tbuckley/cabot-search huggingface dataset:
Quality control: Surgical management of breast cancer—Opportunities and challenges
Authors: W. T. Sause, W. Rees, T. Belnap, B. Rowley, K. Pinto, L. Orr
Journal: Journal of Clinical Oncology (2008)

6521 Background: Intermountain Healthcare is a system of 9 major community hospitals based in Salt Lake City, Utah. The system has a long history of quality improvement and previously has standardized the use of breast preservation and the surgical management of ductal carcinoma in situ (DCIS). This project was undertaken to standardize evaluation of the axilla; specifically the incorporation and utilization of sentinel lymph node biopsy as the standard of care. Methods: Baseline data for sentinel node evaluation was obtained from 9 hospitals showing substantial variation between facilities and among surgeons. A physician-based surgical quality improvement team with system wide representation defined a 75% sentinel node biopsy rate as a minimally achievable goal. This allowed for legitimate omissions of sentinel node evaluation in a minority of patients. Processes put in place to increase compliance included: improved infrastructure, physician mentoring and increased accountability. The project was presented at each facility and surgeons were provided with data on their personal performance. Results were confirmed by individual chart review on a quarterly basis. Results: Sentinel node utilization was tracked in 265 patients treated by 67 surgeons from January 1, 2007 to June 30, 2007. Utilization increased from 69.1% to 82.6% system wide and in one facility increased from 39.1% to 90.9%. Utilization of sentinel node evaluation increased the axillary evaluation of patients with DCIS; an unexpected consequence of this project. Conclusions: Variation in surgical management can be decreased in a large hospital system through validated organizational processes. This process requires constant monitoring to assure gains are maintained and other quality indicators are not adversely affected. No significant financial relationships to disclose.
Evaluating the benefits of perioperative systemic chemotherapy plus targeted agents in patients undergoing liver resection for colorectal cancer metastases.
Authors: M. T. Byrne, G. El-Gazzaz, J. Hammel, E. Berber, F. Aucejo, R. J. Pelley, R. D. Kim
Journal: Journal of Clinical Oncology (2010)

e14073 Background: Liver metastases occur in up to 60% of patients with colorectal cancer (CRC). Hepatic resection provides the best chance for long-term survival; however, most published data is from the 5-FU era. This study examines prognostic factors and survival outcomes in the era of peri-operative targeted therapy for patients undergoing liver resection in the setting of CRC with liver metastases. Methods: 164 patients who underwent liver resection for CRC metastases from 2000–2008 were evaluated. Of these patients, 44 (26.8%) received perioperative chemotherapy, 12 (7.3%) received adjuvant chemotherapy, and 45 (27.4%) received neoadjuvant chemotherapy prior to surgery. The remaining patients did not receive chemotherapy. Kaplan-Meier estimation and log rank tests were used to identify potential prognostic factors of overall survival (OS) and disease-free survival (DFS). Results: The median age was 61 and the median follow-up time for all patients was 15.8 months. 95 (58%) patients had metachronous lesions. 28 (17.1%) received 5-FU/LV, 30 (18.3%) FOLFOX, 13 (8%) FOLFIRI, 43 (26.2%) systemic chemotherapy + bevacizumab, 5 (3%) systemic chemotherapy + cetuximab. 54 (33%) patients had >1 liver lesions and two patients had R1 resection. OS rates at 1, 3, and 5 years were 93.6%, 81.5%, and 39.0%, respectively. DFS rates were 82.4%, 42.3%, and 16.6%, respectively. Timing of chemotherapy did not influence overall outcome (OS p = 0.42, DFS p = 0.43). Systemic + targeted chemotherapy (i.e., bevacizumab or cetuximab) did not show an influence on DFS (p = 0.84) but was associated with improved OS (3-yr 83.4% vs 55.2%, p = 0.06) when compared to systemic chemotherapy alone. In univariate analysis primary tumor stage (p = 0.12) and multiple liver lesions (p = 0.07) were not statistically significant to be predictive of DFS or OS. Conclusions: There is a trend towards benefit of using systemic + targeted therapy with liver resection. Further prospective studies need to be done to confirm this finding. No significant financial relationships to disclose.
Population pharmacokinetic (PK) analysis supports fixed dosing for the humanized monoclonal antibody (huMAb) anti-EGFL7 (MEGF0444A) administered intravenously in patients with advanced solid tumors.
Authors: Y. Xin, M. S. Gordon, D. Jin, E. Wakshull, D. S. Chen, L. S. Rosen, P. N. Munster, L. Naumovski, S. Bai
Journal: Journal of Clinical Oncology (2011)

2586 Background: Monoclonal antibody therapeutics in oncology are most frequently dosed using body weight (BW)-based dosing, which may be due to the perception that BW-based dosing may be more precise. MEGF0444A is a huMAb that targets and inhibits the epidermal growth factor-like domain 7 (EGFL7) and has anti-vascular, and anti-re-growth effects on tumor vasculature and anti-tumor activity, particularly in combination with anti-VEGF. The objective of this analysis was to characterize MEGF0444A PK from two Phase I studies in patients (pts) with solid tumors and to evaluate the potential for using fixed dosing in Phase II studies. Methods: Noncompartment and population analyses were performed using pt data from the Phase Ia (0.3, 1, 3, 7.5, and 15 mg/kg q3wk) and Ib (2, 5, and 10 mg/kg q2wk) studies. Pt demographic data and other clinical relevant covariates were incorporated in the population analysis. PK simulation of 1000 subjects with a BW distribution was performed to compare the inter-individual variability of MEGF0444A exposure following fixed or BW-based dosing. Results: MEGF0444A was characterized by linear PK in the dose range tested. The clearance (CL) and volume of distribution (Vd) values were consistent with those of a typical huMAb. The elimination half-life was approximately 2 weeks. BW effect on CL and Vd was found to be minor to moderate, which appeared to be smaller when compared with other oncology MAbs. PK simulations suggest that fixed dosing may result in less inter-individual variability in MEGF0444A exposure compared with BW-based dosing. In addition, under- and over-exposure in extreme BW pts tended to be reduced with fixed dosing. Conclusions: PK characteristics support dosing of MEGF0444A every 2 or 3 weeks to maintain desired drug exposure. Population PK analysis results support fixed dosing of MEGF0444A at the equivalent 5 mg/kg q2 wk doses (400mg q2 or 600mg q3 wks) in future studies. The current analysis provides valuable insights on fixed dosing for oncology MAbs.
HLA-DR1–Restricted bcr-abl (b3a2)-Specific CD4+ T Lymphocytes Respond to Dendritic Cells Pulsed With b3a2 Peptide and Antigen-Presenting Cells Exposed to b3a2 Containing Cell Lysates
Authors: S.I. Mannering, J.L. McKenzie, D.B. Fearnley, D.N.J. Hart
Journal: Blood (1997)
An individual patient data meta-analysis of adjuvant chemotherapy with UFT in patients with curatively resected rectal cancer
Authors: C. Hamada, J. Sakamoto, M. Yasutomi, S. Saji, H. Nakazato, S. Yoshida, S. Kodaira, K. Fujitani, Y. Ohashi
Journal: Journal of Clinical Oncology (2005)

3571 Background: Reappraisal of benefit of adjuvant chemotherapy with Uracil-Ftrafur (UFT) in patients with curatively resected rectal cancer was made through an individual patient data-metaanalysis Methods: Individual data from2091 patients enrolled in five randomized clinical trials were analysed. In these clinical trials adjuvant chemotherapy with UFT was compared to surgery alone. The endpoint of analysis was overall survival(OS), disease-free survival (DFS) and local relapse free survival(LRFS). Median time for patient follow up was over 5 years. Results: In pooled analysis, 5 year OS rate was 74.0% and 69.0%, 5 year DFS was 67.6% and 57.9%, and 5 year LRFS rate was 70.6% and 63.2%, respectively. UFT had significant advantage over surgery alone in terms of both OS (hazard ratio, 0.83; 95%CI 0.71 to 0.98; p=0.03), DFS (hazard ratio, 0.72; 95% CI 0.62 to 0.83; p<0.0001) and LFRS (hazard ratio, 0.78; 95% CI 0.67 to 0.92; p=0.002). Conclusions: From these results of the metaanalysis, we conclude that the postoperative adjuvant chemotherapy with UFT is significantly beneficial for patients with curatively resected rectal cancer. No significant financial relationships to disclose.
Abstract 15056: High Left Atrial Pressure is an Independent Predictor for Clinical Recurrence of Atrial Fibrillation after Catheter Ablation, Associated with Left Ventricular Diastolic Dysfunction and Left Atrial Remodeling
Authors: Junbeom Park, Boyoung Joung, Hee Sun Mun, Jin Wi, Jae Sun Uhm, Jaemin Shim, Chi-Young Shim, Moon Hyoung Lee, Hui-Nam Pak
Journal: Circulation (2012)

Background: Although it has been known that left ventricular (LV) function may affect to left atrial pressure (LAP) or LA remodeling, their relationships and clinical significance are not clearly elucidated. The purpose of this study was to compare the clinical, image, and electrophysiological parameters in terms of LAP in patients with atrial fibrillation (AF) who underwent radiofrequency catheter ablation (RFCA). Methods: We measured LAP during sinus rhythm (SR) and AF in 454 patients with non-valvularAF (76.7% male, 58±11years, 65.7% paroximal AF) who underwent RFCA. Pressures of LA v-wave (LApeak), LA x-wave (LAnadir), mean LAP (LAmean), and LA pulse pressure (LAP-P) were compared with cardiac CT, Echocardiogram, NavX voltage maps, and clinical outcome. Results: 1 . The group with LApeak(SR)≥22mmHg(n=184) had larger LA dimension (42.61±6.66 vs 40.07±5.77mm, p<0.001), LA volume index (37.11±14.00 vs 33.00±10.56ml/m2, p=0.003),higher E/E’ (11.31±6.59 vs 9.91±5.55, p<0.001), reduced S’ (6.14±1.75 vs 6.78...
Postprandial Abdominal Pain
Authors: Dustin Y. Yoon, Albert A. Nemcek, Melina R. Kibbe
Journal: JAMA Surgery (2016)

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Phase II study of VNP40101M for adults with recurrent malignant glioma
Authors: M. A. Badruddoja
Journal: Journal of Clinical Oncology (2005)

3128 Introduction: VNP40101M is newly synthesized alkylating agent belonging to a novel class of alkylating agents called (1,2-bis(sulfonyl)hydrazines (BCHs). Agents that belong to this class do not produce vinylation and chloroethylation species and hence this class of alkylating agents is thought to have minimal systemic toxicty. VNP40101M does produces two short-lived active species, 1,2-bis(methylsulfonyl)-1-(2-chloroethyl) hydrazine (t1/2=30 seconds at physiologic state) and a thiophilic carbamoylating methylisocyanate species. This agent preferentially produces lesions at the O6-position of guanine. The methyl-isocyanate species may inhibit an important mechanism of resistance against alkylating agents, alkyl-guanine alkyltransferase (AGT). The purpose of this study was to determine the efficacy and tolerability of VNP40101M in patients with recurrent malignant glioma. Methods: Patients were divided into two stratum: Stratum 1-Recurrent glioblastoma multiforme, Stratum 2-Recurrent anaplastic astocytoma or anaplastic oligodendrogliomas. Patients received an intravenous admistration of VNP40101M (300mg/m2) every 6 weeks. Radiographic response, survival data and toxicity were assessed. Results: A total of 38 patients have been enrolled to date of which 36 are evaluable. The median age is 55 years. Seventy-one percent were males. There have been no objective radiographic responses and 15 patients have had a best response of stable disease. Ten patients experienced grade 4 thrombocytopenia and three patients experienced grade 3 neutropenia. Conclusion: VNP40101M administered every 6 weeks seems relatively well tolerated though this schedule may have limited activity for patients with recurrent glioblastoma multiforme. Response and survival data for anaplastic astrocytomas and anaplastic oligodendrogliomas is pending. No significant financial relationships to disclose.
Efficacy of transarterial chemoembolization (TACE) of liver metastases from uveal melanoma
Authors: R. Schuster, M. Lindner, F. Wacker, M. Krössin, N. E. Bechrakis, M. H. Foerster, E. Thiel, U. Keilholz, A. Schmittel
Journal: Journal of Clinical Oncology (2008)

20013 Background: The liver is the predominant site of metastases in the majority of patients with uveal melanoma. Response rates to systemic chemotherapy are low and median survival is very short with 6–9 months. Locoregionary treatment like transarterial chemoembolisation (TACE) is of interest especially in patients in whom the liver is the only site of disease or disease progression after systemic chemotherapy. We therefore report on our experience with TACE in metastatic uveal melanoma. Methods: All patients with documented disease progression in the liver treated with TACE between 2003 and 2007 at our institution were analysed. TACE of liver metastases was performed by interventionally placing a catheter into the hepatic artery followed by the administration of sherex (900mg) and either fotemustin (100mg/m2) or cisplatin (50mg, n=4). The treatment was repeated after a minimum of 2 weeks and terminated in case of disease progression or severe toxicity. Results: 21 patients received a median of 2 TACE (range 1 to 8). Median age was 52 years (range 24 - 80). Median time between diagnosis of metastases and TACE was 10 month (range 1 to 24). All but one patient had prior systemic chemo- or immuno-therapy (median number of prior therapies: 1.5; range 0 to 3). Grade III toxicity consisted of nausea (n=1), fever of unknown cause (n=1), a splenic infarction (n=1), thrombocytopenia (n=1), and a gastric ulcer (n=1). No grade IV toxicity or catheter associated complications were observed. 12 of 21 patients had stable disease for at least 2 month, one a partial, and one a complete remission. The median time to progression (TTP) was 4 months (95% CI: 3–5 month) and the median overall survival (OS) was 5 month (95% CI: 4–6 month). Both TTP and OS where significantly shorter in case of pre-treatment lactate dehydrogenase (LDH) above the twofold upper limit of normal (n=11): TTP 2 versus 5 month (p=0.001) and OS 5 versus 6 months (p=0.026). Conclusions: TACE is well tolerated in patients with liver metastases from uveal melanoma. Although the majority of patients were pretreated with systemic chemotherapy objective remission could be observed. TACE should further be evaluated as first line therapy in prospective studies. No significant financial relationships to disclose.
Safety summary of panitumumab (pmab) in combination with chemotherapy (ctx) from four clinical trials in patients (pts) with metastatic colorectal cancer (mCRC)
Authors: T. J. Price, M. Peeters, J. Douillard, E. Mitchell, A. Cohn, A. H. Strickland, F. Rivera, F. Xu, J. Gansert, S. Siena
Journal: Journal of Clinical Oncology (2009)

e15005 Background: Pmab is a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody approved in the US and EU (wild-type KRAS) as monotherapy for pts with mCRC. Safety data from 4 studies (Siena et al ASCO 2008; Peeters et al ASCO 2008; Cohn et al ASCO 2008; Mitchell et al WORLD GI 2008) of pmab in combination with ctx are summarized. Methods: Two studies are single-arm, phase II trials and two are randomized, phase III trials with pooled, blinded safety data that include ctx-controls. All studies were multicenter. Common pt eligibility criteria included: diagnosis of mCRC with measurable disease per modified RECIST criteria, age ≥ 18 years, and adequate hematologic, renal, hepatic, and metabolic function. All studies required pts to receive FOLFOX, FOLFIRI, or irinotecan ctx in combination with pmab. Pts received pmab 6.0 mg/kg Q2W with FOLFOX Q2W or FOLFIRI Q2W, or pmab 9.0 mg/kg Q3W with irinotecan Q3W. Results from planned interim analyses are available for 3 studies, and results from the final analysis are available for one study. Results: Among the 4-study safety data, 1213 pts received pmab + ctx; 703 pts received pmab + FOLFIRI, 455 pts received pmab + FOLFOX, and 55 pts received pmab + irinotecan. Approximately 1,200 pts were enrolled in each phase III study, and data are available from 1,003 pts who received pmab + ctx and 997 pts who received ctx alone. All pts in the phase III studies, regardless of treatment group, were included in the pooled, blinded interim analysis sets monitored by the data monitoring committee for each study. Safety results for the two phase II studies of pmab + ctx and two phase III studies of pmab ± ctx are summarized (Table). Conclusions: Phase II data are consistent with expectations, and phase III trials are ongoing. A consistent safety profile was observed across studies. [Table: see text] [Table: see text]
Prognostic factors in metastatic carcinoma of unknown primary.
Authors: R Pasterz, N Savaraj, M Burgess
Journal: Journal of Clinical Oncology (1986)

From January 1980 to June 1984, 70 patients with metastatic carcinoma of unknown primary treated with combination chemotherapy were analyzed for prognostic factors influencing objective response and survival. Suspicious germ-cell tumors and neuroendocrine tumors were excluded since patients with these malignancies tend to live longer than those with metastatic carcinoma of unknown primary. Objective response rate to combination chemotherapy was 28%. Median survival of all patients responding to combination chemotherapy was better than those not responding (16 v 3 months). In patients with good performance status, median survival was longer in responders than nonresponding patients (17 v 7 months). External lymph nodes or subcutaneous disease as the only site of disease and good performance status favorably influenced both objective response and survival, while the number of different metastatic sites favorably influenced only survival. Neutropenia and thrombocytopenia were appreciable but not fatal or a great cause of morbidity in those with good performance status. Thus, patients with metastatic carcinoma of unknown primary with good performance status or only external nodes or subcutaneous disease should be treated with combination chemotherapy regardless of age, histology, or number of different metastatic sites of disease.
Changes in cardiopulmonary reserves associated with neoadjuvant therapy in patients with esophageal cancer
Authors: W. L. Hofstetter, C. E. Hightower, G. S. Morris, X. G. Sun, B. J. Riedel, R. J. Mehran, C. M. Hearon
Journal: Journal of Clinical Oncology (2009)

e15589 Background: Recent treatment trends for resectable esophageal cancer have moved toward the addition of neoadjuvant chemoradiotherapy. This additional therapy, however, places these patients at increased risk for loss of physiologic/functional capacity. If present, such declines can delay resection of the primary tumor until the patient has physiologically recovered from this insult. To determine whether physiological reserves decline, peak exercise performance was assessed before and after completing neoadjuvant therapy Methods: In this prospective study seventeen male patients (60.5 + 7.1 years) with esophageal cancers underwent a symptom limited, standard ramp bicycle ergometer cardiopulmonary exercise test (CPET) before and after completing neoadjuvant therapy. The exercise protocol sequentially entailed 3 minutes of quiet resting, 3 minutes of unloaded cycling, ramp protocol to peak exercise tolerance, and 3 minutes of recovery. Ramp rates (5–25 watts/ . min) were individually chosen to achieve test durations of 8–12 minutes. Expired gases were measured for volume and gas fractions via breath-by-breath analysis (Medical Graphics CardiO 2 /CP system). STATISTICAL ANALYSIS: Physiological data were analyzed by paired t-tests (α=0.05). Data are presented as mean + standard deviation. Results: Pre treatment exercise testing occurred immediately before onset of treatment. Post treatment exercise testing typically occurred 45 + 17 days after neoadjuvant ended and 11 + 10 days before surgery. Peak exercise capacity (VO 2peak ) and anaerobic threshold declined 11.9 % and 10.5 % respectively (p &lt; 0.01) over the neoadjuvant therapy treatment period. Both oxygen pulse (VO2/HR) and pulse pressure product (HR X SP) at VO 2peak also significantly declined (p&lt; 0.01) over the treatment period. Conclusions: These results suggest 1) both systemic and peripheral changes contribute to an overall physiological and functional decline in patients undergoing neoadjuvant therapy and 2) efforts aimed at preserving optimal physiological/functional capacity may be warranted during this period. No significant financial relationships to disclose.
Surgeon-determined variability in quality of surgical resection of lung cancer.
Authors: R. A. Ramirez, A. Farooq, J. W. Allen, A. Berry, T. O'Brien, H. Cole, R. U. Osarogiagbon
Journal: Journal of Clinical Oncology (2010)

7068 Background: Surgical resection is the main curative modality for patients with non-small cell lung cancer (NSCLC). Curative intent requires attainment of certain quality measures, including R0 resection, examination of hilar/pulmonary and mediastinal lymph nodes. Pneumonectomy and wedge resections may be associated with increased morbidity or suboptimal oncologic outcomes. We have previously demonstrated disparity in attainment of good quality resection (GQR) criteria in a large community cohort. We hypothesized that individual surgeons' practice may be the major determinant of attainment of GQR and sought to examine the extent of variability in surgical practice. Methods: All curative-intent resections for NSCLC in the Memphis Metropolitan Area from 1/1/04 to 12/31/08 were reviewed for quality measures and attainment of GQR by NCCN and RADIANT trial criteria. Surgeons were grouped by rate of failure to attain GQR criteria and the number of patients at risk was stratified by surgeon group. Results: 746 surgeries performed by 21 board-certified cardiothoracic or general thoracic surgeons were included. Performance is demonstrated (Table). Seven surgeons failed to meet NCCN criteria and 5 surgeons failed to meet RADIANT criteria in 100% of cases, affecting 168 and 134 patients. Conclusions: There is a wide amplitude of variability in performance of GQR by board-certified surgeons in this community-based cohort. In an era emphasizing quality of care and potential pay for performance there needs to be improvement in the characteristics of surgical resection in NSCLC. Rate (%) Surgeons N = 21 Patients N = 746 Resection with positive margins <5 10 233 5-10 8 458 >10 3 55 Resection without mediastinal lymph nodes <10 2 11 10-50 12 535 >50 7 200 Resection without any lymph nodes <10 8 266 10-20 10 455 >20 3 25 Pneumonectomy rate <5 7 194 5-15 7 389 >15 7 163 Wedge resection rate <5 5 102 5-15 11 493 >15 5 151 Failure to meet NCCN criteria <80 2 72 80-99 12 506 100 7 168 Failure to meet RADIANT criteria <80 11 432 80-99 5 180 100 5 134 No significant financial relationships to disclose.