tbuckley/cabot-search huggingface dataset:
Prognostic role of neutrophil-to-lymphocyte ratio (NLR) in men with metastatic, castration-sensitive prostate cancer (mCPSC) undergoing androgen deprivation therapy (ADT) plus docetaxel (D) chemotherapy.
Authors: Louis Everest, Urban Emmenegger
Journal: Journal of Clinical Oncology (2018)

e17031 Background: There is extensive literature on NLR in castration-resistant prostate cancer (CRPC), however, little is known about the role of NLR in mCSPC. Hence, the primary objective of this study was to analyze the correlation of NLR with time from mCSPC diagnosis to CRPC. Methods: We studied hematological parameters of 58 men with mCSPC undergoing ADT plus D from 06/2014 to 12/2017. NLR was calculated a three time points: before ADT, before D, and following D. The optimal NLR cutoff for each time point was determined using Cutoff Finder. Results: With a median follow-up of 580 days, 23 (39.7%) men progressed to CRPC after a median time of 274 days (range 55-750). NLR above cutoff before ADT and D was associated with prolonged time to CRPC, with a restricted mean survival time (RMST) difference of > 5 months. Conversely, following D NLR below cutoff correlated with longer time to CRPC. Conclusions: Our analyses reveal a differential role of NLR in men with mCSPC undergoing ADT plus D therapy. Accounting for the relatively short follow-up and limited patient number, there is a strong trend correlating elevated NLR before ADT and D with longer time to CRPC. In contrast, the opposite applies to NRL calculated following D. While we are continuously updating our database NLR might emerge as an easy available biomarker identifying men with mCSPC who may benefit from treatment intensification beyond ADT plus D. Time point n = NLR cutoff RMST (months) P-value HR P-value Before ADT 48 3.9 +5.44 0.26 0.57 0.20 Before D 58 3.3 +5.96 0.09 0.47 0.07 Following D 42 3.9 -4.42 0.23 1.88 0.17
P01.110 Elderly patients &gt;65years of age with newly diagnosed Glioblastoma multiforme gain life time from treatment with Tumor Treating Fields and Temozolomide
Authors: G F Guzauskas, B C M Wang, A Kinzel, C Proescholdt
Journal: Neuro-Oncology (2018)

Glioblastoma (GBM) is the most aggressive form of primary brain cancer in adults. The EF-14 trial was the first randomized controlled trial to report a survival benefit for newly diagnosed GBM patients in more than a decade with a survival rate greater than 10% at 5-years. A post hoc subgroup analysis of the elderly (>65 years) EF-14 populationshowed the greatest survival beneft from TTFields in this subgroup (HR = 0.51) and a survival at 5-years of 15% for patients treated with TTFields and maintenance TMZ compared to no survivors in the TMZ alone arm. An integrated survival model was calculated, incorporating Kaplan Meier Data of the subgroup over 65 years GBM patients from the EF-14 Trial with epidemiological data on long-term GBM survival. Future survival benefits were discounted at a rate of 3% (i.e., survival in future years was reduced by 3% per year). We also perfomed sensitivity analyses of the results and compared the results of our integrated survival model to regression based extrapolations of the trial data. Elderly patients treated with TTFields and TMZ achieved an undiscounted mean lifetime survival of 3.66 years compared to 1.32 years for patients treated with TMZ alone, resulting in a gain of 2.34 life years for TTFields plus TMZ. After application of the 3% discount rate for future survival benefits, the resulting life time survival is 3.04 vs. 1.29 life years respectively, resuling in 1.75 incremental life years gained. In the subgroup of elderly patients of the EF-14 Trial treatment with TTFields plus TMZ resulted in a substantial increase of the mean lifetime survival of 1,75 life years compared to treatment with TMZ alone, despite the older age of the patients with a naturally lower potential for long-term survival. These results together with the low incidence of adverse events in the EF-14 trial indicate that it may be appropriate to opt for TTFields treatment in newly diagnosed GBM patients 65 years and older.
Genomic landscape of malignant mesotheliomas.
Authors: Shumei Kato, Brett N. Tomson, Timon P.H. Buys, Sheryl Krevsky Elkin, Jennifer Carter, Razelle Kurzrock
Journal: Journal of Clinical Oncology (2016)

8555 Background: Understanding the genomic landscape of malignant mesothelioma may identify novel molecular drivers of this ultra-rare disease, which can lead to an expanded roster of targeted therapies and clinical trial options for patients with mesothelioma. Methods: We examined the molecular profiles of 42 patients with malignant mesothelioma (including pleural, peritoneal, and pericardial) that were referred by clinicians to be tested in a Clinical Laboratory Improvement Amendments (CLIA) laboratory using next-generation sequencing (NGS) (182 or 236 genes). Results: There were 116 alterations with 92 being distinct. The number of genomic alterations per patient ranged from 1 to 5 (median = 3). No two patients had identical molecular portfolios. The most common aberrations were in BAP1 (BRCA1-associated protein 1) (47.6% [20/42]), NF2 (38.1% [16/42]), and CDKN2A/B (loss) (35.7% [15/42]). BAP1 alterations and CDKN2A/B loss were associated with pleural mesothelioma (odds ratio [OR]: 3.4, p = 0.059 [trend] [BAP1]; OR: 5.8, p = 0.01 [CDKN2A/B]). All 42 patients had a molecular abnormality that was potentially actionable (median = 3 actionable alterations per patient, range, 1 to 5]), and, in 40 patients (95.2%), a Food and Drug Administration (FDA) approved drug was applicable. Conclusions: Each individual with malignant mesothelioma harbored a unique set of genomic aberrations, suggesting that NGS-based profiling of patients will be needed if they are to be optimally matched to cognate treatments. All 42 patients had at least one alteration that was, at least in theory, pharmacologically tractable.
Impact of HPV DNA and p16 on radical chemo-radiotherapy response in oropharyngeal cancer patients
Authors: P. Yadav, N. Kumar, S. Beniwal
Journal: Annals of Oncology (2018)

Background: Incidence of Oropharyngeal Cancer varies greatly worldwide showing an increasing trend. This increasing trend in epidemiology of Oropharyngeal Cancer has been attributed to the infection by human papillomavirus [HPV]. In this study we aimed to determine the impact of the presence of HPV DNA and p16 in oropharyngeal cancer on response to treatment and toxicity in patients receiving radical chemo-radiotherapy at regional cancer center. Methods: 80 patients of squamous cell carcinoma of oropharynx were enrolled. HPV DNA and p16 status of all patients was evaluated using polymerase chain reaction and immunohistochemistry. The selected patients for this study were treated with concurrent chemoradiation therapy with weekly cisplatin. Results: Among 80 cases, 17cases (21.2%) shows positive results for p16 P16 was positive in 64.7 % cases of males and 35.3% cases of female on the other hand in p16 negative cases 84.1% cases were male while 15.9% cases were female. Overall, 83.8% of patients were tobacco users (smoking, n = 30 (44.8%); smokeless, n = 18 (26.9%), both, n = 19 (28.3%)). Tonsils (70%) is the most common site involved. Response of treatment was evaluated after 6 weeks of concurrent chemoradiation. Complete response was observed in 14 patients which were p16 positive and 47 patients which were p16 negative. Partial response in 3 (p16 positive) and 15 patients (p16 negativity). Stable disease was observed in 1 patient (p16 negative) and no cases with progression of disease was evaluated in response to treatment. Evaluation of toxicity was done and toxicity was graded in both HPV positive and HPV negative cases according to CTC. In both p16 positive and negative stomatitis (p = 0.75) was the most common adverse event. Oral stomatitis of Grade 1&2 (100% in p16 +ve and 96.8% in p16 -ve patients) and grade 3&4 (58.8% in p16+ and 49.20% in p16_ patients). Conclusions: We concluded that patients with HPV positive and p16 positive OPSCC show better response to treatment. Risk of severe late toxic effect is low after treatment of oropharynx cancer as due to the escalation of therapy risk of late toxic effects are decreased. This may have implication in doing p16 routinely in clinical practice and implication while considering for treatment de-intensification strategies. Legal entity responsible for the study: Priyanka Yadav, Surender Beniwal. Funding: Indian Council of Medical Research, New Delhi, India. Disclosure: All authors have declared no conflicts of interest.
A retrospective analysis of adult head and neck rhabdomyosarcoma (HN RMS) from 1984-2017.
Authors: Shivali Barot, David Benjamin Shultz, Brian O'Sullivan, Abha A. Gupta
Journal: Journal of Clinical Oncology (2018)

e18089 Background: Head and Neck Rhabdomyosarcoma (HN RMS) in adults is an aggressive and challenging approach to managing malignancy. Our goal was to describe the presentation, treatment, outcomes, patterns of failure, and prognostic factors of HN RMS patients treated at our institution between 1984 and 2017. Methods: A retrospective review of adult ( > 16 years) HN RMS patients registered in the multidisciplinary Sarcoma Clinic who received majority of their treatment at our institution was performed. Survival analyses were performed using the Kaplan-Meier Method. Prognostic variables including age, anatomic location, histologic subtype, radiation, and TNM stage were analyzed in univariate (UVA) Cox analyses. Results: Fifty-eight patients were identified, with a median age of 32 years (ranged 16 to 81); 26 were male. Seventy-six percent of tumors (n = 45) were parameningeal and 88% (n = 51) were > 5cm. Fifty percent of patients (n = 29) had clinical node positive disease and 15% (n = 9) had distant metastases at the time of diagnosis. Local treatment consisted of surgery and radiotherapy (RT) versus RT alone in 9% (n = 5), and 91% (n = 53) patients respectively; with 76% (n = 45) receiving chemotherapy. Local and regional control at 5 years was 64% and 73%, respectively. With a median follow-up of 18 months, 5-year Overall Survival (OS) was 34% (95% CI: 20%-48%) and 29% (95% CI: 17%-42%) for non-metastatic and metastatic patients, respectively. Patterns of failure were further analyzed in 49 non-metastatic patients. Sixty-seven percent (n = 30) patients relapsed, with median time to progression of 15 months. Median time to distant failure was 20 months. On UVA, concurrent chemotherapy (HR 2.3, p = 0.029) and tumor size (HR 2.6, p = 0.01) were associated with worse survival. Distant metastasis was the predominant mode of first failure (n = 16, 33%). This population was also enriched for patients with metastases in unusual locations, including testes (n = 2), breasts (n = 2), leptomeninges (n = 12), and bone marrow (n = 9). Conclusions: Adult HN RMS of the head and neck is an aggressive malignancy with an unfavorable prognosis, despite intensive treatment, but is potentially curable, particularly with modern radiotherapy techniques and chemotherapy.
Using telemedicine to increase access to cancer clinical trials for patients in rural areas: A feasibility study.
Authors: Gary C. Doolittle, Adrian Caracione, James Coulter, Karen Olson, Kelly Knoebber-Carr
Journal: Journal of Clinical Oncology (2018)

e18884 Background: Disparities in access to cancer clinical trials between rural and urban areas is concerning, given this should be a standard option for patients with cancer. Many rural communities lack the patient base necessary to support a clinical trials program. Telemedicine technology may enable patients in rural areas to gain access to trials—while remaining in their communities. This project was launched to identify the infrastructure necessary to offer clinical trials via telemedicine. Methods: Telemedicine video technology allows real-time visits between rural patients and an urban oncologist. The specific trial offered was chosen based on mutual interests of the rural and urban sites, and our Novartis [Novartis Pharmaceuticals Corporation, NVS] partner. Patients are prescreened and if interested, a telemedicine appointment is scheduled. During the first telemedicine visit, the patient signs two consents, one for screening and treatment via telemedicine, the second for the specific Novartis study. A schedule regarding treatment and follow up telemedicine visits is developed. For safety concerns, an advanced practice practitioner is present with the patient during each telemedicine visit. Results: To date, two sites are partners, and one patient has gone on trial via telemedicine (COMMPLEEMENT-1, NVS). As anticipated, conducting a trial using telemedicine poses unique challenges. Operationally, the treating oncologist had to obtain privileges at each site, and sign a practice agreement with the rural APP’s. Regulatory issues from the Novartis perspective do not change—with telemedicine sites treated as satellites. The Kansas University Medical Center Human Subjects Committee is the Institutional Review Board of record for all of the sites. Monitoring for the all the sites, from the Novartis perspective remains the same. KUCC staff monitor clinical trial activities on a quarterly basis for the telemedicine sites. Conclusions: Having addressed considerable logistic concerns, we believe rural patients can access clinical trials from a distance via telemedicine. Further study is necessary before this approach is considered standard
The Unintended Consequences of Reframing Denial, Unrealistic Optimism, and Self-Deception
Authors: Andy Kondrat
Journal: The American Journal of Bioethics (2018)

"The Unintended Consequences of Reframing Denial, Unrealistic Optimism, and Self-Deception." The American Journal of Bioethics, 18(9), pp. 36–37
TCT-330 One Year Effectiveness and Safety of Self-Apposing Stentys Drug-Eluting Stent in Left Main Coronary Artery PCI: Multicentre LM-STENTYS Registry
Authors: Wojciech Wanha, Brunon Tomasiewicz, Piotr Kubler, Stanislaw Bartus, Piotr Kunik, Agata Trznadel, Eliano Navarese, Adam Sukiennik, Jacek Kubica, Andrzej Lekston, Michal Hawranek, Krzysztof Reczuch
Journal: Journal of the American College of Cardiology (2018)
Randomized phase II trial of intercalated gefitinib (G) and pemetrexed/cisplatin (Pem/Cis) for never-smokers with chemo-naïve stage IIIB/IV lung adenocarcinoma (LADC).
Authors: Jin Soo Lee, Young Joo Lee, Hyae Young Kim, Byung-Ho Nam, Geon Kook Lee, Heung Tae Kim, Ji-Youn Han
Journal: Journal of Clinical Oncology (2016)

e20505 Background: While concurrent use of EGFR-TKI and chemotherapy failed to improve the clinical outcome, preclinical and clinical data showed that intercalated use of EGFR-TKI within a chemo cycle would improve the outcome by avoiding the putative antagonism of TKI-induced G1 arrest on the efficacy of chemotherapy. Methods: Eligible pts, who were never-smokers with chemo-naive stage IIIB/IV LADC, ECOG PS 0-2, and adequate major organ functions, were randomly assigned to receive either Gefitinib (G) 250 mg or placebo (PCB) on days 5-18 of a 3-weekly cycle of Pem/Cis (500/75 mg/m2 iv on day 1), the best known regimen for LADC, after stratification by TNM stage: IIIb v. IV, ECOG PS: 0-1 v. 2, and EGFR mt: (+) v.(-) or unknown. Chemo was given up to 9 cycles until PD or unacceptable toxicity, after which G or PCB was given daily until PD. Pts who had PD on PCB were crossed over to receive G. Results: Between 06/2012 and 12/2014, 76 pts (M/F: 9/67) with median age of 58.0 (range 32-75) were randomized, 39 on G and 37 on PCB arm. EGFR mt was (+) in 29, (-) in 43, unknown in 4 pts and 72 had stage IV, 4 had stage IIIB tumors. Baseline characteristics were well balanced between the arms. As of 12/22/2015, 9 pts remained on therapy without PD (8 on G and 1 on PCB) while 67 went off treatment. G arm had better ORR (CR/PR 79.5% v. 51.4%, p = 0.01) and longer PFS (median 12.8 v. 7.0 mos, HR = 0.514, p = 0.009) than PCB arm. G arm also had better median OS (29.2 v. 20.4 mos) and 2-year survival rate (67.8% v. 33.5%) than PCB arm but the difference was not statistically significant (p = 0.146), due to the cross-over study design. The benefit of intercalated use of G over PCB was more apparent for the pts with EGFR mt(+) tumor (median PFS, 13.3 v. 7.8 mos, p = 0.08) than those with EGFR mt(-) tumor (median PFS, 6.6 v.6.6 mos, p = 0.08). Overall, treatment was well tolerated with less G-related skin toxicity and no undue safety issue except for peripheral neuropathy, which became more apparent after 6 or more cycles of chemo. Conclusions: Intercalated use of G and Pem/Cis improved PFS of never-smoker LADC pts. It warrants a phase III trial to compare this with the standard EGFR-TKI alone in pts with EGFR mt(+) LADC. Clinical trial information: NCT01502202.
The role of psycho-social distress screening in cancer care.
Authors: N Mullai, Amtullah Khan, Deborah Carey, Maqsood Ahmad Khan
Journal: Journal of Clinical Oncology (2018)

e22122 Background: Distress is an emotional experience that can interfere with patients’ ability to cope with cancer and treatments; recognizing distress can benefit patients. The Commission on Cancer established Standard 3.2 Psycho-social Distress Screening in 2015 that integrated distress intervention in cancer care. This study evaluates its role and benefits. Methods: Patients were screened in hematology, oncology, and radiation offices at least once during their visit, often at their initial encounter. NCCN’s psycho-social distress screening tool (a questionnaire) was used for this purpose. Patients marked their concerns and distress level on a scale of 1 to 10. The Cancer Committee established a threshold of five and above as a trigger point for intervention. Results: Responses from 1,023 patients were analyzed during 2016-2017. The demographic was 58.36% females and 41.64% males. The distribution of disease was 30.79% breast cancer, 12.81% lung cancer, 10.85% GI cancer, 6.74% hematological malignancies, and the remaining other types of cancers. The mean distress score was 3.97, with males having a slightly higher score of 3.96 compared to 3.88 for females. The age group 80-89 years had the highest mean score of 6.05. About 42% of patients had a score of five or greater. Among them, lung cancer had a mean score of 5.67, followed by head and neck at 5.33, and esophagus cancer at 5.25. The main causes of distress that patients reported were their new diagnosis of cancer, their worry and fear about the disease. In patients with distress-score above the threshold, about 48% discussed their concerns with their physician and other caregivers, and about 25% indicated needs for financial help, transportation, and pain control. Conclusions: A coordinated cancer and psycho-social care would benefit most cancer patients at the time of their diagnosis and during treatment. The patients, who exhibited significant distress and expressed particular need for help might benefit the most. The NCCN tool helped to address specific concerns of patients more appropriately, although a majority of them was satisfied talking to their medical teams. Further, the NCCN tool was very helpful to channel resources appropriately based on individual patient’s severity of distress and needs.
Assessing LGBT competency among cancer care physicians at the University of Florida/UF Health Cancer Center.
Authors: Brian Hemendra Ramnaraign, Merry Jennifer Markham
Journal: Journal of Clinical Oncology (2018)

e18645 Background: The purpose of our study was to determine the knowledge of and attitude towards cancer care in the LGBTQ (Lesbian, Gay, Bisexual, Transsexual/Transgender and Queer) community among cancer physicians at the University of Florida/UF Health Cancer Center. Methods: A 43-question online survey was delivered to all cancer physicians via email. The survey included questions about attitudes and knowledge of cancer care in the LGBT community, practice setting, demographics, and asked for comments on experiences with LGBTQ care. Survey responses were confidential and anonymous. The terms lesbian, gay, bisexual, transgender and queer/questioning were defined prior to the survey questions. None of the survey questions were mandatory. The survey remained open for 4 weeks in March-April 2017. At the closure of the survey, a total of 36 responses were collected out of 69 invitations to complete the survey, corresponding to a response rate of 52%. Results: Attitudes towards managing LGBTQ patients were very favorable among providers with 29 of 29 (100%) reporting being comfortable caring for LGB patients and 27 of 29 (93%) being comfortable caring for transgender patients. Only 3 of 28 (11%) reported the LGBTQ population difficult to treat, and the majority would be willing to be listed as a LGBTQ friendly provider (23/28, 82%). While the responses to specific LGBT cancer care questions were correct 47% of the time, “don’t know/prefer not to answer” was the response in 24% of cases. 18 of 28 (64%) would be interested in additional information about the unique needs of this population but only 9 of 28 (32%) feel that it should be mandatory. 7 of 11 (64%) of the open comments requested more education and discussion of this topic. Conclusions: Our survey reveals a lack of knowledge about cancer care in the LGBTQ population but that the majority of providers are interested in learning more. Despite the lack of knowledge, the majority of providers feel comfortable providing care for this population and would be willing to be listed as a LGBTQ-friendly provider. A formal curriculum may be helpful in educating cancer care providers on the unique aspects of cancer care in this group of patients.