Adam Glaser

Defining a standard set of patient-centered outcomes for men with localized prostate cancer.

BACKGROUND Value-based health care has been proposed as a unifying force to drive improved outcomes and cost containment. OBJECTIVE To develop a standard set of multidimensional patient-centered health outcomes for tracking, comparing, and improving localized prostate cancer (PCa) treatment value. DESIGN, SETTING, AND PARTICIPANTS We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The group defined a recommended standard set representing who should be tracked, what should be measured and at what time points, and what data are necessary to make meaningful comparisons. Using a modified Delphi method over a series of teleconferences, the group reached consensus for the Standard Set. RESULTS AND LIMITATIONS We recommend that the Standard Set apply to men with newly diagnosed localized PCa treated with active surveillance, surgery, radiation, or other methods. The Standard Set includes acute toxicities occurring within 6 mo of treatment as well as patient-reported outcomes tracked regularly out to 10 yr. Patient-reported domains of urinary incontinence and irritation, bowel symptoms, sexual symptoms, and hormonal symptoms are included, and the recommended measurement tool is the Expanded Prostate Cancer Index Composite Short Form. Disease control outcomes include overall, cause-specific, metastasis-free, and biochemical relapse-free survival. Baseline clinical, pathologic, and comorbidity information is included to improve the interpretability of comparisons. CONCLUSIONS We have defined a simple, easily implemented set of outcomes that we believe should be measured in all men with localized PCa as a crucial first step in improving the value of care. PATIENT SUMMARY Measuring, reporting, and comparing identical outcomes across treatments and treatment centers will provide patients and providers with information to make informed treatment decisions. We defined a set of outcomes that we recommend being tracked for every man being treated for localized prostate cancer.

Male and female experiences of having fertility matters raised alongside a cancer diagnosis during the teenage and young adult years.

Discussion and management of potential reproductive health sequelae of adolescent cancer are essential and challenging components of care for the multidisciplinary team. Despite this, research has been limited to specific experiences (e.g. sperm banking) or fertility-related concerns of adult survivors. This grounded theory study of 38 male and female survivors of adolescent cancer aged 16-30 years drew on in-depth single interviews to map the range of experiences of being advised that treatment might affect fertility. Strong support for being told at around diagnosis was found regardless of gender, age, incapacity or availability of fertility preservation services. Age and life stage appeared less significant for impact than the perceived level of threat to personal and social well-being. Women were more likely to achieve lower levels of comprehension about the physiological impact, to report later distress from lack of fertility preservation services and to revisit more frequently those decisions made by the few offered fertility preservation. Men found decision making about sperm banking straightforward on the whole and reported satisfaction with having the choice regardless of outcome. Findings suggest that young people can cope with this information alongside diagnosis especially when professional and parental support is proportionate to the particular impact on them.

Patient-reported outcomes of cancer survivors in England 1-5 years after diagnosis: a cross-sectional survey.

Objectives To determine the feasibility of collecting population-based patient-reported outcome measures (PROMs) in assessing quality of life (QoL) to inform the development of a national PROMs programme for cancer and to begin to describe outcomes in a UK cohort of survivors. Design Cross-sectional postal survey of cancer survivors using a population-based sampling approach. Setting English National Health Service. Participants 4992 breast, colorectal, prostate and non-Hodgkins lymphoma (NHL) survivors 1–5 years from diagnosis. Primary and secondary outcome measures Implementation issues, response rates, cancer-specific morbidities utilising items including the EQ5D, tumour-specific subscales of the Functional Assessment of Cancer Therapy and Social Difficulties Inventory. Results 3300 (66%) survivors returned completed questionnaires. The majority aged 85+ years did not respond and the response rates were lower for those from more deprived area. Response rates did not differ by gender, time since diagnosis or cancer type. The presence of one or more long-term conditions was associated with significantly lower QoL scores. Individuals from most deprived areas reported lower QoL scores and poorer outcomes on other measures, as did those self-reporting recurrent disease or uncertainty about disease status. QoL scores were comparable at all time points for all cancers except NHL. QoL scores were lower than those from the general population in Health Survey for England (2008) and General Practice Patient Survey (2012). 47% of patients reported fear of recurrence, while 20% reported moderate or severe difficulties with mobility or usual activities. Bowel and urinary problems were common among colorectal and prostate patients. Poor bowel and bladder control were significantly associated with lower QoL. Conclusions This method of assessing QoL of cancer survivors is feasible and acceptable to most survivors. Routine collection of national population-based PROMs will enable the identification of, and the support for, the specific needs of survivors while allowing for comparison of outcome by service provider.

Cancer survivorship research in Europe and the United States: where have we been, where are we going, and what can we learn from each other?

The growing number of cancer survivors worldwide has led to of the emergence of diverse survivorship movements in the United States and Europe. Understanding the evolution of cancer survivorship within the context of different political and health care systems is important for identifying the future steps that need to be taken and collaborations needed to promote research among and enhance the care of those living after cancer. The authors first review the history of survivorship internationally and important related events in both the United States and Europe. Lessons learned from survivorship research are then broadly discussed, followed by examination of the infrastructure needed to sustain and advance this work, including platforms for research, assessment tools, and vehicles for the dissemination of findings. Future perspectives concern the identification of collaborative opportunities for investigators in Europe and the United States to accelerate the pace of survivorship science going forward. Cancer 2013;119(11 suppl):2094‐108.

Implementing improved post-treatment care for cancer survivors in England, with reflections from Australia, Canada and the USA

Increasing cancer incidence together with improved survival rates are contributing to the growing number of cancer survivors. Survivors may encounter a range of potential effects as a result of the cancer itself or cancer treatments. Traditionally, the major focus of follow-up care has been on detection of cancer recurrence; however, the efficacy of such strategies is questionable. Traditional follow-up frequently fails to identify or adequately address many survivors’ concerns. Aftercare needs to be planned to enable better outcomes for survivors, while using scarce health-care resources efficiently. This review focuses on provision of survivorship care, rather than on research. England’s National Cancer Survivorship Initiative has developed principles for improved care of those living with and beyond cancer. These include risk-stratified pathways of care, the use of treatment summaries and care plans, information and education to enable choice and the confidence to self manage, rapid re-access to specialist care, remote monitoring and well-coordinated care. Many of these principles are relevant internationally, though preferred models of care will depend on local circumstances.

Pharmacokinetics of Dactinomycin in a Pediatric Patient Population: a United Kingdom Children's Cancer Study Group Study

Purpose: Dactinomycin (actinomycin D) is an antitumor antibiotic used routinely to treat certain pediatric and adult cancers. Despite concerns over the incidence of toxicity, little is known about the pharmacology of dactinomycin. A study was done to investigate dactinomycin pharmacokinetics in children. Experimental Design: Dactinomycin was administered to 31 patients by bolus i.v. infusion, at doses of 0.70 to 1.50 mg/m2. Plasma concentrations were determined by liquid chromatography-mass spectrometry up to 24 hours after drug administration and National Cancer Institute Common Toxicity Criteria was assessed. Results: Pharmacokinetic data analysis suggested that a three-compartment model most accurately reflected dactinomycin pharmacokinetics. However, there was insufficient data available to fully characterize this model. A median peak plasma concentration (Cmax) of 25.1 ng/mL (range, 3.2-99.2 ng/mL) was observed at 15 minutes after administration. The median exposure (AUC0-6), determined in 16 patients with sampling to 6 hours, was 2.67 mg/L.min (range, 1.12-4.90 mg/L.min). After adjusting for body size, AUC0-6 and Cmax were positively related to dose (P = 0.03 and P = 0.04, respectively). Patients who experienced any level of Common Toxicity Criteria grade had a 1.46-fold higher AUC0-6, 95% confidence interval (1.02-2.09). AUC0-6 was higher in patients <40 kg, possibly indicating a greater toxicity risk. Conclusions: Data presented suggest that dosing of dactinomycin based on surface area is not optimal, either in younger patients in whom the risk of toxicity is greater, or in older patients where doses are capped.

Late effects in survivors of teenage and young adult cancer: does age matter?

BACKGROUND Late effects (LEs) after cancer treatment are increasing. After childhood cancer, substantial risks include physical, psychological and social LE and vary with age. Teenagers and young adults (TYA) present with particular cancers; their risk of LE may relate to cancer site, treatment or their age itself. The LEs after TYA-onset cancers are described in relation to age at diagnosis of primary tumour. PATIENTS AND METHODS Data were extracted from Medline English language articles, 1999-2009. Keywords were late effect/s, late toxicity and survivor and the frequent TYA cancer sites. Only those articles that reported the relation between LEs risks with age at diagnosis were included. RESULTS The majority of known LEs are described after TYA cancer. No study primarily aimed to relate TYA age to LEs. Many studies did not report LE by age. TYA-specific risks are seen in cardiac toxicity, second malignancies, pulmonary complications and psychosocial difficulties when compared with older or younger cancer survivors. CONCLUSIONS TYA age brings specific LE risks after cancer. Prospective population-based collection of LE data after TYA cancer will inform the development of appropriate services to effectively manage LE.

Health-Related Quality of Life After Colorectal Cancer in England: A Patient-Reported Outcomes Study of Individuals 12 to 36 Months After Diagnosis

PURPOSE This population-level study was conducted to define the health-related quality of life (HRQL) of individuals living with and beyond colorectal cancer (CRC) and to identify factors associated with poor health outcomes. PATIENTS AND METHODS All individuals diagnosed with CRC in England in 2010 and 2011 who were alive 12 to 36 months after diagnosis were sent a questionnaire. This included questions related to treatment, disease status, other long-term conditions (LTCs), generic HRQL (EuroQol-5D), and cancer-specific outcomes (Functional Assessment of Cancer Therapy and Social Difficulties Inventory items). RESULTS The response rate was 63.3% (21,802 of 34,467 patients). One or more generic health problems were reported by 65% of respondents, with 10% of patients reporting problems in all five domains. The reporting of problems was higher than in the general population and was most marked in those age less than 55 years. Certain subgroups reported a higher number of problems, notably those with one or more other LTCs, those with active or recurrent disease, those with a stoma, and those at the extremes of the age range (< 55 and > 85 years). Of respondents without a stoma, 16.3% reported no bowel control. Reversal of a stoma resulted in fewer severe bowel problems but more moderate problems than those who had never had a stoma. A quarter of rectal cancer respondents (25.1%) reported difficulties with sexual matters (compared with 11.2% of colon cancer respondents). CONCLUSION This study demonstrates the success of a national patient-reported outcomes survey. The results have the potential to support system-wide improvement in health outcomes through the identification of particular challenges faced by individuals after treatment for CRC.

Sperm and ova conservation: Existing standards of practice in North America

BACKGROUND AND PROCEDURE Rapid advances have occurred in both reproductive medicine and survival from childhood cancer. To establish the current level of best clinical practice for sperm, ovarian, and prepubertal tissue collection and storage, a cross-sectional survey of a major pediatric oncology collaborative study group (Pediatric Oncology Group, POG) was performed. RESULTS Of the 110 centers surveyed, 69 questionnaires (63%) were completed. No responding center had guidelines regarding which young people should be offered sperm, ovarian, or prepubertal testicular tissue conservation; 93% centers had offered sperm and 10% ova conservation; 15% had offered sperm conservation to males prior to completion of sexual development and 3% to girls prior to sexual maturation. All centers were more likely to offer sperm conservation than ova conservation for any given disease. The most common diseases for which conservation was offered were Hodgkin and non-Hodgkin lymphoma, and sarcomas. Fertility counseling was offered in a variety of settings by 71% of centers by health care professionals, including doctors, nurses, social workers, psychologists, and geneticists. CONCLUSION There was little agreement regarding appropriate indications for, and method of, gamete preservation in childrens cancer centers. It is hard to establish best clinical practice from these data. Unresolved medical, legal, and ethical issues necessitate the development of a voluntary code of practice and guidelines in order to ensure good clinical practice.

Burnout, psychiatric morbidity, and work-related sources of stress in paediatric oncology staff: a review of the literature

Objective: A growing body of research suggests that staff working in adult oncology services are at risk of burnout and psychiatric morbidity, but whether or not these findings can be generalised to staff working in paediatric oncology is questionable. This paper reports the findings of a comprehensive review of the literature on burnout, psychiatric morbidity, and sources of work‐related stress in paediatric oncology staff.