tbuckley/cabot-search huggingface dataset:
A phase II study with single agent erlotinib in chemotherapy-naïve androgen independent prostate cancer (AIPC)
Authors: T. M. Lestingi, K. Tolzien, A. Galvez, S. Kelby, J. D. Bitran, C. Nabhan
Journal: Journal of Clinical Oncology (2008)

16104 Background: Mechanisms of hormone resistance in AIPC are variable. One mechanism is the epidermal growth factor receptor (EGFR) stimulating cell proliferation. We investigated an oral anti-EGFR inhibitor (Erlotinib) in chemotherapy-naïve AIPC patients (pts). The primary endpoint was the overall clinical benefit defined as the sum of complete response (CR), partial response (PR), and stable disease (SD). Secondary endpoints were time to disease progression (TTP) and toxicities. Methods: Between January 2006 and December 2007, 29 pts were enrolled onto this phase II study. Median age was 78 years (61–96). Median PSA at enrollment was 64.1 ng/dl (9.2- 914.2). Median time from initial diagnosis to starting Erlotinib was 8 years (1–14). Erlotinib was given at 150 mg daily during 4-week cycles until disease progression or intolerability. Response assessment occurred every 2 cycles, including computed tomography of measurable disease areas, bone scans, and serum PSAs. Pts who progressed radiographically but maintained a PSA response or those who progressed biochemically but maintained a radiographic response were considered stable and continued on study. Results: The study has completed accrual. Nineteen pts are currently evaluable. 4 are early in their therapy, 4 withdrew consent, and 2 progressed before completing 2 cycles. Erlotinib was well-tolerated and most toxicities were grade 1 or 2. Hematuria occurred in 3 pts but was deemed unrelated to erlotinib. Grade 3 diarrhea and dehydration occurred in 2 pts (8%). One patient (3.4%) developed grade 3 rash. One pt developed a venothromboemblic event and another developed cord compression early in his therapy. One pt (3.4%) required a dose reduction secondary to grade 3 hand/foot syndrome. One pt (3.4%) was unable to tolerate therapy even at the reduced dose because of grade 3 fatigue. With a median follow up of 10 months (1–23), 20 pts (72%) remain alive. Two pts achieved PR and 3 pts demonstrated SD. The calculated overall clinical benefit was 26% (5 responses out of 19 patients). Although median TTP was 2 months (2–20), the 2 PR patients responded for 20 and 13 months respectively. Conclusions: Erlotinib is safe and has modest single-agent activity in AIPC. Further studies are warranted. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genentech™ BioOncology Genentech™ BioOncology
Patterns of palliative care utilization and end-of-life care in adult patients with cancer who died as inpatients at Mayo Clinic.
Authors: Collin Thomas Zimmerman, Shivani S. Shinde, Pashtoon Murtaza Kasi, Mark Robert Litzow, Jeanne M. Huddleston
Journal: Journal of Clinical Oncology (2016)

60 Background: A significant number of patients with advanced cancer die in the hospital. Examination of patterns of care and palliative care (PC) involvement may identify opportunities for process of care improvements for this vulnerable population. Methods: Patients were identified using the institutional mortality review system registry (Mayo Clinic hospitals from July, 2013-June, 2014). Within this group, patients with a diagnosis of terminal malignancy were identified by chart review and ICD-9 codes. Patient demographics, clinical characteristics, and use of PC resources were characterized in the last 60 days of life. Results: There were 159 of 924 decedents identified whose primary cause of death was advanced malignancy (Table). Ninety-two patients (57%) had PC consultation during the index admission preceding death, while 31 (19%) patients had seen PC as an outpatient or inpatient prior to index admission. Lack of inpatient PC consultation at index admission was associated with hematologic malignancy (p &lt; 0.001), full code status at death (p 0.009), shorter median time between change of code status to DNR and death (13 vs 67 hrs, p &lt; 0.001), death in the ICU (58% vs 31%, p &lt; 0.001), and presence of code blue (22% vs 5%, p-value = 0.003). Patients who received a PC consultation were less likely to have chemotherapy within 14 days of death (15% vs 37%, p-value = 0.001), and had a median composite aggressive end of life score (6 factor composite score based on utilization in last 30 days of life, higher score indicating more aggressive care) of 3 vs 4 (p 0.002). Conclusions: Inpatient PC consultation for cancer patients who die in the hospital is associated with less aggressive cancer care at end of life. The single-institution patient population and small sample size are the limitations of our study. [Table: see text]
RECIST 1.0 versus 1.1: Implications for trial interpretation and design in advanced prostate cancer.
Authors: C. I. Piatek, B. B. Desai, D. Wei-Tsao, R. Tang, F. Acosta, J. K. Pinski, T. B. Dorff, A. Goldkorn, H. Jadvar, D. I. Quinn
Journal: Journal of Clinical Oncology (2011)

2563 Background: The purpose of our study was to compare how effectively RECIST 1.1 captures lymph node disease and treatment response in advanced prostate cancer compared to RECIST 1.0 based on “per lymph node” (LN) analysis Methods: 30 study group pts (med. 69 yrs, PSA 55.55 (0.06 – 2625) ng/ml, Gleason 8) are part of an ongoing prospective clinical imaging trial evaluating the diagnostic utility of FDG PET/CT in advanced prostate cancer. Patients underwent a baseline scan followed by 3 scans done at an 4 monthly intervals. 30 validation cohort pts (med. 70 yrs, PSA 253 (9.61 – 2290) ng/ml, Gleason 8) were identified from 3 IRB approved therapeutic trials for castrate-resistant prostate cancer. 2 consecutive scans done after the start of new therapy in both group of patients were evaluated for the extent of disease and for response by RECIST 1.0 & 1.1 criteria. Number of abnormal LN lesions, defined as target lesions based on morphological appearance using RECIST 1.0 (CTLD ≥10 mm) and RECIST 1.1 (CTSD ≥15mm), were calculated for both groups of pts. The response of concordant target LNs was assessed as CR, PR, SD and PD based on RECIST 1.0 and 1.1 cut-off points. Results: Of 75 LNs in the study group considered as target lesions by RECIST 1.0, only 25 (33.4%) were considered abnormal by RECIST 1.1. Similarly, of 83 individual LN lesions in the validation group by RECIST 1.0, only 41 (49.4%) were considered target lesions by RECIST 1.1 measurement criteria. Of the 20 lesions that were considered PD in both groups combined by RECIST 1.0, only 10 (50%) were captured by 1.1 criteria. Only 3 (15.8%) LN lesions were considered CR by 1.0 compared to 19 by 1.1 criteria. Conclusions: RECIST 1.1 criteria for categorizing lymph nodes as normal or pathologic based on more stringent measurement rules may lead to delayed estimates of disease progression or fail to detect it entirely. RECIST 1.1 may also categorize more patients as complete responders than RECIST 1.0. We will further evaluate these cohorts for effect on individual outcome parameters. These preliminary findings need to be assessed in prospective trials and have major implications for comparing trials done with RECIST 1.0 or 1.1.
Postoperative radiotherapy for gallbladder cancer.
Authors: Jin-hong Park, Jong Hoon Kim, Sang Min Yoon, Nuri Hyun Jung, Young-Joo Lee, Kwang-Min Park, Heung-Moon Chang, Kyu-Pyo Kim
Journal: Journal of Clinical Oncology (2013)

289 Background: Gallbladder cancer (GBC) is a relatively uncommon malignancy with high recurrence rate and poor prognosis, even after curative resection. Although postoperative radiotherapy (RT) has been tried to improve the poor results of surgery alone, the benefit of postoperative RT for GBC is still a matter of debate. The present study aimed to evaluate the effect of postoperative RT on locoregional control (LRC), disease-free survival (DFS), and overall survival (OS) in patients with GBC. Methods: Between March 1998 and July 2009, 228 patients with GBC (T2-3 N0-2) underwent surgical resection with potentially curative aim (R0 or R1) at Asan Medical Center. Among the 228 patients, 86 received postoperative RT (RT group) with or without concurrent chemotherapy, and 142 did surgery alone (no-RT group). All patients with postoperative RT received three-dimensional conformal radiotherapy, and the median radiation dose was 50 Gy (range, 45-60 Gy) at 1.8 or 2.0 Gy/fraction daily. Among them, 57 patients (66.3%) had concurrent chemotherapy based on 5-fluorouracil. Results: The median follow-up time was 90 months (range, 35-96 months) for the surviving patients. Although RT group had significantly more advanced disease in overall stage (p = 0.005), T stage (p = 0.002), N stage (p = 0.010), and higher rate of R1 resection (p = 0.027), the 3-year LRC was 78% for RT group and 66% for no-RT group (p = 0.088). Also, there was no significant difference in the 3-year DFS and OS: 51% vs. 52% (p = 0.994) and 53% vs. 56% (p = 0.541), respectively. In multivariate analysis, postoperative RT was a significant predictive factor of improved LRC (p = 0.011), DFS (p = 0.016) and OS (p = 0.036). Conclusions: Although RT group had more adverse risk factors, the treatment outcomes of RT group were similar to those of no-RT group. Moreover, postoperative RT was a significant predictor of improved LRC, DFS and OS after adjusting these factors. These results suggest that postoperative RT might be effective in locoregional control and survival for patients with GBC.
Understanding variations in referral patterns and treatment choices for patients with hepatocellular carcinoma.
Authors: Omar Hyder, David Cosgrove, Hari Nathan, Kenzo Hirose, Christopher Lee Wolfgang, John Bridge, Jean-Francois Geschwind, Nikhil Bhagat, Ahmet Gurakar, Joseph M. Herman, Ihab R. Kamel, Timothy M. Pawlik
Journal: Journal of Clinical Oncology (2013)

293 Background: Patterns of care of physician specialists may differ for patients with hepatocellular carcinoma(HCC). The extent and reasons underlying possible variations are poorly understood. One source of variation may be disparate referral rates to specialists leading to differences in cancer-directed treatments. Methods: We queried the Surveillance, Epidemiology, and End Results(SEER) linked Medicare database for patients with HCC diagnosed between 1998-2007 who consulted one or more physicians following diagnosis. Visit and procedure records were abstracted from Medicare billing records and factors associated with visiting a specialist and subsequent treatment were examined. Results: 6752 patients with HCC were identified;median age was 73 yrs and the majority was male(66%), White(60%) and from a West geographical region(56%). 1379(20%) patients had early-stage disease. In the six months after diagnosis, referral to a specialist varied considerably (hepatology/gastroenterology-60%; medical oncology-62%; surgery-56%; interventional radiology-33%; radiation oncology-9%). 22% patients saw one specialist, while 39% saw ≥3 specialists. Time between diagnosis and visitation with a specialist varied by sub-specialty (surgery-37 days vs. interventional radiology-55 days;P=0.04). Factors associated with referral to a specialist included younger age(OR=2.13), geographic location(Northeast OR=2.09), and presence of early-stage disease(OR=2.21)(all P&lt;0.05). Among patients with early-stage disease, 77% saw a surgeon, while 50% had a medical oncology consultation. Receipt of therapy among patients with early-stage disease varied (no therapy-30%; surgery-39%; interventional radiology-9%; other-22%). Factors associated with receipt of therapy included younger age(OR=2.82), as well as time to consultation with cancer specialist(OR=1.05)(both P&lt;0.05). Conclusions: Following HCC diagnosis, referral to a specialist varied considerably. Both clinical and non-clinical factors were associated with consultation. Variations in referral to a specialist and subsequent therapy need to be better understood to ensure all HCC patients receive appropriate care.
Implementing an innovation to improve coordination of care in breast cancer.
Authors: Nina A. Bickell, Rebeca Franco, Alexandra Moss, Zoe Lawrence, Ann Scheck McAlearney
Journal: Journal of Clinical Oncology (2013)

52 Background: Underuse of adjuvant breast cancer treatments delivered by different specialists may be worsened by fragmented care and improved by effective coordination. To improve care coordination and adjuvant treatment delivery, we assessed the challenges to and feasibility of implementing a web-based Tracking and Feedback (T&amp;F) innovation in hospitals serving predominantly minority breast cancer patients. Methods: We interviewed 67 key informants [Clinical (n = 39), Administrative (n = 14), Clerical (n = 11), Other (IT, Social Work) (n = 3)] from 8 inner-city hospitals to better understand how organizational characteristics might impact coordination of care and implementation of the T &amp; F innovation. We used the constant comparative method of qualitative data analysis and standard techniques to code the data. Results: We found considerable variability across hospitals’ abilities to coordinate and track care. All sites have multi-disciplinary Tumor Board meetings and active Quality Improvement departments. Yet, in several sites, specialty care remains siloed, quality improvement efforts focus on inpatient care and communications systems across outpatient specialties are poor. All hospitals have electronic medical records but they are not integrated and are unable to track requested referrals. Many physicians rely on follow-up appointments to ascertain treatment receipt but sites vary in their ability to address “no-shows.” Several rely on staff to manually identify and follow up “no-shows,” but many of these staff are overwhelmed with ever increasing tasks and responsibilities. While quality was important, several interviewees felt they were bucking an inflexible system and devised ways to work around the obstacles. Perceived successful coordination factors included strong clinical leadership, designated accountabilities, and flexibility of staff. Conclusions: As care integration is encouraged by federal law, specialty care silos and rigid communication systems still pose barriers to change. Our results suggest that a web-based T&amp;F innovation must be tailored to individual hospital characteristics, and flexible to permit modification of care processes at the organization level. Clinical trial information: NCT01544374.
The application of therapeutic music (TM) during the radiotherapy in order to improve the patient compliance and minimize incorrect positioning during the treatment.
Authors: U. Radke, B. Reinold, L. Schlaak, F. Segatz-Thiele, G. Wiedemann, T. Boelling, W. Wagner
Journal: Journal of Clinical Oncology (2011)

e19585 Background: The modern radiotherapy demands a high degree of acceptance and compliance from the patient. It was examined, whether calming and relaxation of the patient with TM during the radiotherapy session can aid in this. TM is specific music with integrated RHS frequency of 60 beats/min. It was examined, whether the relaxation of the patients leads to a more correct positioning and thus to a smaller number of verification films. Methods: From September to December 2010 the pulse of 33 patients was measured with a pulse oxymeter during the radiotherapy and the number of the verifications was recorded; 26 patients listened TM for relaxation and calming, 7 control patients did not listen any TM. In addition to that the subjective mental state via TM was examined with a questionnaire. Results: The pulse frequency of patients, who listened TM during the radiotherapy session had reduced more than the pulse frequency of patients, who did not listen TM, whereupon the effectiveness of TM was high for young (30-40 years = 70 %) and old (80-90 years = 58 %) patients, but decreased for middle aged patients (40-50 years = 42 %; 50-60 years = 40 %; 60-80 years = 51 %). With a longer radiotherapy session per fraction the effectiveness of TM increased (<5 min = 44 %; <10 min = 51 %; <15 min = 60 %). 51 % of the measurements of the 14 female patients and 42 % of the measurements of the 22 male patients showed a pulse reduction via TM. The radiotherapy-verification-quotient (the number of radiation divided by the number of verification) shows, that patients, who listened TM lies more calmly and therefore more exactly (5.5) than patients, who did not listen TM (4.6). The evaluation of the questionnaires points out that 65 % of the patients found TM very good, 35 % found it good; 96 % of the patients stated that they felt noticeably more calmly and relaxed. Conclusions: TM during radiotherapy leads to calming and relaxation (reduced pulse frequency) and to a more correct positioning (higher radiotherapy-verification-quotient) and is felt and estimated subjectively as positive (thus more acceptance and compliance). We are seeking for a controlled randomized phase III-study.
Assessment of MINT 17 methylation in primary breast cancer and normal breast epithelia: A preliminary study
Authors: A. Q. Van Hoesel, C. J. Van De Velde, A. E. Giuliano, D. S. Hoon
Journal: Journal of Clinical Oncology (2008)

11113 Background: Methylated-in-tumor loci (MINTs) are non-coding DNA sequences containing CpG islands. The aim of this preliminary study was to assess presence of aberrant methylation of MINT 17 in primary breast cancer. We hypothesized that MINT 17 methylation index is significantly higher in primary breast tumor tissue than in normal breast tissue. Methods: Paraffin- embedded breast tissues of 42 patients were collected. This selection comprised of 26 breast cancer patients and 16 patients without breast cancer. DNA was isolated from primary tumor tissues, and normal breast epithelia DNA was isolated from non-cancer breast tissue. DNA was subjected to sodium bisulfite modification. Absolute quantitative assessment of methylated alleles (AQAMA) was performed to assess methylation status of MINT 17 by multiplex quantitative methylation-specific PCR. The results were expressed as methylation index (MI): MI=methylated copy number / (Methylated copy number + unmethylated copy number). Medians were compared using Wilcoxon rank sum test. ROC-curve AUC was calculated using logistic regression. Results: Median MI for MINT 17 was significantly higher in tumor tissue than in normal breast epithelia (median MI=0.059 (n=26) vs. 0 (n=16); p=0.0001). MI did not exceed 0.03 in normal epithelia, whereas MI exceeded 0.03 in 77% of the cancer tissues. The AUC for the ROC-curve for MINT 17 methylation as a predictor for cancer was 0.887. Median of MINT 17 MI was significantly higher in ER(+) patients than in ER(−) patients (median MI= 0.315 (n=15) vs. 0.043 (n=9); p=0.033). PR(+) patients had higher median MI than PR(−) patients (median MI 0.313 (n=12) vs. 0.053 (n=13), p=0.055). The AUCs for the ROC-curve for MINT 17 MI as predictor for ER status and PR status was 0.785 and 0.737, respectively. Conclusion: MINT 17 MI is significantly higher in primary breast cancer than in normal breast epithelia, and is an indicator for presence of cancer in breast tissue. MINT 17 MI is related to ER and perhaps PR status in primary breast tumors. No significant financial relationships to disclose.
Changes in treatment patterns for patients with locally advanced rectal cancer in the United States over the past decade: An analysis from the National Cancer Data Base (NCDB).
Authors: Helmneh M. Sineshaw, Ahmedin Jemal, Timur Mitin
Journal: Journal of Clinical Oncology (2016)

691 Background: Neoadjuvant chemoradiation therapy (NACRT) is widely accepted as the standard of care for treatment of locally advanced rectal cancer in the United States. We sought to examine patterns of treatment for locally advanced rectal cancer in US over the past decade. Methods: Using the National Cancer Data Base (NCDB), we identified 66,197 patients diagnosed with stage II-III rectal adenocarcinoma and treated between 2004 and 2012. We described trends in receipt of treatment based on aggregated data for three time periods (2004-2006, 2007-2009, 2010-2012), using trend test. We analyzed 5-yr overall survival (OS) probabilities for 28,550 patients treated between 2004 and 2007. Results: Receipt of NACRT increased significantly over the past decade from 42.9% in 2004-2006 to 50.0% in 2007-2009, and then to 55.0% in 2010-2012 (p &lt; 0.0001). In contrast, use of adjuvant chemoradiation (CRT) decreased steadily from 16.7% in 2004-2006 to 10.5% in 2007-2009, and then to 6.7% in 2010-2012 (p &lt; 0.0001). Similarly, treatment with surgery alone decreased from 13.1% in 2004-2006 to 8.7% in 2010-2012 (p &lt; 0.0001). Older age, presence of comorbidities, larger primary tumor size, lymph node involvement, non-Hispanic white ethnicity, lack of private insurance, and being treated at a non-high case volume facility were associated with a significantly lower chance of receiving NACRT in multivariable logistic regression analysis. 5-yr OS probabilities for patients treated with NACRT, surgery and adjuvant CRT, surgery alone, and definitive CRT were 72.4%, 70.9%, 44.9% and 48.8%, respectively. Conclusions: Utilization of NACRT prior to surgery in US patients diagnosed with locally advanced rectal cancer has substantially increased over the past decade. However, only about half of these patients currently receive the standard therapy as recommended by national guidelines, and there may be social and economic barriers to receiving the standard of care. Tri-modality therapy is associated with the best outcomes for these patients, and surgery alone or definitive chemo-radiation should only be reserved for patients unable to tolerate tri-modality therapy.
The association of chronic kidney disease and microalbuminuria with heart failure with preserved vs. reduced ejection fraction
Authors: Matthew Nayor, Martin G. Larson, Na Wang, Rajalakshmi Santhanakrishnan, Douglas S. Lee, Connie W. Tsao, Susan Cheng, Emelia J. Benjamin, Ramachandran S. Vasan, Daniel Levy, Caroline S. Fox, Jennifer E. Ho
Journal: European Journal of Heart Failure (2017)