tbuckley/cabot-search huggingface dataset:
The results of a randomized phase II study using embolization with or without granulocyte-macrophage colony-stimulating factor (GM-CSF) in uveal melanoma patients with hepatic metastasis.
Authors: D. J. Eschelman, C. F. Gonsalves, M. Terai, M. Laudadio, K. L. Sullivan, M. J. Mastrangelo, T. Sato
Journal: Journal of Clinical Oncology (2011)

8577 Background: Immunoembolization of the hepatic artery with GM-CSF (IE) demonstrated potential efficacy in uveal melanoma (UM) patients with hepatic metastasis in a dose-escalating phase I study. To further investigate the effects of IE on hepatic metastasis from UM, a randomized, double blind phase II study was conducted. Methods: UM patients who had hepatic metastases (<50% liver involvement) without pre-existing extra-hepatic metastasis were enrolled. Patients were first stratified based on the volume of metastasis in the liver (<20% vs. >=20%) and HLA-A2 status. They were then randomized into either IE with 2,000 mcg of GM-CSF or embolization without GM-CSF (plain embolization, PE) in a double-blinded fashion. GM-CSF or normal saline solution was mixed with ethiodized oil and injected into one of the hepatic arteries, followed by infusion of gelatin sponge particles to achieve stasis. Patients were evaluated after every 2 treatments 4 weeks apart. Complete response (CR) and partial response (PR) of liver metastases were considered as the primary endpoint. Progression free survival (PFS) and overall survival (OS) were measured as secondary clinical endpoints. Results: A total of 52 patients (IE 25, PE 27) were enrolled. There were 5 PR and 12 stable disease (SD) responses in IE group, while 3 PR and 19 SD were recorded in PE group. OS and time to progression in extra-hepatic sites (PFS-S) tended to be longer in IE group although they were not statistically significant (median OS: 21.5 vs. 17.2 months; median PFS-S: 10.4 vs. 7.1 months). Interestingly, survival benefit of IE was most marked in patients who had relatively bulky metastases (20%-50% liver involvement) (OS: 18.2 vs. 16.0 months, p=0.07). In contrast, time to progression in liver metastases (PFS-L) was shorter in patients who received IE for small amount of tumors (<20%) (3.7 vs. 7.2 months, p=0.01). Conclusions: IE showed a potential survival benefit in UM patients who have relatively bulky hepatic metastases. Unexpectedly, PFS-L was shorter in patients with small hepatic metastases treated with IE, possibly reflecting an ambivalence biological effect of GM-CSF.
What is the real rate of surgical-site infection?
Authors: Jolyn Sharpe Taylor, Claire Marten, Kimberly Potts, Lynn Cloutier, Katherine Cain, Shauna Fenton, Tara Tatum, Deepthi James, Cheryl Hubbs, Jennifer Burzawa, Shital Vachhani, Alpa Manchandia Nick, Larissa Meyer, Linda Graviss, Kathy Ware, Anne Park, Thomas A. Aloia, Diane C. Bodurka, Charles F. Levenback, Kathleen M. Schmeler
Journal: Journal of Clinical Oncology (2016)

171 Background: Surgical site infections (SSI) are associated with patient morbidity and increased healthcare costs. Although several national organizations monitor SSI including the University Health System Consortium (UHC), National Surgical Quality Improvement Program (NSQIP), National Healthcare Safety Network (NHSN) and Agency for Healthcare Research and Quality (AHRQ), there is no standard reporting methodology. We compared SSI rates from these databases to our own chart review. Methods: We queried the UHC, NSQIP, NHSN and AHRQ databases from 7/2012-6/2014 for SSI following gynecologic surgery at our institution. UHC and AHRQ rely on ICD-9 coding while NSQIP and NHSN employ trained reviewers. Each organization uses different definitions, inclusion and exclusion criteria for SSI. NSQIP reviews 13-17% of cases at our institution while the other agencies include all cases. The rate of SSI was also obtained from chart review for 5/1/2014-6/30/2014 with SSI defined as an infection of the surgical incision or organ space requiring antibiotics. SSI was classified as superficial, deep or organ space (OS). The rates reported by the agencies were compared to the rate obtained by chart review using Fisher’s exact test. Results: The combined UHC/NSQIP/NHSN/AHRQ SSI rate was 5.1% (78/1,540) while the rate found by chart review was 12% (20/166) (p = 0.001). Overall SSI rates for the databases were: UHC 1.6%, NSQIP 8.8%, NHSN 2.9% and AHRQ &lt; 1%. The combined database reported fewer superficial SSI compared to investigator chart review but did not differ significantly when reporting deep and OS: superficial 1.6% v 7.8% (p &lt; 0.001), deep 2.1% v 1.2% (p = 0.57) and OS 2.9% v 3.6% (p = 0.26). The individual databases had wide variation in rate of superficial (UHC 0.7% NSQIP 1.2% NHSN 0.5% AHRQ 0%), deep (UHC 0.7% NSQIP 4.7% NHSN 1.3% AHRQ 0%) and OSI (UHC 0.03% NSQIP 4.4% NHSN 1.4% AHRQ &lt; 1%). Only 19 cases (24.4%) were included in &gt; 1 database. Only one case was included in three databases (1.3%) and no cases were included in all four. Conclusions: There is discordance among national reporting agencies tracking SSI and all agencies reported a different rate of SSI compared to chart review. Adopting standardized metrics across agencies could improve consistency and accuracy in assessing SSI rates.
Advance care planning among seniors of a diverse city.
Authors: Randi Belisomo, Daniel M. Gaitan, Amy R. Eisenstein, Mary Frances Mulcahy
Journal: Journal of Clinical Oncology (2014)

117 Background: Advance care planning (ACP) is a system of education, reflection and documentation of health care wishes. Respecting Choices has been successful in implementing ACP throughout Lacrosse County, WI (J Am Geriatr Soc 2010;58:1249–1255). . A single center study in Melbourne, AU, showed that ACP improves end of life (EOL) care, patient and family satisfaction, and reduces stress, anxiety, and depression in surviving relatives (BMJ 2010;340:c1345).We aim to quantify knowledge about ACP, interest in engaging in ACP, and barriers to effective ACP among the older adults of Chicago. The results will provide actionable items to implement an ACP program in a diverse city. Methods: 17 of the 22 City of Chicago senior centers participated in a survey and education forum “Starting the Conversation”. Participants provided demographic information, awareness and knowledge of EOL wishes and advance directives (AD). Data was tabulated and analyzed using descriptive statistics in IBM SPSS Statistics 22 Software. Results: 375 people completed the survey, the average age was 70+8, (range 41 to 93), 93.3% in English, and 6.7% in Spanish. Respondents live alone (44.5%), with a spouse (29.9%) or child (14.4%). 71% have thought about the medical care they would want at the EOL, 60% have discussed their EOL wishes with their loved ones, and 4% with their doctor. 60.5% do not know what an AD is, 25% have an AD, 76% know who would speak for them if they were unable, 58% have discussed their wishes with that person. Using neighborhood demographics, there was no difference in having an AD for predominately African American neighborhoods compared to others (33% and 27%). Respondents from lower income neighborhoods were less likely to think about medical care at the EOL (65% and 77%), less likely to have discussed EOL care (41% and 30% have not discussed EOL care) and less likely to have an AD (19% and 31%). Conclusions: ACP is underutilized in Chicago. The frequency of AD completion among Chicago seniors mirrors that of the US (Am J Public Health. 2013;103(6):e8-e10). Unlike other population studies, no difference was found among racial groups. Participants are aware of EOL wishes, are interested in engaging in these conversations, but lack the knowledge and collaboration of their healthcare team.
A Global Registry of Patients with Paroxysmal Nocturnal Hemoglobinuria.
Authors: Robert Brodsky, Hubert Schrezenmeier, Petra Muus, Monica Bessler, Jeffrey Szer, Bruno Rotoli, Jaroslaw P. Maciejewski, Gerard Socie, A. Urbano-Ispizua, Wendell F. Rosse, Yuzuru Kanakura, Anders Karnell, Camille Bedrosian, Peter Hillmen
Journal: Blood (2009)
A phase III trial of adjuvant neratinib (NER) after trastuzumab (TRAS) in women with early-stage HER2+ breast cancer (BC).
Authors: P. E. Goss, C. H. Barrios, A. Chan, S. K. L. Chia, S. Delaloge, B. Ejlertsen, J. N. Ingle, B. Moy, H. Iwata, F. A. Holmes, J. Mansi, G. Von Minckwitz, L. Han, A. Thiele, V. Agrapart, A. Freyman, J. Truscello, A. Berkenblit, D. Finkelstein
Journal: Journal of Clinical Oncology (2011)

TPS137 Background: The human epidermal growth factor receptors (HER1-4) are frequently overexpressed in human tumors. Increased HER receptor signaling is associated with increased resistance to standard therapies and poor prognosis. TRAS, an anti-HER2 monoclonal antibody, reduces recurrences and improves disease-free survival (DFS) in patients (pts) with HER2+ early BC. However, 15% to 25% of TRAS-treated pts still experience relapsed disease at 5 yrs. NER is a small molecule, irreversible tyrosine kinase inhibitor of HER2 as well as HER1 and HER4. In a phase II study, orally administered NER 240 mg/d was well tolerated with significant antitumor activity in pts with HER2+ BC, with or without prior TRAS (objective response rates of 24% and 56%; median progression-free survival of 22 wks and 40 wks, respectively). The current study will evaluate the efficacy and safety of NER in pts with early-stage HER2+ BC after adjuvant TRAS. Methods: This double-blind, placebo-controlled, multicenter, phase III study will include approximately 3,300 women with early-stage HER2-overexpressing/amplified, node-positive BC (or no pathologic complete response after neoadjuvant therapy) at high risk for recurrence. Pts will be randomized within 1 yr of prior adjuvant TRAS to oral NER 240 mg or placebo daily for 1 yr. Pts will be followed for up to 5 yrs post-randomization for recurrence and/or survival. Primary endpoint is DFS (time to disease recurrence or death), using a 1-sided log-rank test to compare treatment arms and a Cox proportional hazards regression model for hazard ratio estimation. Other efficacy endpoints include DFS including ductal carcinoma in situ, time to distant recurrence, distant DFS, incidence of central nervous system recurrence, and overall survival. Safety will be monitored, with particular attention to diarrhea. Biomarker analyses (including HER2 confirmation from archived samples) and health-related quality of life (FACT-B and EQ-5D) will also be assessed. Results: As of Jan 25, 2011, a total of 2,050 pts have been randomized, including 934 high-risk pts. Conclusions: Recruitment is planned to continue until late 2013. As of Nov 3, 2010, the IDMC recommended the trial to continue.
HAART influences the presenting characteristics and improves the outcome of patients (pts) with Hodgkin’s disease and HIV infection (HD-HIV)
Authors: M. Spina, G. Rossi, J. Gabarre, R. Cinelli, F. Martellotta, E. Vaccher, U. Tirelli
Journal: Journal of Clinical Oncology (2005)

6584 After the introduction of highly active antiretroviral therapy (HAART) the overall prognosis of patients (pts) with HIV infection and of HIV-related tumours has significantly improved. There is no data on the impact of HAART on HD in HIV setting. With the aim to assess the influence of HAART on the presenting characteristics and outcome of HD-HIV, we report on 146 pts with HD-HIV enrolled in four prospective phase II studies carried out within the Italian Cooperative Group on AIDS and Tumours (GICAT) between 1988 and 2002. As far as the presenting features, we compared pts who have been receiving HAART before the onset of HD (prior HAART=55) vs naive-pts (naive-HAART=91); as far as the outcome we compared pts who had received HAART at any time (#=86) vs pts who never received HAART (#=60). Table 1 summarizes the difference in the presenting features and outcome in the two groups. In our experience, HAART significantly improved the OS and the event-free survival (EFS) (and this may be due to the impact on the underlying HIV infection) and the time-to-treatment failure (TTF) (and this may be due to the impact on the duration of remission through the immunorestoration) of pts with HD-HIV. However, HAART may have modified the presenting characteristics of HD-HIV, with more favourable features at presentation (i.e. less extranodal sites, in particular bone marrow) and with a possible impact on the outcome. Supported by ISS and AIRC grants. No significant financial relationships to disclose.
Prognostic significance of degree of anemia in renal cell carcinoma.
Authors: Mohammad Mozayen, Anteneh Tesfaye, Khalil Katato
Journal: Journal of Clinical Oncology (2012)

469 Background: Anemia can precede the diagnosis of renal cell carcinoma (RCC). It has been well studied that it has a negative effect on the outcome of RCC. The impact of the severity of anemia on the overall all survival of patients with RCC is not well known. Our study examined the impact of severity of anemia on the overall survival of patients with RCC. Methods: We retrospectively reviewed 204 patients diagnosed with RCC between 1995 and 2008 in a community hospital setting. Patients with additional malignancies, lymphoma of the kidneys, with no follow up data or no preoperative Hemoglobin levels (Hg) measurement were excluded from the study. Demographics, preoperative complete blood count (CBC), pathology, disease stage, operative note, and subsequent follow up data were reviewed. Patients were grouped based on their preoperative Hg. Anemia was defined as Hg &lt;12g/dl for females and &lt;13g/dl for males. Patients were divided based on Hg to Group A (females with Hg&lt;10 g/dl, males with Hg&lt;11g/dl), group B (females with Hg 10-12 g/dl, males with Hg 11-13 g/dl), group C (females with Hg &gt;12 g/dl, males with Hg &gt;13g/dl). Last follow up date was used to calculate the 3 year overall survival for patients. The primary outcome was 3 year overall survival. Results: A total of 204 patients were reviewed, 127 (62.3%) were males, 176 (85.9%) were Caucasians. The median age of the study population was 65 (22-91). Clear Cell was the commonest histology (79%). Anemia was found in 90 (44.1%) patients. The median Hg was 12.8 g/dl (Range: 7.2-18.2). Anemia was present in 41.8% of females and 46.2% of males. The median Hg level for stages I, II, III, IV were (13.05, 12.45, 12.45, 11.45) respectively. The 3 year overall survival for the study population was 67.3% (95% CI: 60.4-73.7). The 3-year overall survival for anemic patients was 51.2% (95% CI: 40-61) compared to 81.6% (95% CI: 72-87) in non anemic (p&lt;0.0001). The 3-year overall survival significantly decreased with Hg levels, as shown by the Groups A (33.3%), B (60.7%), and C (81.6%) (p&lt;0.0001). Conclusions: Our finding was consistent with other studies in portraying anemia as a negative prognostic factor in patients with renal cell carcinoma. Our study also showed that the severity of anemia corresponds to poorer overall patients survival.
The effects of anticoagulant use in high-risk prostate cancer treated with radiotherapy on overall survival and biochemical control.
Authors: Stephen G. Chun, Corbin D Jacobs, Jingsheng Yan, Xian-Jin Xie, Kevin S Choe, Raquibul Hannan, David A. Pistenmaa, Yair Lotan, Claus G Roehrborn, Dong W. Kim
Journal: Journal of Clinical Oncology (2014)

146 Background: High-risk localized prostate cancer (PC) has suboptimal treatment outcomes due to therapeutic resistance to radiation and hormone therapy. Previous studies suggest that anticoagulant (AC) use may improve treatment outcomes in high-risk PC. We hypothesized that AC therapy confers a freedom from biochemical failure (FFBF) and overall survival (OS) benefit in patients treated with concurrent radiotherapy in patients with high-risk prostate cancer defined as Gleason Score (GS) 8 or higher, Stage T3a or higher, or prostate-specific antigen (PSA) of 20 or more. Methods: Analysis was performed of 74 patients identified who were treated with definitive external beam radiotherapy with National Comprehensive Cancer Network defined high-risk PC from 2005 to 2008 at The University of Texas Southwestern Medical Center. Of these patients, 43 took concurrent AC including aspirin (95.6%), clopidogrel (17.8%), warfarin (20%), and multiple ACs (31.1%). Associations between AC use and FFBF, OS, distant metastasis, and toxicity were explored. A minimum of 5 years of follow-up were available for all patients. Results: For patients taking any AC compared to no AC, there was improved FFBF compared to of 84.4% versus 62.1% (P = 0.0003), and for aspirin the FFBF was 83.7% versus 64% (P = 0.0008). Aspirin was also associated with reduced rates of distant metastasis of 12.2% versus 26.7% in patients who did not take aspirin (P = 0.039). On multivariate analysis, patients taking aspirin with PSA of 20 or more had 5 year OS 95.8% versus 70% (P = 0.031), and GS 9-10 had 5 year OS 88.2% versus 37.5% (P = 0.013). Conclusions: AC use was associated with a FFBF benefit in high-risk PC which translated into an OS benefit in the highest risk PC patients with PSA of 20 or more or GS 9 to 10 who are most likely to experience prostate cancer specific mortality. This hypothesis generating data suggests AC use may represent an opportunity to improve patient outcomes by overcoming therapeutic resistance.
Prognostic effects of circulating markers of epithelial mesenchymal transition (EMT) in metastatic colorectal cancer patients.
Authors: Neeraj Nailesh Shah, Christopher Hanyoung Lieu, Cristina Ivan, Michael J. Overman, Masayoshi Shimizu, Jeffrey Morris, Hai T. Tran, John Heymach, George Calin, Scott Kopetz
Journal: Journal of Clinical Oncology (2012)

456 Background: EMT is a phenotypic description of cancer cells that include loss of cell adhesion, increased motility, invasion, and chemoresistance. EMT gene signature is a poor prognostic feature in colon cancer. Circulating markers to decipher the EMT signature in colorectal cancer patients (CRC pts) would therefore be of clinical relevance. Studies have shown that miR-21, IL-6 and IL-8 have been associated with EMT in cancer cells in vitro and their expression has been shown to be highly correlated in primary colon cancer tissue Methods: Plasma samples were obtained from two mCRC cohorts: 120 pts with unresectable metastases, and 91 pts who subsequently underwent partial hepatectomy with curative intent. Circulating levels of IL-6, IL-8 and miR-21 (normalized by miR-16) were measured, and dichotomized using previously published cutoffs. Pts with high levels of ≥2 of 3 EMT markers were categorized as having an EMT phenotype. Survival analysis was by log-rank and proportional hazard. Results: As previously seen in colon tissue, miR-21, IL-6 and IL-8 expression were correlated in plasma samples (P&lt;0.001) and individually associated with shorter overall survival (P&lt;0.05). The EMT phenotype, present in 44% of both cohorts, was a strong predictor of poor overall survival in the unresectable cohort (HR 2.6, 95% CI 1.6 to 4.1, median OS 15.5 mo v 27.1 mo, P&lt;0.001) as well as in the validation resectable cohort(HR 3.8, 95% CI 1.9 to 7.7, median OS 41.5 mo vs 81.9 mo, P&lt;0.001). This effect was sustained in a multivariate analysis after adjustment for tumor volume and clinical characteristics (HR 1.92, P=0.009 in unresectable cohort and HR 3.53, p=0.002 in hepatectomy cohort). The EMT phenotype was also predictive of shorter progression-free survival (HR 2.2, 15.8 mo vs 7.8 mo, P=0.02) and relapse-free survival (HR 2.1, 18.4 mo vs 31.4 mo, P=0.01) in the two respective cohorts, consistent with prior preclinical data correlating EMT with chemoresistance Conclusions: As surrogates of EMT, circulating levels of miR-21, IL-6 and IL-8 are co-expressed in plasma of mCRC pts and can be used to predict overall survival and benefit from chemotherapy. This finding highlights the clinical relevance of EMT in colon cancer biology
Long-term survivors after sorafenib therapy in unresectable hepatocellular carcinoma.
Authors: Satoru Imura, Mitsuo Shimada, Yuji Morine, Tetsuya Ikemoto, Yusuke Arakawa, Shuichi Iwahashi, Yu Saito, Shinichiro Yamada, Hiroshi Shibata, Hidenori Miyake
Journal: Journal of Clinical Oncology (2015)

470 Background: Sorafenib is one of the standard therapies for unresectable HCC. Recently, so-called “conversion” cases, who had received curative resection after sorafenib therapy, have been reported sporadically. Here, we investigated outcome of sorafenib treatment and characteristics of long-term survivors. Methods: 1) Thirty-five patients with advanced HCC underwent sorafenib therapy were enrolled. 2) The data of 59 patients from main three hospitals in Tokushima were reviewed to study the characteristics of long-term survivors. Results: 1.) The median treatment period was 3.7mo. The 1-year survival rate was 58%. The rate of partial response was 9% and the rate of stable disease was 34%. These two patients were converted to the surgical resection after sorafenib therapy. Conversion case: 50-year old male with huge unresectable HCC underwent sorafenib therapy as initial treatment. Three months after sorafenib induction, main tumor was shrunken and some intrahepatic metastase were disappeared. Right lobectomy as curative resection could be performed. He has no recurrence for 2 years after surgery. 2.) Of 59 patients, over three-years survivors were four patients (L-group) and twenty-three patients were dead within 1 year after sorafenib induction (S-group). Between the two groups, there was no significant difference in age, gender, liver function, and tumor markers. Only the response to sorafenib was significant factors for long-term survival. Sorafenib administration was continued for more than 3 years in two patients of L-group, but withdrawn in two patients. However, other treatments such as TACE or radiation were done soon after withdrawal. Conclusions: Sorafenib combined with surgical treatment may contribute to improve prognosis of patients with initially unresectable HCC.