tbuckley/cabot-search huggingface dataset:
Randomized cross-over study of patient preference for oral or intravenous vinorelbine in the treatment of advanced NSCLC: A phase IV study.
Authors: Claudio Dazzi, Alessandro Gamboni, Angelo Delmonte, Francesco Rosetti, Alberto Verlicchi, Maximilian Papi, Emanuela Scarpi, Chiara Zingaretti, Mario Nicolini, Petros Giovanis, Claudia Casanova, Federico Cappuzzo
Journal: Journal of Clinical Oncology (2017)

e20676 Background: Elderly and patients with ECOG PS ≥ 2 often present with medical and physiological characteristics that make the selection of their treatment more challenging. Single-agent vinorelbine improves survival and quality of life compared with best supportive care. At constant effectiveness between two treatments formulations patient preference must be taken into account. Methods: Stage IIIB or IV NSCLC patients candidates to receive a first line chemotherapy with Vinorelbine alone due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2, could enter the study. Patients were randomized to receive: • Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of oral vinorelbine (60mg/m2) • Arm B: first cycle of oral vinorelbine followed by a second cycle of IV vinorelbine. In both arms vinorelbine was administered at day 1 and day 8 every 3 weeks. From the third cycle onwards patients had to choose to continue with oral or intravenous vinorelbine. The dosage of oral vinorelbine could be subsequently increased to 80 mg/m2 at physician’s choice. Treatment continued until disease progression, intolerable toxicity or patient refusal. The primary objective of the study was the patient preference for oral or intravenous vinorelbine. Results: Ninety-three patients entered the study and were randomized. Sixty-two were able to complete the first two cycles and to express a preference (32 in Arm A and 30 in Arm B). Forty-five out of 62 were males and 17 females. Median age was 80 (72-89). Nineteen patients had an ECOG PS of 0, 39 a PS of 1 and 4 a PS of 2 (30.7%, 62.9% and 6.4% respectively). Eighteen patients (29%) decided to continue with IV vinorelbine while 44 patients (71%) expressed a preference for oral vinorelbine p = 0.001 (Gart's test). Regarding secondary enpoints, median OS was 5.7 (4.7-7.7) and 5.5 (3.8-9.1) months and median PFS was 3.5 (2.4-4.4) and 3.5 (3.5-5.0) for arm A and arm B respectively. Conclusions: The study has clearly demonstrated that elderly or frail patients with NSCLC prefer to receive an oral rather than an intravenous chemotherapy. The reasons for the choice were expressed in a questionnaire still in evaluation. Clinical trial information: nct01848613.
TCT-265 Comparison of long-term outcomes of percutaneous coronary intervention with Sequent Please® versus In-Pact Falcon® paclitaxel eluting balloon catheter.
Authors: Ignacio Sanchez-Perez, José Abellán-Huerta, Fernando Lozano, Alfonso Jurado-Román, Juan Antonio Requena, María López-Lluva
Journal: Journal of the American College of Cardiology (2018)
Behavioral models for periodontal health and disease
Authors: Jonathon T. Newton, Koula Asimakopoulou
Journal: Periodontology 2000 (2018)

Abstract The oral health‐related behavior of patients with periodontal disease is a critical determinant of their health. Psychological models of behavior provide a framework for the design of interventions to enhance oral health‐related behavior. This article reviews published manuscripts on interventions to enhance oral health‐related behavior, classifying the nature of the interventions according to current psychological models of behavior. Fifteen manuscripts reporting the findings of 14 studies were identified and reviewed. The present article concludes that, based on current evidence, the key elements of effective interventions are: goal setting, planning the behavior change, and self‐monitoring.
Long-term treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib: ENESTop 144-wk results.
Authors: François-Xavier Mahon, Carla Boquimpani, Naoto Takahashi, Noam Benyamini, Nelma Cristina D. Clementino, Vasily Shuvaev, Akil Merchant, Jeffrey H. Lipton, Anna G. Turkina, Raquel De Paz Arias, Beatriz Moiraghi, Franck E. Nicolini, Jolanta Dengler, Tomasz Sacha, Dong-Wook Kim, Rafik Fellague-Chebra, Sandip Acharya, Shalini Chaturvedi, Catherine Bouard, Timothy P. Hughes
Journal: Journal of Clinical Oncology (2018)

7003 Background: TFR is a new treatment goal in CML. In the ENESTop study (NCT01698905) in pts with CML-CP who sustained a deep molecular response with 2L nilotinib, 57.9% and 53.2% remained in TFR 48 wk (primary endpoint) and 96 wk after stopping treatment, respectively. We report an analysis of longer-term durability of TFR in ENESTop. Methods: Pts treated with ≥ 2 y of nilotinib following > 4 wk of imatinib (≥ 3 y total) and achieving MR4.5 (BCR-ABL1 ≤ 0.0032% on the International Scale [BCR-ABL1IS] by quantitative real-time PCR) on nilotinib were eligible. Following a 1-y consolidation phase, pts with no confirmed loss of MR4.5 could attempt TFR; nilotinib was restarted upon loss of major molecular response (MMR; BCR-ABL1IS ≤ 0.1%) or confirmed loss of MR4 (BCR-ABL1IS ≤ 0.01%). The data cutoff for this analysis was Oct 18, 2017, when all pts had completed ≥ 144 wk of TFR, restarted nilotinib, or discontinued the study. Results: Of 126 pts entering TFR, 61 remained in TFR at data cutoff, 58 restarted nilotinib (loss of MMR, n = 34; confirmed loss of MR4, n = 24), and 7 discontinued the study in this phase. The TFR rate at 144 wk was 48.4% (95% CI, 39.4%-57.5%). Of 67 pts in TFR at 96 wk, 6 were no longer in TFR at 144 wk due to confirmed loss of MR4 (n = 3; at 108, 120, and 144 wk), death (n = 2), or study discontinuation (n = 1; pt/guardian decision). Of 34 pts restarting nilotinib due to loss of MMR, 33 (97.1%) and 31 (91.2%) regained MMR and MR4.5, respectively; of 24 pts restarting due to confirmed loss of MR4, 23 (95.8%) regained MR4.5. Stable MR4.5 for 48 wk was achieved by 42 of 54 pts who regained MR4.5 (77.8%). No disease progression or deaths due to CML were reported; 144-wk treatment-free survival rate was 52.0% (95% CI, 42.9%-60.4%). Of 68 pts who remained in TFR for > 96 wk, 10.3%, 51.5%, 19.1%, and 11.8% experienced any-grade musculoskeletal pain–related adverse events in the consolidation phase and first, second, and third 48 wk of TFR, respectively. Conclusions: These results demonstrate the long-term durability of TFR following 2L nilotinib and show that most pts restarting nilotinib regained stable MR4.5. Pts should be routinely monitored for late loss of response. Clinical trial information: NCT01698905.
Updated 5-y landmark analyses of phase 2 (BREAK-2) and phase 3 (BREAK-3) studies evaluating dabrafenib monotherapy in patients with <i>BRAF</i> V600–mutant melanoma.
Authors: Paul B. Chapman, Paolo Antonio Ascierto, Dirk Schadendorf, Jean Jacques Grob, Antoni Ribas, Felix Kiecker, Caroline Dutriaux, Lev V. Demidov, Celeste Lebbe, Piotr Rutkowski, Christian U. Blank, Ralf Gutzmer, Michael Millward, Richard Kefford, Yingjie Huang, Ying Zhang, Matthew Squires, Bijoyesh Mookerjee, Axel Hauschild
Journal: Journal of Clinical Oncology (2017)

9526 Background: Prior analyses of phase 2 (BREAK-2; NCT01153763) and phase 3 (BREAK-3; NCT01227889) trials showed that durable clinical benefit and tolerability lasting ≥ 3 y are achievable with the BRAF inhibitor dabrafenib in some patients (pts) with BRAFV600–mutant metastatic melanoma. Here, we report 5-y landmark analyses for BREAK-2 and BREAK-3. Methods: BREAK-2, a single-arm, phase 2 study, evaluated dabrafenib 150 mg twice daily in pts with stage IV BRAF V600E/K–mutant MM. BREAK-3, an open-label, randomized (3:1), phase 3 study, assessed dabrafenib 150 mg twice daily vs dacarbazine 1000 mg/m 2 every 3 weeks in pts with previously untreated BRAFV600E–mutant unresectable stage III or stage IV MM. Updated analyses were performed to describe ≥ 5-y outcomes in each study. Results: BREAK-2 enrolled 92 pts (V600E, n = 76; V600K, n = 16), of whom most (90%) had prior systemic anticancer therapy. At data cutoff (17 Jun 2016), all pts had discontinued, mostly due to progression (84%). In V600E pts, 5-y progression-free survival (PFS) was 11%, and 5-y overall survival (OS) was 20%. Postprogression immunotherapy was received by 22% of enrolled pts. In BREAK-3 (data cutoff, 16 Sep 2016), median follow-up was 18.6 mo for the dabrafenib arm (n = 187) and 12.8 mo for the dacarbazine arm (n = 63). Follow-up for the 37 dacarbazine-arm pts (59%) who crossed over to receive dabrafenib was based on the initial assignment of dacarbazine. The 5-y PFS was 12% vs 3% and 5-y OS was 24% vs 22% for the dabrafenib and dacarbazine arms, respectively. A subset of pts in each respective arm received postprogression anti–CTLA-4 (24% vs 24%) and/or anti–PD-1 (8% vs 2%) therapy, whereas 31% vs 17% did not receive any further therapy following study treatment. No new safety signals were observed in either study with long-term follow-up. Additional characterization of pts using cfDNA analysis will be presented. Conclusions: These data provide the longest reported PFS and OS follow-up for BRAF inhibitor monotherapy in BRAF V600–mutant MM. Both BREAK-2 and BREAK-3 showed that 11%-12% of pts initially treated with single-agent dabrafenib remained progression free at 5 y. Clinical trial information: NCT01153763; NCT01227889.
Prognostic variables in localized small cell neuroendocrine carcinoma of the bladder: A population-based study.
Authors: Carlo Cattrini, Luigi Cerbone, Alessandra Rubagotti, Linda Zinoli, Maria Maddalena Latocca, Giulia Buzzatti, Giacomo Vallome, Fabio Rizzo, Alessia Cavo, Kristi Beshiri, Davide Soldato, Carlo Messina, Elisa Zanardi, Francesco Boccardo
Journal: Journal of Clinical Oncology (2018)

e16506 Background: Small cell carcinoma of the bladder (SCCB) is a rare, highly aggressive, neoplasm without a standard treatment protocol. We used the Surveillance, Epidemiology, and End Results (SEER) database to study the clinical features, prognostic variables, treatment, and survival of a large population-based sample. Methods: The SEER Research Data (2000-2014) were investigated using the SEER*Stat software. Patients (pts) with pure or mixed SCCB, T2-T4, any N, M0, who received either surgery or radiotherapy with or w/o chemotherapy (neoadjuvant, adjuvant or perioperative) were included in the analysis. We used the Kaplan – Meier method and log-rank test for estimating survival, and Cox proportional hazard regression to evaluate prognostic variables. Results: A total of 384 cases of SCCB were included in the study (T2 n = 204, T3/4 n = 180). Surgery was performed in 233 (60.7%) pts, whereas 151 (39.3%) received radiotherapy. The median overall survival (OS) was 21 months (95%CI, 18-26). Median age was 71 years and ratio of men to women was 3:1. Age, race, chemotherapy use, type of local treatment, T and N staging were identified as independent prognostic variables (P < .05). On multivariate analysis, chemotherapy use (n = 264) was associated with significant better OS (HR[95%CI]: 0.56[0.41-0.76] P < .001). Pts who underwent radiotherapy showed worse outcome compared to those treated with surgery (HR: 1.71[1.26-2.32] P < .001). However, only in T2 subgroup, surgery (n = 89) retained a significant survival benefit compared with radiotherapy (n = 108) (HR: 0.40[0.27-0.61] P < .001). Conclusions: Pts with localized SCCB who received chemotherapy showed longer OS compared to those who did not. Surgery was associated with better outcome compared to radiotherapy in pts with T2 disease. Further prospective, multicentre, studies are warranted to confirm our retrospective data.
Sunlight and testicular germ cell tumor rates in the USA.
Authors: Brandon David Bernard, Sarah C. Markt, Laurence Albiges, Rowan Miller, Andreas Pettersson, Clair Beard, Christopher Sweeney
Journal: Journal of Clinical Oncology (2015)

e15565 Background: Little is known about the cause and increasing rate of testicular germ cell tumors (GCT). Host and environmental factors are thought to play a role based on GWAS, familial risk, race and variable geographic distribution. The aim of this study was to evaluate for differences in age-standardized incidence rates (ASIR) between the northern and southern USA and assess for a link to sun exposure. Methods: The Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research (CDC WONDER) was used to identify the GCT ASIR in men in each state excluding AK and HI. ASIR were calculated per 100,000 using the 2000 US Std million Population. ASIR in northern states (OR, ID, WY, NE, IA, IL, IN, OH, PA, NJ and above) were compared to ASIR in the south, stratified by race. Average daily sunlight (ADS) for each state from 1997-2011 was obtained from CDC WONDER and correlated with ASIR. The Surveillance, Epidemiology, and End Results (SEER) 18 registry was used to assess for concordance between state of diagnosis and birth. Results: 92,842 white men and 2,989 black men were diagnosed with GCT from 1999-2011. Among white men, the ASIR in the north was 6.7 per 100,000 compared to 5.9 per 100,000 in the south (p<0.001). ADS was 14,742.8 KJ/m2 in the north and 16977.0 KJ/m2in the south (p=0.006). There was a moderate inverse correlation between ASIR and ADS (Spearman r = -0.6, p<0.001). Among black men, there was no difference in ASIR between the north and the south (1.4 vs. 1.3, p=0.08), and no correlation between ASIR and ADS (Spearman r = -0.18, p=0.34). There was greater than 75% concordance between state of diagnosis and birth (WA being the exception at 65%). Conclusions: GCT ASIR in white men are significantly higher in northern states and this correlates with lower ADS. Environmental factors such as vitamin D levels may play a part in pathogenesis. GCT ASIR in white men and ADS in the north versus south. ASIR (cases/100,000) ADS (KJ/m2) North 6.7 14,742.8 South 5.9* 16,977.0# *p <0.001; #p =0.006.
The psychological impact of early pregnancy loss
Authors: Jessica Farren, Nicola Mitchell-Jones, Jan Y Verbakel, Dirk Timmerman, Maria Jalmbrant, Tom Bourne
Journal: Human Reproduction Update (2018)

Early pregnancy loss (EPL) is a common event, with scope for long-term personal and societal impact. There are three decades worth of published evidence of profound psychological sequelae in a significant proportion of women. However, the wide variety of outcomes, screening instruments, assessment timings and geographical locations makes it challenging to form a coherent picture of the morbidity within the whole group and its subgroups.This review aims to investigate three questions. (1) What is the evidence for depression, anxiety and post-traumatic stress disorder (PTSD) following a miscarriage or an ectopic pregnancy in women and/or their partners? (2) What is the intensity and duration of these conditions, and how do they compare to those without losses? (3) Which patients have been found to be at highest risk of psychopathology? Answers to these questions are salient not only in day-to-day clinical interactions with those experiencing EPL, whose psychological needs may not be prioritized, but should also form the basis for tailoring healthcare policy in terms of screening for and treating the associated psychological morbidity.The following databases were searched, from the start of each database up to July 2017: MEDLINE (Ovid interface, 1948 onwards), Embase classic + Embase (Ovid interface, 1947 onwards), and PsychINFO (Ovid interface, 1806 onwards). Search strategies were developed using medical subject headings (MeSH). The concepts of psychological morbidity (anxiety, depression or PTSD) and pregnancy loss (miscarriage or ectopic pregnancy) were first expanded with the Boolean operator 'or', then linked together using 'and'. Included studies were of prospective cohort design, including women or men following EPL (with the majority to have experienced losses before 24 weeks gestation), and reporting standardized psychometric measures for anxiety, depression and post-traumatic stress disorder. The timing of follow-up had to be specified and standardized across participants. Manuscript quality and risk of bias was assessed using the Newcastle-Ottawa Scale.We found evidence of significant depression and anxiety in the first month following EPL in women. Partners were also shown to display depression and anxiety, albeit to a generally lower level. There is also evidence of post-traumatic stress symptoms relating to the EPL in three studies.In view of their high frequency, EPLs can significantly contribute to the overall burden of psychopathology within a population. Recognition of this impact is important, so that severely affected individuals may be screened and treated appropriately. Further research to establish risk factors to promptly identify and treat these patients, and to optimize their management, is crucial.
Updated results of frontline ofatumumab-hyper-CVAD in adults with CD20+ acute lymphoblastic leukemia.
Authors: Abhishek Maiti, Hagop M. Kantarjian, Farhad Ravandi, Deborah A. Thomas, Maria Khouri, Guillermo Garcia-Manero, Rebecca S. Garris, Jorge E. Cortes, Nicholas James Short, Koji Sasaki, Ghayas C. Issa, Paul B. Koller, Heather M Schroeder, Tapan M. Kadia, Srdan Verstovsek, Naval Guastad Daver, Nitin Jain, Marina Konopleva, Susan Mary O'Brien, Elias Jabbour
Journal: Journal of Clinical Oncology (2017)

7033 Background: Chemoimmunotherapy is an effective frontline therapy for acute lymphoblastic leukemia (ALL). Ofatumumab (O) binds to a proximal small-loop epitope on CD20 and is more potent in vitro than rituximab. Here we report interim results of its combination with hyper-CVAD (HCVAD) in adult patients (pts) with CD20+ ALL. Methods: Since 7/2011, we have enrolled 63 pts with Ph-negative CD20+ ALL (59 newly diagnosed, 4 previously treated). For the intensive phase, pts received 4 cycles (cy) of HCVAD (odd cy 1, 3, 5, 7) alternating with 4 cy of methotrexate-cytarabine (MTX-Ara-C, even cy 2, 4, 6, 8), and ofatumumab during cy 1-4. For maintenance, pts received POMP for ~30 months (mos), and intensification with MTX/PEGylated asparaginase on mos 6 and 18, and O-HCVAD on mos 7 and 19. Intrathecal MTX-Ara-C was used for CNS prophylaxis. Bulky mediastinal disease was irradiated when indicated. Results: Median age was 41 years (range: 18-71) and median WBC count was 4.6 x10 9 /L (range: 0.6-201 x10 9 /L). 22 pts (35%) had diploid cytogenetics and 8/35 pts (23%) had TP53 mutation. CD20 expression was &gt; 20% in 38 pts (60%), 10-20% in 6 pts (10%) and 1-10% in 16 pts (25%). Median follow-up was 20 mos (range: 1-58) and median number of cy was 8 (range: 1-8). 3 pts (5%) were in CR at the time of enrollment. Of 60 pts evaluable for response, 58 pts (97%) achieved CR; 1 pt achieved CRp and 1 pt died during cy 1 from sepsis. Flow cytometric minimal residual disease (MRD) was negative in 57/62 pts (92%) overall, and in 36/57 pts (57%) at CR. Median time to negative MRD was 0.7 mos. Median time to platelet and neutrophil recovery in cy 1 was 21 and 18 days, respectively. The most common grade 3/4 non-hematological toxicities were infections during induction (49%) and consolidation (72%), elevated transaminases (35%), and hyperbilirubinemia (21%). 5 pts (7%) experienced a grade 3/4 transfusion reaction. 8 pts (13%) received stem cell transplantation in CR1. 10 pts (16%) have relapsed (8 morphological, 2 MRD only). Overall survival and 2-year CR duration rates were 80% and 81%, respectively. Survival outcomes were independent of percentage of CD20 expression. Conclusions: O-HCVAD is safe, effective and results in durable responses in pts with CD20+ ALL. Clinical trial information: NCT01363128.
Trust in doctors and non-doctor sources for health and medical information.
Authors: Leo Chen, Gaurav Vasudev, Amanda Szeto, Winson Y. Cheung
Journal: Journal of Clinical Oncology (2018)

10086 Background: Patients today have unprecedented access to health and medical information (HMI) from a diverse range of sources. This access helps inform patients, but it may also misinform and adversely affect patients' trust in doctors (TD). In this study, TD is compared with trust in 8 other sources of HMI. Methods: This study examines the Health Information National Trends Survey (HINTS-5) data published July 2017 by the National Cancer Institute. A nationally representative sample was generated from 3,295 Americans, and analyses included the 1873 who sought cancer information. Trust was ranked 1 (not at all) to 4 (a lot). Trust in family (F), news (N), radio (R), internet (I), TV, government (G), charities (C), and religious sources (RS) were independently compared to TD. Logistic regression was used to evaluate associations between demographic characteristics and viewing non-doctor sources as equal or superior to TD (EOSTD) for HMI. Results: Post-survey weighting, 75.6% of the sample trusted doctors "a lot", followed by trust in G (32.1%), I (15.4%), and C (8.3%). 60.4% viewed at least one non-doctor source as EOSTD. Earning $75,000 or more was inversely associated with viewing F (OR 0.89, p = 0.009), N (OR 0.91, p = 0.027), T (OR 0.84, p = 0.004), C (OR 0.83, p = 0.003), and R (OR 0.88, p = 0.004) as EOSTD for HMI compared to earning < $20,000. Compared to not completing high school, some college (OR 0.82, p = 0.029), college (OR 0.80, p = 0.011), or postgraduate education (OR 0.80, p = 0.011) reduced OR for viewing TV as EOSTD. Compared to being White, being Non-Hispanic increased viewing I as EOSTD, while being Black (OR 1.14, p = 0.007) or Non-Hispanic (OR 1.27, p = 0.034) increased viewing TV as EOSTD. Being female was associated with viewing F as EOSTD (OR 1.04, p = 0.040). Conclusions: Doctors are the most trusted HMI source, but most respondents viewed at least one non-doctor source as EOSTD. Patients should be reminded that alternative sources are not equivalent to doctors for HMI.