tbuckley/cabot-search huggingface dataset:
Outcomes and toxicity in patients treated with bimodality or trimodality therapy for esophageal carcinoma with intensity modulated radiation therapy (IMRT).
Authors: Ajay Patel, Stephen Ko, Sarah Elizabeth James, Jonathan Ben Ashman, William G. Rule, Corey James Hobbs, Christopher Leigh Hallemeier, Emily R. Brennan, Michael Heckman, Katherine S. Tzou, Laura Vallow, Jennifer Layton Peterson, Robert Clell Miller, Steven J. Buskirk
Journal: Journal of Clinical Oncology (2016)

88 Background: There is not yet a consensus on the efficacy and safety of IMRT for the treatment of patients with esophageal carcinomas. We report on our experience with outcomes and toxicity with IMRT for these patients. Methods: Fifty-five patients with esophageal carcinoma were treated with IMRT at our institution from 12/2008 and 12/2014. Medical records were retrospectively reviewed. All patients received concurrent chemotherapy (majority 5-FU with oxaliplatin). Thirty-one (56%) patients underwent surgery. Fifty (91%) received 50.4 Gy in 28 fractions. Seventy-three percent of cases were adenocarcinoma. Regions include mid-thoracic (15%), lower thoracic (64%), and GE junction (22%). Clinical uT-stages were as follows: T1 (2%), T2 (20%), T3 (69%), and T4a (5%). Clinical N-stages were as follows: N0 (33%), N1 (53%), N2 (13%), and N3 (2%). Results: Median follow-up for all patients was 15 months (1.5 - 64.5) and 25.5 months (1.5 - 64.5) for patients who were alive at follow-up (n = 31). Fifty-one (93%) patients completed RT. Of the 31 patients who underwent surgery, 9 (29%) were found to have a complete pathologic response. Site of first recurrence was local (n = 2, 4%), regional (n = 3, 6%), and distant (n = 14, 26%). At 12 and 24 months, overall survival was 72% and 58%, freedom from recurrence was 78% and 65%, and freedom from distant recurrence was 78% and 68%. On univariate analysis, improved OS was noted with patients who underwent surgery (RR 0.29) or were cN0 (RR 0.27). Twenty eight patients (51%) experienced &gt; / = CTCAE v.4grade 3 acute toxicity; notable were hematologic (n = 14, 25%), esophagitis (n = 6, 11%), acute coronary event (n = 1, 2%), and post-chemoRT pneumonia (n = 1, 2%). Fifteen patients (31%) experienced &gt; grade 3 late toxicity; notable were esophageal stricture (n = 7, 14%), post-op pneumonia (n = 3, 6%), post-CRT pneumonia (n = 2, 4%), and COPD exacerbation (n = 1, 2%). Conclusions: Patient receiving IMRT with concurrent chemotherapy for esophageal carcinomas have good LC rates, with or without surgery. Majority of patients are able to finish treatment with acceptable rates of late toxicity. Patient who underwent surgery or were cN0 had better OS.
Front-line management patterns in the prospective metastatic renal cell cancer (MaRCC) registry.
Authors: Michael Roger Harrison, Nrupen Anjan Bhavsar, Steven Paul Wolf, Brian Addis Costello, Walter Michael Stadler, Hans J. Hammers, Ulka N. Vaishampayan, Leonard Joseph Appleman, Che-Kai Tsao, Patricia A. Creel, Greg P. Samsa, Eric M. Richardson, Kathleen A. Johnson, Azah Borham, Daniel J. George
Journal: Journal of Clinical Oncology (2016)

617 Background: Over the past decade, seven agents were approved for metastatic renal cell carcinoma (mRCC) leading to a rapidly evolving clinical landscape. Clinical trials addressing treatment efficacy, sequencing, and other questions may continue to impact management decisions. Furthermore, our prior retrospective experience indicates a significant proportion of pts may not receive systemic therapy in the first year after diagnosis with metastatic disease. This analysis describes contemporary patterns of care in the first 109 real world pts enrolled in a multicenter, prospective, observational registry. Methods: MaRCC Registry will enroll 500 pts from up to 60 US academic (ACAD) and community (COMM) sites with ~2 years of recruitment and ≥ 3 years of follow-up. Key inclusion criteria are age ≥ 18 years and diagnosis of mRCC with no prior systemic therapy (STx) for mRCC at study entry. Pts currently not on STx but who are being observed are permitted. Key endpoints include descriptive characteristics of treatments (e.g. treatment agents, sequence, duration, reasons for therapy choice and discontinuation), treatment effectiveness (e.g. overall response rate, progression free survival, overall survival), quality of life (PROs), medication adherence, and health resource utilization. Results: At data cutoff, 105 pts have been accrued with known STx status; median age 64 (Q1-3 range, 56-70); 66% male; 75% ACAD; 87% clear cell histology; and 31% stage IV at diagnosis. Initial management strategies are shown in the table. The initial management decision after accrual was to defer systemic therapy (Def STx) in 40% (N=44). In ACAD and COMM sites, Def STx percentages were 38% and 48% respectively. Baseline demographics and clinical characteristics were not notably different between Def STx pts and those treated with STx. Conclusions: In our prospective registry, we have identified a large percentage of pts who initially received Def STx. In the context of contemporary pts undergoing investigational and standard of care STx, we will describe the management and outcomes of the Def STx population. [Table: see text]
The performance of targeted magnetic resonance imaging/ultrasound fusion biopsy versus random 12-core biopsy for prediction of total prostate cancer tumor volume.
Authors: Chinonyerem Okoro, Soroush Rais-Bahrami, Arvin George, Annerleim Walton-Diaz, Minhaj Siddiqui, Nabeel Shakir, Jason Rothwax, Dima Raskolnikov, Lambros Stamatakis, Daniel Su, Baris Turkbey, Peter L. Choyke, Bradford J. Wood, Maria Merino, Peter A. Pinto
Journal: Journal of Clinical Oncology (2014)

34 Background: Tumor quantification with percent core and/or core length involvement is a parameter used to determine burden of disease for patients with prostate cancer (PCa). However, controversy exists regarding tumor quantification in random 12-core biopsies due to discrepancies in lesion targeting and overall needle core lengths obtained. Targeted MRI/US fusion biopsy allows for more optimal lesion targeting and interpretation of this parameter. We aim to correlate highest percentage core involvement and corresponding tumor length for both targeted fusion and random 12-core biopsies with total tumor volume. Methods: Patients who underwent multiparametric MRI (MP-MRI) with targeted MRI/US fusion biopsy at our institution between 2007 and 2012 were reviewed. Those that met Johns Hopkins criteria for active surveillance (AS) based on outside 12−core biopsy were then identified. MRI tumor volumes were calculated in fusion biopsy positive lesions and correlated with the highest percentage core involvement and corresponding tumor length for both targeted fusion biopsy and 12-core biopsy. Bivariate analysis was used to determine the empirical relationship between these variables. Results: Six hundred ninety six patients had MP-MRI with MRI/US fusion biopsy, 109 of which met Johns Hopkins criteria for AS upon entry and 47 of these patients had fusion biopsy confirmed PCa. Mean age was 61 and mean PSA was 5.6ng/ml. For highest percentage core involvement, targeted biopsy showed a positive correlation (r=0.57) whereas 12-core biopsy showed a poor correlation (r=0.016) with the total tumor volume (p&lt;0.0001 and p=0.91 respectively). Similarly, for tumor length of the highest percentage core, targeted biopsy showed a positive correlation (r=0.6) whereas 12-core biopsy showed a poor correlation (r=0.01) with the total tumor volume (p&lt;0.0001 and p=0.94 respectively). Conclusions: Highest percentage core involvement and corresponding tumor length on targeted MRI/US fusion biopsy positively correlate with total tumor volume. Targeted biopsy better predicts overall burden of disease and can aid in risk stratification of patients seeking AS.
Long-term follow-up of patients with Barrett esophagus: Progression to high-grade dysplasia and esophageal adenocarcinoma according to histology at presentation.
Authors: Allon Kahn, Vishnu Kommineni, Jonathan Callaway, Rahul Pannala, David Fleischer, Jonathan Ben Ashman, Helen J. Ross, Francisco Ramirez
Journal: Journal of Clinical Oncology (2015)

20 Background: Esophageal adenocarcinoma (EAC) incidence is rising and prognosis is uniformly poor, even with early stage disease. Barrett esophagus (BE) serves as a premalignant marker for EAC, with an estimated progression of 0.5% per year. Low-grade (LGD) and high-grade dysplasia (HGD) confer a higher risk of progression, providing an opportunity for intervention and surveillance. Aims: To evaluate a large cohort of patients undergoing endoscopic evaluation of BE and thereby better understand the natural history of BE and dysplasia. Methods: A retrospective review of endoscopic databases was conducted for all patients with the diagnosis of BE undergoing upper endoscopy at a tertiary academic medical center from 1991-2010. All endoscopy and accompanying pathology reports were reviewed. Only those patients with 2 biopsies documenting specialized intestinal metaplasia were analyzed. Results: 848 patients underwent upper endoscopy for evaluation of BE. Of these, 674 patients met inclusion criteria, at a mean follow up of 66.6 months. Table 1 depicts the distribution of patients according to their histology at presentation. 22 (3.2%) patients presented with established EAC, while EAC developed in 51 (7.6%). Of patients with HGD, LGD, or no dysplasia (ND) at presentation, EAC ultimately developed in 30.6%, 6.6%, and 2.7%, respectively. EAC developed in 4 patients despite RFA treatment for ND (2) or LGD (2). HGD developed in 6 such patients after treatment for ND (3) and LGD (3). Only 1 patient in each RFA-treated cohort required esophagectomy, while the others cleared dysplasia or EAC with continuous treatment. Conclusions: In this large cohort of patients with Barrett’s esophagus, higher grade of dysplasia at first endoscopy was associated with development of EAC. Continuous surveillance during and after endoscopic treatment is necessary and often results in clearance of dysplasia and EAC. [Table: see text]
Dose-adjusted infusional chemotherapy with/without rituximab (DA EPOCH+/-R) in aggressive non-Hodgkin lymphoma (NHL): A single-institution experience.
Authors: E. Walsh, S. O'Briain, O. Mcardle, C. Gillham, C. Johnston, E. Vandenberghe, D. O'Mahony
Journal: Journal of Clinical Oncology (2011)

e18545 Background: Traditionally, the standard of care for aggressive NHL has been anthracycline based bolus chemotherapy (CHOP), with or without rituximab and consolidation radiotherapy to bulky disease. Up to 40 % of patients will relapse with this approach. The NCI designed regimen, DA EPOCH-R, is a rationally designed approach based on dose and schedule optimization which has been reported to overcome adverse effects such as tumour proliferation. Methods: We retrospectively reviewed all patients with aggressive NHL receiving dose adjusted EPOCH+/-R in our institution. Patient demographics, pathology, stage, International Prognostic Index (IPI), dose intensity, toxicity, response and outcomes were assessed. Results: Forty three patients were treated with DA EPOCH+/-R in a four year period. Of those, 17 (40%) were female. The median age was 51 years, range 20-87 years. The majority (84 %) of patients had diffuse large B cell NHL (DLBCL). Only 2 patients received this regimen in the relapsed setting. Patients had stage IIB or higher disease in 70%, in fact 53% had stage IV disease. Sixteen patients (38%) had an IPI of three or more. A median of 6 cycles (range 1-6) have been administered. In total, 207 cycles were administered; dose intensity was maintained in 75%. Forty one patients were evaluable for response. 78% of patients achieved CR and 5% PR. Of those with a low IPI score (≤2), 84% responded. In the high IPI group (>2), 87% responded. 51% of cycles resulted in grade 4 neutropenia and 10% grade 4 thrombocytopenia. Grade 3 non-hematological toxicity was seen in 11% of cycles; only one cycle resulted in grade 4 toxicity. Conclusions: We await the results of the CALGB phase III randomized study comparing R-CHOP to DA R-EPOCH in aggressive B-cell NHL with interest. Our review demonstrates reproducible outcomes and acceptable toxicity similar to the NCI published experience.
Patient and physician perspective on published therapy management recommendations for TKI-treated patients with a focus on sunitinib: The TheMaPaC project (Therapy Management Patient Consensus).
Authors: Berit Eberhardt-Wetherington, Valerie Gall, Melanie Lang, Manuela Schmidinger, Viktor Gruenwald, Christina Claussen, Markus Wartenberg, Rainer Niedtner, Daniel Kalanovic
Journal: Journal of Clinical Oncology (2013)

445 Background: Optimizing outcomes in RCC or GIST patients (pts) receiving TKI (e.g. sunitinib ([U]) involves therapy management as a key component. Reduction/elimination of adverse events (AEs) by prevention/early intervention may improve quality of life and enable adequate duration of therapy. Published recommendations (RECs) for AE management are heterogeneous and often rely on hypothetical considerations or limited evidence. A collaborative effort of physicians, patients, and Pfizer addresses these issues. An initial analysis of a patient survey on real-life validity of RECs in 27 TKI-treated pts was shown at ASCO 2012 (abstr. 99588). We report an updated combined analysis with an expert survey in 23 physicians experienced in SU use for RCC and GIST. Methods: RECs for AE management in pts receiving SU or other VEGFR-TKIs were retrieved from the literature since 2006 and listed in a questionnaire (QU). For the patient survey, RECs were converted into patient-friendly language, RECs requiring physician intervention/decision were excluded. Pts rated RECs in 5 categories (positive/negative experience [self/others]; no information). Experts rated the RECs according to strength of their consent and own experiences. Results: 27 pts had evaluable QUs. Pts were on SU for 16 months (median). On average, 49% of RECs were rated positive; 44% based on individual experience. 20 RECs were rated positively by &gt;80% of pts. Pts had most positive experiences with RECs concerning pt/physician communication on AEs, care/protection of feet and skin, food preference, hydration, and fatigue. Pts had a preference for RECs with low interference in daily life. RECs rated positive by &gt;80% of pts were supported by most experts. Several RECs supported by most experts were unknown to many pts, including dermatological interventions, dietary counselling, and self-perception. Conclusions: To our knowledge, this is the first patient and expert survey on validity and practicability of published AE management RECs. The data identify useful consensual RECs from real-life perspective. TKI therapy management may be improved by enhanced pt education.
Influence of concurrent medications on PSA doubling time (PSADT) in patients (pts) with nonmetastatic biochemically relapsed prostate cancer (BRPC M0) after local therapy (tx).
Authors: Wilmosh Mermershtain, Maya Ish-Shalom, Natalie Maimon, Maya Gottfried, Keren Rouvinov, Roberto Pili, Hans J. Hammers, Victoria J. Sinibaldi, Michael Anthony Carducci, Mario A. Eisenberger, Daniel Keizman
Journal: Journal of Clinical Oncology (2013)

e16051 Background: In patients with BRPC(M0) after local tx, the most important prognostic factor is probably the PSADT (high risk &lt; 3, intermediate risk 3–8.9, low risk ≥9.0 months). Pre-clinical and clinical studies in several cancer types have shown that commonly prescribed medications may inhibit tumor growth. The effect of commonly prescribed medications on PSADT in pts with BRPC(M0) is poorly defined. Aims: To study the effect of commonly prescribed medications on PSADT in pts with BRPC (M0) after local tx. Methods: We reviewed the records of 156 BRPC(M0) pts enrolled in 1 prospective (Keizman, CCR 2010) and two retrospective (Keizman, prostate 2012; Mermershtain, EMUC 2011) studies, in 2 centers across 2 countries. The effect of clinicopathologic factors and the use of statins, aspirin, and angiotensin system inhibitors (ASIs; ACE-I and ARBs) on initial PSADT (from the time of first PSA relapse to the initiation of any systemic tx) was analyzed using the Mann-Whitney or Kruskal-Wallis tests and regression analyses. Results: In the whole patient cohort (n=156), median age was 62, prior local tx consisted of radical prostatectomy in128 pts and EBRT in 28, and median PSADT was 6.7 months (mos). Median PSADT in ASIs users (n=48) vs non users (n=108) was 7.85 vs 5.6 mos (p=0.011). In multivariate analysis, the use of ASIs and Gleason score were associated with median PSADT. The use of statins (n=58) or aspirin (n=72), primary tx modality, and time from primary tx to PSA relapse had no significant effect on median PSADT. PSADT risk grouping in ASIs users vs non users was low 48% vs 27%, intermediate 42% vs 49%, and high 10% vs 24% (p=0.02). In multivariate analysis, the use of ASIs, Gleason score, and prior ADT were associated with PSADT risk grouping. The use of statins or aspirin, primary tx modality, and time from primary tx to PSA relapse had no significant effect on PSADT risk grouping. Conclusions: The use of ASIs, Gleason score, and prior ADT may be associated with PSADT (median and risk grouping) of pts with BRPC (M0) after local tx. This should be investigated prospectively, and if validated, applied in clinical practice and clinical trials.
Abstract 12657: Perceptions of the Role of Community Health Workers in Hypertension Management: A Qualitative Analysis of the LARK Hypertension Study
Authors: Salina Bakshi, Violet Naanyu, Jemima H Kamano, Jackson K Rotich, Peninah Kiptoo, Kennedy K Lagat, Claire Kofler, Diana Menya, Sylvester Kimaiyo, Thomas S Inui, Carol R Horowitz, Valentin Fuster, Rajesh Vedanthan
Journal: Circulation (2015)

Background: Hypertension, a major risk factor for cardiovascular disease, is the leading risk factor for global mortality. Increasing access to hypertension care is critically important to reducing the burden of global cardiovascular disease. The use of community health workers (CHWs) to increase access to care represents a potential strategy to improve hypertension treatment and control; however, it is not known how rural communities in low- and middle-income countries perceive the use of CHWs for this purpose. Our study therefore aims to examine community perceptions of CHWs in hypertension management. Methods: Traditional community gatherings and focus group discussions (20 sessions, 411 participants) were organized in rural western Kenya. Discussion topics included chronic diseases, factors related to linkage to care, and the role of CHWs in hypertension management. We performed inductive content analysis of transcripts from these sessions using NVivo 10 software. Coded items were grouped together into distinct themes, and relationships among these themes were formulated. Results: Six themes emerged from our analysis, each with implications regarding CHWs’ role in linkage and retention to hypertension care (Table). These themes included (1) CHWs’ intimate knowledge of the community; (2) CHWs’ role in providing health education; (3) CHWs’ role in facilitating logistical support to enable community members to access care; (4) the importance of psychosocial support that CHWs can provide; (5) the need for ‘professionalization’ of the CHW workforce; and (6) negative perceptions towards CHWs. Conclusions: Our themes are consistent with findings in the literature regarding the work that CHWs traditionally perform for communicable diseases and maternal/child health. Use of CHWs for hypertension management, leveraging the prior experience of other CHW programs, may be an effective strategy to reduce the burden of hypertension in low-resource settings.
Survival outcome of a phase I trial: Hypofractionated stereotactic body radiation therapy concurrent with nelfinavir following gemcitabine and 5FU in patients with locally advanced pancreatic adenocarcinoma.
Authors: Chi Lin, Aaron R. Sasson, Quan P. Ly, James K. Schwarz, Chandrakanth Are, Beth M Kos, Audrey J Lazenby, Marsha A Ketcham, Eugene D Sehi, Jean L. Grem
Journal: Journal of Clinical Oncology (2014)

284 Background: We analyzed overall survival (OS) of patients enrolled in a phase I trial of hypo-fractionated stereotactic body radiation therapy (HFSBRT) concurrent with nelfinavir as part of neoadjuvant chemoradiation regimen in patients with borderline resectable and unresectable pancreatic adenocarcinoma. Methods: Forty-six patients (pts) with borderline resectable or unresectable pancreatic adenocarcinoma without metastasis were enrolled between October 2008 and May 2013 and treated with 3 cycles of Gemcitabine/5-Fluorouracil followed by 5-fraction-HFSBRT/Nelfinavir. [Dose escalation: 1)25Gy/625mgBIDx3week(wk); 2)25Gy/1250mgBIDx3wk; 3)30Gy/1250mgBIDx3wk; 4)35Gy/1250mgBIDx3wk; 5)35Gy/1250mgBIDx5wk; 6)40Gy/1250mgBIDx5wk] Surgery was performed within 4-8 wk for those down staged to resectable disease. Survival was evaluated using the K-M method. Results: The median follow-up is 12 months (M) [5-38]. The median OS (MOS) for the group is 15M [12-17]. The MOS for 13 patients with resected tumor is significantly higher than those with unresectable tumor (21M [12-29] vs. 14M [10-17]), Log-Rank p=0.02). Among patients with unresectable tumor, the MOS for those (22 pts) who received ≥ 35 Gy is significant higher than those (11 pts) who received &lt; 35 Gy (16M [12.5-22] vs. 10M [4-15], Log-Rank p=0.006). During and 1.5M post HFSBRT, ≥ grade 3 GI, hematologic and other toxicities were 2.6%, 2.6% and 13% respectively. Postoperative ≥ grade 3 GI, hematologic and other toxicities were 8%, 8% and 24%, respectively. [Number]=95%CI. Conclusions: Overall survival in patients with resectable disease after HFSBRT/Nelfinafir is higher than those with unresectable disease. Among those who continue to have unresectable disease after HFSBRT/Nelfinavir, overall survival is higher in those who received 35-40 Gy than those who received &lt; 35 Gy. Clinical trial information: NCT01068327.
The optimal dose period of indisetron tablets for preventing chemotherapy-induced nausea and vomiting (CINV) induced by mFOLFOX6: An exploratory trial HGCSG0703.
Authors: S. Yuki, H. Nakatsumi, M. Tateyama, Y. Uehata, M. Kudo, K. Kato, T. Miyagishima, M. Uebayashi, M. Asaka, Y. Komatsu
Journal: Journal of Clinical Oncology (2011)

589 Background: Indisetron is a 5-HT 3 receptor antagonist which shows also 5-HT 4 antagonistic activity, that had approved in 2004 by Japan's PMDA. There are no recommendations of prophylactic regimens for preventing nausea and vomiting induced by FOLFOX therapy. To explore the optimal dose period of indisetron tablets during mFOLFOX6, we designed the study to compare the antiemetic efficacy and safety of 3-day regimen of indisetron with a single dose regimen. Methods: Advanced colorectal cancer patients who were treated with mFOLFOX6 (+/- bevacizumab) as first-line chemotherapy were enrolled in this study. They were randomly assigned to Group A (3-day of indisetron) or Group B (a single dose of indisetron). Dexamethazone (8mg) was also administered intravenously in both groups before administering of oxaliplatin. The follow-up period was 5 days from the start of chemotherapy. The primary endpoint was complete protection from vomiting, and secondary endpoints were complete protection from nausea, no use of rescue therapy, and severe adverse events. Results: Of 45 patients enrolled in this trial, 42 (93.3%) were assessable. The proportions of patients with complete protection from vomiting were 85.7% in Group A, and 81.0% in Group B (p=1.000; Fisher's exact test). The proportions of patients with complete protection from nausea were 47.6% in each group (p=1.000; chi-square test). The no rescue therapy rates were 66.7% in Group A, and 57.1% in Group B (p=0.525; chi-square test). No severe adverse events were observed in both groups. Conclusions: We suggested that the efficacy of a single dose of indisetron might be equivalent of 3-day regimen for preventing from nausea and vomiting induced by mFOLFOX6. [Table: see text]