tbuckley/cabot-search huggingface dataset:
PI-REAL: A study of informed consent (IC) communication in real-time during phase I clinical trial encounters.
Authors: Manish Sharma, Fay J. Hlubocky, Mark J. Ratain, Mark Siegler, Christopher Daugherty
Journal: Journal of Clinical Oncology (2015)

22 Background: Advanced cancer patients (ACP) in phase I clinical trials are unable to recall significant elements of IC, yet the actual verbal and non-verbal content of trial discussion between oncology fellows and ACP consenting in real time to such trials has not been well described. Methods: Phase I Communication in Real Time Fellow-ACP Encounters (PI-REAL) study is an evidence-based intervention designed to improve communication about phase I clinical trial IC. ACP completed follow-up questionnaires after new patient visits to assess understanding of IC elements, such as research purpose. Video recordings were analyzed using CanCode for verbal and non-verbal skills associated with IC elements. Results: To date, 61 ACP-fellow clinical encounter video recordings were available for analysis. Average length of encounters: 45.4 min (range: 5.7-87.8 min). ACP demographics included: median age 60y (33-83); 55% male; 89% Caucasian; 55% median income &gt; $60,000. Fellows were coded as verbally disclosing: 1. Purpose of phase I trial as dose-determining in 49% of encounters; 2. Physical risks of trial in 75% of encounters; 3. Potential benefits (e.g. improved QOL) gained by ACP participation in trial in 70% of encounters; 4. Alternatives to trial entry (e.g. other trials, palliative/supportive care) in 55% of encounters. A significant association existedbetween coded fellow empathic statements and ACP subsequently recalling the purpose of the trial as dose-determining, with 72% of subjects who heard empathic statements identifying “dosage” compared to 10% of subjects who did not (72% v. 10%, p &lt; 0.05). Regarding non-verbal skills, fellows: leaned toward ACP in 64% of encounters; observed ACP face directly in 72% of encounters; had relaxed body posture in 55% of encounters; and displayed responsive facial expressions in 77% of encounters. Conclusions: Empathic statements by fellows appear to be associated with improved ACP understanding of Phase I trial research purpose as dose-determining. Additional encounters continue to undergo video recording and analysis.
Phase II trial of cetuximab in patients (pts) with metastatic and/or locally advanced soft tissue and bone sarcomas
Authors: H. T. Ha, R. Chugh, K. A. Griffith, D. G. Thomas, S. M. Schuetze, D. R. Lucas, J. S. Biermann, M. M. Zalupski
Journal: Journal of Clinical Oncology (2008)

10537 Background: Cytotoxic therapy has resulted in limited improvement in outcomes of pts with advanced sarcoma. The epidermal growth factor receptor (EGFR) pathway plays a role in tumorigenicity and is expressed in many sarcoma subtypes. Blockade of EGFR in certain sarcoma cell lines has decreased cell growth and increased tumor apoptosis. Therefore, we conducted a phase II trial of the anti-EGFR monoclonal antibody cetuximab in EGFR positive(+) and negative sarcoma and report here results of the EGFR+ group. Methods: Pts ≥ 16 years old with advanced sarcoma who progressed on ≥ 1 prior therapy were eligible. Cetuximab was administered at 400mg/m2 on day 1 and 250mg/m2 during subsequent weekly infusions. A cycle was defined as 4 weeks of therapy with radiographic assessment every 2 cycles. The primary objective was 4-month progression-free survival (PFS) rate in EGFR+ pts. Using a Simon two-stage design and a 10 and 30% rate as the null and alternative hypothesis, 22 pts were to be accrued in the first stage, with an additional 11 pts if ≥ 3 pts met primary endpoint. EGFR+ was defined by immunohistochemistry (IHC) as 1+, 2+, or 3+. Secondary objectives included assessment of response rate and evaluation of molecular alterations in EGFR pathway by IHC and mutational analysis using PCR/direct sequencing. Results: 22 evaluable pts with EGFR+ sarcoma were enrolled. Subtypes included synovial (32%), liposarcoma (27%), malignant fibrous histiocytoma (18%), leiomyosarcoma (14%), myxofibrosarcoma (4%), and malignant peripheral nerve sheath (4%). The median number of prior therapies was 2; the median number of cycles was 2; the median PFS was 52 days (95% CI: 48 - 54). One patient was free of progression for over 4 months. No objective responses were seen. Two patients withdrew from study due to ileus and acute renal failure. MAP-K, PTEN, and phospho-EGFR staining revealed variable expression without discernible pattern. No EGFR mutations were detected in exons tested in available specimens. Conclusions: Cetuximab has minimal activity in advanced EGFR+ sarcoma, and further investigation as a single agent is not indicated. Cetuximab in combination with cytotoxic therapy or following definition of specific molecular abnormalities in sarcoma requires further study. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bristol-Myers Squibb
Evaluation of PET response to neoadjuvant therapy for patients with gastric and GEJ adenocarcinoma.
Authors: Jonathan M. Hernandez, Volkan Beylergil, Debora Goldman, Heiko Schöder, Mithat Gonen, Laura H. Tang, Robert J. Downey, Manish A. Shah, Vivian E. Strong, Daniel G. Coit
Journal: Journal of Clinical Oncology (2014)

114 Background: The implications of response to neoadjuvant treatment as measured by PET remain poorly defined for patients with gastric and gastro-esophageal junction (GEJ) adenocarcinoma. Our aims are to determine if changes in PET avidity correlate with histologic response, and to determine the best predictor(s) of disease-free survival (DFS) and overall survival (OS). Methods: We reviewed a prospective database to identify patients with gastric and GEJ adenocarcinoma who were evaluated with PET imaging prior to andfollowing neoadjuvant treatment. Spearman correlation and Cox proportional hazards were utilized. Results: Since 2002, 216 patients of median age 63 years met our criteria. At last follow-up (median 22 months, range: 0 - 119), 118 patients recurred or died. The median DFS and OS for expired patients were 7.5 months (range: 0-62) and 14 months (range: 0 - 69), respectively. Between baseline and follow-up PET imaging (median 63 days, range: 15 - 454), 170 patients were treated with chemotherapy and 46 patients with chemoradiotherapy. The median change in SUV was 43% (range: -300 - 100.0%) and the median histologic tumor response was 50% (range: 0 - 100%). No association was identified with the use of chemoradiation (as compared to chemotherapy alone) and change in SUV (p=0.8). We identified a significant relationship between change in SUV and histologic response (r=0.32, p&lt;0.01). Furthermore, the change in SUV was related to both DFS and OS on univariate analysis, as was tumor response and pathologic stage (Table). On multivariate analysis only pathologic stage, and specifically the presence of lymph node metastases, was related to DFS (p&lt;0.01) or OS (p&lt;0.01). Conclusions: Following neoadjuvant therapy for gastric and GEJ adenocarcinoma, PET response is prognostic, although pathologic nodal status is the best predictor of outcome. [Table: see text]
Patterns in<i> KRAS</i> testing and EGFRi therapy across lines of treatment for metastatic colorectal cancer in Canada: A retrospective analysis.
Authors: Hagen F. Kennecke, Jean Alfred Maroun, Petr Kavan, Nathalie Aucoin, Felix Couture, Melanie Poulin-Costello, Brad Gillesby, Scott R. Berry
Journal: Journal of Clinical Oncology (2016)

665 Background: Selection and sequencing of treatment regimens for individual metastatic colorectal cancer (mCRC) patients is governed by the goals of maintaining reasonable quality of life while extending survival. The timing of KRAS testing and its effect on EGFRi therapy is poorly described. The goals of this analysis wereto describe rates and timing of KRAS testing relative to EGFRi therapy for Canadian patients diagnosed with mCRC. Methods: A retrospective chart review conducted at 6 Canadian centres included patients diagnosed with mCRC from Jan 1, 2009 onwards, who commenced 1 st -line systemic treatment for mCRC between Jan 1–Dec 31, 2009. Information on the proportion of patients who received 2 nd , 3 rd , or subsequent lines of systemic therapy for mCRC was determined and the rates and timing of KRAS testing was ascertained. Results: 200 patients commenced 1 st -line therapy and the median age was 62 yr; 78% had mCRC at the time of diagnosis. The proportions of patients who started 2 nd , 3 rd , and 4 th lines of systemic therapy were 70%, 30%, and 15%, respectively. 103 (52%) patients had KRAS testing; 6%, 18%, 57%, 16%, 2%, and 1% of patients were tested at diagnosis or before the 2 nd , 3 rd , 4 th , 5 th and 6 th lines of therapy, respectively. Median time from testing to EGFRi treatment was 105 (range, 7–1192) days, and varied by site. The frequency of KRAS testing for patients ranged from 30%–70% across study sites; across provinces, the frequency of testing ranged from 46%–60%. 38/68 (56%) of patients with wt KRAS tumors received EGFRi; 31 (46%) patients received EGFRi therapy as next therapy following KRAS testing. 19 (28%) died and 4 were lost to follow-up within 120 days of KRAS testing with no other therapy. 2 additional patients with unknown KRAS status received EGFRi (1 without KRAS testing; 1 undetermined). Conclusions: KRAS testing occurred after starting 2 nd line in 76% of cases and varied by site and province. About half of patients underwent KRAS testing and 56% of those patients with wt KRAS tumors received an EGFRi. The short time interval between (K)RAS testing and EGFRi therapy may point to the need for earlier testing if EGFRi therapy is to be used in earlier lines of therapy.
Effect of a spiritual care training program on patient quality of life and spiritual well-being.
Authors: Grace Meijuan Yang, Yung Ying Tan, Yin Bun Cheung, Dennis Dignadice, Amy Lim, Weng Kit Lye, Lola Ng, Tan Ying Peh, Akhileswaran Ramaswamy, Sarasvathy Suppiah, Angela Tan, Yee Pin Tan, Zhi Zhen Xu, Alethea Yee, Xia Zhu, Patricia Neo
Journal: Journal of Clinical Oncology (2015)

235 Background: Spiritual care (SC) is a vital part of palliative care (PC) but its provision is still not routine. We studied the effect of a SC training program for staff on patient quality of life (QOL) and spiritual wellbeing (SPS), as measured by the Functional Assessment of Chronic Illness Therapy – Spiritual Well-Being (FACIT-Sp). Methods: This study was conducted at two sites: a PC consultative service in an acute hospital and a home PC service. The program comprised a 30 min training session for nurses and doctors on using the FICA tool for spiritual assessment and subsequent referral to a medical social worker (MSW) if needed, and a 60min training session with the MSWs on how to manage spiritual problems. A prospective cluster-controlled trial was done across 7 clusters. FACIT-Sp comprises 27 items for QOL (FACT-G) in the 4 domains and 12 items for SPS. This was administered at T1: upon referral to the palliative care service and T2: after 3 clinical visits by the PC team (doctor, nurse or MSW visits). Results: QOL data from 142 participants (69 intervention and 73 control) were analyzed. There appeared to be some benefit of the program on all domains of QOL as well as SPS, although only the FACT-G score achieved statistical significance. After further statistical adjustment for scores at T1 (to account for any regression to the mean), FACT-G score remained practically significant (p value 0.076). Conclusions: A brief SC training program for staff (30 min for nurses and doctors, 60 min for MSWs) appeared to result in some improved QOL and SPS for patients. However, a larger sample size will be needed to estimate the degree of benefit more accurately. [Table: see text]
Prognostic utility of a multi-gene signature (the cell cycle proliferation score) in patients with renal cell carcinoma (RCC) after radical nephrectomy.
Authors: Todd Matthew Morgan, Rohit Mehra, J. Stuart Wolf, Placede Gangnang Fosso, Brian Orr, Shulin Wu, Zaina Sangale, Steven Stone, Chin-Lee Wu, Adam S. Feldman
Journal: Journal of Clinical Oncology (2016)

555 Background: There are currently no RCC biomarkers being routinely used in the clinic, and prognostic nomograms rely almost entirely on tumor size, stage and age. There is a critical need for improved prognostic discrimination given the increasing awareness that some patients may be managed with active surveillance, while others with higher risk disease might benefit from adjuvant therapy following surgery. We hypothesized that a previously developed multi-gene proliferation signature would predict long-term oncologic outcomes in surgically resected RCC. Methods: The cell cycle proliferation (CCP) score was derived after radical nephrectomy in 305 patients who were treated at a single center from 2000 to 2007 for clear cell, papillary or chromophobe RCC with localized disease (N0M0). Sixty-four percent of the cohort had stage I disease. Outcomes were either disease recurrence (local or metastatic), or disease specific mortality (DSM). Association with outcomes was evaluated by CoxPH survival analysis and likelihood ratio tests. Hazard ratios (HR) are given for one-unit increase in CCP score (equivalent to a doubling of gene expression). Results: Patient data were censored at 5-years of follow-up, by which time 32 patients (10%) recurred and 16 (5%) died of disease. The median CCP score was 0.095 (IQR -0.50 to 0.60). In univariable analysis, CCP score was a significant prognostic variable for both recurrence (p &lt; 10 -4 ) and DSM (p &lt; 10 -5 ). After adjusting for clinical variables including tumor size, stage, and grade, the CCP score HR for recurrence was 1.74 (95% CI (1.14, 2.65)), and for DSM was 2.59 (95% CI (1.43, 4.67)). There was no interaction between CCP and any clinical variable. A prognostic model combining clinical and molecular information will be presented along with external validation in a second cohort (N~400). Conclusions: The CCP score appears to be a significant and independent predictor of key long-term oncologic outcomes in patients who have undergone nephrectomy for RCC, providing prognostic information beyond what is available from clinical parameters. Once validated, the CCP score may have utility in the clinical management of patients with RCC.
Health care satisfaction among older cancer survivors.
Authors: Michael T. Halpern, Matthew Urato, Erin E. Kent
Journal: Journal of Clinical Oncology (2016)

18 Background: Cancer survivors experience unique challenges in receiving needed health care services. There is little information on individual-level factors affecting satisfaction with health care services among survivors. Methods: This study used satisfaction ratings provided by cancer survivors in the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Medicare Survey linked to data from NCI’s SEER Program (SEER-CAHPS). CAHPS data on self-reported general and mental health status and five composite measures of satisfaction with health care interactions (customer service, doctor communications, getting care quickly, getting needed care, and getting prescription drugs) were linked to patient sociodemographic and cancer characteristics from SEER. Medicare beneficiaries diagnosed with cancer in SEER regions 1997-2011 participating in CAHPS Medicare Survey &gt; 1 year after cancer diagnosis were included. The study included individuals alive &gt; 1 year following CAHPS completion, at least age 66, and diagnosed with non-metastatic breast, colorectal, lung, or prostate cancer. Analyses were performed separately by cancer type. Results: Among 23,969 cancer survivors with linked SEER-CAHPS data, higher general health was associated with higher satisfaction for all survivors except those diagnosed with lung cancer; higher mental health predicted higher satisfaction only among lung and prostate cancer survivors. Higher education predicted lower satisfaction among breast cancer survivors. Non-white survivors generally had lower satisfaction, although results were mixed. Among breast and prostate cancer survivors, fee-for-services Medicare (vs. Medicare advantage) was associated with lower customer service satisfaction but higher satisfaction with getting prescription drugs. Breast cancer patients diagnosed with stage 3 disease reported greater satisfaction than did those diagnosed at stage 1. Conclusions: Factors associated with health care satisfaction ratings for cancer survivors showed substantial variations by cancer types. Programs to improve survivorship care and outcomes need to be tailored to survivors’ clinical and sociodemographic characteristics.
Surgical, histopathologic, and patient-related factors associated with isolated brain metastases (IBM) in patients with stages I-IIIA non-small cell carcinoma (NSCLC) undergoing surgical resection in comparison with patients developing other distal metastases (ODM).
Authors: J. M. Varlotto, L. N. Medford-Davis, J. Shelkey, J. C. Flickinger, A. Recht, M. Nikolov, M. Reed, J. Toth, M. M. DeCamp
Journal: Journal of Clinical Oncology (2011)

7542 Background: To assess surgical, histopathologic, and patient-related factors associated with isolated brain metastases (IBM) in patients with stages I-IIIA non-small cell carcinoma (NSCLC) who underwent a definitive surgical resection ± adjuvant chemotherapy as compared to patients developing other distal metastases (ODM). Methods: 593 consecutive patients who underwent a definitive surgical resection ± adjuvant chemotherapy for NSCLC from 2000–2007 were qualified for analysis if they did not receive any adjuvant/neo-adjuvant radiotherapy, had at least three months of follow-up, and did not have a history of other cancers within 5 years of the diagnosis of their NSCLC. Univariate and multi-variate analyses were performed to assess risk factors for IBM as the only site of metastatic relapse and compare these risk factors to those of patients with ODM. Results: After a median follow-up of 33 months, 92 patients (25 IBM and 67 ODM) presented with distal metastases. Median time to the development of IBM and ODM was 10 (range 1-42) and 12 months (range 1-74) respectively. IBM was the most common site of isolated distal failure (DF) occurring with a rate of 3, 5, and 9% at 1, 2, and 4 years. ODM occurred with a rate of 6, 11, and 21% at 1, 2, and 4 years. Risk factors for IBM included peri-neural invasion, adenocarcinoma, pneumonectomy, weight loss, and post-surgical transfusion by multivariate analysis. Risk factors for ODM include presence of hemoptysis, receipt of post-surgical transfusion, N stage, number of positive nodes by multi-variate analysis. Conclusions: IBM was the most common cause of isolated distal failure in patients undergoing surgical resection of NSCLC. Other than post-surgical transfusion, risk factors for IBM are different than those for ODM. Patients with adenocarcinoma, especially those with peri-neural invasion should be considered for routine radiographic brain surveillance after undergoing surgical resection of NSCLC.
Impact of bleomycin (BLM) administration on the development of pulmonary toxicity in advanced germ cell tumors (GCT) receiving first-line chemotherapy (CT): A meta-analysis of randomized studies.
Authors: Karima Oualla, Rosalba Miceli, Guru Sonpavde, Nicola Nicolai, Daniele Raggi, Patrizia Giannatempo, Roberto Boffi, Alessandra Busia, Luigi Mariani, Roberto Salvioni, Andrea Necchi
Journal: Journal of Clinical Oncology (2016)

482 Background: Little is known about the impact of BLM administration on the development of pulmonary toxicity (PT) in patients (pts) with advanced GCT. This information is critical to further enhance the successful delivery of effective and safe CT in these pts. Methods: Literature was searched for randomized trials of 1st-line CT ( ≥ 3 cycles) for GCT. Descriptive statistics were used to summarize data, dichotomized by BLM-containing vs non containing CT. Univariable and multivariable analyses by random effect models evaluated the predictive role of BLM administration on the development of all grade and G3-4 PT, adjusted for the length of follow-up (FUP, continuous), time-frame of treatment ( ≤ 1997 versus &gt; 1997) % of pts with lung metastases (LM), % of primary mediastinal GCT (PMGCT), IGCCCG risk group. Results: 53 arms of 26 phase II and III trials totalling 6,498 pts were selected: 40 with BLM (n = 5,093) and 13 without BLM (n = 1,405). Median % of pts with LM was 44% (range 22-84%) and 31% (19-79%) in BLM-containing and non containing arms (Wilcoxon test p = 0.505). Median % of PMGCT was 15% (range 0-48%) and 2% (0-13%), respectively (p = 0.146). Median BLM total dose and No. of administrations were 360mg (range 120-375) and 12 (2-24). Median FUP was 52 and 53 months, respectively. The pooled probability of all grade PT was 11.7% (95% CI: 8.4-16.0%) and 1.7% (95% CI: 0.7-4.2%) in BLM-containing and non containing arms. Univariably, BLM administration was associated with the incidence of both all grade (odds ratio [OR]: 7.57, 95%CI: 2.84-20.18, Wald test p &lt; 0.001) and G3-4 PT (OR: 5.19, 95%CI: 1.57-17.16, p = 0.007). Multivariably, BLM administration was significantly associated with the incidence of all grade PT (OR: 4.14, 95%CI: 1.36-12.59, p = 0.012) and trended to significance for G3-4 toxicity (OR: 2.24, 95%CI: 0.91-5.51, p = 0.080). Conclusions: In this meta-analysis, BLM administration was significantly associated with the development of PT in pts with GCT. The quantification of the magnitude of incidence of PT provided here might be useful to optimize the delivery of non-PEB CT in the 1st-line setting.
Is cerebrospinal fluid cytology a useful test?
Authors: C. M. Zoccoli, O. Zalatimo, M. J. Glantz
Journal: Journal of Clinical Oncology (2011)

2079 Background: Cerebrospinal fluid (CSF) is a valuable diagnostic tool in patients with cancer. Cytology, culture, glucose, and protein are the most routinely performed analyses of the CSF, however these tests are of questionable usefulness when not guided by clinical judgment. Methods: A retrospective analysis of the utility of CSF cytology was conducted. Assessment of the usefulness of this exam was based on the difference between the pre-test probability of disease and the post-test probability of disease, with a test being considered useful if it changed the probability of disease by a clinically informative degree. Patients without cancer (n=403), patients with known cancer without suspicion of neoplastic meningitis (n=41), and patients with known cancer and suspected neoplastic meningitis (n=81) were analyzed separately, and costs incurred by uninformative testing were estimated. Similar analyses were conducted for CSF culture, glucose, and protein exam. Results: The positive likelihood ratio (LR+) and negative likelihood ratio (LR-) for CSF cytology were >106 and 0.33, respectively, in patients without known cancer. Since the prevalence (pre-test probability) of neoplastic meningitis (NM) in this cohort was already very low (0.7%), a negative test decreased the probability of NM to 0.2% (post-test probabilities). In patients with known cancer, +LR (24.3), LR- (0.29). A positive test increased the likelihood of NM from 15% to 81% and a negative test decreased the likelihood of NM to 5%. In patients with known cancer and suspected NM, +LR (> 106 ) –LR (0.048). A positive test increased the likelihood of NM from 26% to 100% and a negative test decreased the likelihood of NM to 1.6%. The percentage of performed tests which were uninformative (true negative) were 99%, 80%, and 74% for a total cost of $110,432. Similar calculations for utility and cost were applied to CSF culture, glucose, and protein. Conclusions: In patients without known cancer, routine CSF cytology is uninformative, inefficient, and costly. In patients with known cancer but without suspicion of NM, routine CSF cytology is more informative and cost effective, but in patients with known cancer and suspected NM, CSF cytology is most informative, and its routine use can be justified.