tbuckley/cabot-search huggingface dataset:
Mental health outcomes in a national sample of adult cancer survivors in the United States: Has psychosocial care improved?
Authors: Robin L. Whitney, Janice F. Bell, Jill G. Joseph, Richard J. Bold
Journal: Journal of Clinical Oncology (2013)

120 Background: Recent cancer care recommendations include routine mental health (MH) screening and support. We provide national estimates of psychological distress, MH visits, and unmet need (defined as having distress but no MH visit) for MH services among adult cancer survivors. Additionally, we test for temporal differences between years 2005 and 2010 to assess whether the estimates differ before and after important policy recommendations for psychosocial cancer care. Methods: This study analyzed cross-sectional data from the National Health Interview Survey (NHIS), years 2005 and 2010, for adults (≥18yrs) in the United States (n=58,585) categorized as having: 1) no chronic disease; 2) chronic disease other than cancer; 3) cancer without co-morbid chronic disease; 4) cancer with co-morbid chronic disease. In these four groups we compared psychological distress, MH visits, and unmet need for MH services. Survey-weighted logistic regression was used to model the dependent variables as functions of disease status, socio-demographic variables and self-reported health status. Estimates are generalizable to the US civilian non-institutionalized population. Results: Compared to the group with no chronic disease, the cancer with co-morbid chronic disease group had the highest odds of psychological distress (OR 2.78; 95% CI: 2.18, 3.54) and MH visits (OR 1.7; 95% CI: 1.42, 2.05), with no change from 2005 to 2010. The other two groups (cancer without co-morbid chronic disease and chronic disease other than cancer) also had statistically significantly higher odds of both outcomes compared to those with no chronic disease. Among individuals with cancer, estimates of unmet need for MH services were significantly lower in 2010 (OR 1.53; 95% CI: 1.03, 1.88) compared to 2005 (OR 2.89; 95% CI: 2.09, 3.99). Conclusions: Individuals with cancer have disproportionate MH needs. We find evidence of MH care quality improvement among individuals with cancer between 2005 and 2010, a time period that coincides with continued policy and clinical attention to psychosocial needs in this population. These efforts appear to have reduced, but not eliminated, unmet need for MH services for individuals with cancer.
Invasive disease-free survival benefit following neratinib as extended adjuvant therapy in centrally-confirmed HER2+ early-stage breast cancer: The ExteNET phase III randomized placebo-controlled trial.
Authors: Arlene Chan, Miguel Martin, Gunter Von Minckwitz, Bent Ejlertsen, Stephen K. L. Chia, Marc E. Buyse, Janine Mansi, Michael Gnant, Frankie Ann Holmes, Beverly Moy, Hiroji Iwata, Alvin Wong, Alshad S. Lalani, Richard Bryce, Judith D Bebchuk, Suzette Delaloge
Journal: Journal of Clinical Oncology (2015)

117 Background: Neratinib is an irreversible pan-HER tyrosine kinase inhibitor with clinical efficacy in trastuzumab pre-treated HER2-positive (HER2+) metastatic breast cancer (BC). ExteNET is an ongoing multicenter randomized placebo-controlled phase III trial evaluating the efficacy and safety of a 1-year course of neratinib in patients with early-stage HER2+ BC after trastuzumab-based adjuvant therapy (clinicaltrials.gov: NCT00878709). Methods: Women with locally-confirmed early-stage HER2+ BC were randomly assigned to oral neratinib 240mg/day or matching placebo for 1 year. Archived diagnostic tumor samples were submitted for HER2 gene amplification testing at a central laboratory. Primary endpoint: invasive disease-free survival (iDFS). Secondary endpoints: DFS including ductal carcinoma in situ (DFS+DCIS); distant disease-free survival (DDFS); time to distant recurrence (TDR). Stratified Cox proportional-hazards models were used to estimate hazard ratios (HR) for the ITT and amended ITT (aITT) populations; unstratified models were used for the centrally confirmed HER2 population. Treatment groups were compared using 2-sided log-rank tests. Results: The ITT population included 2840 patients (neratinib, N=1420; placebo, N=1420). The higher-risk aITT population (i.e. node-positive disease and randomized ≤1 year of completing prior trastuzumab) included 1873 patients (neratinib, N=938; placebo, N=935). Of the tumor samples analyzed, 1463 (86%) were centrally confirmed (neratinib, N=741; placebo, N=722). Conclusions: Neratinib significantly improves iDFS in trastuzumab-treated early-stage HER2+ BC patients. An enhanced treatment effect is observed with neratinib in women with centrally confirmed HER2+ tumors. Clinical trial information: NCT00878709. [Table: see text]
Preferred cost communicator and financial distress (FD) in patients with cancer.
Authors: Ellie Proussaloglou, Bonnie J. Yap, Jeremy O'Connor, Christopher Daugherty, Jonas A. De Souza
Journal: Journal of Clinical Oncology (2016)

26 Background: Prior research has shown that cancer patients (pts) are willing to discuss the costs of their care. Professional societies have thus encouraged physicians to discuss these costs with their pts. We assessed the preferred communicator from the pts’ perspective and the predictors of this preference. Methods: Pts with advanced cancers who had completed at least 3 months of chemotherapy were asked for their preferred cost communicator. Pts were allowed to choose one or more cost communicators. Options included physician, financial counselor, social worker, nurse, and other. We collected demographics, therapy type, mood states, income, length of disease (LoD), clinical trial status, ECOG PS, and health-related quality of life (HRQoL). FD was assessed by the COmprehensive Score for financial Toxicity (COST – FACIT) instrument. Multivariable logistic regression was used to identify factors associated with the preferred cost communicator. Results: 233 patients were assessed. Most pts were female (58.4%), Caucasian (66.4%), and privately insured (67.4%). In total, 114 pts (48.9%) preferred speaking about costs to financial counselors, followed by physicians (n = 74, 31.8%), social workers (52, 22.3%), nurses (16, 6.9%), and others (7, 3.0%). In total, 91 patients (39.1%) had no FD, while 142 (60.9%) had some degree of FD. Restricting the analyses by the preferred cost communicator and controlling for sociodemographics, HRQoL, mood states, LoD, clinical trial status, and ECOG PS, the presence of any degree of FD was associated with willingness to discuss costs with financial counselors (OR = 1.94, p = 0.03). In contrast, the absence of FD (OR = 1.93, p = 0.03) was associated with willingness to discuss cancer costs with physicians. A trend was seen with pts on oral therapy willing to discuss costs with their physicians (OR = 1.78, p = 0.06). Lastly, non-Caucasians were more willing to discuss costs with a social worker (OR = 2.28, p=0.01). Conclusions: Physicians are not the preferred cost communicators for pts with FD. These pts are willing to discuss costs with financial counselors. Following an evidence-based approach that integrates patients’ preferences may facilitate the inclusion of cost discussions in clinical practice.
Primary care provider engagement about breast cancer care during treatment: Results from the iCanCare Study.
Authors: Lauren P. Wallner, Paul Abrahamse, Christopher Ryan Friese, Steven J. Katz, Sarah T. Hawley
Journal: Journal of Clinical Oncology (2016)

101 Background: Collaborative care between cancer specialists and primary care providers (PCP) ensures high quality cancer care. Yet, little is known about patient’s perspectives about the level of PCP engagement in and communication about breast cancer (BC) care during treatment. Methods: A weighted random sample of newly diagnosed breast cancer patients in the Georgia and Los Angeles SEER registries were surveyed approximately 6 months after diagnosis (expected final N = 2600, 70% current response rate). PCP BC engagement and communication were defined using 2 outcome measures (categorized as less (never/rarely) vs. more (sometimes/often/always)): how informed the respondent’s PCP was about BC treatment and how often respondents talked with their PCP about their BC care visits. Overall PCP quality was assessed by averaging patient responses (5 categories, never to always) to 5 questions: ease of access to PCP (3 questions) and PCP’s awareness of patient values (2 questions) and categorized as high ( ≥ 4), moderate (3) and low ( &lt; 3). The associations between patient factors and PCP quality with BC engagement and communication were evaluated using multivariable logistic regression. Results: In a preliminary sample (N = 2054), the majority of women reported high PCP quality (63%), high PCP BC engagement (65%) and communication (68%). (Table) Women who reported less PCP BC engagement were more likely to report low PCP quality (OR: 15.7, 95%CI: 9.5, 25.9;) and chemotherapy use (OR: 1.3, 95%CI: 1.1, 1.6), adjusting for age, race, insurance, comorbidities and PCP continuity. The results were similar for PCP communication. Conclusions: Patient perceptions of PCP quality, engagement and communication during BC treatment are high for most women with BC. However, there remains opportunity for improvement in both, as many women report poor engagement and communication despite perceiving high quality primary care. Targeting these patients and their clinicians may be particularly effective in interventions to improve collaborative care in cancer. [Table: see text]
Cistrome Control of Hematopoieitic Stem/Progenitor Cell Function
Authors: Kyle Hewitt, Kirby D. Johnson, Duk-Hyoung Kim, Prithvia Devadas, Rajalekshmi Prathibha, Chandler Zuo, Colin Dewey, Rajendran Sanalkumar, Jin-Soo Kim, Sunduz Keles, Emery H Bresnick
Journal: Blood (2015)
Is it time for quality time? Intensive medical oncology follow-up during treatment for esophageal adenocarcinoma.
Authors: Nishi Kothari, Ravi Shridhar, Sarah E. Hoffe, Kenneth L. Meredith, Jacques Fontaine, William J. Fulp, Khaldoun Almhanna
Journal: Journal of Clinical Oncology (2014)

29 Background: Concurrent chemotherapy and radiation for esophageal cancer patients is morbid with many potential complications. The efficacy of intensive patient follow up by medical oncology during concurrent treatment was retrospectively evaluated at our cancer center. We hypothesized that weekly follow up would result in better compliance and less toxicity, leading to better outcomes. Methods: Patients with locally advanced esophageal adenocarcinoma referred to our cancer center for potentially curable neoadjuvant therapy were identified. Age, gender, radiation dose, weight loss, hospital admissions, and outcome were compared between patients who had intensive follow up and patients who did not. Wilcoxon Rank Sum Test and Chi-squared test, both exact tests using Monte Carlo estimation, were used to compare weekly follow-up status with continuous and categorical factors, respectively. Kaplan-Meier curves and Log-Rank tests were used for OS analysis, and a multivariable model was fit using Cox Proportional Hazard models. Results: 169 were patients eligible for analysis, including 154 men and median age of 66 years. 108 patients were seen weekly by medical oncology while on treatment. Groups had balanced baseline characteristics except for age; the weekly follow up patients were older (68 vs. 63 years, p=0.007). There was no difference in hospitalization rate (33% vs. 28%) or weight loss (4 kg vs. 4.7 kg) between groups. In multivariate analysis, advanced age and stage were associated with worsened OS. Weekly follow up did not lead to improved survival at 3 years (42% vs. 50%). Conclusions: This study is retrospective in nature, but to our knowledge it is the first of its kind to investigate the impact of intensive follow up during concurrent chemotherapy and radiation. Though we did not find improved outcome in patients who were seen weekly, a potential confounder is the older age of these patients. In addition, at our institution patients have close weekly follow up with radiation oncologists, dieticians and oncology nurses. While we were not able to substantiate our hypothesis that weekly follow up by medical oncology leads to improved outcomes, our preliminary findings merit further study.
Novel intervention for decision support and distress in female cancer survivors considering fertility preservation.
Authors: Andrea Michele Bradford, Laura Covarrubias, Leslie R. Schover, Terri Lynn Woodard
Journal: Journal of Clinical Oncology (2016)

114 Background: Treatment-related infertility is a source of long-term psychological distress in cancer survivors, particularly among women. Decisions about fertility preservation (FP) are made under conditions of high stress and time pressure, which may contribute to the relatively low uptake of FP among women with cancer. Little is known about the effect of interventions to support the decision-making process and reduce fertility-related distress in cancer survivors considering FP. We describe the design and preliminary data from a randomized trial to determine whether incorporating psychological assessment and intervention into the standard FP consultation enhances satisfaction with decision-making and psychosocial outcomes. Methods: We developed a brief intervention for women referred to our institution’s oncofertility service for consideration of FP. The intervention focuses on values clarification for decision support, identification of unmet psychosocial needs, and mindfulness and acceptance-based skills. Participants were randomized to usual care (consultation with a reproductive endocrinologist and nurse) or the intervention (usual care plus a 1-hour visit with a psychologist and two follow-up calls). Outcomes included feasibility measures and measures of decisional conflict (Decisional Conflict Scale) and satisfaction with the FP program (Client Satisfaction Questionnaire-8). Results: All 14 participants randomized to date have completed baseline and 1-month assessments. The mean age was 32 (SD = 7.5, range 20-44), and the majority were nulliparous (n = 9, 64%). All 7 intervention participants completed at least 1 follow-up call, and 5 (71%) completed both follow-up calls. Across all participants, Decisional Conflict Scale scores decreased from baseline (M = 24.8, SD = 17.2) to 1 month (M = 22.2, SD = 16.3). Overall satisfaction with the program at 1 month was high (M = 29 out of a possible 32). Conclusions: Incorporating a psychological assessment and intervention into a standard FP consultation appears feasible and may improve levels of decisional conflict over time. Women appeared to find the intervention helpful when contemplating FP.
Evaluation of national treatment trends in ovarian cancer.
Authors: Brian S. Seal, Jianying Yao, Jonathan K Kish, Dana Stafkey-Mailey, Michael Eaddy
Journal: Journal of Clinical Oncology (2014)

204 Background: Evaluate patterns of care among women diagnosed with metastatic (M) and non-metastatic (NM) ovarian cancer (OvCa). Methods: Using MarketScan Commercial/Medicare databases, women ≥18 years old with primary diagnosis of OvCa continuously enrolled ≥6 months pre- and post-index diagnosis were selected. Patients receiving chemotherapy (chemo) prior to index diagnosis were excluded. Eligible patients were stratified into NM and M cohorts and M patients into those diagnosed with M ≤90 days (M1), 91-180 days (M2) and ≥ 181 days (M3) post index diagnosis. Types of treatments, time to initiation and adherence to NCCN treatment guidelines were evaluated. Results: A total of 64,483 women were included; 59,277 (91.9%) NM and 5,472 (8.1%) M. Among M patients, 70.5% were M1, 4.5% M2 and 25.0% M3. Of the NM 57.1% underwent surgery (mean = 43 days), 2.5% received chemoradiation (chemorad) therapy (mean = 618 days), 2.5% received chemo (mean = 213 (NCCN) to 496 (nonNCCN) days), 3.4% received any oral antineoplastic (chemo/non, hormone, other, mean = 635 (NCCN) to 584 (nonNCCN) days), and 1.7% received hormone therapy (mean = 537 days) post index diagnosis. In comparison 70.0% of M patients had surgery, 37.2% received chemorad, 63.9% received chemo, 10.2% received an oral antineoplastic, and 19.0% received hormone therapy. As time to M diagnosis increased, utilization of chemorad (33.5% M1 to 46.9% M3), hormone therapy (17.9% M1 to 21.6% M3), and oral antineoplastic (8.9%% M1 to 14.2% M3) increased while receipt of surgery (76.6% M1 to 53.1% M3) and chemo (68.6% M1 to 52.3% M3) decreased. Time to initiation of all treatments increased as time to M increased. Among NM patients receiving oral antineoplastic 1.9% received NCCN recommended agents compared to 66.0% of M patients (72.2% M1 to 55.7% M3).Similarly, 52.2% of NM patients receiving chemo received NCCN recommended treatment compared to 98.3% of M patients (99.0% M1 to 96.2% M3). Conclusions: As recommended by the NCCN guidelines surgery was the standard of care for all patients. Utilization of chemo, chemorad and oral antineoplastics were largely reserved for M patients. M patients with a longer duration between initial and M diagnosis were more likely to receive treatment not recommended by NCCN guidelines.
Impact of prior response to abiraterone acetate (AA) on subsequent activity of docetaxel (D) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts).
Authors: Arun Azad, Renee Lester, Daniel Yick Chin Heng, Bernhard J. Eigl, Kim N. Chi
Journal: Journal of Clinical Oncology (2014)

97 Background: Questions about optimal sequencing of systemic agents in mCRPC and whether cross-resistance occurs between agents remain largely unanswered. Recently, it was reported that D is inactive in mCRPC pts who did not have a ≥ 50% PSA decline on prior AA (Ann Oncol 2012; 23(11):2943-7). To investigate this further, we evaluated the activity of D in mCRPC pts who had previously received AA. Methods: Cancer registries at two Canadian centers were used to identify mCRPC pts treated with D after AA. Outcomes from D treatment were compared between AA responders (≥ 50% PSA decrease with prior AA) and AA non-responders (&lt; 50% PSA decrease with prior AA). Progression-free survival (PFS) (Prostate Cancer Working Group 2 criteria) and overall survival (OS) were estimated using the Kaplan-Meier method. Results: Of 40 eligible pts, 14 (35%) were classified as AA responders and 26 (65%) as AA non-responders (including 16 pts who had no PSA decline on AA). The median number of cycles of D administered to AA responders and non-responders was 6 (range: 1-10) and 4 (range: 1-13) respectively. Thirty (75%) pts had also received D prior to AA. Notably, among 39 pts evaluable for PSA response, no difference was seen in the proportion of AA responders and non-responders who had PSA falls ≥ 50% (p=0.72; Fisher’s exact test) or ≥ 30% (p=0.75; Fisher’s exact test) on D (Table). Analysis of survival outcomes from date of initiation of D also revealed similar median PFS (p=0.54; log-rank) and median OS (p=0.93; log-rank) in both groups (Table). Conclusions: PSA response rates to D did not differ between AA responders and non-responders. These data suggest that the anti-tumor activity of D in mCRPC may be independent of prior response to AA and that chemotherapy is still a therapeutic option in patients who do not respond to AA. Prospective studies evaluating optimal sequencing of AA and D in mCRPC are warranted. [Table: see text]
Resource expectations for pediatric studies: Correlation of study type and patient number for FDA labeling
Authors: S. Hirschfeld
Journal: Journal of Clinical Oncology (2008)

6632 Background: An incentive program consisting of granting an additional 6 months marketing exclusivity for drug products that adequately respond to a Written Request for pediatric studies from the Food and Drug Administration (FDA) was begun in 1997. Methods: Data were abstracted from product labels and medical and pharmacologic reviews posted on the FDA public Internet web site and entered into a relational database (Microsoft Access) for analysis Results: Data from 195 individual studies across 33 drug classes in 12 disease categories was examined in detail. The average number of studies per product was 2.6 ± 1.7 (range 1–9) and the average number of total patients enrolled per product was 357 ± 341 (range 11–1547). The total number of patients enrolled for all products was about 25 000. Nine products with oncologic indications accounted for a total of 28 studies enrolling 1205 patients. The average number of patients per product was 134 with an average of 43 per trial. Studies were classified as pharmacokinetic (PK) if only pharmacokinetics were determined, PK and pharmacodynamic (PD) if pharmacokinetic measurements and PD assessments were made, PD if only pharmacodynamic assessments, including clinical outcomes, were made, and efficacy if a study was designed with a clinically relevant outcome measure and adequately powered to formally establish efficacy. The distribution of study types across all therapeutic areas was 20% PK, 18% PK-PD, 29% PD and 33% efficacy. On average across all therapeutic areas, about 33 patients was considered informative for a PK study, 68 for a PK-PD study, 157 for a PD study and 250 for an efficacy study The oncology products were only studied in PK-PD studies (n=13, average enrollment=21, range 3–62 patients) and PD studies (n=15, average enrollment=66, range=21–170 patients). Conclusions: The FDA incentive program has been successful in stimulating pediatric research. Across therapeutic classes the type of study can reliably predict the anticipated number of patients considered to be informative. Oncology drug products have enrolled fewer patients than the general averages to achieve the same goals. The study of pediatric patients for oncology drug products can be a cost effective mechanism to extend marketing exclusivity. No significant financial relationships to disclose.
CMV-Seropositive Patients Allografted with a CMV-Seronegative Donor Show Delayed or Missing CMV-Specific T-Cell Immune Response and Are at Higher Risk for CMV-Viremia and CMV-Disease.
Authors: Susanne Ganepola, Chiara Gentilini, Urte Hilbers, Goetz Hartung, Thoralf Lange, Joerg Hofmann, Uwe G. Liebert, Markus Hammer, Elisabeth Engelmann, Dietger Niederwieser, Eckhard Thiel, Lutz Uharek
Journal: Blood (2005)