tbuckley/cabot-search huggingface dataset:
Correlation of psychosocial factors (PSF) before and throughout treatment with response to chemotherapy (CTx) in patients (pts) with advanced gastrointestinal (GI) cancers: Does psychosocial status predict tumor remission?
Authors: Anna Maria Offergeld, Anna Drabik, Karin Oechsle, Anja Mehnert, Djordje Atanackovic, Dirk Arnold, Alexander Stein
Journal: Journal of Clinical Oncology (2013)

542 Background: CTx has shown to have a positive impact on improving or maintaining quality of life (QoL) in patients with advanced GI cancers. The role of PSF in relation to objective tumor response (OTR) to CTx is not well described yet. We thus evaluated the predictive value of pretreatment PSF on OTR as well as the continuous evaluation of PSF in regard to OTR throughout treatment. Methods: Eligible pts had metastatic or recurrent GI cancer and were about to receive first- and second-line palliative CTx. QoL, physical symptoms and PSF were assessed by the EORTC QLQ C30, the MSKCC-Symptom Assessment Scale (MSAS), and a modified Brief-COPE before treatment start and after discussing the results of the first follow up OTR assessment. OTR was either classified according to RECIST or using a remission based approach (RA), classifying response as any decrease in size, and no change or progression as non-response. Results: 50 pts (median age 61.8 years, ECOG 0/1/2 12%/62%/26%, 21 female, 40% colorectal, 28% biliopancreatic, 24% esophagogastric, 78% 1 st line CTx) were enrolled. OTR was 32% partial response, 50% stable disease and 18% progressive disease according to RECIST, and 60% response vs. 40% non-response according to RA. Interestingly, patients responding (RECIST and RA) to CTx had better role/emotional/cognitive functioning, mental state, global distress index, active coping, positive reframing, and belief in control over their lives, and less acceptance of their disease before treatment. PSF significantly predicted response (RA) to CTx, even if adjusted for age, cancer type, and line of treatment (p&lt;0.05). During course of treatment, PSF remained largely unchanged in responders, whereas non-responders loose belief and confidence in control, safety and equity and tend to increased denial (RECIST and RA). Those findings were more pronounced using the RA classification than RECIST. Conclusions: Pretreatment PSF seem to have predictive value for response to CTx in GI cancer patients. PSF changes in non-responding patients may be an early indicator for the need for psychological support in this patient group.
A retrospective review of chemotherapy for patients with small bowel adenocarcinoma in British Columbia.
Authors: Donat Duerr, Susan Ellard, Eric Cormier, Marianne Taylor, Sanjay C. Rao
Journal: Journal of Clinical Oncology (2013)

242 Background: Small bowel adenocarcinoma (SBA) can be associated with a poor prognosis. Randomized phase III trials of chemotherapy are not available due to the rarity of the disease. The Provincial Cancer Registry of the British Columbia Cancer Agency (BCCA) contains data on patients with SBA. Therefore we analyzed the outcome of patients with SBA diagnosed between 1990 and 2008. Methods: Individual charts of 150 patients with a histological diagnosis of SBA were retrospectively analyzed. Epidemiological data as well as information on chemotherapy administered were collected. DFS, PFS and OS were estimated by the Kaplan-Meyer method. Cox proportional hazards regression was performed to model the dependence on different parameters and model selection was done to determine their significance. Results: The baseline characteristics of patients, such as median age at diagnosis (65 years), tumor stage (I-II 33%, III-IV 58%, unknown 9%), and tumor location (duodenum 48%, jejunum 31%, ileum 21%) were consistent with data published in the literature. 55% of our patients had a positive family history of cancer; 29% developed a second tumor. CEA was elevated in 84% of stage IV patients, while it was normal in 85% of stage I-III patients. The DFS of 28 patients treated with adjuvant chemotherapy was identical to that of 47 patients without. However prognostic factors such as nodal status were not well balanced in the two groups. In the palliative setting patients treated with polychemotherapy (20 patients) had a statistically better OS than patients treated with monochemotherapy (12 patients) (p= 9.31e-06). Conclusions: Our study suggests a survival benefit for advanced-stage SBA patients treated with poly- versus monochemotherapy. However it should be taken in account that this is a retrospective analysis with several potential confounders. Nevertheless our study adds support to the body of evidence that chemotherapy may be beneficial for patients suffering from SBA, at least in the palliative setting.
Preliminary decision-tree analysis of costs to payors associated with a pancreatic multidisciplinary clinic.
Authors: Shereef M. Elnahal, Aaron Tyler Wild, Hao Wang, Christopher Lee Wolfgang, Timothy M. Pawlik, Joseph M. Herman
Journal: Journal of Clinical Oncology (2012)

118 Background: Multidisciplinary clinics (MDC) are well-established formats for delivering thorough oncologic evaluation and treatment. Although much evidence identifies an association between MDCs and superior clinical outcomes, their effect on total costs to payors is not well described. We performed a preliminary decision analysis of likely costs associated with a pancreatic MDC versus other settings, referring to known changes in diagnosis resulting from our pancreatic MDC (Pawlik, Ann Surg Oncol.2008; 15(8):2081-8). Methods: We extracted cost data from previous decision-analyses to determine expected cancer treatment costs for patients with resectable (Ljungman, World J Surg. 2011; 35:662-670), locally advanced (Murphy, Cancer. 2011;118:1119-1129), and metastatic disease (Attard. J Clin Oncol. 2012 [suppl 4; abstr 199]), using the most updated studies available. We then mapped these costs to a decision-analysis, modeling staging patterns that change after referral to the MDC. The expected cost of each disease stage was multiplied by its frequency of occurrence for both scenarios. A unique Markov analysis with consistent assumptions was not available at submission, but will be at the time of the meeting. Results: From the literature, an initial diagnosis of resectable disease was associated with the highest cost, and metastatic disease with the lowest. The percentage of patients managed for each disease stage in both clinic settings are indicated in the table. Because the MDC scenario resulted in a lower frequency of resectable and a higher frequency of metastatic staging at initial diagnosis, costs were 4.7% lower in the MDC scenario. Conclusions: In this preliminary analysis, the MDC showed potential to achieve up to 4.7% in cost-savings over treatment in conventional clinic settings, suggesting that the MDC setting for pancreatic cancer may be cost-saving to payors. [Table: see text]
A novel auditing procedure for an oral chemotherapy process improvement project.
Authors: Adam Bursua, R. Alejandro Sica, Katherine Sencion, Amer Sidani, Christina Haaf, Diana Sullivan, Neeta K. Venepalli
Journal: Journal of Clinical Oncology (2016)

164 Background: A process to standardize ordering, documentation, and administration of inpatient oral chemotherapy was implemented at the University of Illinois Hospital and Health Sciences System. The process requires oncology clinician review and endorsement of inpatient oral chemotherapy drug orders via an oral chemotherapy note within the electronic health record. Pharmacists are instructed to reject oral chemotherapy drug orders that lack this required documentation. A novel auditing procedure was established in order to track adherence to these new requirements and provide real time and adaptable feedback to front-line staff critical to the project’s success. Methods: To support continuous quality improvement (QI) with this project, an auditing tool was developed in REDCap, a secure, web-based data management application. The auditing tool was originally developed as a traditional web-based data collection instrument with the primary purpose of tracking performance. By utilizing more advanced features offered by the REDCap platform, the auditing tool generated automated follow-up surveys to pharmacists involved in non-adherent outlier cases. The survey solicited information on the root cause of non-adherence, and based on the end-user response, provided adaptable continuing education tailored to this root cause. Results: Between June and September 2015, a total of 67 orders for oral chemotherapy were audited. Compliance with process improvement requirements was noted in 58%, 100%, 78%, and 93% of cases in June, July, August, and September, respectively. Outlier surveys were sent to 12 pharmacists in the non-adherent cases; of 11 responses, the most common response reflected an unfamiliarity with the process. Following targeted education, through September 2015, no single pharmacist has been involved in more than one non-adherent case. Conclusions: The novel auditing tool supported the continuous quality improvement process by engaging front-line staff, generating automated and real time surveys for outlier responses, and providing targeted and personalized education aimed at resolving the root cause in non-adherent cases. As such, it can be applied towards any REDCap QI projects.
Toxicity and outcomes of adjuvant chemoradiotherapy in patients with resected gastric adenocarcinoma
Authors: Z. Kassam, J. Ringash, J. Brierley, C. Swallow, M. Moore, J. J. Knox, L. Siu, R. Wong, B. Cummings, A. Oza
Journal: Journal of Clinical Oncology (2005)

4157 Background: The Intergroup 0116 study showed a survival benefit with adjuvant chemoradiotherapy (CRT) for resected gastric cancer using conventional 2D planning, but with significant toxicity. In an attempt to reduce toxicity, CRT with a 5 field conformal technique has been used since October 2000 at Princess Margaret Hospital. Outcomes are reported. Methods: Patients with resected gastric or gastro esophageal junction (GEJ) adenocarcinoma, PS ≤2, stage 1B to IV (M0), were treated using 5 cycles of 5FU/leucovorin chemotherapy and 45Gy/25 fractions concurrent with cycle 2 and 3 as per the Intergroup 0116 study. Retrospective analysis on the 1st 50 patients is reported. Acute toxicity was scored using CTC v3.0. Results: Patient characteristics: mean age 54.5 years (21.6 -74.8); M: F 62%: 38%; Site: stomach 92%, GEJ 8%. Surgery: total 16%, subtotal 22%, partial distal 40%, other 22%; RO: R1 resection 98%: 2%. UICC stage IB 20%, II 34%, IIIA 36%, IIIB 2%, IV (M0) 8%. Toxicity grade 3 and 4: upper GI 36%, lower GI 2%, hematological 38%, all types 52%. One patient died of neutropenic sepsis. 60% of patients completed CRT. 38% did not complete chemotherapy, 36% required delays in chemotherapy, 30% required dose reductions; 16% required reductions and delays. 10% did not complete radiotherapy. Median follow up was 27.5 months (4.5- 49.5). Eighteen (36%) patients have relapsed (5 locoregional relapse (LR), 8 LR and distant disease, 5 distant disease alone). Fifteen patients (30%) have died of recurrent disease. Median time from diagnosis to 1st relapse was 15.9 months (5.9–34) and diagnosis to death was 20.0 months (6.9–37.9). Overall and progression free survival was 86% and 84% at 1 year. Median survival has not been reached. Conclusions: Despite use of conformal radiotherapy techniques, adjuvant CRT for gastric cancer has significant toxicity. Early results are comparable to the Intergroup 0116 study. We are currently conducting a phase I/II trial using a modified chemotherapy protocol of infusional 5FU and cisplatin in an attempt to reduce toxicity. No significant financial relationships to disclose.
Stratification of patients with neuroblastoma for targeted ALK inhibitor therapy.
Authors: D. Weiser, M. Laudenslager, E. Rappaport, E. Carpenter, E. F. Attiyeh, S. Diskin, W. B. London, J. M. Maris, Y. P. Mosse
Journal: Journal of Clinical Oncology (2011)

9514 Background: Mutations in the ALK proto-oncogene are the major cause of hereditary neuroblastoma (NB), can be somatically acquired, and may offer a tractable therapeutic target for a subset of patients. Methods: We identified 1,604 paired constitutional and tumor DNA samples from patients representative of the natural spectrum of NB for comprehensive evaluation of ALK genomic status. This set has complete annotation of clinical covariates and patient outcome, and provides sufficient power to identify clinically relevant ALK aberrations within each NB risk group. We performed DNA sequencing of the ALK kinase domain and defined ALK copy number (CN) status using quantitative PCR. For each tumor where a somatic mutation was identified, we sequenced matched germline DNA, allowing us to understand the frequency of hereditary predisposition to NB. Results: Mutations were discovered in 126/1,604 (7.9%) primary NB tumor samples distributed across the spectrum of phenotypes. Mutations at R1275 were most common (n=54) followed by F1174 (n=39) and F1245 (n=15), with those 3 locations accounting for 86% of all mutations. I1170 and I1171 were identified twice and 17 other previously unidentified mutations were seen only once. Work is ongoing to determine the functional significance of these mutations, as is evaluation of matched germline DNA. We found a statistically significant higher number of ALK mutations in high-risk versus low-risk cases (p=0.018) and in cases with MYCN amplification (p=0.031). There was no significant difference between other risk stratification covariates including age (< or > 1 year, p=0.066), histology (p=0.103) and ploidy (0.922). ALK CN gain was found in 197/1345 (14.6%) samples, while those with amplification were identified in 24/1345 (1.8%) and almost exclusively seen concurrently with MYCN amplification. CN gain was seen more frequently in high-risk, as compared with low- and intermediate-risk, disease (p<0.01). Conclusions: Combining ALK mutation and CN data overall and within each risk group and correlating this with other genetic factors, clinical phenotype, and patient outcome will allow us to determine the clinical significance of ALK mutations in NB and develop strategies for future clinical trials.
Pre-Treatment p27 and Bcl-6 Staining Levels Correlate with Response to Bortezomib in Non-Hodgkin Lymphoma: Results from a Tissue Microarray Analysis
Authors: John Gerecitano, Sivaraman Gounder, Julie Feldstein, Shahiba Ogilvie, Dorothy Lin, Junting Zheng, Zhigang Zhang, Alice McDonald, George Mulligan, Owen A. O’Connor
Journal: Blood (2007)
Medical therapy for renal cell cancer with pancreatic metastases: Experience of the Gustave Roussy Institute.
Authors: Ludovic S. Doucet, Lisa Derosa, Laurence Albiges, Christophe Massard, Yohann Loriot, Karim Fizazi, Bernard J. Escudier
Journal: Journal of Clinical Oncology (2015)

503 Background: The prognosis of renal cell carcinoma (RCC) patients with pancreatic metastases has been reported to be better amongst patients with metastatic disease in several series. However, the benefit of medical treatments, especially antiangiogenic (AA) therapy, is still poorly reported. Methods: We retrospectively reviewed clinical outcomes of RCC patients with pancreatic metastases treated with systemic treatments between 2000 and 2014. Results: Eighty-four patients (pts) were recorded, among which 24 underwent local treatment of pancreatic metastases (83% surgery). Clear cell histology accounts for 92%. At the initiation of systemic treatment, prognostic score according to IMDC was good, intermediate, or unknown in 36%, 50%, and 13% respectively. Median overall survival (OS) was 83,2 months (mo) (55.6-29.4). Median OS was 127 mo (106.6-not reached [NR]) for patients who underwent a local treatment on the pancreas vs. 56.5 (39.8-NR) for those who did not (p=0.04). Cytokines used as first-line systemic therapy (n=27, 52% interleukin-2-based, 22% good prognostic group, 59% intermediate, 19% unknown) yielded an overall response rate (ORR) of 26%, a median treatment duration of 5.4 months (mo) (4.7-5.9) and a time to treatment failure (TTF) of 14.5 mo (12-32.2). Patients who received AA (n=77, previous cytokines 25%) showed, for the first use of AA, an ORR of 61%, with a median treatment duration of 11.5 mo (9-14.7) and a TTF of 18.2 mo (12.4-25.8). OS from the time of first systemic therapy was 107 mo (63.8-140.4) in patients who received AA vs. 30 mo (5.4-NR) in those who did not (p=3.10-5). Conclusions: This study confirms the more favorable prognosis of patients with pancreatic metastases from RCC. ORR to both cytokines and AA is higher than that observed in a general population of patients with metastatic RCC. The molecular basis for this observed better outcome deserves further investigation.
ASCO research program quality assessment tool: Basics for a quality community-based research site.
Authors: Patricia A. Hurley, Renee Yvonne Smith, Nicholas J. Robert
Journal: Journal of Clinical Oncology (2014)

97 Background: In 2008, ASCO published a statement to identify minimum standards and exemplary attributes of clinical trial sites. Recommendations were made to assist with the development and implementation of high-quality research programs. Based on feedback from an ASCO needs assessment survey, ASCO’s Community Research Forum (CRF) sought to develop a tool to help community-based research sites exceed the minimum standards of conducting clinical research, and to identify important components for an internal quality assurance program. Methods: A tool was developed to incorporate elements of ASCO publications on minimal standards and exemplary attributes of research sites. The tool was designed to assist community-based research sites with the development and implementation of an internal quality assurance program. A checklist was also developed to help sites easily conduct an assessment of their program. Community-based researchers provided feedback on the tool’s content and utilization. Feedback was incorporated and the tool was released for widespread use in March 2014. Results: The tool was very well received by reviewers. All reviewers indicated that the level of detail of the tool was sufficient; 94% indicated that it presented realistic expectations, in terms of resources required to implement; and 81% indicated that it would be valuable for conducting a quality assessment of their research program. As of July 2014, the tool was downloaded by over 150 practices from 8 different countries and early feedback continued to be favorable, particularly from small and/or new research programs. Conclusions: Many community-based research programs do not have the resources to support an effective quality assurance program and rely heavily on external audits. The ASCO Research Program Quality Assessment Tool provides self-directed continual process improvement to help community-based research sites create an internal quality assurance program and exceed minimum standards of conducting clinical research. The CRF will learn more from users of the tool about the quality of research programs and processes, and key quality metrics. The tool is available for download at www.asco.org/communityresearchforum.
CCP score and risk stratification for prostate cancer patients at biopsy.
Authors: E. David Crawford, Neal Shore, Peter T. Scardino, John W. Davis, Jonathan D. Tward, Lowndes Harrison, Kelsey Moyes, Lisa Fitzgerald, Steven Stone, Michael K. Brawer
Journal: Journal of Clinical Oncology (2014)

47 Background: New prognostic markers for prostate cancer play an important role in addressing the controversies of over diagnosis and treatment. The cell cycle progression score (CCP) (Prolaris, Myriad Genetic Laboratories, Inc.) is a new RNA-based marker, which improved the prediction of prostate cancer aggressiveness in eight separate cohorts. Each one-unit increase in CCP score corresponds with approximately a doubling of the risk of the studied event (recurrence or death from prostate cancer). In this analysis, we characterized the CCP score distribution from our initial CCP signature commercial testing. Methods: Our current laboratory database was evaluated for patients whose biopsy was analyzed with the CCP test and whose clinicopathologic data was collected by the ordering physician. Formalin fixed, prostate biopsy tissue from 1,648 patients diagnosed with adenocarcinoma ordered by more than 300 physicians were analyzed. The CCP score was calculated by measuring the RNA expression of 31 cell cycle progression genes normalized to 15 housekeeping genes. Results: Of the 1,648 samples that contained sufficient carcinoma (more than 0.5mm linear extent), 1,604 (97.3%) provided quality RNA for analysis. This retrospective analysis showed a normal distribution for the CCP score ranging from −2.9 to 3.1. Correlation with Gleason score was r=0.35. A relative classification of cancer aggressiveness based on CCP of approximately1,200 patients from multiple cohorts was developed to interpret how the patient’s CCP score compared to that of patients within the same AUA risk category. The thresholds between each of the five intervals are one unit of CCP score apart, with the "consistent" interval centered at the median CCP score. Based on the CCP score, 27.9% of men had a less aggressive cancer compared to the clinicopathologic prediction and were assigned to a lower risk group while 27.6% of patients had a more aggressive cancer. Conclusions: The CCP signature test is a novel assay that can improve risk stratification for men with prostate adenocarcinoma independent of the Gleason score and prostate-specific antigen level. Over 50% of men initially tested in the commercial assay were assigned to a different risk category than predicted by clinicopathologic features alone.
Medical informatics: Documenting quality of end-of-life oncologic care.
Authors: Jennifer Carrie Obel, Diletta Orlando-Brooks, Chad Konchak, Abigail Harper, Michael Marschke, Maureen Kharasch, Bruce Brockstein, Michael Raymond, Ari Robicsek
Journal: Journal of Clinical Oncology (2012)

311 Background: NorthShore University HealthSystem has created, via the Electronic Health Record (EHR), quarterly reports to measure quality of care for patients who die of cancer during the reporting time frame. Specific reports for 22 oncology providers and measurements across the population will be derived. Reports are automated with seamless data retrieval based on algorithms designed through the use of discrete, searchable entry fields. Goals include establishing a pre-report baseline, educating oncologists about their terminally ill patients’ outcomes and documenting improvements in end-of-life care through educational initiatives for patients and providers. Methods: To standardize reporting, a cohort of terminally ill patients was created based on QOPI definitions (Denominator). A set of quality end points to describe cancer utilization near the end of life was added as Numerator Values, to establish rates of potential inappropriate use of resources. Results: The OP, oncology EHR was changed to allow ADN/CSO placement that carry over to the IP EHR (hyperlink in patient header). The average time between a patient’s first OP, oncology visit and when the oncologist placed ADN/CSO will be calculated. ADN/CSO reports will be stratified by a patient’s age, race and oncologist. Each separate report will be validated prior to the “go live” phase. Conclusions: These metrics allow routine hypothesis generating queries of end-of-life care to assess compliance with quality measures. [Table: see text]