satisfaction, patient education, and on-boarding of new staff. Conclusions: Clinical Process Analysis provides an engaging first step to drive improvement in clinical quality and financial performance.
Impact of Medicare Part D on out-of-pocket drug costs and utilization for patients with cancer.
Authors: Sheetal Mehta Kircher, Michael Johansen, Matthew M. Davis
Journal: Journal of Clinical Oncology (2013)

275 Background: Medicare Part D was designed to reduce out of pocket (OOP) costs for Medicare beneficiaries, but the extent to which this occurred for patients with cancer has not been measured. The aim of this study is to quantify the impact of Part D eligibility on OOP cost for prescription drugs and utilization for cancer patients. Methods: Differences-in-differences analyses were used to estimate the effects of Medicare Part D eligibility on OOP drug costs, by comparing 4 year periods before and after Part D implementation. Analyses were based on data from the publicly available Medical Expenditure Panel Survey, a nationally representative, all-payer sample of the United States non-institutionalized civilian population. Our analysis compared per-capita OOP burden between Medicare beneficiaries (age 65+) with cancer to near-elderly individuals age 55-64 years old with cancer. Results: 2,077 near-elderly individuals with cancer and 4,723 individuals with Medicare and cancer were included (total n=6,800), representing over 85 million people. Prescription drug coverage increased among individuals with Medicare from before Part D (39%) to after (65%); in contrast, prescription drug coverage among the near-elderly remained stable before vs. after Part D (82.4% vs. 81.4%). The mean per-capita OOP cost for Medicare beneficiaries with cancer before Part D was $1,111 (SE ±45) and decreased to $694 (±35) after implementation of Medicare Part D—a decline of 37%. Compared with changes in OOP drug costs for non-elderly patients with cancer over the same period, implementation of Medicare Part D was associated with a further reduction of $286 per person. OOP costs for cancer-associated drugs (i.e., antineoplastic, pain medications, anti-emetics) accounted for 6.5-11.1% of the total OOP cost with no significant trends between 2002-2010. Conclusions: The implementation of Medicare D has significantly reduced OOP prescription drug costs for seniors with cancer, beyond trends observed for younger patients. Considering prescription drugs for all medical conditions, cancer associated drugs compose a minority of the cost, highlighting that cancer patients have many comorbid conditions contributing to overall costs.
Predictors of residual disease after breast-conserving surgery.
Authors: Sanjay Aneja, Donald R. Lannin, Brigid K. Killelea, Nina Ruth Horowitz, Anees B. Chagpar
Journal: Journal of Clinical Oncology (2012)

168 Background: Locoregional failure after breast conserving surgery (BCS) is often due to undetected residual disease, and the risk of such residual disease frequently guides management. We sought to determine clinical and pathologic factors correlating with the finding of residual invasive cancer and/or DCIS in patients undergoing BCS. Methods: We performed a retrospective cohort study for all invasive and in situ breast cancer treated with BCS at a single institution in 2009. The main outcome variable of interest was residual disease determined by pathologic examinations of cavity shave margins or reexcision. Chart review and statistical analyses were performed to evaluate clinical and pathological factors correlating with residual DCIS or invasive cancer. Results: 256 in situ or invasive breast cancers were treated with BCS in 2009. Of these, 207 (80.9%) underwent additional resection either for close margins or as routine practice. These formed the cohort of interest for this study. 39 patients (18.8%) had residual DCIS and 22 (10.6%) had residual invasive disease. Age, race, histology, ER, PR, her-2-neu and margin distance for invasive disease did not predict the finding of residual DCIS nor invasive cancer. Lymphovascular invasion, while not predicting residual DCIS, was correlated with the finding of residual invasive disease (28.0% vs. 7.9%, p=0.007). Margin distance for DCIS was not predictive of residual invasive cancer but was predictive of residual DCIS. 33.8% of lesions with DCIS margins &lt;1mm were associated with residual DCIS, while 3.4% of those with DCIS margins &gt;5mm were associated with residual in situ disease (p=0.002). Increasing tumor size for invasive and in situ disease were associated with residual DCIS (median 19.5 vs. 13.0 mm, p=0.001 and 22.5 vs. 15.0 mm, p&lt;0.001, respectively); however, neither size component was associated with residual invasive disease. Conclusions: While margin distance and tumor size are associated with residual DCIS in patients undergoing BCS, these are not correlated with residual invasive disease. Conversely, the finding of lymphovascular invasion predicts residual invasive cancer, but not DCIS. These factors may aid in risk stratification of patients and guide postoperative management.
A Scoring System Based on Clinical, Blood Count and Immunophenotypic Data Can Predict the Risk of Disease Progression in Patients with Chronic Lymphocytic Leukemia
Authors: Sina Alipour, Heather Leitch, Linda M Vickars, Lynda M Foltz, Paul F Galbraith, Chantal S Leger, Khaled M Ramadan
Journal: Blood (2008)
Mechanisms of telomere maintenance in liposarcomas (LPS)
Authors: M. von Mehren, R. J. Varkonyi, J. E. Johnson, D. Broccoli
Journal: Journal of Clinical Oncology (2005)

9017 Background: Maintenance of telomeres is essential for the continued cellular proliferation that is a hallmark of cancer. Accordingly, the components of the pathways regulating telomere length have been the subjects of intense study. In most epithelial tumors, telomeric DNA is replicated and maintained by telomerase. In contrast, sarcomas often utilize a telomerase-independent pathway for telomere maintenance, Alternative Lengthening of Telomeres (ALT). Methods: LPS were characterized for presence of telomerase activity using the telomere repeat amplification protocol (TRAP) assay. As an independent assay for telomerase activity we carried out RT-PCR to detect mRNA encoding the telomerase catalytic subunit, hTERT. Southern analysis was used to determine telomere length. Indirect immunofluorescence was done to detect association of telomeric components with the PML nuclear body in ALT-associated PML bodies (APBs), structures characteristic of cells that use ALT for telomere maintenance. Results: Thirty LPS were analyzed, of which 8 (27%) had evidence of telomerase activity by either TRAP or RT-PCR. Telomerase activity was present in all grades of tumor. Telomeres characteristic of ALT were found in 4 of the 22 (18%) telomerase-negative tumors. “ALT-type” telomeres were also observed in 2 of the telomerase-positive LPS. Low or intermediate grade telomerase-negative tumors had telomeres within the size range more commonly associated with telomerase-positive samples (<15kb). APBs were present in all of the telomerase-negative tumors with ALT-type telomeres, as well as in one telomerase-negative tumor with shorter telomeres. APBs were not observed in any telomerase positive LPS. APBs were also not detected in some telomerase negative tumors that had telomeres of intermediate length, 9 kb to 12 kb. Conclusions: Telomerase is only active in a subset of tumors limiting the potential efficacy of telomerase inhibitors. ALT is active in a significant fraction of LPS. We have not found evidence of the two pathways, telomerase and ALT, being active in a single LPS. A proportion of tumors that can not be classified as either ALT or telomerase, suggesting that neither pathway is constitutively active in some LPS. No significant financial relationships to disclose.