Explore the vast range of titles available.

Background Bone metastases commonly occur in conjunction with solid tumors, and are associated with serious bone complications. Population-based estimates of bone metastasis incidence are limited, often based on autopsy data, and may not reflect current treatment patterns. Methods Electronic medical records (OSCER, Oncology Services Comprehensive Electronic Records, 569,000 patients, 52 US cancer centers) were used to identify patients ≥18 years with a solid tumor diagnosis recorded between 1/1/2004 and 12/31/2013, excluding patients with hematologic tumors or multiple primaries. Each patient’s index date was set to the date of his or her first solid tumor diagnosis in the selection period. Kaplan-Meier analyses were used to quantify the cumulative incidence of bone metastasis with follow-up for each patient from the index date to the earliest of the following events: last clinic visit in the OSCER database, occurrence of a new primary tumor or bone metastasis, end of study (12/31/2014). Incidence estimates and associated 95% confidence intervals (CI) are provided for up to 10 years of follow-up for all tumor types combined and stratified by tumor type and stage at diagnosis. Results Among 382,733 study patients (mean age 64 years; mean follow-up 940 days), breast (36%), lung (16), and colorectal (12%) tumors were most common. Mean time to bone metastasis was 400 days (1.1 years). Cumulative incidence of bone metastasis was 2.9% (2.9–3.0) at 30 days, 4.8% (4.7–4.8) at one year, 5.6% (5.5–5.6) at two years, 6.9% (6.8–7.0) at five years, and 8.4% (8.3–8.5) at ten years. Incidence varied substantially by tumor type with prostate cancer patients at highest risk (18% – 29%) followed by lung, renal or breast cancer. Cumulative incidence of bone metastasis increased by stage at diagnosis, with markedly higher incidence among patients diagnosed at Stage IV of whom11% had bone metastases diagnosed within 30 days. Conclusions These estimates of bone metastasis incidence represent the experience of a population with longer follow-up than previously published, and represent experience in the recent treatment landscape. Underestimation is possible given reliance on coded diagnoses but the clinical detail available in electronic medical records contributes to the accuracy of these estimates.

An IOM committee focused on biomarkers for molecularly targeted therapies has issued recommendations about regulatory, reimbursement, and clinical practice issues, in order to guide precision medicine in advancing the care of patients with cancer and other diseases. As the promise and the pitfalls of precision medicine gain increasing attention, 1 , 2 enthusiasm about the field has been heightened by a rapid reduction in the cost of high-throughput genomic sequencing and a dramatic increase in the identification of potential molecular targets for therapy. Biomarker tests for molecularly targeted therapies can help physicians to select the most effective therapy for a patient's condition and avoid treatments that could be ineffective or harmful. If precision medicine is to reach its potential, such biomarker tests will have to be developed in a timely fashion. Some observers, however, have expressed concern that these . . .

The American Cancer Society Head and Neck Cancer Survivorship Care Guideline was developed to assist primary care clinicians and other health practitioners with the care of head and neck cancer survivors, including monitoring for recurrence, screening for second primary cancers, assessment and management of long-term and late effects, health promotion, and care coordination. A systematic review of the literature was conducted using PubMed through April 2015, and a multidisciplinary expert workgroup with expertise in primary care, dentistry, surgical oncology, medical oncology, radiation oncology, clinical psychology, speech-language pathology, physical medicine and rehabilitation, the patient perspective, and nursing was assembled. While the guideline is based on a systematic review of the current literature, most evidence is not sufficient to warrant a strong recommendation. Therefore, recommendations should be viewed as consensus-based management strategies for assisting patients with physical and psychosocial effects of head and neck cancer and its treatment.

The purpose of the American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline is to provide recommendations to assist primary care and other clinicians in the care of female adult survivors of breast cancer. A systematic review of the literature was conducted using PubMed through April 2015. A multidisciplinary expert workgroup with expertise in primary care, gynecology, surgical oncology, medical oncology, radiation oncology, and nursing was formed and tasked with drafting the Breast Cancer Survivorship Care Guideline. A total of 1073 articles met inclusion criteria; and, after full text review, 237 were included as the evidence base. Patients should undergo regular surveillance for breast cancer recurrence, including evaluation with a cancer-related history and physical examination, and should be screened for new primary breast cancer. Data do not support performing routine laboratory tests or imaging tests in asymptomatic patients to evaluate for breast cancer recurrence. Primary care clinicians should counsel patients about the importance of maintaining a healthy lifestyle, monitor for post-treatment symptoms that can adversely affect quality of life, and monitor for adherence to endocrine therapy. Recommendations provided in this guideline are based on current evidence in the literature and expert consensus opinion. Most of the evidence is not sufficient to warrant a strong evidence-based recommendation. Recommendations on surveillance for breast cancer recurrence, screening for second primary cancers, assessment and management of physical and psychosocial long-term and late effects of breast cancer and its treatment, health promotion, and care coordination/practice implications are made.

Background Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance on obtaining and managing datasets based on a review of the literature and practical examples and observations. Methods We systematically searched MEDLINE, Embase, and the Cochrane Library, until January 2019, to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD. Results Our scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed. For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues. Conclusions Knowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for obtaining and managing data for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing.

The leading cause of death in patients with giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) is cardiovascular disease. The objective of this study was to determine whether the use of selective serotonin reuptake inhibitors (SSRI) and serotonin norepinephrine reuptake inhibitors (SNRI) in veterans with GCA and PMR could have a cardio-modulatory effect as compared to nonuse. Patients with GCA and PMR were identified through the Veterans Affairs Informatics and Computing Infrastructure. After a 2:1 propensity score matching for SSRI or SNRI users, we identified nonusers with similar covariates. We then applied a multivariate logistic regression (MLR), to calculate the odds ratio (OR) for cardiovascular event (CVE) outcomes within 5 years after the index date. Related hazard ratios (HR) were also calculated to validate the discovery of our findings. We identified 2249 patients with GCA and 3906 patients with PMR. Among patients with GCA, 174 (27%) SSRI users had incident cardiovascular disease as compared to 47 (28%) SNRI users and 277 (19%) nonusers; in the PMR cohort, 108 (13%) were SSRI users compared to 71 (15%) SNRI users and 255 (11%) nonusers. The adjusted ORs of the CVE outcome associated with venlafaxine (2.44, p=0.01) and sertraline (1.45, p=0.04) were significantly greater than 1 in GCA, with similar results observed in the PMR cohort (2.01, p=0.02, and 1.45, p=0.04, respectively). Cox-regression analysis was also conducted, and the hazard ratios were qualitatively consistent with the MLR analysis. In conclusion, the adjusted risk of CVE in patients with GCA or PMR using either venlafaxine or sertraline was higher than that in the non-exposed groups.

Purpose Granulocyte colony-stimulating factors (G-CSF) are commonly used in clinical practice to prevent febrile neutropenia (FN). US and EU prescribing information and treatment guidelines from the NCCN, ASCO, and EORTC specify that pegfilgrastim, a long-acting (LA) G-CSF, should be administered at least 24 h after myelosuppressive chemotherapy. Nevertheless, many patients receive LA G-CSFs on the same day as chemotherapy. This systematic literature review evaluated the relative merits of same-day versus next-day dosing of LA G-CSFs. Methods A broad Ovid MEDLINE® and Embase® literature search was conducted that examined all publications indexed before May 9, 2016 that compared same-day versus next-day LA G-CSF administration. A congress abstract literature search included congresses from January 1, 2011 to April 6, 2016. The parameters for this review were prospectively delineated in a research protocol and adhered to the PRISMA Guidelines. Results The first part of the systematic literature search identified 1736 publications. After elimination of duplicates, title/abstract screening was conducted on 1440 records, and full text review was conducted on 449 publications. Eleven publications met all criteria and are included in this systematic review; of these, four included data from randomized or single arm prospective studies, and seven were retrospective studies. In most studies included in this review and across a variety of tumor types, administration of pegfilgrastim at least 24 h after myelosuppressive chemotherapy resulted in improved patient outcomes. Conclusions Data from multiple publications support administration of pegfilgrastim at least 1 day after chemotherapy.

Background Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy. Clinical practice guidelines recommend routine prophylactic coverage with granulocyte colony-stimulating factor (G-CSF)—such as pegfilgrastim—for most patients receiving chemotherapy with an intermediate to high risk for FN. Patterns of pegfilgrastim prophylaxis during the chemotherapy course and associated FN risks in US clinical practice have not been well characterized. Methods A retrospective cohort design and data from two commercial healthcare claims repositories (01/2010–03/2016) and Medicare Claims Research Identifiable Files (01/2007–09/2015) were employed. Study population included patients who had non-metastatic breast cancer or non-Hodgkin’s lymphoma and received intermediate/high-risk regimens. Pegfilgrastim prophylaxis use and FN incidence were ascertained in each chemotherapy cycle, and all cycles were pooled for analyses. Adjusted odds ratios for FN were estimated for patients who did versus did not receive pegfilgrastim prophylaxis in that cycle. Results Study population included 50,778 commercial patients who received 190,622 cycles of chemotherapy and 71,037 Medicare patients who received 271,944 cycles. In cycle 1, 33% of commercial patients and 28% of Medicare patients did not receive pegfilgrastim prophylaxis, and adjusted odds of FN were 2.6 (95% CI 2.3–2.8) and 1.6 (1.5–1.7), respectively, versus those who received pegfilgrastim prophylaxis. In cycle 2, 28% (commercial) and 26% (Medicare) did not receive pegfilgrastim prophylaxis; corresponding adjusted FN odds were comparably elevated (1.9 [1.6–2.2] and 1.6 [1.5–1.8]). Results in subsequent cycles were similar. Across all cycles, 15% of commercial patients and 23% of Medicare patients did not receive pegfilgrastim prophylaxis despite having FN in a prior cycle, and prior FN increased odds of subsequent FN by 2.1–2.4 times. Conclusions Notwithstanding clinical practice guidelines, a large minority of patients did not receive G-CSF prophylaxis, and FN incidence was substantially higher among this subset of the population. Appropriate use of pegfilgrastim prophylaxis may reduce patient exposure to this potentially fatal but largely preventable complication of myelosuppressive chemotherapy.

Despite the importance of chemotherapy-associated adverse events in oncology practice and the broad range of interventions available to mitigate them, limited systematic efforts have been made to identify, critically appraise and summarize the totality of evidence on the effectiveness of these interventions. Herein, we review the most common long-term (continued beyond treatment) and late or delayed (following treatment) adverse events associated with chemotherapy and other anticancer treatments that pose major threats in terms of survival, quality of life and continuation of optimal therapy. These adverse effects often emerge during and continue beyond the course of therapy or arise among survivors in the months and years following treatment. For each of these adverse effects, we discuss and critically evaluate their underlying biological mechanisms, the most commonly used pharmacological and non-pharmacological treatment strategies, and evidence-based clinical practice guidelines for their appropriate management. Furthermore, we discuss risk factors and validated risk-assessment tools for identifying patients most likely to be harmed by chemotherapy and potentially benefit from effective interventions. Finally, we highlight promising emerging supportive-care opportunities for the ever-increasing number of cancer survivors at continuing risk of adverse treatment effects.The effective management of treatment-related events remains an unmet need in oncology. The authors of this Review discuss the underlying biological mechanisms, risk factors, most commonly used pharmacological and non-pharmacological management strategies, and clinical practice guidelines for the most common long-term (continuing beyond treatment) and late or delayed (following treatment) adverse events associated with chemotherapy and other anticancer treatments.

Despite the enthusiasm surrounding novel targeted agents and immunotherapies, chemotherapy remains the mainstay treatment for most human malignancies, either alone or in combination. Yet, the burden of chemotherapy-associated adverse events (CAAEs) remains high and, importantly, is associated with considerable morbidity, mortality and costs that affect patients across multiple dimensions, including physical, emotional and social functioning. CAAEs can directly affect patient outcomes and indirectly increase the risk of cancer recurrence by compromising treatment intensity and continuity. Systematic efforts to identify and critically summarize the evidence on management approaches for CAAEs remain limited. Herein, we review the most common acute CAAEs having a major effect on survival, quality of life, function and/or continuation of optimal therapy. We focus on selected acute toxicities that occur during treatment, summarizing their underlying pathophysiology, multifactorial aetiologies, evidenced-based treatments, prevention strategies and management recommendations. We also summarize the available evidence on risk factors, validated risk assessment tools and other efforts to optimize symptom control in patients most likely to benefit in order to personalize the prevention and treatment of acute CAAEs. Finally, we discuss innovative symptom monitoring and supportive care interventions that are under development to further improve the outcomes of patients with cancer.allEither alone or in combination, chemotherapy remains the mainstay treatment for most human malignancies. This treatment modality is associated with a high burden of chemotherapy-associated adverse events (CAAEs) that greatly affect patients because of their considerable morbidity, mortality and costs. Kuderer et al. discuss the pathophysiology, management and risk factors of the most common acute CAAEs with a major effect on survival, quality of life, function and/or continuation of optimal therapy.