tbuckley/cabot-search huggingface dataset:
Phase II trial of combination therapy with metronomic capecitabine (C) and fulvestrant (F) in the treatment of hormone receptor-positive metastatic breast cancer (HR+ MBC).
Authors: L. J. Blakely, L. S. Schwartzberg, G. Wang, B. G. Somer, B. M. Wheeler, E. J. Stepanski, M. Walker, A. Johns
Journal: Journal of Clinical Oncology (2011)

e11087 Background: The standard approach to HR+ MBC is sequential single endocrine agents, but in the current era of adjuvant AI therapy, alternatives to AIs for first line MBC endocrine treatment are desirable. We designed this trial to assess the feasibility, safety and efficacy of a combined chemoendocrine approach with continuous low dose oral chemotherapy (metronomic) along with a potentially non-cross resistant estrogen receptor down regulator. Methods: Eligible patients (pts) in this single arm, multicenter trial had HR +, HER2- biopsy proven MBC, were post-menopausal, had no prior chemotherapy for metastatic disease, had evaluable or measurable disease by RECIST criteria, and no prior exposure to C or F. C was given at a fixed divided dose of 1500-2000 mg, depending on weight, continuously daily without interruption. F was given IM at standard 250 mg after loading doses. Cycles were 28 days, with assessment for response Q 2 cycles. Primary endpoints were progression free survival (PFS) and time to progression (TTP). Results: 42 pts were accrued, 41 are evaluable. Mean age 64.5 years (range 37-85), 37% African American, ECOG 0/1/2: 17/20/4; ER+ 40, PR+ 27, prior endocrine therapy 21, prior adjuvant chemo 16. The median (range) cycles delivered were 8 (2-27+), with 12 pts receiving 12 or more months of therapy. As of 1/1/11, 17 pts remain on study. Discontinuation occurred due to disease progression in 18, toxicity in 2, investigator discretion in 3 and 1 withdrew consent. The only grade 3/4 toxicity occurring in >5% of pts was grade 3 hand/foot syndrome in 4 (9.8%). Dose reduction of C occurred in 12 (29.3%) pts, typically during cycles 2-8. F was given in full dose in 383/391 (97.7%) total cycles delivered. Overall response rate was 22%, with 2 (4.9%) achieving CR and 29 (70.7%) pts with stable disease. The clinical benefit rate (CR+ PR+ stable > 6 months) was 53.7 %. The PFS and TTP were both [median (95% CI)] 10.87 (7.26- NR) months. Conclusions: Metronomic continuous capecitabine and fulvestrant monthly following loading dose is feasible, well tolerated even with prolonged periods of administration in HR+ MBC, and is effective in maintaining PFS and TTP.
An analytic framework for capturing trends in utilization, costs, and quality metrics in cancer patients’ last 6 months of life.
Authors: Brian Cassel, Nevena Skoro, Kathleen Kerr, Lisa Shickle, Egidio Del Fabbro, Patrick J. Coyne
Journal: Journal of Clinical Oncology (2012)

240 Background: Increasingly, reimbursement models are shifting to bundled payments and pay-for-performance models. While cancer care is often profitable for hospitals in the fee for service model, it is important to monitor outcomes that could influence reimbursement, such as 30-day readmissions; possible indicators of poor quality, such as 30-day mortality admissions; and to utilize longitudinal measures of costs and revenues. Methods: We evaluated trends in the outpatient and inpatient care at an academic cancer center for patients across their last 6 months of life. All-payor hospital claims data were linked to Social Security Death Index data to determine patients’ date of death even if they did not die in-hospital. All utilization at our center was analyzed for the 3,128 cancer patients who died between January 2009 and June 2011. Results: Admissions increased over the final six months, with sharp increases in ICU and total bed days in the final three months. 31% of admissions were 30-day re-admissions; 40% had a negative net margin; and all (1,178) in the final month were 30-day mortality admissions. 63% of hospice referrals occur in the final month. Conclusions: With each month this hospital is increasingly exposed to the risks of 30-day mortality and 30-day readmissions. Are the escalating costs and risks justified in terms of outcomes or quality? These findings reinforce the need for care practices that ensure that care is aligned with patient and family preferences, and that alternate care options are available and presented to patients and families in a timely fashion. [Table: see text]
Epidermal growth factor receptor mutations in Chinese patients with non-small cell lung cancer
Authors: C. Zhou
Journal: Journal of Clinical Oncology (2005)

7101 Background: About 10–19% of patients with non-small cell lung cancer(NSCLC)have a rapid and often dramatic clinical response to gefitinib or erlotinib. Somatic mutations in the tyrosine kinase (TK) of the epidermal growth factor receptor (EGFR) gene are reportedly related to sensitivity of NSCLC to them. The mutations in Chinese NSCLC population are not known. Methods: EGFR tyrosine kinase genes (exons 18, 19 and 21) were sequenced in 80 NSCLC patients. The incidence of the mutations of EGFR gene was compared among sexes, smoking status, histology etc. Results: Somatic mutations were identified in the tyrosine kinase domain of the EGFR gene in 21 of 80 NSCLC patients with the incidence of 26.25%. In-frame deletions of exon 19 occurred in 13 patients and point mutation occurred in codon 858(exon 21) in 8 patients. All mutations were heterozygous and identical mutaions were observed in multiple patients. The mutations were significantly higher in the adenocarcinoma than in squamous carcinoma and squmaous-adenocarcinoma (16/38 vs 3/31 vs 2/11,χ2 =9.702,p<0.01), in the female patients than in the male patients (14/29 vs 7/51,χ2=11.4,p<0.01)and in non-smokers than in smokers (16/40 vs 5/40, χ2 =7.812,p<0.01). In the smokers, the mutations developed in 4/12 adenocarcinoma, 1/7 squamous-adenocarcinoma and 0/20 squamous carcinoma(χ2=7.782,p<0.01). In the male patients, the mutations happened in 6/19 adenocarcinoma and 1/26 squamous carcinoma (p<0.05). The mutations in the female adenocarcinoma were not significantly more common than in the female squamous carcinoma. The mutations were not related to patients’ age, TNM staging, etc. Logistic multi-factor regression showed that the mutations were highly associated with sexes and tumor histology. Conclusions: Somatic mutations of EGFR gene develop in NSCLC and are more common in the female, non-smoker and adenocarcinoma patients. No significant financial relationships to disclose.
Hypofractionated radiotherapy for patients with locally advanced pancreatic cancer using tomotherapy Hi-Art and CyberKnife: A study of the treatment outcome and failure patterns.
Authors: H. Jang
Journal: Journal of Clinical Oncology (2011)

342 Background: To evaluate the treatment outcome and pattern of failure in the patients with locally advanced pancreatic cancer, who were treated with hypofractionated radiotherapy (RT) using TomoTherapy Hi-Art and Cyberknife. Methods: From April 2004 to May 2010, Twenty four patients with locally advanced pancreatic cancer received hypofractionated RT using TomoTherapy Hi-Art and Cyberknife at Seoul St. Mary's Hospital, the Catholic University of Korea. Eleven patients (45.8%) were treated using TomoTherapy Hi-Art and 13 patients (54.2%) using Cyberknife. The total dose delivered were 45∼55 Gy (median: 50 Gy) in 15∼22 fractions with TomoTherapy Hi-Art and 24∼40 Gy (median 30 Gy) in 3∼5 fractions with Cyberknife. The RECIST version 1.1 was used for the response evaluation. The follow-up duration was 3.0∼77.1 months (median: 34 months). Results: In the initial response evaluation, the rates of partial response, stable disease and progressive disease were 45.8%, 54.2% and 0%, respectively. Median survival duration was 11.1 months. One year and two year survival rates were 39.4% and 21.1%, respectively. Two patients (8.3%) had local failures and 11 patients (45.8%) had distant failures. Distant failures were main cause of failures. Median time to distant failures was 7.8 months and one year distant progression-free survival rate was 35.1%. The difference of the treatment outcome between TomoTherapy Hi-Art and Cyberknife was not statistically significant. Most patients experienced abdominal discomfort and pain after RT. However, no severe gastrointestinal complication such as ulcer, bleeding, perforation and fistula were noted. Conclusions: Hypofractionated RT for the patients with locally advanced pancreatic cancer showed excellent local control. However, overall survival still remains poor because of distant failures. Therefore, effective systemic chemotherapy should be considered with RT, either concurrently or sequentially. No significant financial relationships to disclose.
Accuracy of neutrophil to lymphocyte ratio and platelet to lymphocyte ratio in predicting node positivity and metastatic disease in patients with gastrointestinal malignancies.
Authors: Matthew Doepker, Kabisa Baughen, Richard H. Brown, Steven Kucera, Justin Lee, Ravi Shridhar, Kenneth Meredith
Journal: Journal of Clinical Oncology (2016)

462 Background: Accurate predictors of node positivity and metastatic disease for patients with gastrointestinal (GI) malignancies are currently lacking. Neutrophil-lymphocyte ratio (NLR), and platelet lymphocyte ratio (PLR) have been introduced as a possible prognostic scoring system. We sought to evaluate the accuracy of NLR and PLR in predicting advanced disease in patients with GI malignancies. Methods: We queried a prospective GI oncology database to identify 116 patients. NLR and PLR were calculated from complete blood counts before and after neoadjuvant therapy (NT) and pre-operatively in patients not treated with NT. The associations between NLR and PLR and the clinicopathologic parameters were assessed via χ 2 or Fisher’s exact tests where appropriate. All the tests were two-sided, and p &lt; 0.05 was considered statistically significant. Results: We identified 49(42.2%) esophageal, 34 (29.3%) pancreatic, 14 (12.1%) colorectal, 13 (11.2%) gastric, and 6(5.2%) biliary cancers. There were 36 (31%) LN-, 52 (44.8%) LN+, and 28 (24.2%) patients with metastatic disease. The median NLR for LN – patients was 1.78 (0.2-4.5) and for LN + and metastatic patients was 4.48 (2.38-24.1) p &lt; 0.00001. The median PLR for LN– patients was 123 (66-207) and for LN+ and metastatic patients was 212 (112-2185) p &lt; 0.00001. The sensitivity (SENS), specificity (SPEC), positive predictive value (PPV) and negative predictive value (NPV) for a NLR &gt; 2.25 was 98.8%, 72.2%, 89%, and 96% respectively with an overall accuracy of 91%. The SENS, SPEC, PPV, and NPV for PLR &gt; 140 was 95%, 78%, 90%, and 88% respectively with an overall accuracy of 90%. Utilizing both NLR &gt; 2.25 and PLR &gt; 140 the SENS, SPEC, PPV and NPV was 95%, 89%, 95%, and 89% respectively and the overall accuracy was 93%. Conclusions: NLR and PLR can be used to identify patients with node positivity and metastatic disease. Individually, NLR has a higher sensitivity and NPV while PLR has a higher specificity and PPV. However, the combination of NLR and PLR has the highest accuracy of predicting advanced disease among all gastrointestinal malignancies.
Phase II study of single agent clofarabine in previously untreated older adult patients with acute myelogenous leukemia (AML) unlikely to benefit from standard induction chemotherapy
Authors: H. P. Erba, H. M. Kantarjian, D. Claxton, M. Arellano, R. Lyons, T. Kovacsovics, J. Gabrilove, S. Eckert, R. Abichandani, S. Faderl
Journal: Journal of Clinical Oncology (2008)

7025 Background: Studies have identified a population of older AML patients unlikely to benefit from standard combination induction therapy ("7+3") based on adverse prognostic factors such as advanced age, poor performance status (PS), antecedent hematologic disorder (AHD), or intermediate/unfavorable risk karyotype. This study assessed the efficacy and safety of single agent clofarabine (CLO) in this population. Methods: Single arm, Phase II, open-label, 2-stage study; planned total enrollment of 109 patients. Eligible untreated AML patients included adults ≥60 years with ≥1 adverse prognostic factor: ≥70 years, AHD, PS 2, and/or intermediate/unfavorable risk karyotype. CLO given on days 1–5 as a 1-hr IV infusion: 30 mg/m2 during induction and 20 mg/m2 during re-induction/consolidation (6 cycles maximum). Primary endpoint was overall remission rate (ORR = CR + CRp). Preliminary Results: Enrollment completed with 116 patients. As of Aug 2007, safety data were available for 54 patients; efficacy data for 40 patients. Median age was 71 years. Baseline prognostic factors: 65% ≥70 years, 37% with AHD (13% yet unreported), 70% with intermediate/unfavorable risk karyotype (30% yet unreported), and 19% with PS 2. 30-day all-cause mortality was 13%. Drug related adverse events in >20% of patients: nausea (41%), vomiting (28%), diarrhea (26%), febrile neutropenia (24%), and rash (20%). Most treatment-related events were Grades 1–2. Treatment emergent Grade 3 febrile neutropenia occurred in 30% of patients. Treatment emergent Grade 4 neutropenia was reported in 33% of patients with baseline ANC values available. The ORR was 43% (95% CI: 27.0%, 59.1%): 40% CR (95% CI: 24.9%, 56.7%) plus 3% CRp (95% CI 0.1%, 13.2%). ORR by prognostic factor: 58% for unfavorable risk karyotype, 44% for intermediate risk karyotype; 44% for AHD; 32% for age ≥70, 67% for age <70; and 14% for PS 2. Conclusions: These interim data indicate that single agent CLO is active and well-tolerated in treatment-naïve, older AML patients with ≥1 adverse prognostic factor, especially unfavorable risk karyotype and/or AHD. Safety and efficacy results for all patients will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genzyme Genzyme Genzyme Genzyme Genzyme Corporation
Association of partial nephrectomy and presence of robotic surgery for kidney cancer in the United States.
Authors: Steven V. Kardos, Brian Shuch, Peter Schulam, Quoc-Dien Trinh, Maxine Sun, Nathan D. Shippee, Jesse D. Sammon, Simon P. Kim
Journal: Journal of Clinical Oncology (2014)

484 Background: While hospital and surgeon characteristics are associated with the type of nephrectomy performed for renal cell carcinoma (RCC), it is unknown whether hospital presence of robotic surgery increases the likelihood of patients receiving partial nephrectomy (PN). Therefore, we evaluate the relationship of PN and hospital presence of robotic surgery from a population-based cohort in the U.S. Methods: After merging the Nationwide Inpatient Sample (NIS) and the American Hospital Association (AHA) survey from 2006 to 2008, we identified 21,999 patients who underwent either PN or radical nephrectomy (RN) for RCC. The primary outcome of this study was the type of nephrectomy performed. Multivariable logistic regression was used to identify hospital characteristics associated with receipt of PN, after adjusting for patient case mix. Results: Overall, we identified 4,832 (22.0%) and 16,347 (88.0%) patients who were surgically treated for RCC with PN and RN, respectively. On multivariable analysis, patients undergoing surgery were more likely to receive PN at academic (OR: 2.77;p&lt;0.001), urban (OR: 3.66; p&lt;0.001), and American College of Surgeon (ACOS) designated cancer centers (OR: 1.10; p&lt;0.05) compared to non-academic, rural, and non-designated hospitals, respectively. After adjusting for patient and hospital characteristics, patients undergoing surgery at hospitals with presence of robotic surgery were also associated with higher adjusted odds ratios for receipt of PN compared to those treated at hospitals without the presence of this advanced treatment technology (OR: 1.28; p&lt;0.001). Conclusions: While academic status and urban locations are established characteristics influencing the type of nephrectomy performed for RCC, ACOS cancer center designation and hospital presence of robotic surgery were also associated with higher use of PN. Our results are informative in identifying key hospital characteristics which may facilitate greater adoption of PN.
Experience of a Single Latin-American Institution Using a Colloidal Iron Oxide Coated with a Semisynthetic Carbohydrate (ferumoxytol) for Iron Deficiency Anemia (IDA) in Patients with Intolerance or Treatment Failure with Oral Iron
Authors: Roberto Ovilla, Dannia Calles-Payan, Lucia A Reynolds-Ocampo, Gabriela Ruiz-Reyes, Carolina Balderas-Delgado, Andres Montesinos-Ovilla, Alvaro Cabrera Garcia
Journal: Blood (2014)
Efficacy and safety of venting percutaneous endoscopic gastrostomy (VPEG) tube placement in patients with malignant obstruction.
Authors: Rajesh N. Keswani, Rachel B Issaka, David M Shapiro, Mary Frances Mulcahy, Srinadh Komanduri, John A. Martin, Neehar Parikh
Journal: Journal of Clinical Oncology (2013)

538 Background: Refractory nausea and vomiting are common in patients with advanced malignancy. A venting percutaneous endoscopic gastrostomy (VPEG) tube can be placed to eliminate the need for a nasogastric tube and palliate obstructive symptoms. The aim of this study was to determine the outcomes of VPEG placement in patients with advanced malignancy. Methods: We retrospectively reviewed all patients in whom a VPEG tube was attempted for a malignant indication over a 13-year period (1998-2010). Demographic and clinical information, procedure details, and immediate &amp; delayed complications were recorded. Results: Endoscopic VPEG placement was attempted in 96 patients (95% inpatient) with a median age of 57y. Colorectal (27%), pancreas (18.8%), and gynecologic (17.7%) malignancies were most common. Ascites was present in 46.9% of patients with drainage performed in a minority of patients (35.6%). VPEG was successfully placed by endoscopy in 89 patients (92.7%). Relief of obstructive symptoms was observed in 91.7% of patients. Eight patients had refractory obstructive symptoms despite functioning VPEG tube. Ten post-procedural complications were noted in 9 patients, with 1 death. Patients with ascites were more likely to have infectious complications (12.2%) than those without ascites (0%, p=0.02) with a trend towards decreased infectious complication when ascites was drained prior to VPEG placement (14.8% vs. 7.1%, p=NS). We observed decreased survival when complications occurred (73 days) compared to when they did not (141 days, p = NS). Conclusions: VPEG tubes can be safely placed in patients with inoperable malignancy and obstructive symptoms with complete relief of symptoms in the majority of patients. The presence of ascites was a risk factor for post-procedural infectious complications. Drainage of ascites prior to VPEG tube placement may minimize this risk, though this warrants further study.
Characteristics of Chinese patients with advanced prostate cancer: A muliticentre, non-interventional, observational, prospective, registry study of docetaxel.
Authors: Dalin He, Zhongquan Sun, Jianming Guo, Zhigen Zhang, Yuxi Shan, Lulin Ma, Hanzhong Li, Jie Jin, Yiran Huang, Jiaquan Xiao, Qiang Wei, Dingwei Ye
Journal: Journal of Clinical Oncology (2016)

328 Background: Prostate cancer (PC) is the second most frequently diagnosed malignancy in males worldwide, and stands in 7 th place among malignancies in Chinese males. This study investigated the real-world treatment patterns of docetaxel as chemotherapy in patients with advanced PC in China. Methods: This was a multi-center, prospective, observational, non-interventional, product registry study. All patients with advanced PC who failed with previous endocrine therapies, were receiving docetaxel containing chemotherapy, and consented to participate in the study were eligible to be enrolled. Patients were followed-up 2 years, for the collection and analysis of data on docetaxel treatment mode, prostate specific antigen (PSA) remission rate, survival time, etc. Results: A total of 407 patients were enrolled from Aug 2011 through Jun 2014, with a mean Gleason score of 8.0 (SD: 1.11), and median PSA of 61.0 (range: 0.0 to 5000.0) ng/ml. 302 (74.2%) patients were classified as clinical stage IV. For Eastern Cooperative Oncology Group (ECOG) score, 145 (35.6%), 205 (50.4%), 48 (11.8%), patients had scores of 0, 1, 2, respectively. Metastasis to bone was present in 340 (83.5%) patients; metastasis to other organs (liver, lungs, adrenal glands, brain, etc.) was present in 57 (14.0%) patients. Last disease progression prior to enrolment was evidenced by tumor progression in 132 (32.4%) patients and by PSA elevation in 379 (93.1%) patients. 173 (43.0%) and 120 (29.9%) patients started docetaxel therapy after failure of the first line and second line endocrine therapies, respectively; 51 (12.7%) patients after failure of the third line or more endocrine therapies. Conclusions: This abstract presented characteristics of Chinese patients with advanced PC revealed by a Chinese PC study, which indicated Chinese patients were in later stage and higher risk compared with their western counterparts. The majority of patients started docetaxel therapy after failure of first line and second line endocrine therapies. PSA elevation and tumor progression were the 2 main causes that Urologists determined for disease progression. Clinical trial information: no registration number.
Effectiveness and morbidity of reirradiation in conservative salvage management of recurrent soft tissue sarcoma
Authors: D. J. Indelicato, K. Meadows, C. G. Morris, R. A. Zlotecki
Journal: Journal of Clinical Oncology (2008)

21507 Background: The management of isolated local recurrence of soft tissue sarcoma is therapeutically complex, and functional conservative management would be preferable to radical or amputative salvage surgery. This study reviews the University of Florida experience using conservative resection and reirradiation to manage isolated local recurrences of soft tissue sarcoma after primary treatment by resection and radiotherapy. Methods: From February 1976 to February 2005, 14 patients who had underwent primary conservative resection and irradiation for soft tissue sarcoma developed an isolated local recurrence and were managed with conservative salvage by combined resection and reirradiation. Three patients had tumors of the distal extremity, 8 of the proximal extremity, and 3 of the trunk. At the time of recurrence, 64% of tumors were greater than 5 cm and 79% were high grade. In combination with gross total resection, 13 of 14 patients received external beam radiotherapy with or without brachytherapy, and 1 patient was treated with brachytherapy alone. Two patients received chemotherapy. Results: The median follow-up was 30 months and no living patients were lost during follow-up. From retreatment, the 5-year actuarial overall survival, cause-specific survival, and local control rates were 40%, 40%, and 18%, respectively. There was a 50% incidence of serious complication requiring either reoperation or leading to permanent functional impairment. Of the 14 patients, only 1 remains disease free and without any significant complication. No treatment factors, including achieving wide surgical margins or delivering higher radiation dosages, seemed to confer an advantage in local control. Patients who were managed with planned preoperative external beam radiation therapy combined with perioperative brachytherapy demonstrated the greatest risks of complications. Conclusions: Salvage therapy for management of locally recurrent soft tissue sarcoma is challenging and the effects of reoperation and reirradiation can be severe. New management strategies are needed that improve the potential for disease control while minimizing the risk of complications. No significant financial relationships to disclose.
Efficacy and acceptability of rectal and perineal sampling for identifying gastrointestinal colonization with extended spectrum β-lactamase Enterobacteriaceae
Authors: E Dyakova, K N Bisnauthsing, A Querol-Rubiera, A Patel, C Ahanonu, O Tosas Auguet, J D Edgeworth, S D Goldenberg, J A Otter
Journal: Clinical Microbiology and Infection (2017)