bluuebunny/crossref_metadata_2025 huggingface dataset:
Geriatric assessment (GA) predictors of 1y mortality in older adults with gastrointestinal (GI) malignancies: Results from the CARE study.
Authors: Williams Grant Richard , Dai Chen , Al Obaidi Mustafa , Giri Smith , Kenzik Kelly , McDonald Andrew Michael , Smith Crystal Young , Gbolahan Olumide B. , Paluri Ravi Kumar , Richman Joshua , Bhatia Smita
Published: May 2020

12047

Background: Chronologic age is an imperfect predictor of morbidity and mortality in older patients with newly-diagnosed GI malignancies. Identifying patients with GI malignancies that are at increased risk of mortality within the 1st year remains challenging given no prior studies have focused on this population, yet is critical to developing personalized treatment plans. To fill this gap, we examined predictors of 1y mortality using variables from a patient-reported GA in a prospective cohort of older adults with GI malignancies. Methods: Cancer and Aging Resilience Evaluation (CARE) is a prospective registry of older adults (≥60y) with cancer seen at UAB (J Geri Onc 2019; PMID 31005648). Patients with GI malignancies with GA completed within the timeframe of 3 mo. before and up to 6 mo. after diagnosis were included. Vital status (up to 12/7/2019) was ascertained by linking participants to LexisNexis. Multivariable Cox regression analysis was used to estimate associations between GA variables and 1y mortality, adjusting for age at cancer diagnosis, race, cancer stage (IV vs. I-III), cancer group (high risk: pancreatic, hepatobiliary, esophageal vs. low risk: colorectal, GIST, neuroendocrine, etc.), and planned chemotherapy (yes/no). Results: A total of 356 participants met eligibility criteria. Mean age at enrollment was 70y; 56.4% were females; 25% black; 47.1% had high-risk cancers. In unadjusted analysis, high-risk cancers, cancer stage, malnutrition, impaired performance status, limitations in social activities, impaired instrumental activities of daily living (IADL), physical health, mental health, anxiety, and ≥3 comorbidities were associated with higher 1y mortality. Our base model (demographic and clinical variables) demonstrated good discrimination (c statistic 0.758), but was improved with the addition of all significant GA variables (c-statistic 0.810). Fatigue and malnutrition were identified as the strongest predictors among the GA variables, and a model adding those to the base model retained high discrimination (c-statistic 0.804). The estimated 1yr survival was 53.1% for those with both fatigue and malnutrition compared to 88.1% in those with neither. Conclusions: Among older adults with GI malignancies, malnutrition and fatigue were the strongest GA predictors of 1yr mortality after adjusting for age and clinical factors. These findings provide evidence for developing targeted interventions in older patients with newly-diagnosed GI malignancies to reduce 1y mortality.
An international cohort study investigating the impact of age on clinical outcome in patients with hepatocellular carcinoma treated with sorafenib.
Authors: Sharma Rohini , Hajiev Saur , Aval Leila Motedayan , Bettinger Dominik , Arizumi Tadaaki , Pirisi Mario , Rimassa Lorenza , Personeni Nicola , Pressiani Tiziana , Giordano Laura , Kudo Masatoshi , Thimme Robert , Park Joong-Won , Taddei Tamar Hamosh , Kaplan David Edward , Ramaswami Ramya , Pinato David James , Allara Elias
Published: May 2020

12049

Background: There is no consensus on the effect of sorafenib dosing on efficacy and toxicity in elderly patients with hepatocellular carcinoma (HCC). Older patients are often empirically started on low dose therapy with the aim to avoid toxicities whilst maximising clinical efficacy. We aimed to verify whether age impacts on overall survival (OS) of patients with HCC, and whether a reduced starting dose of sorafenib impacts on OS or rates of toxicity experienced by the elderly. Methods: In this international, multicentre cohort study, patients with a confirmed diagnosis of advanced-stage HCC receiving sorafenib were recruited from seven specialist centres. Demographic and clinical data including development and grade of sorafenib toxicity and sorafenib starting dose were collected prospectively. Survival time (months) was recorded prospectively. Outcomes for those < or > 75 years were determined Results: A total of 5598 patients were recruited; 792 (14.1%) were over the age of 75. The elderly were more likely to have larger tumours ( > 7cm)(39 vs 33%, p = 0.07) with Child-Pugh A liver function(67 vs 57.7%) and less portal vein thrombosis compared to those < 75years(22.1 vs 29.4)(p < 0.001). They were more likely to be commenced on lower starting dose of sorafenib i.e 400mg/200mg (38.7 vs 37.2%, P < 0.01). In terms of OS, there was no difference in the median OS of those >75 years and patients < 75 (7.3months vs 7.2months; HR 0.98 (95% CI 0.90–1.06), p = 0.63). There was no relationship between starting dose of sorafenib, 800mg vs 400mg/200mg, and OS between those < or > 75years. The elderly experienced a similar incidence of grade 2-4 sorafenib-related toxicity compared to < 75years(74.3 vs 61.7%, p = 0.051)(except for anorexia (14.0 vs 7.2%, p < 0.01) and rash (3.1 vs 6.3%, p < 0.05), irrespective of the dose prescribed. The elderly were more likely to discontinue sorafenib due to toxicity (27.0 vs 21.6%, p < 0.01). This did not vary between different starting doses of sorafenib. The mean duration of treatment was similar between those < and > 75 and, again, the starting dose of sorafenib did not affect treatment duration in the elderly. Conclusions: The median OS in the elderly is the same for that of patients under 75 years and is independent of the dose of sorafenib prescribed. Therefore, sorafenib should be offered to elderly patients and they should not be excluded from therapy
Living life post cancer treatment (LLPCT): An assessment of a 12-week multidimensional wellness intervention to improve quality of life and physical activity in cancer survivors.
Authors: Marino Christopher C. , Dwyer Colleen , Poppenberg Janette T. , Brufsky Jill , Zhai Shuyan , Van Londen G J.
Published: May 2020

12052

Background: Cancer survivors face unique health challenges with implications on health-related quality of life (HRQoL) and physical, social, and emotional wellbeing. With advancements in cancer treatment and aging populations, the prevalence of cancer survivors is expected to grow prompting the need for improved survivorship care delivery and comprehensive rehabilitative services. Living Life Post Cancer Treatment (LLPCT) is a community-based 12-week program that provides multidimensional support to patients of any cancer diagnosis transitioning from active treatment to post-treatment life. This single-arm intervention study aims to assess the program’s impact on HRQoL and physical activity in cancer survivors. Methods: A total of 125 participants within 2 years of treatment completion were enrolled in a 12-week program comprised of 9 sessions of engaging workshops, personalized exercise training, and nutrition and psychosocial counseling with an interprofessional team of oncology providers, social workers, exercise trainers, and dietitians. The program consisted of 8 consecutive weekly sessions followed by a 1-month follow-up session at week 12. Ninety-six (77%) participants completed the eighth or ninth session of the program and were included in the analysis. A series of questionnaires were administered at baseline and weeks 8 and 12. Primary outcomes assessed were HRQoL using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire and physical activity using average daily steps by pedometer and 2-minute step test performance. Results: Among the 96 participants (mean age 60.4 ± 11.7) who completed the program, the majority were female, white, and married. Post-intervention median FACT-G scores significantly increased from baseline at weeks 8 (+8.8, p = 0.002) and 12 (+7.3, p < 0.001). Average daily steps by pedometer increased by 1063 (p = 0.003) and 1233 (p = 0.015) and 2-minute step test performance increased by 18 (p < 0.001) and 21 (p < 0.001) steps at weeks 8 and 12, respectively. Participants reported high levels of satisfaction and improved self-efficacy to incorporate lifestyle modifications. Conclusions: These findings suggest that this 12-week intervention improves HRQoL and step-based physical activity levels in cancer survivors and could serve as a multidimensional model for post-treatment support. Further research is needed to determine if these benefits are sustained long-term.
The impact of tobacco retail density on overall survival (OS) in lung cancer survivors.
Authors: Eng Lawson , Hueniken Katrina , Norwood Todd A , Romme Gerald J , Brown M. Catherine , Hope Andrew J. , Bezjak Andrea , Sacher Adrian G. , Bradbury Penelope Ann , Shepherd Frances A. , Leighl Natasha B. , Pierre Andrew , Selby Peter , Goldstein David Paul , Xu Wei , Giuliani Meredith Elana , Evans William K. , Chaiton Michael , Liu Geoffrey
Published: May 2020

12058

Background: Continued smoking after a cancer diagnosis is associated with poorer outcomes. We previously identified that tobacco retail outlet density is negatively associated with cessation in lung cancer survivors (ASCO 2019). However, the impact of tobacco retail density on survival has not been evaluated. We evaluated the impact of tobacco retail density on OS in lung cancer patients (pts). Methods: Lung cancer pts diagnosed from 2009-2012 were recruited at diagnosis and completed a baseline questionnaire on their socio-demographics, ECOG and smoking history. Clinicopathologic data including stage, histology and OS data were collected. Validated tobacco retail location data obtained from Ministry of Health and pt home addresses were geocoded using ArcGIS 10.6.1, which calculated tobacco outlet density within 250 meters (m) and 500m from pts. Multivariable Cox proportional hazard models evaluated the impact of tobacco outlet density on OS adjusted for significant clinicodemographic covariates. Results: Among 1411 pts, median age 66, 53% female, 8% small cell/56% adenocarcinoma/17% squamous/19% other, 28% stage 1/9% stage 2/20% stage 3/35% stage 4, 38% were current smokers at diagnosis and 40% were ex-smokers; median OS was 24 months. On average, there was one vendor (range 0-23) within 250m and four vendors (range 0-44) within 500m from pts; 33% and 60% of pts lived within 250m and 500m from at least one vendor respectively. The final baseline multivariable model consisted of age, gender, stage, smoking status, ECOG and neighbourhood marginalization index ( P< 0.05). Among all pts, not living within 250m to an outlet improved OS (aHR 0.84 [0.72-0.97] P= 0.02). Living near more outlets within 250 m (aHR 1.03 per outlet [1.00-1.05] P= 0.03) or 500 m (aHR 1.01 per outlet [1.00-1.02] P= 0.04) worsened OS. Subgroup analysis based on smoking status at diagnosis, identified that among current smokers, not living within 250m to an outlet improved OS (aHR 0.76 [0.60-0.97] P= 0.03), and among ex-smokers, living near more outlets within 500 m worsened OS (aHR 1.02 per outlet [0.99-1.03] P= 0.07); other associations showed similar directionality. Among 135 current smokers at diagnosis with follow-up smoking status, not living within 250m to an outlet continued to show a trend towards improved OS (aHR 0.57 [0.31-1.03] P= 0.06), after also adjusting for follow-up smoking status. Conclusions: Living near a greater density of tobacco outlets is associated with poorer OS among lung cancer pts. Reducing the density of tobacco outlets may be a strategy that can help improve lung cancer pt outcomes.
Impact of immune checkpoint and BRAF inhibitors on the incidence of second primary malignancies (SPM) in melanoma.
Authors: Budhathoki Nibash , Timilsina Sunita , Atluri Prashanti , Weber Jeffrey S. , Braunstein Marc Justin
Published: May 2020

12061

Background: Prior studies have shown an increased risk of SPM in melanoma, however there is limited data on the incidence of SPM following the 2011 approvals of immune checkpoint (ipilimumab) and BRAF (vemurafenib) inhibitors, which have become standard of care. We present data comparing SPM rates before and after introduction of these agents for advanced cutaneous melanoma. Methods: Adult melanoma patients with regional or distant metastases were identified from SEER-18 database and divided into cohorts: 2005-2010 and 2011-2016. SPM was defined as tumors diagnosed ≥6 months from diagnosis of the primary cancer. SEER*stat was used to calculate SPM by multiple primary standardized incidence ratio based on observed (O) and expected (E) cases. The expected numbers of new cancers of specific types were estimated by assuming that incidence rates for new primary tumors corresponded to sex, age, and calendar time–specific SEER rates for similar invasive primary cancers and applying those rates to the accumulated person-years (PYR) of observation. Excess absolute risk (EAR) of malignancy per 10,000 PYR at risk was calculated as ([O − E]/PYR) × 10,000. Results: As shown in the table, from before 2005-2010, 421 of 7991 patients (5.2%) with advanced melanoma had 444 SPM (O/E ratio 2.2, 95% CI 1.9-2.4, P < 0.0001, EAR 157). In comparison, from 2011-2016, 527 of 9341 patients (5.6%) developed 584 SPM (O/E ratio 2.5, 95% CI 2.3-2.7, P < 0.0001, EAR 193). Incidence of AML, myeloma, and pancreatic cancer increased in 2005-2010, while soft tissue malignancies increased from 2011-2016. The incidence of thyroid, brain, and small bowel tumors increased in both groups from 2005-2016. Conclusions: There is a distinct pattern as well as increased latency of SPM in patients with advanced melanoma in the era of immune checkpoint and BRAF inhibitors. We speculate that reduction in chemotherapy use, augmentation of immunosurveillance, and inhibition of oncogenic pathways may impact the pathogenesis of SPM. [Table: see text]
Impact of preexisting cardiovascular disease (CVD) on treatments and outcomes of patients with breast or lung cancer.
Authors: Batra Atul , Kong Shiying , Rigo Rodrigo , Cheung Winson Y.
Published: May 2020

12063

Background: Prior cardio-oncology and geriatric oncology research has mainly focused on cancer treatments and their late effects on cardiac health, but little information is known about how cardiac health may influence subsequent cancer treatments. This real-world study aimed to evaluate the associations of pre-existing CVD on treatment adherence and survival in patients with breast or lung cancer. Methods: We linked administrative data from the population-based cancer registry, electronic medical records, and billing claims in a large province (Alberta, Canada) over a 10-year time period (2006-2015). Multivariable logistic regression analyses were performed to identify associations of CVD with cancer treatments. Multivariable Cox proportional hazards models were constructed to determine the effect of CVD on overall survival (OS), while adjusting for receipt of cancer treatments. Results: We identified 46,227 patients with breast or lung cancer, of whom 77% were women and median age was 65 years. While 82% of patients with breast cancer were early stage, 50% with lung cancer had metastasis. The prevalence of pre-existing CVD was 20% where congestive heart failure was most frequent. In logistic regression, CVD was associated with lower odds of receiving appropriate chemotherapy (OR, 0.60, 95% CI, 0.56-0.65, P<.0001), radiotherapy (OR, 0.76, 95% CI, 0.72-0.81, P<.0001), and surgery (OR, 0.60, 95% CI, 0.54-0.66, P <.0001), irrespective of tumor site (Table). The 5-year OS was lower in patients with baseline CVD as compared to those without (46% vs 58%, P<0.0001). Upon adjusting for stage and treatment, CVD continued to correlate with worse OS (HR, 1.23, 95% CI, 1.19-1.26; P<.0001). Conclusions: Cancer patients with prior CVD were less likely to receive standard cancer therapy. Even among those who underwent cancer treatments, worse outcomes were observed in those with CVD. Early cardio-oncology and geriatric oncology engagement may reduce treatment bias and ensure that carefully selected patients with a cardiac history are still offered appropriate cancer therapy. [Table: see text]
Patient reported outcomes in older breast cancer survivors.
Authors: Giordano Sharon H. , Liao Kai-Ping Eric , Li Liang , Zorzi Daria , Chavez-MacGregor Mariana , Peterson Susan K.
Published: May 2020

12072

Background: The majority of breast cancer patients are age 66 years or older at diagnosis, yet little is known about the symptom burden of older breast cancer survivors. Methods: Using the same process as for SEER-Medicare, data from the Texas Cancer Registry (TCR) and Medicare claims were linked. From this TCR-Medicare dataset, patients age 65 years and older at diagnosis, with localized or regional breast cancer, diagnosed in 2012 and 2013, and still alive in 2018 were identified. To assess long-term outcomes, a mailed survey, which included selected questions from the NCI’s PRO-CTCAE question bank, was sent to 4591 eligible patients along with a $10 gift card. Non-responders were sent a follow-up questionnaire at 4-6 weeks and 8-10 weeks after initial mailing. The percentage reporting symptoms, overall and by treatment received, are described. Results: 1594 survivors completed the questionnaire (35% response rate). Median time from diagnosis to survey completion was 67 months. 70% of responders were age 65-74, 26% age 75-84, and 3% age 85+ at diagnosis. 84% were non-Hispanic white, 6% black, and 9% Hispanic. 77% had localized stage disease and 23% had regional disease at diagnosis. 58% had lumpectomy, 36% had mastectomy, and 2% reported no surgery. 77% had ER+ breast cancer. 28% received adjuvant chemotherapy. 48% had Part D claims for adjuvant endocrine therapy. PROs are reported in Table, overall and by use of chemotherapy and endocrine therapy. Conclusions: Older breast cancer survivors, particularly those who were treated with chemotherapy, experience a high symptom burden. [Table: see text]
Financial toxicity among breast cancer survivors with health insurance.
Authors: Landier Wendy , Dai Chen , Sparks Jessica , Anthony Katie Rose , Barrett Jeffrey S. , Hageman Lindsey , Francisco Liton , Rocque Gabrielle Betty , Stringer-Reasor Erica Michelle , Nabell Lisle , Bhatia Smita
Published: May 2020

12073

Background: Cancer treatment and its sequelae have been associated with financial toxicity in breast cancer survivors, particularly those who have no health insurance. However, the prevalence of financial toxicity in the insured survivors, and the underlying factors are not well understood. Methods: Breast cancer survivors attending a survivorship clinic (University of Alabama at Birmingham) completed a survey assessing demographics, financial toxicity (i.e., material resources; food/housing/energy insecurity), and health-related quality of life (HRQL: SF-36). Clinical characteristics were abstracted from medical records. A multivariable logistic regression model was developed to understand factors associated with financial toxicity; the model included survivor age, race, socioeconomic status, insurance type, marital status, cancer stage, time since diagnosis, current medications, and physical and mental domains of HRQL. Results: The 368 participants (1% male; 67% white, 25% African American, 8% other) were a median of 61y of age (range, 33-86y) and 4.3y post-diagnosis (1-34y) at survey completion; 90% had stage 0-II disease; 34% were single (not currently married/partnered); type of health insurance included private/military (57%), Medicare (39%), and Medicaid/self-pay (4%). Overall, 31% reported financial toxicity; 26% endorsed not being able to live at current standard of living > 2 mo. if they lost all current sources of income; 6% endorsed energy insecurity, 5% endorsed food insecurity, and 4% endorsed housing insecurity. In a multivariable model, financial toxicity was associated with age ≤60y at survey (Odds Ratio [OR] 5.1; 95% confidence interval [CI] 2.0-13.3); household income < $50K/y (OR 5.3; 95%CI 2.5-11.2); being single (OR 2.6; 95%CI 1.3-5.4); and lower physical (OR 2.6; 95%CI 1.2-5.4) and mental (OR 2.2; 95%CI 1.2-4.3) HRQL. Cancer stage, race, time from diagnosis, and insurance type were not associated with financial toxicity. The prevalence of financial toxicity among survivors who were single, ≤60y at survey, and with household income < $50k/y was 79.3%, compared with 6.7% among those who were older, married/partnered, and with higher income. Conclusions: Financial toxicity is prevalent among insured breast cancer survivors several years after cancer diagnosis, and is exacerbated among the younger survivors who are single, with low household income, and endorse poorer physical and mental quality of life. These findings inform the need to develop interventions to mitigate financial toxicity among at-risk breast cancer survivors.
Relationships between worry about dying in patients with advanced cancer and their illness understanding, treatment preferences, and advance care planning.
Authors: Rodenbach Rachel , Althouse Andrew , Smith Thomas J. , White Douglas B. , Chu Edward , Bakitas Marie , Schenker Yael , Arnold Robert M
Published: May 2020

12080

Background: Patients with advanced cancer often worry about dying, yet little is known about the role their fears play regarding future care. We aimed to explore relationships between patients’ worry about dying and their illness understanding, treatment preference, and advance care planning. Methods: This cross-sectional study uses baseline data from a community-based, primary palliative care intervention trial. Patients had metastatic solid tumors, an Eastern Cooperative Oncology Group performance status of 0-2, and their oncologist “would not be surprised” if they died in the next year. Using patients’ response to “I worry about dying” (not at all, a little bit, somewhat, quite a bit, or very much) from the Functional Assessment of Chronic Illness - Palliative Care survey instrument, univariate and multivariate analyses assessed associations with illness understanding (report of being terminally ill or not), treatment preference (life-extending vs. symptom-focused), and advance care planning (completion of an advance directive or not). We also performed sensitivity analyses substituting “I feel scared about my future” (strongly disagree, disagree, agree, or strongly agree) from the Herth Hope Index for “I worry about dying.” Results: Of 672 patients, 54% were female, 94% white, and 69% currently receiving chemotherapy. 47% reported worrying about dying “not at all,” while 9.7% worried “quite a bit” or “very much.” In regression analysis, those who worried “quite a bit” or “very much” were more likely to describe themselves as terminally ill (adjusted odds ratio (AOR)=1.98, 95% CI=1.10-3.54, p=0.021) and more likely to prefer life-extending treatment over symptom-focused care (AOR=2.61, 95% CI=1.30-5.22, p=0.007) compared with patients who reported not worrying about dying. They also were less likely to have completed an advance directive (AOR=0.49, 95% CI=0.25-0.94, p=0.032). The same relationships were observed using patients’ response to “I feel scared about my future.” Conclusions: Patients with advanced cancer who worry more about dying can affirm they are terminally ill and are more likely to want life-extending treatment over symptom care while less likely to engage in advance care planning. Understanding these patients’ decision making is critical to ensuring that their values are known and understood near the end of life.
Results of a randomized, open-label, multicenter trial to assess the safety, dose, and schedule ofRRx-001(001) in reducing incidence, severity and duration of severe oral mucositis (SOM) inpatients receiving concomitant chemoradiation (CRT) for advanced head and neck cancer (HNC).
Authors: Bonomi Marcelo Raul , Sher David , Blakaj Dukagjin , Kabarriti Rafi , Colvett Kyle , Oronsky Bryan , Sonis Stephen T. , Bianco James A.
Published: May 2020

12081

Background: SOM occurs in 70% of patients receiving CRT for HNC with consequent pain, treatment interruptions and increased costs of care. Supraphysiologic levels of oxidative stress are key SOM initiators. 001 activates nuclear factor erythroid related factor 2 (Nrf2) increasing expression of multiple antioxidant genes including superoxide dismutase glutathione peroxidase and glutathione S-transferase. This trial examined the effect of dose and schedule on safety and efficacy of 001. Primary efficacy endpoint was duration of SOM (WHO criteria assessed); secondary endpoints included time to onset, incidence grade 4 through 60Gy and 70Gy. Methods: Locally advanced HNC treated with definitive or postoperative CRT (cisplatin + RT) received one of 3 001 schedules: (ARM1) 2 doses/wk for 2 weeks (prior to) CRT. ARMS 2, 3: prior to + 2 doses or 6 doses with CRT respectively or standard of care (SOC). Results: 53 patients randomized, 45 evaluable. Benefit trends for endpoints were consistent across all 3 001 arms with greatest effect size in pre-treatment only, ARM1. Compared to SOC, 001 reduced duration of SOM by 45% (40 vs 22 days). Through 60Gy and 70Gy a reduction of 95% and 79% in duration SOM was also observed (17 vs 1 day, and 23 vs 5 days) respectively. No patients in ARM1 developed grade 4, (0% vs SOC 30%). Side effects were comparable to SOC. Conclusions: In this small, open label trial, 001 demonstrated a favorable risk-benefit profile supported by reductions in overall SOM duration including through 60Gy and 70Gy with no grade ARM1 was most effective suggesting short periods of Nrf2 activation before CRT oxidative stress generation may increase the threshold and buffering capacity of upregulated antioxidants. Larger, blinded trials, confirming the observed dose, schedule and treatment effects are warranted. Clinical trial information: NCT03515538 .
Assessing the impact of antiemetic guideline compliance on prevention of chemotherapy-induced nausea and vomiting (CINV): Results of the Nausea/Emesis Registry in Oncology (NERO).
Authors: Aapro Matti S. , Chrápavá Marika , Curca Razvan-Ovidiu D. , Gales Laurentia , Grigorescu Alexandru Calim , Karlínová Bára , Kellnerová Renata , Petru Edgar , Pluzanski Adam , Rubach Maryna , Steger Guenther G. , Tesarova Petra , Yordanov Nicolay , Walaszkowska-Czyz Anna
Published: May 2020

12083

Background: Evidence-based antiemetic guidelines offer predominantly consistent recommendations for CINV prophylaxis. However, studies and surveys suggest that adherence to these recommendations is suboptimal. We explored potential inconsistencies between clinical practice and guideline-recommended treatment with a registry evaluating the effect of guideline-consistent CINV prophylaxis (GCCP) on patient outcomes. Methods: This was a prospective, non-interventional, observational, multicenter study designed to assess overall (0-120 h) complete response (CR: no emesis/no rescue use) rates in patients who received GCCP or guideline inconsistent CINV prophylaxis (GICP) using diaries for 5 days following chemotherapy. Cycle 1 results are presented in patients who received either 1) anthracycline/cyclosphosphamide (AC) highly emetogenic chemotherapy (HEC), non-AC HEC or carboplatin, with GCCP for all these groups consisting of prophylaxis with an NK1 receptor antagonist (RA), 5-HT3RA, and dexamethasone (DEX) prior to chemotherapy or 2) moderately emetogenic chemotherapy (MEC), with GCCP consisting of a 5-HT3RA and DEX prior to chemotherapy as per MASCC 2016 guidelines. CR rates for cohorts deemed to be GCCP and GICP were compared using a chi-square test. Results: A total of 1,089 patients were part of the cycle 1 efficacy evaluation. Overall GCCP was 23% for all patients. CR rates were significantly higher in patients receiving GCCP versus GICP (Table). Conclusions: Consistent with prior studies, GCCP was very low. The primary endpoint of the study was achieved as there was a significant benefit of almost 10% improved prevention of CINV when administering GCCP. As per MASCC/ESMO guidelines such an absolute difference should be practice changing. Comprehensive multifaceted strategies are needed to achieve better adherence to antiemetic guidelines. [Table: see text]
Optimizing management of the oncological patient with pulmonary embolism: Validation of the epiphany index—PERSEO study.
Authors: Sánchez Cánovas Manuel , Cejuela Solís Mónica , De la Haba Vacas Irma , Gómez David , Casado Elía Diego , Fernandez Montes Ana , Morales Giménez Roberto , Biosca Mercedes , Fernández Garay David , Arrazubi Virginia , Sequero Silvia , Sánchez Cendra Cristina , Otero Candelera Remedios , Justo de la Peña Marina , Moreno Diana , De Castro Eva Martinez , Ortega Laura , Muñoz Martín Andres J. , Jiménez-Fonseca Paula , Carmona Bayonas Alberto ,   PERSEO Investigators
Published: May 2020

12085

Background: EPIPHANY is the first algorithm to predict serious complications in both suspected and unsuspected cancer-associated pulmonary embolism (PE), overcoming limitations of previous models. Methods: PERSEO is a prospective multicenter study. We recruited cancer patients with both incidental and symptomatic PE treated between Oct. 2017 and Dec. 2019. The primary aim was to determine the percentage of serious complications in patients at low predicted risk, with at least 3% accuracy. We also compared the predictive parameters of EPIPHANY with other available scores for prediction 15-day serious complications and 30-day mortality. Results: Cohort includes 831 patients (men, 58.6%; median age, 66 years). Most frequent tumors were lung (27.1%), colorectal (19%) and breast (7.8%). 78.6% had stage IV disease, and 77.6% were receiving antineoplastic treatment. EPIPHANY classified 27%, 24% and 49% of patients as low, medium and high risk, respectively. The rate of 15-day serious complications increased significantly across these prognostic categories: 2.67 (95% CI 0.6 - 4.8), 8.9% (95% CI 0.5 - 12.8), and 25.9% (95% CI 21.7 - 30.2), for low, intermediate, and high risk patients, respectively (p<0.001, linear-by-linear test). In comparison with other validated scores, EPIPHANY has a higher negative predictive value, lower negative likelihood-ratio, and comparable sensitivity (Table). Conclusions: The EPIPHANY index is able to identify a subgroup of patients with cancer-associated pulmonary embolism at very low risk of serious complications or short-term mortality, with potential implications for decision making. [Table: see text]
Phase II randomized controlled trial (RCT) of medical intensive nutrition therapy (MINT) to improve chemotherapy (CT) tolerability in malnourished patients with solid tumor malignancies.
Authors: Shusterman Michael , Brar Gagandeep , Klute Kelsey , Cooley Victoria , Rosenstock Alexandra , Hwang Eun Kyeong , Elmonshed Dina , Ruggiero Joseph T. , Ocean Allyson J. , Popa Elizabeta C. , Tagawa Scott T. , Molina Ana M. , Nanus David M. , Scheff Ronald J. , Saxena Ashish , Goncalves Marcus D. , Christos Paul J. , Shah Manish A.
Published: May 2020

12090

Background: Malnutrition is an underrecognized predictor of inferior cancer related outcomes. Subjective global assessment (SGA), a brief validated survey for malnutrition, may predict increased CT toxicity. This phase II RCT was performed to validate SGA as a predictive tool for malnutrition and to evaluate the impact of MINT on CT associated toxicity. Methods: CT naive pts screened by SGA were assigned to well-nourished (SGA A) or malnourished (SGA B/C) cohorts. Both cohorts were followed for CT delivery, toxicity, quality of life (QOL) by FACT-G, biomarkers, radiology, and survival. SGA B/C pts, stratified by regimen/disease, were randomized 1:1 to MINT vs. usual care. The MINT cohort received weekly registered dietician counseling and symptom assessment over the 8-week study period. Percent standard and planned CT doses were calculated. Wilcoxon rank sum tests were used for differences between groups, log-rank tests for survival, and multivariable linear regression for adjusted comparisons. Results: 186 eligible pts were enrolled (94 SGA A, 92 SGA B/C). SGA A were younger (median age [range]; 63 [22, 89] vs. 70 [22, 91], p = 0.011) and more fit (ECOG 0-1; 96.8% vs. 72.8%, p < 0.001). Baseline QOL was higher for SGA A (median [range], 87 [34, 115]) vs SGA B/C (70 [31, 101], p < 0.001). SGA A was associated with higher CT delivery: median proportion of planned CT (1 [Q1 0.87, Q3 1] vs 0.94 [0.70, 1], p = 0.022) and standard CT (0.91 [0.72, 1] vs. 0.74 [0.57, 0.95] p < 0.001). Adjusted for age/ECOG, SGA A remained associated with > 80% of planned (OR 2.32, p = 0.05) and standard (OR 2.33, p = 0.04) CT. SGA B/C pts (n = 92) were randomized to MINT vs usual care: median nutrition encounters MINT 5.5 vs. usual care 0.5; we observed no differences in CT delivery: median proportion of planned CT (0.91 [0.69, 1] vs. 0.94 [0.74, 1], p = 0.84) and standard CT (0.75 [0.58, 0.96] vs 0.71 [0.52, 0.99], p = 0.59). SGA A was associated with a longer 12-month survival (77.8% [95% CI 69.6%, 86.9%]) vs. B/C (53.3% [42.8%, 66.4%], p < 0.0001; 12-month survival was similar for MINT (52.3% [38.1%, 71.9%]) vs usual care (54.4% [40.2%, 73.6%], p = 0.58). Conclusions: SGA is a validated tool to characterize malnutrition in pts receiving CT. Malnourished pts received significantly less CT, experienced worse baseline QOL, and had worse 12-month survival. Intensive medical nutrition therapy was not associated with differences in CT associated toxicity. Novel nutritional interventions are still needed to improve pt outcomes.
Depression, anxiety, and patterns of mental health care among men with prostate cancer on androgen deprivation therapy (ADT).
Authors: Tsao Phoebe A. , Ross Ryan , Bohnert Amy S. B. , Mukherjee Bhramar , Caram Megan Veresh
Published: May 2020

12100

Background: ADT is associated with an increased risk of depression and anxiety, raising the concern that a substantial portion of men with prostate cancer need mental health care. We sought to investigate the development of depression or anxiety and subsequent patterns of mental health care in men with prostate cancer on ADT. Methods: Clinformatics DataMart, a claims database of commercially insured patients, was used to identify men with prostate cancer who received ADT between 2001-2015 and had continuous enrollment for 1 year before and 2 years after starting ADT. We determined the rate of incident diagnoses of depression or anxiety and the incident use of mental health treatments - psychotherapy and psychiatric medications (≥ 5 day supply) - after the start of ADT. Results: Among 37,388 men in the final analytic cohort, 11.3% (n=4239, 95% confidence interval (CI) 11.0-11.6%) received new diagnoses of depression or anxiety: 5.8% depression (95% CI, 5.5-6.0%), 3.7% anxiety (95% CI 3.5-3.9%), and 1.8% both (95% CI, 1.7-1.9%). Those who received a diagnosis of depression or anxiety were more likely to be white (68% v. 64%, p<0.01); no differences were noted in age, education, or household income. Among those with a new diagnosis of depression or anxiety, 0.07% received psychotherapy (95% CI, 0.02-0.23%), 34.9% a selective serotonin reuptake inhibitor (95% CI, 33.5-36.4%), 11.6% a serotonin norepinephrine reuptake inhibitor (95% CI, 10.7-12.6%), and 19.9% a benzodiazepine (95% CI, 18.7-21.1%). Conclusions: Among men with prostate cancer receiving ADT, more than 1 in 10 received a new diagnosis of depression or anxiety. Of those, 1 in 5 were introduced to a benzodiazepine, a drug class with risks of dependence, cognitive impairment, falls, and fractures, whereas receipt of psychotherapy was rare. Further investigation into how to improve the mental health care of men on ADT is needed. [Table: see text]
High-dose vitamin D supplementation for cancer-treatment-induced bone loss in 164 breast and prostate cancer patients: A pooled analysis of two randomized controlled trials (RCTs).
Authors: Peppone Luke Joseph , Kleckner Amber , Inglis Julia Ellen , Reschke Jennifer E , Belcher Elizabeth , Kleckner Ian , Xu Huiwen , Lin Po-Ju , Mustian Karen Michelle , Janelsins Michelle Christine , Culakova Eva
Published: May 2020

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Background: Aromatase Inhibitor (AI) therapy and androgen deprivation therapy (ADT) significantly accelerate bone loss and increase fracture risk. Vitamin D (VITD) protects against bone loss, but it is unclear whether the recommended daily allowance (RDA; 600 IU/day for ages 51-70) of VITD is sufficient for cancer patients. Data from two RCTs were pooled to examine the safety and efficacy of high-dose VITD versus the RDA of VITD on bone mineral density (BMD). Methods: 164 breast and prostate cancer patients on AIs and ADT, respectively, with low VITD (<32 ng/ml) were randomized to either high-dose VITD (50,000 IU/week; n=99) or placebo (n=65) for 24 weeks. All subjects received 600 IU/day of VITD. Of the 99 subjects assigned to high-dose VITD, 38 breast subjects also received the Exercise for Cancer Patients (EXCAP) program combining walking and resistance training. Serum VITD and calcium were assessed at weeks 0, 6, 12, 18, and 24. BMD was assessed at the hip and spine via DXA at weeks 0 and 24. The effect of high-dose VITD was tested via ANCOVA model adjusted for cancer type, baseline BMD and VITD. Results: High-dose VITD significantly reduced the amount of hip BMD loss versus the RDA of VITD (high-dose VITD: −0.8% vs placebo: −2.6%; p<0.01) over 24 weeks. Hip BMD loss was greater for subjects on ADT (high-dose VITD: −1.5% vs placebo: −4.1%; p=0.03) than subjects on AI therapy (high-dose VITD: −0.2% vs placebo: −1.7%; p=0.02). Among the high-dose VITD group, there was no BMD difference at the total hip between those who received EXCAP exercise vs no EXCAP (p=0.96). The largest differences in BMD were for those with lower baseline VITD levels (<27 ng/ml) for both total hip (high-dose VITD: −0.6% vs placebo: −3.2%; p<0.001) and femoral neck (high-dose VITD: +0.2% vs placebo: −2.4%; p=0.03). No between-group pooled differences were noted for total spine BMD (high-dose VITD: −0.2% vs placebo: −0.1%; p=0.82). High-dose VITD increased serum VITD without negatively affecting serum calcium (Table). Conclusions: High-dose VITD was safe and effective in significantly reducing hip BMD loss, with the largest benefit in those with lower baseline VITD levels. A phase III RCT is needed to confirm these findings. NCI Funding: K07 CA168911/R21 CA175793/UG1 CA189961/T32 CA102618 Clinical trial information: NCT02064946, NCT01419730 . [Table: see text]
Safety and effectiveness of medical cannabis as a complementary option for supportive cancer care: Results from the Cannabis Pilot Project.
Authors: Vigano Antonio , Aprikian Saro , Kasvis Popi , Bacis Virginie , Al Harrasi Amna , Aubin Nathalie M , Vigano MariaLuisa , Borod Manuel
Published: May 2020

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Background: Access to medical cannabis (MC) is a common request by patients and caregivers in supportive cancer care (SCC). However, healthcare professionals require more evidence on MC safety and effectiveness. Methods: The Cannabis Pilot Project (CPP) was implemented at the Cedars Cancer Centre of the McGill University Health Centre to evaluate MC as a complementary option for symptom control in SCC. Referral to the CPP was reserved for patients who were receiving SCC but had not obtained adequate symptom relief. An interdisciplinary team (physician, nurse and research coordinator) was established to systematically assess patients, prescribe and monitor MC treatments and record data on their safety and effectiveness. Patients were enrolled in the CPP between February 2018 and December 2019 and reassessed at intervals of one to six months. Results: Ninety-six cancer patients (mean age 60.0y (±13.9); 41 (42.7%) males) had at least one follow-up (FUP) and were included in the study. The main cancer types were breast (19.8%), lung (9.4%) and colorectal (9.4%). Adverse events (top three: drowsiness, low energy and nausea) were reported in 28% of patients, with 9% having to stop MC. Mean Brief Pain Inventory scores significantly improved between baseline, FUP-2 and FUP-3 for worst pain (5.4± SEM 0.3 vs 4.3±0.3 and 3.7±0.4) and average pain severity (4.2±0.2 vs 3.2±0.3 and 3.2±0.4). Anorexia improved (3.4±0.3 vs 2.2±0.4 and 1.7±0.4), as measured via the revised Edmonton Symptom Assessment System (ESAS-r). ESAS-r wellbeing improved significantly between baseline and FUP-1 (4.4±0.2 vs 3.7±0.2). Between baseline and each FUP, approximately a third of patients dropped their use of concurrent medications (including analgesics, antidepressants and anxiolytics), as measured by the Medication Quantification Scale. Conclusions: The CPP data support the safety and effectiveness of MC as a complementary option for improving pain control, appetite and quality of life in SCC.
Questions prompt lists used by palliative care teams help trigger discussions on prognosis and end-of-life issues with advanced cancer patients.
Authors: Bouleuc Carole , Burnod Alexis , Cottu Paul H. , Pierga Jean-Yves , Dolbeault Sylvie
Published: May 2020

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Background: Accuracy of prognosis perception is a key element to allow advanced cancer patients to make informed decisions and to reflect on their end-of-life priorities. This study aims to explore whether a question prompt list can promote discussions on prognosis and end-of-life issues during palliative care consultations for advanced cancer patients. Methods: In this multicentric randomised study, patients assigned in the interventional arm receive a question prompt list during the first palliative care consultation (T1) after referral by oncologists. The primary endpoint is the number of questions asked by patients during the second palliative care consultation (T2) one month later. Secondary objectives are anxiety and depression, quality-of-life, satisfaction with care, coping assessed at baseline (T1) and at two months (T3). Palliative care teams from 3 french comprehensive cancer centers participate in the study. Main inclusion criteria were adult patients with metastatic non-haematological cancer referred to the palliative care team and with an estimated life expectancy less than one year. Results: Patients (n = 71) in the QPL arm asked more questions (mean 21.8 versus 18.2, p-value = 0.03) during the palliative care consultations compared to patients in the control arm (n = 71). These questions addressed palliative care (mean 5.6 versus 3.7, p-value = 0.012) and end-of-life issues (mean 2.2 versus 1, p = 0.018) more frequently than in the control arm. At two months, compared to baseline, there was no change in anxio-depressive symptoms or quality of life. Conclusions: QPL favours discussion on prognosis and end-of-life care during the palliative care consultations for advanced cancer patients. Clinical trial information: NCT02854293 .
A prospective analysis of chemotherapy-induced nausea and vomiting in gastrointestinal cancers: Results from a tertiary cancer center.
Authors: Kapoor Akhil , Ostwal Vikas S. , Ramaswamy Anant , Bhargava Prabhat Ghanshyam , Gupta Sudeep , Prabhash Kumar
Published: May 2020

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Background: Chemotherapy-induced nausea and vomiting (CINV) is a bothersome side-effect associated with cancer chemotherapy which adversely impacts both quality of life and the ability to carry out the activities of daily living. This study was conducted to assess the proportion of patients developing CINV after receiving chemotherapy for gastrointestinal (GI) cancers, in spite of receiving antiemetic prophylaxis as per the standard guidelines. Methods: Consecutive patients with GI malignancy who had not received previous chemotherapy were eligible for enrollment in the study if they were scheduled to receive at least one cycle of chemotherapy. SPSS version 20 was used for all statistical calculations. Results: 701 patients fulfilling the eligibility criteria were included in this study, out of which 55.4% were males, median age was 51 years (range 22-77). Biliary tract cancer (34%) was the most common diagnosis followed by colorectal (30.2%) and gastric cancer (19.6%). As per MASCC guidelines, 22.1% patients received highly emetogenic chemotherapy, 56.0% moderately emetogenic chemotherapy (MEC) while 19.9% received regimen with low emetogenicity. Failure to achieve complete response (CR, absence of acute and delayed CINV) was found in 27.4% patients. On separately analysing MEC group, overall CR was not achieved in 33.8% with failure in acute settings in 17.8% and delayed in 16.0% patients. Only significant factor for not achieving CR was use of oxaliplatin based chemotherapy (p = 0.018 for acute and p = 0.014 for delayed CINV). Conclusions: More than one fourth patients failed to achieve complete response for CINV in gastrointestinal cancers despite using prophylaxis as per standard guidelines. Use of oxaliplatin based therapy is an important factor for MEC causing CINV. There is urgent need to update the guidelines for prophylaxis in this setting. [Table: see text]
Nonconscious nonverbal synchrony and patient and physician affect and rapport in cancer treatment discussions with black and white patients.
Authors: Hamel Lauren M. , Moulder Robert , Penner Louis , Albrecht Terrance Lynn , Boker Steven , Dougherty David W. , Eggly Susan
Published: May 2020

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Background: Clinical communication is poorer with Black patients than with White patients, but most studies are limited to verbal communication. Nonverbal synchrony, the subtle, nonconscious coordination of movement between individuals, has been shown to reflect relationship quality. We investigated nonverbal synchrony’s association with patient and physician affect and rapport in cancer treatment discussions, and if those associations differed by patient race. Methods: We used motion detection software to measure overall synchrony and synchrony based on who is leading in the interaction (similar to leading in dancing) in video recordings of 68 Black patients and 163 White patients discussing treatment with their non-Black physicians. Additionally, naïve observers rated the interaction for six constructs: patient and physician positive and negative affect and patient-physician positive and negative rapport. We examined associations between nonverbal synchrony and the six constructs. Results: In interactions with Black patients, overall synchrony was positively associated with patients’ positive affect and positive patient-physician rapport and negatively associated with patients’ negative affect and negative patient-physician rapport. When the physician was leading, synchrony was positively associated with patients’ positive affect and positive patient-physician rapport and negatively associated with patients’ negative affect and negative patient-physician rapport. When the patient was leading, synchrony was positively associated with patients’ and physicians’ positive affect and positive patient-physician rapport, and negatively associated with patients’ negative affect and negative patient-physician rapport. In interactions with White patients, overall synchrony was positively associated with patient positive affect; when the physician was leading, synchrony was negatively associated with patient negative affect. Conclusions: This is the first study to use an innovative measure of dynamic communication in patient-physician cancer treatment discussions. Nonverbal synchrony was related to patient and physician affect and rapport in interactions with Black patients, but only patient affect in interactions with White patients, suggesting nonverbal synchrony is particularly important in interactions with Black patients. Next steps include investigating associations with patient outcomes (e.g., satisfaction). Findings could contribute to physician training.