Diagnosed Cancer Patients Research Articles

The predictors of poor quality of life in a sample of Saudi women with breast cancer.

BackgroundThe protocols for treatment, along with many adverse effects, can strongly affect cancer patients’ quality of life (QoL). As there is limited research on the QoL of Saudi Arabian women being treated for breast cancer, the purpose of this study was to identify the predictors of poor QoL in a sample of Saudi women with breast cancer.MethodsA cross-sectional study was conducted on 145 Saudi women with breast cancer who attended the Oncology Outpatient Clinic at King Abdulaziz Medical City, Riyadh for routine follow-up. Sociodemographic and clinical data were collected for each patient, and a Medical Outcome Study Health Survey 36-Item Short Form (SF-36) instrument was used to assess QoL.ResultsOf 145 breast cancer patients studied, 42.1% had a family history of cancer and 52.4% were newly diagnosed cancer patients (first-year-after-cancer diagnosis). According to linear regression analyses, cancer patients with metastasis tended to have pain, along with poor physical function, little vitality, and poor general health (a decrease in SF-36 scores of 22.9, 15.0, 19.4, and 16.9, respectively). Regular exercise was a positive predictor of poor general health (an increase in the SF-36 score of 8.2). Patients with first-year-after-cancer diagnoses tended to have poor emotional well-being (a decrease in the SF-36 score of 8.5).ConclusionIn breast cancer patients, regular exercise was a significant positive predictor of better general health. Breast cancer patients with multiple tumors, metastasis, or fever tended to experience significantly poor QoL in several SF-36 domains. Clearly, a routine assessment of QoL in breast cancer patients is important.

Evaluation of treatment-related mortality among paediatric cancer deaths: a population based analysis

Background:Objectives were to describe the proportion of deaths due to treatment-related mortality (TRM) and to identify risk factors and probable causes of TRM among paediatric cancer deaths in a population-based cohort.Methods:We included children with cancer ⩽18 years diagnosed and treated in Ontario who died between January 2003 and December 2012. Deaths were identified using a provincial registry, the Pediatric Oncology Group of Ontario Networked Information System. Probable causes of TRM were described.Results:Among the 964 deaths identified, 821 were included. The median age at diagnosis was 6.6 years (range 0–18.8) and 51.8% had at least one relapse. Of the deaths examined, TRM occurred in 217/821 (26.4%) while 604/821 (73.6%) were due to progressive cancer. Deaths from TRM did not change over time. Using multiple regression, younger age, leukaemia diagnosis and absence of relapse were independently positively associated with TRM. The most common probable causes of TRM were respiratory, infection and haemorrhage.Conclusions:TRM was responsible for 26.4% of deaths in paediatric cancer. Underlying diagnosis, younger age and absence of relapse were associated with TRM and causes of TRM differed by diagnosis group. Future work should evaluate TRM rate and risk factors among newly diagnosed cancer patients.

Second Primary Neoplasms: A Clinico-Pathological Analysis from a Sub Himalayan Cancer Centre in India

Background: There is a lifetime risk of developing another de novo malignancy in diagnosed cancer patients. Detection of new primary has increased due to advances in both diagnostic and treatment modalities. This article aims to analyze the pattern of presentation of second primary neoplasm and to review the relevant literature. Materials and Methods: We analyzed patients presenting with histologically proven synchronous or metachronous second primaries from July 2011 to July 2016. Warren and Gate's criteria have been used to designate a case as second primary neoplasm. Various details such as age at diagnosis, sex, whether synchronous or metachronous, site, stage, histopathology, treatment were collected. Results: Over a period of 5 years total 40 cases were observed, out of which 13 were synchronous (33%) and 27 (67%) were metachronous. The median age at the diagnosis of primary malignancy was 65.5 years (range 27-84). Out of the 40 patients, 28 (70%) were males and 12 (30%) were females. The most common site of primary tumor was head and neck and genito-urinary, 11 cases each. Among the second malignancy most common site was gastrointestinal tract (11 cases), followed by genitourinary (10 cases) and lung (9 cases). Conclusion: The likelihood of diagnosis of second malignancy has increased with the advent of newer diagnostic modalities as well as increased compliance to follow up and progress in the management. Appearance of new signs and symptoms should raise a suspicion and early detection of the disease leads to appropriate management.

Pattern of Adverse Drug Reactions to Anticancer Drugs: A Quantitative and Qualitative Analysis.

Introduction:Anticancer drugs contribute significantly to the global burden of adverse drug reactions (ADRs). Any attempt to quantify their magnitude and provide upgraded knowledge would help oncologists in writing safer prescriptions.Aim:This observational follow-up study was conducted on newly diagnosed cancer patients receiving anticancer therapy with an aim to determine the frequency, severity, causality, predictability, and preventability of ADRs.Subjects and Methods:The patients were followed up for 6 months for the appearance of adverse events. Data were analyzed using IBM SPSS Statistics for Windows, Version 22.0. (Armonk, NY) and presented in the form of descriptive statistics.Results:Each patient was prescribed approximately 6.85 ± 1.51 (mean ± standard error) drugs on average. All the patients (100%) receiving anticancer chemotherapy had ADRs. Alopecia, nausea and vomiting, burning tingling, and numbness were the most frequently encountered ADRs. The incidence of alopecia (P < 0.0004), nausea (P < 0.03), and oral ulceration (P < 0.02) was higher in females. Maximum reactions were of Grade 2 (69.53%). Most of the reactions (75.80%) appeared within 10 days of receiving the first cycle. 99.58% reactions were not serious. According to the WHO – The Uppsala Monitoring Centre criteria, 99.47% ADRs fell in possible category. According to the Naranjo's algorithm, 100% ADRs fell in probable category. About 94.80% reactions were found to be predictable. About 56.47% reactions were probably preventable, and 43.53% reactions were not preventable.Conclusion:Multiple ADRs were seen in newly diagnosed cancer patients. Most of them were predictable, of mild-to-moderate severity, nonserious, and preventable. A majority of the ADRs recovered over time.

P1.07-051 Incidence and Clinical Characteristics of Pulmonary Large-Cell Neuroendocrine Carcinoma: An Overview of Our Own Data

Pulmonary neuroendocrine tumors are a heterogenous group of neoplasms. They are classified into four histological types: typical carcinoid, atypical carcinoid, small-cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma (LCNEC). They represent about 20% of all lung cancers. The most frequent one is small-cell lung cancer with incidence about 15%. In contrast, large-cell neuroendocrine carcinoma is an orphan disease with estimated incidence between 2.1% and 3.5%. Because of many diagnostic difficulties, LCNEC is considered to be of a higher frequency. It is lung neuroendocrine tumor, but it is also a type of non-small-cell lung cancer (NSCLC). So its features overlap with both of these groups. However, the clinical behavior of LCNEC is very similar to SCLC and so new term high-grade neuroendocrine carcinoma (HGNEC) is in use. We retrospectively analyzed patients diagnosed with cancer at our department between January 1, 2012 and December 31, 2014, with special focus on pulmonary neuroendocrine tumors. We examined incidence of different histologic types of pulmonary neuroendocrine tumors and sorted out patients with diagnosis of large-cell neuroendocrine carcinoma. We also analyzed clinical characteristics of patients with LCNEC. During the three-years period 1242 pulmonary patients were admitted to our department. Among them there were 726 newly diagnosed cancer patients. Various types of lung cancer were found in 652 patients. There were 104 patients with pulmonary neuroendocrine tumors, what makes about 16%. Thirteen of them (2%) were “pure” LCNEC, 16 (2,5%) mixed LCNEC with small-cell component, 68 SCLC (10%), 4 atypical carcinoid, 2 typical carcinoid and 1 typical carcinoid in patient with adenocarcinoma. Generally in our patients high-grade neuroendocrine tumors make about 15%, and low-grade neuroendocrine tumors (carcinoides) make only 1% of all lung cancers. Most patients diagnosed with LCNEC were men over 50 years, heavy smokers, which is consistent with published data, but one patient was a 40-year-old woman. Pulmonary neuroendocrine tumors are group of neoplasms classified into four categories based on their patohistology. Three of them (carcinoides and LCNEC) are rare tumors. LCNEC is type of neuroendocrine tumor with most diagnostic and therapeutic difficulties. Clinical features of our patients are similar to previously published, while incidence is slightly lower.

Antioxidant activity of ginger extract as a daily supplement in cancer patients receiving adjuvant chemotherapy: a pilot study.

PurposeThe aim of this study was to examine the antioxidant activity of ginger extract oral supplement in newly diagnosed cancer patients receiving adjuvant chemotherapy compared to placebo.Patients and methodsNewly diagnosed cancer patients receiving moderate-to-high emetogenic potential adjuvant chemotherapy were randomized to receive either a ginger extract (standardized 6-gingerol 20 mg/day) or a placebo 3 days prior to chemotherapy, which they continued daily. Oxidant/antioxidant parameters, including the activities of superoxide dismutase (SOD) and catalase (CAT) and levels of glutathione peroxidase (GPx), total glutathione (GSH/GSSG), lipid peroxidation products detected as malondialdehyde (MDA) and NO2−/NO3−, were measured at baseline and at days 1, 22, 43 and 64 after undergoing chemotherapy. Two-sided statistical analysis, with P < 0.05, was used to determine statistical significance.ResultsA total of 43 patients were included in the study: 19 and 24 patients were randomly assigned to the ginger group and placebo group, respectively. Antioxidant activity parameters, including SOD, CAT, GPx and GSH/GSSG, were significantly increased at day 64 in the ginger group compared to those in the placebo group, while MDA and NO2−/NO3− levels were significantly decreased (P < 0.0001). When compared to the baseline, the activities of SOD and CAT and the levels of GPx and GSH/GSSG were significantly higher on day 64 (P = 0.01), while the blood levels of MDA and NO2−/NO3− were significantly decreased (P < 0.01).ConclusionDaily supplement of ginger extract started 3 days prior to chemotherapy has been shown to significantly elevate antioxidant activity and reduce oxidative marker levels in patients who received moderate-to-high emetogenic potential chemotherapy compared to placebo.

Body image and emotional distress in newly diagnosed cancer patients: The mediating role of dysfunctional attitudes and rumination

Body image concerns (BIC) has been reported to be associated with emotional distress for cancers across various sites. This study sought to examine two cognitive vulnerability mechanisms: dysfunctional attitudes and rumination, and their combined effects on the relationship between BIC and emotional distress in newly diagnosed Asian cancer patients. Participants were 221 newly diagnosed adult cancer patients who were assessed on BIC, rumination, dysfunctional attitudes, and emotional distress. Path analysis was used to examine the hypothesized mediation model. The hypothesized mediation model controlling for age, sex, marital status, education level, cancer type, cancer stage, and treatment modality revealed that both dysfunctional attitudes and rumination mediated the relationship between BIC and emotional distress. The present study provides evidence for a mediating role of dysfunctional attitudes and rumination between BIC and emotional distress. Psychological treatment should target dysfunctional attitudes and rumination in cancer patients experiencing BIC.

Prevalence and characteristics of cancer patients receiving care from single vs. multiple institutions

IntroductionPatients may receive cancer care from multiple institutions. However, at the population level, such patterns of cancer care are poorly described, complicating clinical research. To determine the population-based prevalence and characteristics of patients seen by multiple institutions, we used operations data from a state-mandated cancer registry. Methods and materials59,672 invasive cancers diagnosed in 1/1/2010-12/31/2011 in the Greater Bay Area of northern California were categorized as having been reported to the cancer registry within 365days of diagnosis by: 1) ≥1 institution within an integrated health system (IHS); 2) IHS institution(s) and ≥1 non-IHS institution (e.g., private hospital); 3) 1 non-IHS institution; or 4) ≥2 non-IHS institutions. Multivariable logistic regression was used to characterize patients reported by multiple vs. single institutions. ResultsOverall in this region, 17% of cancers were reported by multiple institutions. Of the 33% reported by an IHS, 8% were also reported by a non-IHS. Of non-IHS patients, 21% were reported by multiple institutions, with 28% for breast and 27% for pancreatic cancer, but 19%% for lung and 18% for prostate cancer. Generally, patients more likely to be seen by multiple institutions were younger or had more severe disease at diagnosis. ConclusionsPopulation-based data show that one in six newly diagnosed cancer patients received care from multiple institutions, and differed from patients seen only at a single institution. Cancer care data from single institutions may be incomplete and possibly biased.

Safety of Anticoagulant Therapies for Treatment of Venous Thromboembolism in Patients with Cancer

▪Introduction: Anticoagulation is effective for the treatment of venous thromboembolism (VTE) in cancer patients, but it is also associated with an increased risk of bleeding. Previous clinical trials (e.g., CLOT and CATCH) of LMWH and warfarin for the treatment of VTE in cancer patients reported major bleeding in 3% to 6% of treated patients. The objective of this observational study was to compare the risk of major bleeding in cancer patients treated with anticoagulants for VTE in a real world setting.Methods: Medical and pharmacy claims from the Humana Database from 1/1/2013 to 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis, and with ≥1 dispensing of an anticoagulant within 7 days after their VTE diagnosis, were selected. Based on the first anticoagulant received, patients were classified into one of the following cohorts: LMWH, warfarin, and rivaroxaban (other agents not included due to low utilization). Inverse probability of treatment weights based on propensity score were used to adjust for differences between treatment cohorts for the following comparisons: LMWH vs. rivaroxaban, LMWH vs. warfarin, and rivaroxaban vs. warfarin. Patients were followed up until the earliest event, either treatment non-persistence (gap > 60 days between the end of the days of supply of a dispensing and the start date of the next dispensing), or end of data availability. Major bleeding events were identified using validated criteria (Cunningham et al., 2011). Kaplan-Meier rates at 3 and 6 months and Cox proportional hazards models were used to compare the risk of bleeding between different treatment cohorts. To better understand the risk of major bleeding in cancer patients unrelated to anticoagulation, a cohort of patients with cancer who did not have VTE and did not receive an anticoagulant was added as a control cohort.Results: A total of 2,428 patients (LMWH: n=660; warfarin: n=1,061; rivaroxaban: n=707) were included. Baseline demographic and clinical characteristics were well balanced among treatment cohorts. Median duration of therapy with LMWH was shorter than rivaroxaban (1.0 vs. 3.0 months, p<.0001) and warfarin (1.0 vs. 3.5 months, p<.0001). Rates of major bleeding for LMWH and rivaroxaban were 8.3% and 8.2%, respectively at 6 months with a hazard ratio (HRs [95% CI]) of 1.03 (0.64-1.65; Figure 1A). In the comparison between LMWH and warfarin cohorts, major bleeding rates were 8.5% and 8.6%, respectively at 6 months with hazard ratio (HRs [95% CI]) of 1.04 (0.69-1.57; Figure 1B). The risk of major bleeding was also similar for rivaroxaban and warfarin cohorts, 9.0% and 8.7%, respectively at 6 months with a hazard ratio (HR [95% CI]) of 1.01 (0.71-1.43; Figure 1C). For the control cohort of cancer patients without VTE and not receiving anticoagulation median follow-up was 5.6 months. Rates of major bleeding events for the control cohort were 2.6% and 4.2 % at 3 and 6 months, respectively.Conclusion: This real world study of cancer patients treated for VTE found that the risk of major bleeding was similar for the 3 most widely prescribed anticoagulants in current clinical practice: LMWH, warfarin, and rivaroxaban. The observed rates of major bleeding were generally higher than what has been reported for LMWH and warfarin in the CLOT and CATCH trials. Patient characteristics such as older age (average age 73 years) could have contributed to the higher major bleeding rate seen in this study compared to the CLOT and CATCH trials, respectively. [Display omitted] [Display omitted] [Display omitted] DisclosuresStreiff:Portola: Research Funding; Janssen: Consultancy, Research Funding; Roche: Research Funding; CSL Behring: Consultancy, Research Funding. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. McCrae:Janssen: Membership on an entity’s Board of Directors or advisory committees. Yannicelli:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Nelson:Janssen Scientific Affairs: Employment, Equity Ownership. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Khorana:Roche: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding.

VTE-Related Healthcare Resource Utilization and Costs Associated with Venous Thromboembolism in Cancer Patients Treated with Anticoagulants

Introduction: The standard of care for treatment of cancer-related venous thromboembolism (VTE) is a low molecular heparin (LMWH). In our previous claimsbased analysis, we showed that besides LMWH oral anticoagulants, warafrin and rivaroxaban are widely prescribed in clinical practice (Khorana, 2015). The objective of this study is to compare VTE-related healthcare resource utilization and costs of cancer patients treated with anticoagulant therapies.Methods: Medical and pharmacy claims from the Humana Database between 1/1/2013 and 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis and with ≥1 dispensing of an anticoagulant agent within 7 days after their VTE diagnosis, were selected. Based on the first anticoagulant agent received, patients were classified into one of the following cohorts: LMWH, warfarin, and rivaroxaban. Inverse probability of treatment weights based on propensity score was used to adjust for differences between treatment cohorts. Baseline characteristics were evaluated during the 6 month period prior to the index VTE. VTE-related resource utilization and costs were identified with a primary or secondary diagnosis of deep vein thrombosis or pulmonary embolism and were evaluated for the entire follow up period, starting from the initiation of the anticoagulant therapy until the earliest either end of enrollment or end of data availability (05/31/2015). Resource utilization components included: number of hospitalizations, hospitalization days, emergency room (ER) visits, and outpatient visits. Comparisons between the different treatment cohorts were performed using rate ratios (RR) and statistical differences between groups as well as 95% confidence intervals [95% CI] were calculated using Poisson regression models. Healthcare costs were evaluated in per-patient-per-year (PPPY) and compared using mean cost difference.Results: A total of 2,428 patients (LMWH: n=660; warfarin; n=1,061; rivaroxaban: n=707) were included. Baseline demographic and clinical characteristics were well balanced across the treatment cohorts including hospitalizations, emergency room (ER) visits, and outpatient visits. Compared to patients treated with LMWH, patients treated with rivaroxaban had significantly fewer VTE-related hospitalizations, hospitalization days, ER visits, and outpatient visits (Figure 1). This resulted in significantly higher VTE-related health care cost difference of $12,000 for LMWH relative to rivaroxaban treatment cohort (Table 1).Patients treated with rivaroxaban had significantly lower VTE-related resource utilization compared to patients treated with warfarin (Figure 1). The total VTE-related costs were however similar between two cohorts (Table 1). The higher drug costs ($1,519) were offset by significantly lower outpatient (-$1,039) and hospitalization costs (-$522) in rivaroxaban relative to warfarin cohort.Conclusion: Healthcare resource use and costs associated with VTE treatment in cancer patients are the highest with LMWH relative to warfarin and rivaroxaban treatments. Healthcare resources use and costs are significantly higher in warfarin relative to rivaroxaban cohort but these resource costs were offset by higher drug costs of rivaroxaban. These results are in line with previous study in cancer patients that found fewer re-hospitalizations related to VTE recurrences in patients treated with rivaroxaban compared to patient treated with LMWH or warfarin (Streiff, 2016). [Display omitted] [Display omitted] DisclosuresStreiff:Roche: Research Funding; Portola: Research Funding; Janssen: Consultancy, Research Funding; CSL Behring: Consultancy, Research Funding. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. McCrae:Janssen: Membership on an entity’s Board of Directors or advisory committees. Fortier:Janssen Pharmaceuticals: Research Funding. Laliberté:Janssen Scientific Affairs: Research Funding. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Khorana:Sanofi: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria.

Healthcare Resource Utilization and Costs Associated with Venous Thromboembolism Recurrence in Patients with Cancer

Introduction: Patients with cancer are not only at a high risk for developing primary but also recurrent venous thromboembolism (VTE). These events lead to increased burden of cancer management and healthcare costs. It was estimated that all-cause health care costs for cancer patients with VTE were $30,538/patient higher than in those without VTE (Khorana, 2013). To our knowledge, very little information exists on cost of VTE recurrence among cancer patients. The objective of this study was to analyze resource utilization and costs of patients with cancer experiencing a VTE recurrence using a large claims database.Methods: Medical and pharmacy claims from the Humana Database between 1/1/2013 and 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis and with ≥1 dispensing of an anticoagulant agent within 7 days after their VTE diagnosis, were selected. Baseline characteristics were evaluated during the 6 month period prior to the index VTE. VTE recurrences were defined as hospitalizations with a primary diagnosis of VTE. Patients were classified into two groups: patients who experienced a VTE recurrence and patients who did not. Resource utilization and costs were evaluated for the entire follow up period, starting with the initiation of the anticoagulant therapy until whichever was earlier, end of eligibility or end of data. Healthcare resource utilization evaluated included number of hospitalizations, hospitalization days, emergency room (ER) visits, and outpatient visits. All-cause and VTE-related healthcare resource utilization was evaluated. Comparisons between patients with a VTE recurrence and patients without a VTE recurrence were performed using rate ratios (RR) and statistical differences between groups as well as 95% confidence intervals [95% CI] were calculated using Poisson regression models. All-cause and VTE-related healthcare costs were evaluated in per-patient-per-year (PPPY) and compared using mean cost difference.Results: A total of 2,428 newly diagnosed cancer patients who developed VTE and were treated with anticoagulants were identified. Of these, 413 (17.1%) experienced recurrent VTE during the follow up period. Patients who developed recurrent VTE and those who did not were similar in terms of age, gender, race, and region. No statistically significant differences between groups were observed in Charlson comorbidity index or in selected comorbidities during the 6 month baseline period. However, more patients with recurrent VTE recurrence had their index VTE documented during a hospitalization (61.3% vs. 55.4%, p=0.03). Patients with a VTE recurrence had significantly more ER and outpatient visits at baseline compared to those without recurrence, but no statistically significant difference was observed in baseline total healthcare costs ($29,352 vs. $27,955, p=0.44, respectively).The mean follow-up was similar between groups: 9.6 months for patients experiencing a VTE recurrence and 9.3 months for patients without a VTE recurrence (p=0.4059). Patients with a VTE recurrence had higher all-cause resource utilization rates (RRs; 95% CI) compared to patients without a VTE recurrence (hospitalization [2.37; 2.23 - 2.52], hospitalization days [2.64; 2.57 - 2.72], ER visits [1.62; 1.48 - 1.76], and outpatient visits [1.26; 1.24 - 1.28]). The rates of VTE-related hospitalization and VTE-related hospitalization days were close to $30,000 higher in patients with a VTE recurrence (Figure 1). The all-cause healthcare costs were $84,708 PPPY in patients with a VTE recurrence compared to $44,903 in patients without a VTE recurrence. The difference was mainly explained by lower VTE-related hospitalization costs (Figure 2).Conclusion: This real-world claims analysis showed that cancer patients with recurrent VTE consume significantly more healthcare resources. Total healthcare costs were nearly 2-fold higher in cohort with than in cohort without VTE recurrence. Close to 75% of the total cost difference was associated with VTE recurrence. VTE-related costs were ~4-fold higher in cohort with than in cohort without VTE recurrence. Reducing VTE recurrence in patients with cancer could lead to substantial healthcare cost savings. [Display omitted] [Display omitted] DisclosuresKhorana:Pfizer: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding; Leo: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria. McCrae:Janssen: Membership on an entity’s Board of Directors or advisory committees. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock.

Men’s health supplement use and outcomes in men receiving definitive intensity-modulated radiation therapy for localized prostate cancer

Background: Approximately 50% of newly diagnosed cancer patients start taking dietary supplements. Men’s health supplements (MHSs), which we define as supplements that are specifically marketed with the terms men’s health and prostate health (or similar permutations), are often mislabeled as having potential anticancer benefits.Objective: We evaluated the effects of MHSs on patient outcomes and toxicities in patients who were undergoing definitive intensity-modulated radiation therapy (IMRT) for localized prostate cancer.Design: This retrospective analysis included patients who were being treated at a National Cancer Institute–designated comprehensive cancer center and consented to have information stored in a prospective database. MHSs were queried online. Outcome measures were freedom from biochemical failure (FFBF) (biochemical failure was defined with the use of the prostate-specific antigen nadir + 2-ng/mL definition), freedom from distant metastasis (FFDM), cancer-specific survival (CSS), and overall survival (OS) as well as toxicities. Kaplan-Meier analysis, log-rank tests, Fine and Gray competing-risk regression (to adjust for patient and lifestyle factors), and Cox models were used.Results: From 2001 to 2012, 2207 patients were treated with IMRT with a median dose of 78 Gy, and a median follow-up of 46 mo. Of these patients, 43% were low risk, 37% were intermediate risk, and 20% were high risk; 10% used MHSs. MHSs contained a median of 3 identifiable ingredients (range: 0–78 ingredients). Patients who were taking an MHS compared with those who were not had improved 5-y OS (97% compared with 92%, respectively; P = 0.01), but there were no differences in the FFBF (94% compared with 89%, respectively; P = 0.12), FFDM (96% compared with 97%, respectively; P = 0.32), or CSS (100% compared with 99%, respectively; P = 0.22). The unadjusted association between MHS use and improved OS was attenuated after adjustment for patient lifestyle factors and comorbidities. There was no difference in toxicities between the 2 groups (late-grade 3–4 genitourinary <3%; gastrointestinal <4%).Conclusion: The use of MHSs is not associated with outcomes or toxicities.

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study.

BackgroundBeing diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients.Methods/designIn a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist (“minimal-contact”) based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients’ characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program.DiscussionNew technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often comparable to face-to-face interventions. With our study we open this field to the population of newly diagnosed cancer patients. We will not only assess clinical efficacy but also further refine the target population who has the most potential to benefit. An internet-based minimal-contact stress management program might be an attractive, time- and cost-effective way to effectively deliver psychological support to newly diagnosed cancer patients and an opportunity to include those who currently are not reached by conventional support.Trial registrationClinicalTrials.gov NCT02289014.

Emotion regulation and emotional distress: The mediating role of hope on reappraisal and anxiety/depression in newly diagnosed cancer patients.

A proportion of newly diagnosed cancer patients may experience anxiety and depression. Emotion suppression has been associated with poorer psychoemotional outcomes, whereas reappraisal may be an adaptive emotion regulation strategy. Few studies have examined potential mechanisms linking reappraisal to psychoemotional outcomes in cancer patients. This study aims to replicate findings on reappraisal and suppression and further examines if hope mediates the association between reappraisal and anxiety/depression in patients newly diagnosed with cancer. Participants were 144 adult cancer patients (65.3% female, mean age=48.96years, SD=9.23). Patients completed a set of study questionnaires, including the Emotion Regulation Questionnaire, Adult Hope Scale, and the Hospital Anxiety and Depression Scale. Path analysis was used to examine if hope mediated the association between reappraisal and anxiety/depression. Prevalence of anxiety was 39.6% and depression was 25.0%. Reappraisal and hope were correlated with lower anxiety and depression, whereas suppression was correlated with higher anxiety and depression. The hypothesized mediation model provided fit to the data, comparative fit index=0.95, Tucker-Lewis index=0.94, root-mean-square-error of approximation=0.05. There was a significant indirect effect of reappraisal on anxiety and depression via hope, b=-0.95, SE=0.42, 95% confidence interval=-1.77 to -0.12, whereas the direct effect of reappraisal was nonsignificant. The study findings suggest that hope mediated the association between reappraisal and anxiety/depression outcomes. Moreover, the high prevalence of anxiety and depression implies a need for healthcare providers to attend to the psychoemotional needs of newly diagnosed cancer patients.

Face Threats and Additional Reasons for Perceiving Support as Unwanted: A Study of Recently Diagnosed Cancer Patients

ABSTRACTThis study investigated instances of support that were deemed unwanted by a recipient in the wake of a cancer diagnosis. The investigation was framed by politeness theory and considered the face threats evident in cancer patients’ descriptions of unwanted support. Additional reasons for viewing support as unwanted, as well as the outcomes of receiving unwanted support, were also explored. Interviews (N = 15) were conducted with cancer patients who had been initially diagnosed within the previous 12 months. Analyses demonstrated that face threats are among the reasons for viewing some support as problematic; however, additional reasons beyond face threats also occurred. The most frequently occurring reasons for regarding support as unwanted were threats to the receiver’s negative face and messages failing to convey empathy. Finally, the influence of receiving unwanted support on cancer patients is discussed in terms of recipients’ ability to manage emotions, respond to the support, potentially view the support provider negatively, and assert greater control over future supportive interactions.

Universal screening for depression in cancer patients and its impact on management patterns.

232 Background: Screening for distress in cancer patients (pts) is recommended by several national guidelines. High distress scores are associated with increased depression. We established universal depression screening and investigated its impact on cancer patient management. Methods: Patient Health Questionnaire (PHQ9) was administered to newly diagnosed cancer patients prior to receiving their first non-oral antineoplastic agent. Patient demographics, disease characteristics, chronic medication load, antidepressant use, treatment interruptions, weight change, referral and adherence to psychiatry were recorded. Pts with high (&gt; 9) and low (&lt; 4) PHQ9 scores were compared using Chi-square and Wilcoxon rank-sum tests. Results: Screening was performed in 1,190 consecutive pts over an 18 month period at Mayo Clinic. Responses were received from 1055 (89%) pts, of which 144 had high score (PHQ-H). These were compared with 99 randomly selected low score (PHQ-L) pts. The 243 pts (median age 65; range 18-92 years) in the final analysis included: 53.5% females, 90% Caucasians, 74% married and 77% living with others. Diagnosis was solid organ cancer in 81% and metastatic disease in 54% patients, and 13% were on antidepressants for preexisting depression. PHQ-H were more likely to be on antidepressants than PHQ-L (19% vs. 3%; p = 0.0002), be referred to psychiatry (69% vs. 12%; p &lt; 0.0001), attend psychiatry appointment (45% vs. 12%; p &lt; 0.0001) and require behavioral therapy (50% vs 8%; p = 0.0065). PHQ-H did not have a significantly increased antidepressant use, treatment interruptions (p = 0.5) or weight change (p = 0.4). Race, gender, chronic medication load, marital status, living situation, metastatic disease and type of cancer were not significantly different between PHQ-H and PHQ-L. Conclusions: We implemented a universal depression screening and management plan for cancer pts and noted that previously being on antidepressants was associated with higher patient distress. Higher score led to more frequent behavioral therapy, possibly preventing non-compliance or need for increased psychotropic medications. Our model identifies cancer pts with depression and implements an effective management plan for their care.

Prevalence, risk factors, and the desire for help of distressed newly diagnosed cancer patients: A large-sample study.

Beginning in 2007, all newly diagnosed cancer patients at the Koo Foundation Sun Yat-Sen Cancer Center (KF-SYSCC) were screened for psychosocial distress. Our social workers, as part of the psychosocial care team (PCT), have engaged in proactive outreach with patients identified as distressed. The goal of the present study was to assess the prevalence of psychosocial distress and the extent of contact between the PCT and distressed patients. Newly diagnosed patients who were treated at KF-SYSCC between 2007 and 2010 for cancer were eligible if there were at least 100 patients with the same type of cancer. Before treatment began, they were screened with the Pain Scale and the Distress Thermometer (DT) and had the option to specify a desire for help. The rates of distress were analyzed by cancer type and by probable related factors. Information regarding contact with the PCT was retrieved from computerized databases. Overall, some 5,335 cancer patients representing 12 major cancer types were included in our study. Of these, 1,771 (33.20%) were significantly distressed. By multivariate logistic regression, younger age, female gender, higher pain score, and disease stage, but not cancer type, were found to be associated with higher rates of distress. Among these distressed patients, 628 (36%) had some contact with the PCT. This Taiwanese study with a large sample size revealed a prevalence rate of psychosocial distress similar to rates found in Western countries. Contact with the PCT was established in only 36% of significantly distressed patients, despite a proactive outreach program. It is very important to have screening results made available in a timely fashion to the psycho-oncology team so that appropriate care can be offered promptly.

Patient perceptions concerning clinical trials in oncology patients.

BackgroundClinical trials are critical to scientifically evaluate promising new therapies in oncology, but patient accrual to these studies is persistently low. Patient preference plays an important role in enrollment in these trials. We performed this survey to evaluate the perceptions of newly diagnosed oncology patients about clinical trials and the reasons why they wish to or not to participate in these trials.MethodsPatients were given a ten question survey reflective of their attitudes regarding clinical trials as a treatment option at their initial visit. The self-directed questionnaire was scored on an ordinate scale from strongly agree [1] to strongly disagree [5].ResultsNinety three patients were surveyed in the cancer specific multispecialty clinics in an academic center. Our patients expected their providers to discuss all information relating to clinical trials and eligibility at the first visit (65.4% agree and 15.4% neutral, p < 0.0001). Patients felt their privacy and safety would be safeguarded in the University sponsored trials (56.8% agree, and 25.7% neutral, p < 0.0001). Over 80% patients showed their unwillingness to participate in randomized clinical trials (disagree 61%, neutral 19.5%, p < 0.001). Patients also showed less likelihood to participate in clinical trials as a first treatment option (48.7% disagree and 28.9% neutral, p0.0161), but were willing to consider participating in a clinical trial if the conventional treatment failed. Industry sponsored trials, phase 1 trials, investigator initiated trials with the involved tests and time commitment and altruistic reasons did not significantly deviate from the mean preference analyzed using Fisher's exact test analysis.ConclusionsPatients consider the option of clinical trials as important in their treatment, and expect to be informed by their oncologist about such trials. Newly diagnosed cancer patients perceive randomization and first line trials negatively. Since randomization data provides new standards of care and hope for improved treatment, patients and their families must be educated of their importance.

A randomised, placebo-controlled trial assessing the efficacy of an oral B group vitamin in preventing the development of chemotherapy-induced peripheral neuropathy (CIPN).

Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating side effect resulting from neurotoxic chemotherapeutic agents. This study aimed to assess the efficacy and safety of an oral B group vitamin compared to placebo, in preventing the incidence of CIPN in cancer patients undergoing neurotoxic chemotherapy. A pilot, randomised, placebo-controlled trial was conducted. Newly diagnosed cancer patients prescribed with taxanes, oxaliplatin or vincristine were invited to participate. A total of 71 participants (female 68%, male 32%) were enrolled into the study and randomised to the B group vitamin (n=38) arm or placebo (n=33). The data from 47 participants were eligible for analysis (B group vitamins n=27, placebo n=22). The primary outcome measure was the total neuropathy score assessed by an independent neurologist. Secondary outcome measures included serum vitamin B levels, quality of life, pain inventory and the patient neurotoxicity questionnaires. Outcome measures were conducted at baseline, 12, 24 and 36weeks. The total neuropathy score (TNS) demonstrated that a B group vitamin did not significantly reduce the incidence of CIPN compared to placebo (p=0.73). Statistical significance was achieved for patient perceived sensory peripheral neuropathy (12weeks p=0.03; 24weeks p=0.005; 36weeks p=0.021). The risk estimate for the Patient Neurotoxicity Questionnaire (PNQ) was also statistically significant (OR=5.78, 95% CI=1.63-20.5). The European Organisation of Research and Treatment of Cancer (EORTC) quality of life, total pain score and pain interference showed no significance (p=0.46, p=0.9, p=0.37 respectively). A trend was observed indicating that vitamin B12 may reduce the onset and severity of CIPN. An oral B group vitamin as an adjunct to neurotoxic chemotherapy regimens was not superior to placebo (p>0.05) for the prevention of CIPN. Patients taking the B group vitamin perceived a reduction in sensory peripheral neuropathy in the PNQ. Moreover, a robust clinical study is warranted given that vitamin B12 may show potential in reducing the onset and severity of CIPN. Trial number: ACTRN12611000078954 Protocol number: UH2010000749.

Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial

BackgroundDespite the well-established risks of persistent smoking, 10–30% of cancer patients continue to smoke after diagnosis. Evidence-based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/designA two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. DiscussionThis trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients.